Pharmaceutical News

PMSI report sees reversal of three-year trend on pharmacy spend

The company’s 2011 Annual Drug Trends Report shows decreases in pharmacy costs and utilization based on an analysis of 5.4 million retail and mail-order transactions between 2008 and 2010. The overall 2.3 percent drop in the average spend per injured worker was driven by reductions in both the average cost per day of supply and the average days of supply per injured worker.

“The average cost per day of supply is an indicator of overall drug product cost,” said Maria Sciame, PMSI’s executive director of clinical services. “Another, more familiar term for this indicator is drug price.” PMSI’s report showed that the average cost per day of supply decreased by 2 percent. Additionally, the average days of supply per injured worker dropped by 0.3 percent.

“The average days of supply per injured worker is a measurement of utilization that may be usedinstead of the number of prescriptions per injured worker,” Sciame said. “We found that the average days of supply per injured worker accounts for utilization changes associated with mail-order pharmacy transactions more effectively since the quantity of medication associated with retail and mail-order prescriptions may differ significantly. It could be the difference between a 30-day retail supply of medication versus a 90-day mail-order supply.”

PMSI also credits its improved mail-order penetration rate, a 2.8 percent increase to 29.3 percent, as one reason for the overall decrease in pharmacy spend. The average mail order cost per day of supply in 2010 was approximately 19 percent less than the average retail cost per day of supply.

Another major factor contributing to the improved results was the unusually small increase in the average wholesale price, which Sciame likens to the sticker price of a medication. The year 2010 was the first full year following the average wholesale price adjustment for hundreds of National Drug Codes, as a result of a class action settlement involving two major publishers of drug pricing information.

“In previous years, average wholesale price increased between 8 and 10 percent,” Sciame said. “After the rollback, we measured an increase of only 3.5 percent. This small increase certainly had an impact on overall prescription cost.”

Finally, a focus on less-expensive medications combined with comprehensive utilization control initiatives helped push down overall pharmacy spend. “We were really successful in our ability to impact brand to generic mix,” Sciame said.

According to the report, generic dispensing, the percentage of all prescriptions dispensed that are generic, increased by 3.5 percent. Generic efficiency, the percentage of generics dispensed when a generic formulation is available, increased by 0.7 percent.

“Since we were able to drive the use of less-expensive drugs, overall prescription costs went down,” Sciame said. “This, combined with the utilization decrease associated with our MedAssess clinical program, tipped the scales in favor of an overall spend decrease.”

CVS Caremark to introduce pilot ePA

CVS Caremark, a pharmacy care provider in the US with integrated offerings across the entire spectrum of pharmacy care, is set to unveil a pilot of a real-time, integrated electronic prior authorization (ePA) capability for its CVS Caremark Pharmacy Benefit Management (PBM) clients.

The CVS Caremark ePA pilot will help the company’s PBM clients in improving patients’ experience and speed access to prescription medications.

It will also enable prescribers for coordinating a real-time ePA request when initiating a prescription for a patient.

CVS Caremark chief medical officer Troyen Brennan said the prior authorization process is currently evolving to keep pace as prescribers transition towards electronic prescribing and electronic patient records to better manage their patients’ pharmacy care.

“This pilot is an important step toward demonstrating how the industry can integrate ePA with e-prescribing to streamline and speed up processing of prior authorizations to ensure that members have quick access to care that is medically appropriate and cost-effective,” Brennan said.

Glenmark Gets Licensing Deal Boost

Glenmark Pharmaceuticals Ltd. stock got a booster Monday after the company said it has agreed to license out development and commercialization rights of a biologic treatment to France’s Sanofi-Aventis S.A.

Shares in the company zoomed up almost 20% to 327.80 rupees ($7.31) – the highest price in a month – before paring some of the gains. In afternoon trade on the Bombay Stock Exchange, Glenmark was up 12% at 306.60 rupees, while the benchmark Sensex was down 0.7%.

This is the sixth such deal that the Indian drug maker has signed in its endeavor to create a new product under a licensing agreement with a foreign pharmaceutical company. The strategy is aimed at helping finance costly and lengthy research.

The difference this time is that Glenmark isn’t licensing out a chemicals-based molecule. It is selling the licenses for an experimental biological drug – complex proteins manufactured in living cells – aimed at treating Crohn’s disease and other conditions such as multiple sclerosis.

Under the deal, Sanofi could potentially pay Glenmark $613 million for the drug, code-named GBR500, achieving certain development, regulatory and commercial milestones, including $50 million as upfront payment.

Glenmark claims that it’s the first Indian company to have successfully sold a license for a biologic treatment.

“It’s the first novel biologic out-licensing deal coming from any Indian company,” Glenmark Chief Executive Glenn Saldanha told reporters in Mumbai Monday.

Macquarie Capital analyst Abhishek Singhal told television news channel CNBC-TV18 that the deal “reinforces the credibility of Glenmark’s innovation pipeline where they have been able to crack an out-licensing deal on a novel biological entity.”

Mr. Singhal said Glenmark is one of Macquarie’s preferred pharmaceutical stock picks. Macquarie has a target price of around 445 rupees on Glenmark, without valuing any upside from the Sanofi deal.

An analyst with a Mumbai-based brokerage said that the deal is positive for Glenmark as it will allay investor concerns over the company’s cash flow issues.

But the analyst, who declined to be named, said he doesn’t expect Glenmark stock to move up further from current levels as Monday’s bounce more than accounts for the upside from the Sanofi deal news.

Glenmark has experienced a turnaround since the fiscal year ended March 31, 2009, when its net profit plunged to 1.93 billion rupees from 6.32 billion rupees as sales fell across markets. Cash flows were further strained when financing costs shot up on loans taken to fund the company’s aggressive global expansion, while milestone payments from drug licensing partners dried up.

Glenmark has since focused on improving its cash flow position by controlling working capital expenditure, deferring non-essential spending and paring debt. At the same time, it has benefited from growth returning to most markets and renewed interest in its drug research and development programs.

The company last week reported net profit of 4.58 billion rupees for the fiscal year through March 2011. It added that this number conformed to International Financial Reporting Standards and may not be comparable with the previous fiscal year.

Mr. Saldanha told reporters Monday that the company will use the $50 million received upfront from Sanofi to repay part of its debt, which he said currently stands at about 19 billion rupees ($423 million).

Dennis Fenton, Ph.D. to Join Board of Napo Pharmaceuticals, Inc.

Napo Pharmaceuticals, Inc. (Napo) which focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners, is pleased to announce the appointment of Dr. Dennis M. Fenton, Ph.D., to the Napo Board of Directors. Dr. Fenton has over thirty years of pharmaceutical and biotechnology experience including over 25 years at Amgen, Inc. where he coordinated the design, construction and expansion of manufacturing facilities for Epogen(R) (epoetin alfa) and Neupogen(R) (filgrastim), two of the premier products in the biotechnology industry. Dr. Fenton served in numerous positions at Amgen including executive roles in process development, manufacturing, sales and marketing and research and development, with his last position being Executive Vice President.

Dr. Fenton is a director of life science companies including Xenoport, Inc., Amira Pharmaceuticals, Inc., Genelux Corporation and Kythera Biopharmaceuticals. He is a Director/Trustee at Rutgers University and a Trustee of the Keck Graduate Institute, and the Biotechnology Institute.

Dr. Fenton holds 5 US patents in microbiology and has published over 50 papers and abstracts. Dr. Fenton has a B.S. in Biology from Manhattan College and a Ph.D. in Microbiology from Rutgers University.

“We are extremely pleased to announce the addition of Dr. Fenton to our Board of Directors. His expertise in manufacturing and the pharmaceutical industry in general is a very timely addition to Napo’s Board of Directors. Importantly, Dennis also shares our vision and goal of providing access to crofelemer to global populations,” said Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc.

“I am thrilled to be joining the Board of Napo Pharmaceuticals, Inc. I think Napo has a great opportunity and I look forward to drawing on my experience in manufacturing and operations to help Napo continue its progress,” said Dr. Fenton.

About Napo Pharmaceuticals, Inc.

Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. The company seeks partners in both traditional high-value markets as well as in the higher volume business models of emerging and developing economies. Napo was founded in November 2001 and is based in San Francisco, Calif., with a subsidiary in Mumbai, India.

About Crofelemer

Napo’s proprietary patented gastrointestinal compound, crofelemer, is a first-in-class anti-secretory agent extracted from Croton lechleri, a medicinal plant sustainably harvested under fair trade working conditions from South America. Crofelemer is in various stages of clinical development for four distinct indications:

1. Crofelemer for HIV-related diarrhea (CRO-HIV), completed Phase 3; highly significant data recently released, NDA filing targeted for mid-2011.

2. Crofelemer for diarrhea predominant irritable bowel syndrome (CRO-IBS), Phase 2

Teva buys Japanese drugmaker for $460m

Teva of Israel took a leap towards its ambition of becoming Japan’s largest generic drugs group with the purchase of the majority of Taiyo Pharmaceutical Industry for $460m.

The cash payment, for 57 per cent of the privately held company, gives it control of Japan’s third-largest generic drugs provider, even ahead of extending its offer to all other shareholders.

The deal marks the latest international step for Teva, already the world’s largest generic drugs group which recently acquired Cephalon in the US.

It indicates fresh interest in Japan, the second-largest market for pharmaceuticals and one where government policy is encouraging generic expansion to tackle the rising cost of medicines for its ageing population.

The latest deal gives Taiyo an enterprise value of $1.3bn, and Teva said the transaction was expected to be accretive to GAAP earnings within four quarters after closing.

Taiyo, which has a portfolio of over 550 drugs with a particular strength in hospital-prescribed injectables, reported sales of $530m last year.

Shlomo Yanai, Teva’s president and chief executive, said: “This acquisition will enable Teva to deliver on our strategic objective of becoming a leading player in the fast-growing Japanese generics market.”

He said the company now expected to reach a 2015 target of $1bn in sales in Japan ahead of schedule.

Low-cost, off-patent generics have traditionally struggled to gain a strong foothold in Japan with a penetration of just 23 per cent, reflecting the marketing strength of innovative companies and suspicions over the quality of generic drugs, a sector dominated by smaller businesses.

Larger groups are investing in the market, including Daiichi Sankyo which acquired Ranbaxy, of India. The Japanese government aims to expand the penetration rate domestically to 30 per cent initially by 2012.

The transaction will be funded through a combination of cash and bank debt.

FDA Approves Merck’s New Drug Victrelis For Treatment Of Hepatitis C

The U.S. Food and Drug Administration (FDA) announced late yesterday that it has approved Victrelis for the treatment of hepatitis C.

Victrelis (boceprevir), which will be marketed by the U.S. pharmaceutical company Merck, is approved for use in combination with the current standard of treatment for hepatitis C, peginterferon alfa (Pegasys or PegIntron) plus ribavirin (Copegus, Rebetol).

“This is an exciting day for physicians and patients because Victrelis is the first major advancement for the treatment of chronic hepatitis C approved in a decade,” said Dr. Bruce Bacon, professor of internal medicine at Saint Louis University School of Medicine and one of the Victrelis clinical trial leaders, in a Merck press release.

“Compared to current standard therapy, Victrelis can significantly increase a patient’s chance of achieving undetectable levels of the virus, thereby obtaining an SVR [sustained virologic response]. For many patients, Victrelis may allow for a shorter total duration of treatment,” he added.

The approval is based on clinical trial results showing that Victrelis increased cure rates for hepatitis C – called a sustained virologic response, or SVR – from around 40 percent to about 65 percent (see related AIDS Beacon news).

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). If untreated, infection with HCV can cause damage and scarring to the liver, liver cancer, and eventually liver failure. Once the liver fails, a liver transplant is necessary for a patient to survive. Some people who are infected can spontaneously clear the virus themselves; the rest need treatment with antiviral drugs.

Victrelis has been approved for use in adults with hepatitis C who have never been treated or who have previously failed treatment. It may be taken even by patients who have cirrhosis (scarring and poor liver function caused by advanced liver disease).

Victrelis has not yet been approved for people with HIV-HCV co-infection. Merck is currently conducting clinical trials to evaluate the drug’s safety and efficacy in people who are infected with both HIV and HCV (see related AIDS Beacon news).

The approved dosing schedule for Victrelis, as anticipated, is somewhat complicated. Most patients taking Victrelis will undergo response-guided therapy. Under this model, the length of treatment varies depending on how well a patient responds to the drugs.

Treatment-naïve patients will receive four weeks of standard treatment (ribavirin plus peginterferon alfa), then 24 weeks of standard treatment plus Victrelis (for a 28 week total treatment length). However, if patients still have detectable HCV levels after eight weeks of Victrelis, treatment is extended with an additional eight weeks of Victrelis, then 12 weeks of just peginterferon alfa plus ribavirin (for a total treatment length of 48 weeks).

Patients who have been treated previously for hepatitis C will receive four weeks of standard treatment, then 32 weeks of standard treatment plus Victrelis (for a 36 week total treatment length). If patients still have detectable HCV levels after eight weeks of Victrelis, treatment is extended with an additional 12 weeks of peginterferon alfa plus ribavirin after finishing Victrelis (for a total treatment length of 48 weeks).

Patients who have cirrhosis will take peginterferon alfa and ribavirin for four weeks, followed by 44 weeks of Victrelis, peginterferon alfa, and ribavirin.

If HCV is still detectable after 24 weeks, Merck recommends discontinuing treatment with all three drugs.

Victrelis is taken three times daily with food, every seven to nine hours, in the form of four 200 mg pills.

Merck stated in its press release that it will start shipping Victrelis to pharmacies within a week. The company will also add Victrelis to its patient assistance program, which provides free medications to people who are uninsured and who meet income requirements (annual income of no more than $43,320 for an individual). Victrelis will cost $1,100 per week, or between about $26,000 and $48,000 for an entire course of therapy.

Victrelis is one of two new hepatitis C drugs currently being evaluated by the FDA. Victrelis and telaprevir, which will be marketed by Vertex Pharmaceuticals and Johnson & Johnson, are both HCV protease inhibitors, which work by inhibiting HCV replication in the body. The FDA is expected to announce its decision on telaprevir’s potential approval within the next two weeks.

Pfizer to settle remaining hormone therapy lawsuits for $300 million minimum

Thousands of women who say they developed breast cancer and other diseases after hormone-replacement therapy are poised for victory after Pfizer Inc. announced it expects to settle for at least $300 million this last round of lawsuits in the public-health controversy.

The New York-based pharmaceutical giant, which has research-and-development sites in Groton and New London, expects to pay at least $772 million to settle the more than 10,000 lawsuits that alleged that Wyeth Pharmaceutical’s hormone-replacement therapy drug Prempro caused their health problems, according to a regulatory filing.

This includes the $300 million the company paid out in a previous round of settlements, according to the documents, and $172 million in reported settlements last quarter.

“Additional charges may be required in the future,” Pfizer said.

Critics allege that Wyeth, bought by Pfizer two years ago for $67 billion, never properly studied the effects of hormone replacement before starting to market the treatment in 1995. The therapy is prescribed to ease menopausal symptoms.

It wasn’t until 2002 – after the release of a Women’s Health Initiative study that suggested a connection between hormone replacement and cancer, heart attacks and stroke – that the medical community started to revise its thinking about the by-then standard therapy.

The National Institutes of Health, which sponsored the study, said on its website that hormone therapy – also known as HRT – can still have benefits, including reducing the risk of bone breaks in older women.

“If you do decide to take HRT, it should be the lowest dose that helps and for the shortest time needed,” the health organization said.

Pfizer said it stands by its hormone therapy medicines.

“The FDA has said that hormone therapy ‘is the most effective FDA approved medicine for relief of hot flashes, night sweats or vaginal dryness,'” a company statement said.

Pfizer didn’t reveal in its filing late Thursday with the U.S. Securities and Exchange Commission how many cases were being put to rest in the latest round of Prempro settlements. Bloomberg News Service estimated the number at more than 3,000, but Pfizer said only that the $300 million set-aside is expected to be the minimal amount required to cover a third of the pending cases.

“The decision to settle cases reflects a business decision by the company to avoid the cost and distraction of prolonged litigation,” Pfizer spokesman Christopher Loder said in a statement Friday.

Analysts saw the settlements as good news for the company’s stock price over the long haul, since it releases another cloud of doubt over Pfizer. The stock hit near its one-year high Friday, closing at $20.92 a share.

Pfizer’s stock, under the leadership of new chief executive Ian Read, has been booming – up 25 percent since his December ascension – even as the company faces concerns over the loss of patent exclusivity for Lipitor, its blockbuster cholesterol pill.

Prempro is a combination of Wyeth’s estrogen replacement Premarin and Pfizer’s progestin hormone Provera. It is still on the market, bringing in only $161 million in annual sales two years ago, compared with more than $2 billion at its height when 6 million Americans were on hormone therapy.

Pfizer no longer pulls out Prempro sales separately, now referring to the “Premarin family” of medicines, whose $235 million in sales in the first quarter were an 8 percent decrease from the same period last year.

The most recent round of cases that Pfizer is settling was consolidated in U.S. District Court in Little Rock, Ark.

Last year, the U.S. Supreme Court refused to hear a Pfizer appeal that sought to have the hormone therapy cases heard in federal courts rather than in state jurisdictions.

AcelRx Pharmaceuticals Reports First Quarter 2011 Financial Results

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (“AcelRx”), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, reported financial results today for the first quarter ended March 31, 2011.

Net loss for the first quarter of 2011 was $3.2 million, or $0.30 per share, compared with a net loss of $3.7 million, or $5.85 per share, for the first quarter of 2010. Common shares used in calculating earnings per share were 10,742,182 in the first quarter of 2011 compared to 629,006 common shares in the first quarter of 2010. Research and development expenses for the three months ended March 31, 2011 totaled $1.9 million, compared with $2.8 million for the three months ended March 31, 2010. General and administrative expenses were $1.6 million for the quarter ended March 31, 2011, compared with $0.7 million for the quarter ended March 31, 2010. The increase in General and Administrative expenses results primarily from incremental public company expenses and non-cash stock compensation.

As of March 31, 2011, AcelRx had cash, cash equivalents and short-term investments of $36.2 million, compared with $3.7 million as of December 31, 2010. In February 2011, AcelRx completed its initial public offering, or IPO, resulting in net proceeds to AcelRx of $35.2 million. In connection with the IPO, $8.0 million in outstanding convertible notes as of December 31, 2010 converted to common stock. On March 31, 2011, AcelRx had $4.0 million in debt outstanding.

“Progress continues towards initiating the Phase 3 program for our lead product candidate, ARX-01, in acute post-operative pain,” said Richard King, President and Chief Executive Officer of AcelRx. “We have manufactured NanoTabs for all Phase 3 clinical trials, and are in the process of manufacturing components for the ARX-01 device. We have selected the CRO to conduct the Phase 3 studies for ARX-01, and anticipate initiating enrollment in our first Phase 3 study, an efficacy study in major abdominal surgery, in the second half of 2011. We anticipate initiating enrollment for our second Phase 3 study, a head-to-head comparison of ARX-01 to the standard of care, IV PCA morphine, in early 2012.”

“We continue to believe that ARX-01 could become the treatment of choice for patient-controlled management of moderate-to-severe post-operative pain,” said Mr. King.

Financial Outlook

AcelRx anticipates that research and development expenses will increase over the next several years as it seeks to complete Phase 3 development of ARX-01. AcelRx does not intend to initiate the third ARX-01 Phase 3 study, an efficacy study in orthopedic hip and knee replacement surgeries until additional funding is obtained. The development of ARX-02,a product candidate for the treatment of cancer breakthrough pain, and ARX-03, a product candidate for mild sedation and pain relief in procedures conducted in a physician’s office, will not advance until additional funding or the identification of a partner to support this effort is secured. Additionally, AcelRx anticipates increases in general and administrative expenses due to costs associated with operating as a public company and expansion of its corporate infrastructure to support ongoing development of its product candidates.

AcelRx believes its current cash and cash equivalents, and the interest earned thereon, are sufficient to fund operations through the second quarter of 2012.

About AcelRx Pharmaceuticals, Inc.

Based in Redwood City, CA, AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx’s lead product candidate, the ARX-01 Sufentanil NanoTab(R) PCA System, which has completed Phase 2 clinical development, is designed to solve the problems associated with post-operative intravenous patient-controlled analgesia (IV PCA) which has been shown to cause harm to patients following surgery because of the side effects of morphine, the invasive IV route of delivery and the inherent potential for programming and delivery errors associated with the complexity of infusion pumps. AcelRx has two additional product candidates which have completed Phase 2 clinical development: ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for providing mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician’s office.

Forward Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to AcelRx Pharmaceuticals’ financial performance, clinical trial update and future financial performance, including 2011 financial outlook, and statements relating to the timing of the clinical trials and product candidate development. These forward-looking statements are based on the company’s current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of AcelRx Pharmaceutical’s product development activities and clinical trials; its ability to obtain and maintain regulatory approval of its product candidates; its ability to obtain funding for its operations; its plans to research, develop and commercialize its product candidates; its ability to attract collaborators with development, regulatory and commercialization expertise; the accuracy of AcelRx Pharmaceutical’s estimates regarding expenses, capital requirements and needs for financing; and other risks detailed in the “Risk Factors” and elsewhere in AcelRx Pharmaceuticals’ Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-K for the year ended December 31, 2010. AcelRx Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Takeda says has not agreed to buy Nycomed

Takeda, Japan’s largest drugmaker, said on Friday it has not agreed to buy Swiss rival Nycomed, following reports it was in talks to buy the privately held company for more than $12 billion.

Such a deal would boost Takeda’s global reach into Europe and emerging markets.

“The company would like to make clear that Takeda has not agreed to any such an agreement as suggested by certain newspaper publications,” the group said in a statement on its website.

“Takeda is constantly seeking and evaluating opportunities to increase shareholder value and enhance our business through strategic investment; however, there is nothing that needs to be announced at this point,” Takeda said.

A person familiar with the matter told Reuters that a deal, which would be Japan’s second-biggest overseas takeover, was in its final stages but might take time to conclude.

Teva Generic Sales Remain Weak

Teva Pharmaceutical Industries’ (TEVA – Analyst Report) first quarter earnings of $1.04 per American Depository Share (ADS) were in-line with the Zacks Consensus Estimate. Earnings, however, increased 14.3% from the year-ago period.

While first quarter revenues increased 11.7% to $4.1 billion, revenues fell short of the Zacks Consensus Estimate of $4.3 billion. The company reported sales growth in Europe (66%) and EEMA, Latin America and Asia (26%). However, North America disappointed with sales declining 11%.

The Quarter in Detail

US generic sales remained weak in the first quarter. Sales in North America declined 11% to $2,064 million with US generic and other sales declining 32% to $952 million. The lack of major launches in the first quarter of 2011 affected performance.

Moreover, the voluntary suspension of production at the Irvine plant and the slowdown in the Jerusalem facility due to the receipt of a warning letter from the US Food and Drug Administration (FDA) affected generic revenues. Both these factors impacted revenues by $100 million.

Teva resumed partial production at the Irvine plant in April 2011 with full production expected to resume by year end. The company also submitted a response to the warning letter for the Jerusalem facility and has requested the FDA to re-inspect the facility.

We expect the US generics business to bounce back in the second half of 2011. Teva has about 40 potential launches lined up for 2011. Important product launches include generic versions of Zyprexa, Levaquin, Aricept and Nasacort. Approval of generic Lovenox would be a major boost for the stock.

Key branded product, Copaxone, posted global in-market sales of $907 million, up 14%. While US in-market sales increased 22% to $624 million, ex-US in-market sales remained flat at $283 million. Sales were driven by price increases and unit growth in certain markets which were partially offset by price cuts in Germany and other markets. The company reported that Copaxone’s global market share increased to 31%. Teva took a price increase for Copaxone in January 2011.

Other products/segments that contributed to growth were Azilect at $90 million, up 16%, and the women’s health business which recorded 30% growth with sales coming in at $103 million. The inclusion of sales of Theramex products helped drive growth in the women’s health business.

We were pleased to see a 19% increase in sales from the global respiratory business. Sales came in at $229 million with growth being driven by strong sales in Europe, especially for Qvar.

Teva is working on strengthening its position in the respiratory market and expects to file for approval of four new products in 2011, including a May 2011 filing for Qnaze for the treatment of perennial allergic rhinitis.

Pharmaceutical revenues in Europe increased 66% to $1,344 million, mainly due to strong generic sales in Italy, Spain, Germany, and France. Results benefited from the inclusion of ratiopharm’s business. Teva’s acquisition of ratiopharm should help the company strengthen its position in key European markets, especially in Germany. European sales should continue improving in the coming quarters.

International (EEMA, Latin America and Asia) pharmaceutical revenues grew 26% during the quarter with sales coming in at $672 million. Increased sales in Russia and Latin America helped boost revenues.

API sales increased 32% to $184 million. Currency fluctuations boosted total revenues by $27 million.

Research & Development expense increased 15% to $239 million. Meanwhile, Selling and Marketing (S&M) expenditures (excluding amortization of purchased intangible assets) increased 10.9% to $825 million. General and Administrative expenditures also increased from the year-ago quarter to $221 million, up 21.4%.

Maintains 2011 Guidance

Teva maintained its guidance for 2011. The company expects earnings in the range of $4.90 to $5.20 on revenues of $18.5 billion to $19 billion. Performance is expected to be stronger during the second half of the year. The guidance does not include the impact of any acquisitions in 2011. The Zacks Consensus Estimate currently points at earnings of $5.08 on revenues of $18.7 billion.

Earlier this month, Teva announced its intention to acquire Cephalon, Inc. (CEPH – Analyst Report) for $6.8 billion The Cephalon deal is in-line with Teva’s long-term strategy of expanding and strengthening its branded and specialty pharma business. Once the acquisition goes through, the combined company’s branded product portfolio will consist of more than 20 products representing sales of about $7 billion.

P&G Deal to Make Teva Leader in Consumer Health Care

During the first quarter of 2011, Teva entered into a partnership agreement with Procter & Gamble (PG – Analyst Report) that will target the consumer health care market. The partnership will bring together both companies’ existing over-the-counter (OTC) medicines and complementary capabilities.

While P&G will bring its strong brand-building, consumer-led innovation and go-to-market capabilities to the partnership, Teva’s broad geographic reach, R&D experience, and extensive product portfolio will be used to drive growth. With this deal, Teva is looking to become a leader in the consumer health care market.

Sagent Pharmaceuticals Reports First Quarter 2011 Financial Results

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT) today announced financial results for the first quarter ended March 31, 2011 and provided a corporate update.

“The company has already made tremendous progress so far in 2011 as we grew our revenues by more than 250 percent year-over-year and completed our initial public offering in April, pricing at the high end of the range, increasing the number of primary shares offered by 15%, and had our underwriters exercise their overallotment option for an additional 15% of the offering,” said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. “We expect the funds used from our recently completed initial public offering to be used to support the forthcoming launches of the 45 products represented by the 79 ANDAs that have been recently approved or are pending approval by the FDA, to more rapidly expand our development pipeline and for general corporate purposes.”

Recent Accomplishments
Priced its initial public offering on April 19, 2011 and began trading on the NASDAQ Global Market under the trading symbol “SGNT” on April 20, 2011. Net proceeds from Sagent’s initial public offering were approximately $95.5 million.
Announced U.S. Food and Drug Administration (“FDA”) approval and the launch of four presentations of midazolam injection, USP, a general anesthetic. Midazolam is offered in latex-free vials.

First Quarter 2011 Financial Results

Net revenue for the first quarter of 2011 was $30.3 million, an increase of $21.7 million, or 251%, compared to $8.6 million in the first quarter of 2010. The launch of 31 new codes or presentations of 11 new products since March 2010 contributed $14.2 million, or 65%, of the net revenue increase for the first quarter. Gross profit for the first quarter of 2011 was $4.6 million, or 15.1% of net revenues, compared to $0.3 million, or 3.4% of net revenues, in the first quarter of 2010.

Total operating expenses for the first quarter of 2011 were $8.0 million, compared with $7.4 million for the same period in 2010. Product development expense for the first quarter totaled $2.4 million compared to $2.8 million in the first quarter 2010. Selling, general and administrative (“SG&A”) expenses for the first quarter 2011 totaled $5.0 million compared to $4.2 million in the first quarter 2010, the increase due primarily to increases in headcount and corporate infrastructure to support Sagent’s initial public offering and revenue growth. SG&A comprised 16.4% and 48.2% of net revenue in the first quarter of 2011 and 2010, respectively. The decrease in SG&A as a percentage of revenue reflects the benefit of anticipated sales growth over Sagent’s relatively fixed and in-place selling and administrative infrastructure.

Cash and cash equivalents at March 31, 2011 totaled $32.6 million, and working capital totaled $40.9 million. This does not include the net proceeds of approximately $95.5 million generated from our initial public offering that was completed in April 2011.

Aurobindo turns billion dollar pharmaceutical company

Hyderabad-based Aurobindo Pharma has joined the billion-dollar club of pharma fraternity as the company’s consolidated revenues registered a growth of 22.5% at Rs 4381.5 crore in the financial year ended March 31, 2011 as against Rs 3575.4 crore last year.

The company s net however, did not witness an upward momentum due to a dip in forex gains. Its net was at Rs 563.45 crore compared to Rs 563.4 crore in the previous year. “Though the sales have gone up, the company s margins have not expanded considerably. That is one of the reasons for net profit being flayed on a yearly basis.

Besides, this fiscal, the company’s forex gain was Rs 37 crore as against Rs 110 crore last year. We expect margins to improve in FY13 when its formulations business is expeted contribute about 70% of its gross sales, said Sarabjit Kaur Nangra, V-P (research), Angel Broking. The spurt in sales is led by growth in formulations business especially anti-retrovirals (ARVs).

Its formulations business clocked 30.8% growth at Rs 2423.1 crore compared to last financial year while ARV sales went up by 40% to Rs 693.6 crore. Currently, formulations sales constitute 57.3% of the company s gross sales. The company s sales in the US went up by 30.4% to Rs 1189.7 crore. In fact, the increased allocation to PEPFAR by the US augurs well for Aurobindo. US President’s Emergency Plan for AIDS Relief (PEPFAR) is the largest effort by any nation to combat a single disease. Aurobindo is one of the largest participants in PEPFAR. “The results are in line with our expectations.

Majority of the company’s ARV revenues come from PEPFAR. The net remains flat because the company s staff cost has gone up by 30% due to its SEZ becoming operational in AP. Besides, material cost also has gone up,” said Rahul Sharma, Analyst, Karvy Stock Broking.

The Company has filed and received approvals for a large number of products in various key therapeutic segments across several countries. As on March 31, 2011, the company filed 209 abbreviated new drug applications (ANDAs) in the US, of which 134 have been approved, including 32 tentative approvals . During FY 2011, the company filed 1270 formulations dossiers in other key regulated markets including multiple registrations in European Union.

Avanir Pharmaceuticals’ CEO Discusses F2Q11 Results – Earnings Call Transcript

Good afternoon. My name is Piya and I will be the conference operator today. At this time I would like to welcome everyone to the Avanir Pharmaceuticals fiscal 2011 second quarter conference call. (Operator Instructions)

Thank you. At this time I would like to turn the conference over to Mr. Ian Clement. Sir, you may begin.

Ian Clement

Thank you and good afternoon everybody. Joining me on today’s conference call are Keith Katkin, President and Chief Executive Officer, Bill Sibold, Chief Commercial Officer; Christine Ocampo, Vice President of Finance and Dr. Randall Kaye, Chief Medical Officer.

Earlier this afternoon Avanir issued a news release announcing the company’s results for fiscal 2011, second quarter and first six months. If you have not received this news release or if you would like to be added to the company’s distribution lists please call the investor relations of the company or you can sign up through the IR section of the company’s website.

Copies of news releases and SEC filings can also be found in the IR section of our website. There is always a gap, I would like to remind you that the statements made on the call represent our judgment as of today, May 9, 2011. Our remarks and responses to questions during this conference call may constitute forward-looking statements, including plans, expectations, and financial projections, all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from the expected results expressed in our forward-looking statements.

The company’s actual results may differ materially from the statements made during today’s call and the company undertakes no obligation to update any of these statements.

From an investor communications perspective we will be presenting an overview of the company at one meeting this month, tomorrow, Tuesday May 10th, we will present at the Bank of America/Merrill Lynch healthcare conference in Las Vegas, Nevada. A webcast of this presentation will be accessible through the investor relation section of our website.

With that said, I would now like to turn the call over to Keith.

Keith Katkin

Thank Ian, and thank you for joining us on the conference call today. During today’s call I would like to discuss recent achievements and provide an overview of our business. I will then hand the call over to Bill Sibold who will comment on the launch of NUEDEXTA, the commercial potential moving forward and why he found it a compelling opportunity to join Avanir.

Christine will then follow with an update on the quarter’s financial results that were released earlier today. Finally, Randall will then discuss our clinical plans for AVP-923, I will then conclude with an update on our key upcoming milestones and events.

Second quarter of 2011 marked another exciting busy and successful period for Avanir. Before adjusting the launch of NUEDEXTA I would like to take a moment to highlight a couple of other recent corporate highlights.

First, as we transition from a development stage company to an integrated commercial stage biopharmaceutical company ensuring we have the right talent in place is a key imperative for us. In the first few months of calendar 2011 we made a couple of important additions to the senior management team. This morning we announced Elona Kogan, has been appointed in the position of Vice President of Legal Affairs. Elona’s legal, regulatory and business expertise will be a valuable asset to our organization.

Promotion of Greg Flesher to the critical role of Chief Business Officer will help position Avanir to grow into a successful CNS company. Greg’s broad pharmaceutical background in business development, sales and marketing and research and development provide strong foundation to achieve this growth through an increased focus on business development and product lifecycle management.

In April, I was delighted that we were able to announce the appointment of Bill Sibold to the position Chief Commercial Officer. Previously, Bill was responsible for leading a $2.8 billion franchise and the management of over 800 people in the commercial organization of Biogen Idec. His proven ability to build and lead cross functional teams to drive growth, to develop and launch new products further enhances our already strong commercial leadership team.

Second, the filing of an IND application with the FDA for AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis underscores our commitment to the continued development of AVP-923 for additional indications. Third, the recently announced PRISM registry, the largest ever observational study in PBA will allow us to further assess the prevalence of PBA across multiple underlying neurologic conditions and PBA’s impact on quality of life.

Moving on to the launch of NUEDEXTA, I believe we are off to a promising start as we build and develop a market for the first and only FDA approved treatment for patients living with PBA. We are measuring our success across a number of variables from a broad perspective including both quantitative and qualitative measures. We agree prescription data is trending in a positive direction and demonstrating overall continued growth. Awareness of PBA and NUEDEXTA are critical to the long term success of our business. Market research shows that awareness is growing through such activities as field sales force interactions, peer to peer speaker programs and advertising.

As expected our data demonstrates that call frequency makes a difference. Doctors called on more than once since the launch of NUEDEXTA are three times more likely to have prescribed NUEDEXTA than doctors called on just one time. From a qualitative perspective anecdotally we continue to hear success stories from physicians and patients. Many of these success stories from physicians have highlighted the life changing benefit NUEDEXTA has brought to their patients.

For example, a neurologist recently prescribed NUEDEXTA to a multiple sclerosis patient. The patient was complaining of excessive crying, both the patient and the caregiver had “reached the end of their road” and the patient was pretty much house bound. Two weeks after starting treatment the patient and caregiver are so happy with the results that they are able to leave the house again.

A physician was keen to share this story with the sales representative as he wanted to let us know that Avanir had “hit a home run” with NUEDEXTA. The patient a 20 something year old male had a TBI traumatic brain injury from a motorcycle accident. Whenever the physician would see the patient and simply ask him how he was doing the patient would immediately go into an episode of loud uncontrollable line, the doctor said the crying was so loud that his medical staff would actually come to the exam room to see if everything was okay. The doctor said he had tried everything but no treatments were working.

The patient’s mother recently called the doctor to say that they could no longer manage caring for the sun because his behavior was causing too much destruction in their household. Having just heard of NUEDEXTA the doctor told the mother there was something brand new he would like to try. He immediately placed the patient on NUEDEXTA and after approximately 10 days of therapy the mother reported that no episodes had occurred during the last four days.

Feedback like this not only serves as tremendous motivation for all of our employees but furthers our passion and belief that there is a tremendous need for NEUDEXTA which is the first and only FDA approved treatment of PBA and confirms our belief that there is a significant market opportunity for NUEDEXTA in PBA.

As there has been a high level of interest in prescription data we thought we would share IMS data for the past quarter as well. In January when we were loading the distribution channels and not yet actively promoting NUEDEXTA to physicians, a total of 50 prescriptions were written all of which were new prescriptions.

In February, when physician promotion commenced on February 7, a total 323 prescriptions were written of which 295 were new prescriptions, and for March, our first full month promoting NUEDEXTA a total 846 prescriptions were written of which 710 were new prescriptions. Thus for the quarter we had a total 1219 prescriptions, of which 1055 were new prescriptions which we believe represent new patients on NUEDEXTA therapy.

Looking to April, we do not have the monthly data at this time, however, the weekly data for the four weeks ending Friday, April 29th, showed almost 1,100 total prescriptions and nearly 800 new prescriptions. I am pleased that despite the fact, in April, many of our core neurologist-prescribing physicians were at the American Academy of Neurology Meeting in Honolulu, we continue to see positive trends in the prescription numbers for NEUDEXTA. In addition, over 10% of our field sales force were also at the AAN Meeting in Honolulu.

On the payer front, we continue to make progress. One of our imperatives for the launch is to ensure wide access to NEUDEXTA. We have a team of eight account managers who are focused on working with Medicare Part D, Medicaid and commercial plan providers. We have already negotiated contracts with a number of managed care organization including two of the three largest pharmacy benefit managers, Medco and Express Scripts. We believe we are on track to establish favorable formulary replacement with a wide number of plans by the end of this calendar year.

As of May 6, approximately 24% of insured lives were covered on tier 2. We remain focused on increasing the portion of patients with tier 2 access as the lower copays associated with tier 2 should allow more patients to afford their prescriptions.

To-date, approximately 60% of prescriptions have been filled under commercial plans and about 25% from Medicare Part D. What is encouraging about the split is that so many prescriptions are being filled under Medicare Part D, despite the fact that 70% of lives covered Medicare Part D require a letter of medical necessity for a patient to receive therapy, and the copay is relatively high compared to commercial plans. This has been the default status of NEUDEXTA on several large Med D plans prior to formulary reviews and contracting discussions.

Our managed care team is working diligently to improve reimbursement on Medicare Part D plans with a goal of securing preferred formulary placement by January 2012.

Turning to patient awareness, one of the main thrust of our efforts involves working closely with patient advocacy groups. In March, we held a very successful patient advocacy summit where seven advocacy groups were in attendance. These groups represented patients across the MS, ALS, brain injury, stroke, Parkinson’s and Alzheimer’s communities. The advocacy groups shared ideas for educating patients and family members about PBA and we expect many helpful, educational programs to be created over the coming year in support of our goal of increasing awareness and diagnosis.

As a couple of examples from the meeting, the National MS Society recently released a learn-online program called Uncontrollable Laughing and Crying, which is available on the website and on YouTube. The National Stroke Association has developed a patient brochure on PBA after stroke which will be available in the next few weeks.

Finally, we’ve been actively participating in scientific conferences where we continue to present data from our star clinical trial and findings from additional studies conducted by Avanir and third parties.

With that update on our operations, I will now ask Bill Sibold to say a few words. Bill?

William Sibold

Thanks Keith and hello everybody. I’m thrilled to be joining Avanir at such an exciting time. The launch of NUEDEXTA represents a significant opportunity for the company and most importantly patients and their caregivers and loved ones.

NUEDEXTA is a highly differentiated product. It work well, it works fast and does not have the additional burdens of black box warning or REMS programs. In addition to PBA which itself represent the large market opportunity, NUEDEXTA has many potential follow on indications to grow into so the future is very promising. I’m a strong believer in symptomatic therapy while focusing on the underlying neurological disease is critical, focusing on the patient’s overall wellbeing is an important treatment goal. I’ve spent many years in the MS field and have seen firsthand the number of issues these patients experience.

PBA is a prevalent yet often not discussed problem for MS patients. And looking ahead at our development pipeline, pain for MS suffers is a highly prevalent problem and has the potential to represent the next indication for NUEDEXTA. Between the existing large PBA population in ALS, MS, stroke, dementia and TBI, and potential future indications, I believe that Avanir and NUEDEXTA are extremely well-positioned for long term sustainable growth.

Of course success is predicated on having the right team and I believe AVANIR has one of the most talented and experienced team that I’ve had the pleasure of working with. It is the other major reason that I joined Avanir. I have been impressed with what has already been accomplished by this team and I am excited by what we will achieve together.

My observations of launch thus far are very favorable. We are building a market which takes time and we are making great progress. Until NUEDEXTA was launched in the middle of February, PBA was not on the radar of most physicians managing these at risk patients. Each day, PBA awareness is growing and more patients are benefiting from NUEDEXTA. I look forward to reporting this continued progress on future calls.

I will now hand the call over to Christine to address our financial results. Christine?

Christine Ocampo

Thanks Bill, and good afternoon everyone. My comments today will cover our financial results for the second quarter and first six months of fiscal 2011. In addition to the results summarized in the press release issued earlier this afternoon, you can find additional information in our upcoming 2011 quarterly report on Form 10-Q.

All figures discussed today are approximate. First I’ll address the financial results for the second quarter of fiscal 2011. We reported total net revenues for the three months ended March 31, 2011 of $1.4 million as compared to $1 million for the comparable period in fiscal 2010. The increase from prior year was primarily due to net product revenue from sales of NUEDEXTA.

Gross sales of NUEDEXTA were $505,000; net sales of NUEDEXTA were $462,000, total NUEDEXTA net shipments were $3.1 million and deferred NUEDEXTA revenue was $2.6 million. Gross margin on the sales of NUEDEXTA was 93% excluding an inventory reserve charge of $82,000.

Finished goods inventory consist of batches that were manufactured in 2010 to obtain FDA approval, this product is currently being sold to wholesalers and it’s scheduled to expire in 2012. Wholesalers generally will not purchase product within 12 months of expiration. As such, we recorded an inventory write down for the estimated amount of product that may not be shipped due to short dating.

NUEDEXTA revenue is recognized using a deferred revenue recognition model. NUEDEXTA cap full shipments to wholesalers are initially recorded as deferred revenue and later recognized as revenue when the product has left the distribution channel and is no longer subject to right of return. This effectively represent reported and user prescriptions and non retail shipments of NUEDEXTA capital.

Research and Development expenses were $2.5 million for the quarter ended March 31, 2011, compared with $3.8 million for the same period in the prior year. R&D expense decreased for the fiscal 2011 second year was primarily due to reduced expense with respective clinical trials.

Selling, General and Administrative expenses of $13.3 million for the fiscal second quarter of 2011 increased from $3.6 million for the corresponding period of the prior year. The increase was primarily due to an increase in expenses related to the commercialization activities surrounding NUEDEXTA.

Total operating expenses for the quarter were $15.8 million compared with $7.4 million for the comparable quarter in 2010. For the three months ended March 31, 2011 and 2010 the company reported $951,000 and $665,000 respectively of stock based compensation expense.

Our net loss for the second quarter of fiscal 2011 was $14.5 million or $0.12 per share compared with a net loss of $6.4 or $0.08 per share for the same quarter in 2010. These increases in our net loss during 2011 were primarily due to significant increase on our sales and marketing expenditures as a result of our preparation for the commercialization of NUEDEXTA.

Now, turning to the year-to-date results. Total revenue for the first six months of fiscal 2011 totaled $3.3 million compared to a $2.5 million, a 31% increase for the first six months of fiscal 2011. Cost of product sales for the first six months of 2011 was $114,000 compared with zero reported for the first six months of fiscal 2010.

Total operating expenses for the first six months of 2011 were $29.7 million versus $13.8 million for the comparable period in fiscal 2010. For the first six months ended March 31, 2011 and 2010 the company reported $1.8 million and $1.4 million respectively of stock based compensation expense. Net loss for the first six months of fiscal 2011 was $26.6 million or $0.23 per share compared with $11.3 million or $0.14 per share for the comparable period in fiscal 2010.

As of March 31, 2011, Avanir had total cash, cash equivalents and short term restricted investments in marketable securities of $105.1 million. We continue to expect total operating expenses in fiscal 2011 to be between $75 and $85 million. As previously indicated, we plan to provide more guidance on revenue once the company has more established run rate with respect to NUEDEXTA sale.

With that summary of our financial results I’d like to turn the call over to Randall. Randall?

Kaye Randall

Thanks Christine and good afternoon everyone. We continue to be active and productive in our clinical research and medical affairs departments. Recently we presented data on both PBA and NUEDEXTA at the American Academy of Neurology Meeting in Honolulu, both the poster presentation on PBA prevalence and the podium presentation highlighting data on onset of action of NUEDEXTA were well attended and generated terrific discussions, we were delighted that in April we filed and IND application with the FDA for AVP-923 for the treatment of central neuropathic pain in patients with multiple sclerosis.

The 30-day FDA commentary period has now passed and we are now progressing to next steps in this trial. We have selected our CRO and are moving forward with site selection activities. It is our intent to enroll the first patient before the end of this calendar year. The objectives of the study are to evaluate the safety, tolerability and efficacy of the three dose levels of AVP-923 capsules for the treatment of central neuropathic pain in the population of patients with MS.

As you know, AVP-932 is a six-dose combination of dextromethorphan and quinidine. This trial is a multicenter, randomized, double-blind, placebo-controlled four-arm parallel study. Eligible patients will be randomized to receive one of the three dose levels of AVP-923. And these will contain either 45 milligrams of dextromethorphan, or DM, and 10 milligrams of quinidine, or Q; 30 milligrams of DM and 10 of Q; 20 milligrams of DM and 10 of Q or placebo; is being administered daily for 12 weeks.

The primary efficacy endpoint is the pain rating scale that is obtained from daily patient diaries. Secondary endpoints include measures of the fatigue and disability, impact of MS on daily lives, sleep quality, cognition and depression. Safety will be assessed by monitoring adverse events, clinical lab tests, ECGs, physical examinations and vital signs.

The filing of this IND represents the next step in our plan to broadly develop AVP-923 for conditions of the central nervous system with high unmet medical need. We expect to enroll approximately 400 patients at 65 centers, both in the U.S. and internationally.

As we announced a few days ago, we have also initiated plans for a patient registry to further quantify the prevalence and quality of life impact of PBA. I am very excited about the PRISM registry because this will ultimately be the largest PBA clinical registry ever performed. Among other things, the registry will allow us to assess the prevalence of PBA across the at-risk populations and evaluate the relationship between pseudobulbar affect and its impact on quality of life. Additionally, collecting data across multiple sites in the United States will ultimately allow participating investigators to compare the incidence of PBA within their practice to both regional and national numbers.

The objectives of the PRISM registry are to define the prevalence of PBA in patients with associated underlying neurologic conditions, including ALS, MS, Parkinson’s, stroke, traumatic brain injury and Alzheimer’s disease. We anticipate recruiting 10,000 patients who have an underlying neurologic condition into the registry across approximately 500 sites in the United States. We expect to begin recruiting sites and enrolling patients later this month and overall enrolment is expected to take at least six months. The data collected should serve as the basis for medical meeting presentations, peer review publications and educational content.

Finally, it’s worth mentioning that we’ve had a higher number of interactions with physicians who are interested in our investigator initiated studies program. This interest is indicative of the unique mechanism of action of NUEDEXTA and its many potential therapeutic applications.

Our medical science liaison team is working with a number of these physicians to identify and facilitate the submission of some of the most promising of proposals.

With that update on clinical research and medical affairs activities I’d like to hand the call back over to Keith now.

Keith Katkin

Thanks Randall. A few comments in closing before we open the call to questions. With a strong balance sheet, a high performing commercial team, and a clinical development team with a track record of proven success, our priorities for the next 12 months are clear. First, the continued focus on a successful launch of NUEDEXTA in PBA. We are executing on key launch activities and have made significant progress in a short period of time. Performance metrics are moving in a positive direction, our team is excited, and most importantly we are hearing stories of how NUEDEXTA is positively impacting patient’s lives.

Second, the enrollment of the first patient into the new clinical study for AVP-923 for the treatment of central neuropathic pain, multiple sclerosis, third the initiation and completion of a PRISM registry, and finally advancing the European filing of NUEDEXTA in PBA. We believe, we’re delivering on these imperatives will create substantial value for our shareholders.

Pharmaceuticals

Liisa Bayko, an analyst at JMP Group Inc.’s JMP Securities, earned the No. 1 ranking in the pharmaceutical sector in the Best on the Street survey by focusing on the industry’s science side. She picks stocks, she says, after identifying diseases that are primed for significant advances in treatment and then finding companies that are best positioned to take advantage.

Such was the case with Pharmasset Inc., Ms. Bayko’s top-performing pick in 2010. She concluded that the company’s experimental drugs were poised to do what current hepatitis C treatments couldn’t: prevent the virus from developing resistance to therapy. Ms. Bayko entered 2010 with a buy rating on Pharmasset and kept it there all year. Shares more than doubled on the year.

Ms. Bayko’s research led her to another high-performing pick, Ardea Biosciences Inc. Ardea has a gout treatment called lesinurad under development that could provide a major improvement when combined with a current drug, she says. Yet investors were concerned that lesinurad could cause kidney problems, dimming its prospects for approval.

Ms. Bayko’s study suggested the fears were overstated. She recommended buying Ardea throughout 2010, and shares returned 86% for the year. In January of this year, Ardea issued positive top-line results from a Phase II study on lesinurad.

The science-first approach follows from Ms. Bayko’s background. The 39-year-old is a medical biophysicist by training who worked for Monsanto Co.’s Searle drug unit before entering finance. She realized during graduate school at the University of Toronto that she preferred talking about her laboratory’s work with fellow researchers to doing the actual experiments. “That’s why what I do now is a good fit,” she says.

Not all of Ms. Bayko’s picks worked out. In September, she put a buy on Trius Therapeutics Inc. She considered the stock a value after reviewing the clinical-trial data for its experimental treatment for antibiotic-resistant bacteria, but shares fell 13.7% through the end of the year.

Ms. Bayko says the stock was hurt because Trius wasn’t going to be able to provide any Phase III clinical-trial data on its antibiotic, torezolid, until the beginning of 2012. She says the drug’s Phase II data show promise, and she still recommends buying Trius shares. The stock has rebounded somewhat this year.

Overall, Ms. Bayko says investors will need to be more selective when choosing where to make their bets this year. Stocks, she says, can’t benefit generally like they did in 2010 after the health-care overhaul turned out to be less onerous than feared. And, she adds, many enjoyed big gains last year that will be tough to match.

Both Pharmasset and Ardea remain key picks for Ms. Bayko in 2011. Though Pharmasset surged last year, shares could jump even further as the company releases more data about its hepatitis C pipeline, Ms. Bayko says.

Ms. Bayko is also excited about the potential of a class of therapies known as Janus kinase, or JAK, inhibitors, to treat a range of diseases, from rheumatoid arthritis to psoriasis and even cancer. Two of her favorite stocks for this year, Incyte Corp. and YM BioSciences Inc., are working on such therapies.

J&J files new Concerta lawsuit against Impax Labs

Impax Laboratories Inc. said Friday it received a second patent lawsuit from Johnson & Johnson’s Alza Corp. division related to Impax’s proposed generic version of drug Concerta, which treats the attention deficit hyperactivity disorder.

Impax said the lawsuit alleges its generic violates patents belonging to Alza supporting Concerta tablets of 18 milligrams, 27 milligrams and 36 milligrams.

In November, another J&J unit — Ortho-McNeil-Janssen Pharmaceutical — sued Impax over a generic version of 54-milligram Concerta tablets.

Impax, based in Hayward, Calif., said U.S. sales of Concerta totaled $1.4 billion in the 12 months ended Feb. 28.

On Monday, Watson Pharmaceuticals Inc. started selling an authorized generic version of Concerta. Ortho-McNeil-Janssen Pharmaceutical is making and supplying the drug to Watson. Watson is marketing the drug and pays Ortho-McNeil-Janssen a share of the revenue from sales. The agreement lasts until 2014.

Impax’s generic has not been approved by the Food and Drug Administration. Teva Pharmaceutical Industries Ltd. will market Impax’s drug once the product is approved.

Shares of Impax Laboratories shares fell 74 cents, or 2.6 percent, to $27.40 on Friday.

Shares of Johnson & Johnson, which is based New Brunswick, N.J., rose 26 cents to $65.27 Friday and fell 4 cents to $65.23 in aftermarket trading.

Optimer Pharmaceuticals Reports First Quarter 2011 Financial Results

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced its financial results for the quarter ended March 31, 2011.

Optimer reported net income for the first quarter of 2011 of $45.1 million, or $1.06 and $1.04 per basic and diluted share, respectively, as compared to a net loss for the first quarter of 2010 of $13.5 million, or ($0.39) per share on both a basic and diluted basis. The increase in net income was primarily due to licensing revenue from a $69.2 million upfront payment received from Astellas Pharma in connection with the DIFICID™ collaboration and license agreement. The increase was partially offset by a $10.4 million increase in operating expenses, including $4.3 million in licensing costs due to a royalty payment to Par Pharmaceutical associated with the Astellas upfront payment.

In addition, marketing expenses for the first quarter of 2011 increased $3.2 million compared to the prior year period due to market research and pre-commercialization efforts related to the DIFICID program. General and administrative expenses increased $5.9 million compared to the first quarter of 2010 due to increases in consulting expenses and advisory fees related to DIFICID collaborations, increases in compensation expense, including a $1.0 million increase in stock compensation expense, and increased headcount, including the establishment of a market access team. Research and development expenses decreased $2.9 million compared to the first quarter of 2010 due to a $5.0 million milestone payment in the prior year due to Par for the successful completion of the second DIFICID Phase 3 trial offset by an increase in medical affairs and publication expenses.

As of March 31, 2011, Optimer held cash, cash equivalents and short-term investments of $180.1 million.

“Optimer was extremely productive in the first quarter of 2011. We participated in a highly successful FDA Advisory Committee meeting, wherein we secured a unanimous vote supporting the safety and efficacy of DIFICID for the treatment of CDI. We also entered into collaboration agreements with Astellas in Europe and other countries to market DIFICID and with Cubist in the U.S. to co-promote DIFICID. We believe this will help us maximize the impact of a potential DIFICID commercial launch,” said Pedro Lichtinger, President and CEO of Optimer. “We continue to work with the FDA as it considers our DIFICID NDA and we look forward to the FDA’s decision on our NDA by the May 30th PDUFA date. Meanwhile, we are continuing to build our commercial team and marketing program with the goal of positioning for a successful product launch pending FDA approval.”

First Quarter and Recent Corporate Highlights
U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee recommended in a unanimous 13-0 decision, that the FDA approve DIFICID for the treatment of patients with Clostridium difficile infection (CDI). While the advisory committee vote was split on how best to describe the recurrence benefit, the committee members overwhelmingly recognized that DIFICID at 30 days after treatment was superior to vancomycin. The FDA has assigned a Prescription Drug User Fee Act goal date of May 30, 2011.
Announced co-promotion agreement with Cubist Pharmaceuticals to market DIFICID for the treatment of CDI in the U.S. In an effort to accelerate the rate of launch of DIFICID, if approved, Optimer and Cubist will co-promote DIFICID to physicians, hospitals, long-term care facilities and other healthcare institutions and will also jointly provide medical affairs support for the product.
Announced collaboration with Astellas Pharma Europe Ltd. to develop and commercialize DIFICID for the treatment of CDI in Europe and certain other countries in the Middle East, Africa, and the Commonwealth of Independent States. Optimer received a $69.2 million upfront cash payment and is eligible to receive milestone payments of up to approximately 115.0 million Euros and tiered double-digit royalty payments on net sales of DIFICID in the territory.
Raised $73.1 million in net proceeds in a public offering of common stock in February 2011.
Strengthened the management team in preparation for the potential commercial launch of DIFICID with the appointments of Nancy M. Ruiz, M.D., as Senior Vice President of Research and Development, Cynthia Schwalm, as Senior Vice President of International, Kasia Petchel, M.D., as Senior Vice President of Pharmacovigilance, and Glenn Tillotson, Ph.D., as Senior Vice President of Medical Affairs. Optimer also made two significant promotions, consisting of the promotion of Sherwood Gorbach, M.D. to the position of Chief Scientific Officer and Senior Vice President, and the promotion of Marc Lesnick, Ph.D., to Vice President of Regulatory Affairs.
DIFICID North American Phase 3 trial results were published in The New England Journal of Medicine in an article titled, “Fidaxomicin versus Vancomycin for Clostridium difficile infection,” in the February 3, 2011 issue.
Two DIFICID patents were issued by the U.S. Patent and Trademark Office, one which covers methods of CDI treatment with DIFICID and one which covers additional dosage forms of DIFICID. Both patents are eligible for listing in the FDA’s Orange Book.
Announced appointment of former Chief Executive Officer and Chairman of the Board of Directors of Pfizer, Hank McKinnell, Ph.D. to Optimer’s Board of Directors.

About Optimer Pharmaceuticals

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has two anti-infective product candidates in development, DIFICID™ (fidaxomicin) and Pruvel™ (prulifloxacin). DIFICID is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company’s request for six-month Priority Review of the NDA for DIFICID, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a MAA with the European Medicines Agency (EMA) for DIFICID. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.

Forward-looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the development and potential approval and commercialization of DIFICID, the expected benefits of and activities under Optimer’s collaboration and co-promotion agreements, the timing of any review of regulatory submissions, and the potential payment of milestones or royalties by Astellas. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer’s business including, without limitation, risks relating to: whether the FDA or other regulatory authorities will meet their goals for reviewing Optimer’s regulatory submissions, whether Optimer will receive regulatory approval for DIFICID, the fact that the FDA may not follow the advice of the Advisory Committee with respect to the approval of DIFICID, Optimer’s ability to recognize anticipated benefits from its collaborations with Astellas and Cubist, the costs and timing of commercializing DIFICID in the U.S., if approved, potential labeling restrictions on DIFICID, if approved, the ability of Optimer and its collaboration partners to successfully commercialize DIFICID, if approved, and other risks detailed in Optimer’s filings with the Securities and Exchange Commission.

Arizona pharmaceutical fined, put on probation for making dietary supplements with steroids

BOISE, Idaho — An Arizona-based pharmaceutical company has been fined and placed on probation for violating federal laws governing dietary supplements.

Tribravus Enterprises, which also does business as IForce Nutrition in California, was penalized this week in federal court in Boise. The company was convicted for distributing drugs that violated the federal Food, Drug and Cosmetic Act.

U.S. District Judge B. Lynn Winmill fined the company $125,000 and imposed stricter testing protocols during a three-year probation to make sure the company’s future diet pills don’t contain banned steroids.

Food and Drug Administration investigators found that the company’s dietary pills and capsules contained synthetic steroids and should have been regulated as unapproved drugs under federal laws.

The charges were filed in Idaho because Tribravus delivered its products to an Idaho retail company for wider distribution.

Georgia joins $44.3 million pharmaceutical settlement

Georgia has joined other states and the U.S. government in reaching a $44.3 million settlement with the pharmaceutical manufacturer EMD Serono Inc., the state Attorney General’s Office said Thursday.

The agreement settles allegations that false or fraudulent claims for the drug Rebif, which treats multiple sclerosis, were submitted to the Medicaid program. From 2002 through 2009, according to the allegations, EMD Serono paid inducements to health-care professionals to get them to prescribe Rebif. Under the agreement, Georgia will receive $399,412.

The inducements included activities such as promotional speaking engagements, attending speaker training, advisory and consultant meetings, educational grants and charitable contributions, the AG’s office said. The investigation was launched after a federal whistle-blower lawsuit was filed against the company in Maryland.

Investigators from the National Association of Medicaid Fraud Controls Units participated in the probe and conducted settlement negotiations with EMD Serono on behalf of the states, the AG’s office said.

Par 1Q profit falls on costs, lower sales

Par Pharmaceutical posted a first-quarter loss Thursday following a quarter in which the generic drug developer saw sales of a key drug slide and also a hefty legal charge.

The $196 million charge was related to a settlement related for federal and state claims that the company improperly inflated wholesale drug prices. Excluding the charge, the company said it earned 96 cents per share. Analysts polled by FactSet expected 89 cents per share in profit on $227.8 million in revenue.

The company lost $109 million, or $3.07 per share, compared with a profit of $26.3 million, or 75 cents per share, during the same period a year prior. Revenue fell 20 percent to $233 million from $291.9 million.

Savient Pharmaceuticals Reports First Quarter 2011 Financial Results

Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today reported financial results for the three months ended March 31, 2011. Savient ended the quarter with $268.0 million in cash and short-term investments, an increase of $203.1 million since December 31, 2010, primarily due to the issuance and sale of $230 million in convertible notes during February 2011. For the first quarter of 2011, the Company had a net loss of $13.5 million, or $0.19 per share, on total revenues of $1.3 million. This compares with a net loss of $8.3 million, or $0.13 per share, on total revenues of $1.1 million for the same period in 2010.

“The first quarter of 2011 was dedicated to the U.S. launch of KRYSTEXXA® into the refractory chronic gout market,” said John H. Johnson, chief executive officer of Savient. “Since the March market introduction, we have had a laser focus on our commercialization efforts and we are pleased with the positive reception that KRYSTEXXA has received. As part of our long-term strategy to expand the global opportunity for KRYSTEXXA, we have submitted a Marketing Authorization Application to the European Medicines Agency. We are focused on achieving our goals while carefully managing costs and building value for shareholders.”

Johnson continued, “In the short period of time since our launch, we have learned a great deal and we now have a clearer picture of how we can most effectively accelerate the market introduction of KRYSTEXXA. The miscellaneous J-code has presented some Medicare billing concerns. We expect to receive the permanent J-code in January, which we believe will provide a catalyst for many doctors to move their patients onto KRYSTEXXA, and anticipate that the full effect of our efforts on the ramp up will be realized in the second quarter 2012.”

Operational Highlights:
Submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for KRYSTEXXA for the treatment of chronic gout in adult patients refractory to conventional therapy.

Announced that three abstracts will be presented at the European League Against Rheumatism (EULAR) 2011 Annual Congress, two for oral presentation and one for poster presentation.

Enhanced management team with key new members, including Rick Crowley as Executive Vice President Biopharmaceutical Operations.

Received a contract by the U.S. Department of Veterans Affairs (VA) to supply KRYSTEXXA and Oxandrin® to the VA for a term of five years effective April 1, 2011.

Received notice from the Centers for Medicare and Medicaid Services that a temporary “C-code” has been assigned to KRYSTEXXA (pegloticase) effective April 1, 2011.

Financial Results of Operations for the Three Months Ended March 31, 2011

Total revenues increased $0.2 million, or 18%, to $1.3 million for the three months ended March 31, 2011, as compared to $1.1 million for the three months ended March 31, 2010. The increase in net sales resulted primarily from the Company’s full commercial launch of KRYSTEXXA during March 2011, generating $0.3 million in net sales during the quarter.

Research and development expenses decreased $2.6 million, or 41%, to $3.7 million for the three months ended March 31, 2011, as compared to the three months ended March 31, 2010. The decrease in expenses related to lower costs associated with process validation work at our potential secondary source supplier of pegloticase drug substance coupled with a decrease in clinical trial costs relating to the wind down of the open label extension study for KRYSTEXXA in 2010.

Selling, general and administrative expenses increased $11.7 million, or 236%, to $16.6 million for the three months ended March 31, 2011, from $4.9 million for the three months ended March 31, 2010. The higher costs were primarily due to increased selling and marketing expenses associated with the full commercial launch of KRYSTEXXA in March 2011. We incurred significant costs related to the build out of a commercial infrastructure to support the launch of KRYSTEXXA including the hiring of a 60-person sales force and other sales support personnel.

Interest expense was $3.1 million for the three months ended March 31, 2011, primarily related to $1.7 million of interest expense from the 4.75% coupon on our convertible notes coupled with $1.4 million of non-cash amortization expense also associated with the issuance of our convertible notes.

Global Pharmaceutical Market Remains in Declining Growth Trend

Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that in 2010, the global pharmaceutical market continued to show declining growth. According to new data from Decision Resources’ Pharmaview suite, global pharmaceutical sales grew year-over-year by a mere 3.2 percent to reach $669 billion, compared with 3.5 percent year-over-year growth in 2009 and 7.5 percent year-over-year growth in 2008. Over the next seven years, the global market is expected to record a compound annual growth rate (CAGR) of 2.2 percent, reaching $778 billion in 2017.

“The limited growth is not surprising as patent expires, payer cost-containment strategies and lack of research and development productivity continue to negatively impact the pharmaceutical market”

In the United States, sales continued to stagnate, with 0.7 percent year-over-year growth in 2010, increasing to $283 billion. The U.S. market will continue to idle, with an expected CAGR of 1.7 percent between 2010 and 2017, reaching $318 billion in 2017.

“The limited growth is not surprising as patent expires, payer cost-containment strategies and lack of research and development productivity continue to negatively impact the pharmaceutical market,” said Decision Resources’ Pharmaview Director Alasdair Milton, Ph.D. “In response, many large pharmaceutical companies are revamping R&D efforts, diversifying their business models into consumer health and generics, and collaborating with small biotechs and peer companies. They are also looking at emerging markets; while the sheer size of patient numbers involved make these geographies attractive targets, companies should realize that doing business in these areas poses its own unique challenges.”

The sales findings are from the most recent release of Decision Resources’ Pharmaview, which assesses the commercial aspect of the global pharmaceutical market and provides continually updated analysis of more than 2,200 drugs from more than 240 companies, covering 150 product classes and 14 therapy areas. Pharmaview also provides company profiles on the leading players in the pharmaceutical market, recently adding Otsuka to its coverage.

UPDATE 1-Cephalon profit misses, company likes Teva deal

* Q1 adjusted EPS $1.98 vs Street view $2.04

* Revenue $745.1 million

* Says Teva offer provides maximum shareholder value

NEW YORK, May 3 (Reuters) – Cephalon Inc (CEPH.O), which this week agreed to be bought by Teva Pharmaceutical Industries Ltd (TEVA.TA) for $6.8 billion, reported lower-than-expected first-quarter earnings as costs jumped 37 percent and revenue fell short of Wall Street estimates.

Cephalon had resisted an unsolicited takeover bid by Canada-based Valeant Pharmaceuticals International (VRX.TO) when Israel-based Teva swooped in with its higher offer.

“After analyzing a full range of strategic options, our board concluded that the Teva offer provides the maximum shareholder value for Cephalon shareholders,” Chief Executive Kevin Buchi said in a statement.

The specialty pharmaceutical company reported a net profit of $211.1 million, or $2.64 per share, compared with a profit of $100.3 million, or $1.35 per share, a year ago.

Excluding items, Cephalon had adjusted earnings of $1.98 per share. Analysts on average expected $2.04 cents per share, according to Thomson Reuters I/B/E/S.

Revenue rose 25 percent to $745.1 million, but fell short of Wall Street estimates of $751 million.

Costs and expenses rose 37 percent to $569.3 million. (Reporting by Bill Berkrot. Editing by Robert MacMillan)

Jazz Pharmaceuticals Announces First Quarter 2011 Financial Results

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced financial results for the first quarter of 2011.

Total revenues for the quarter ended March 31, 2011 were $50.9 million, compared to $35.2 million for the first quarter of 2010. Total revenues included net product sales, royalties and contract revenues.

GAAP net income for the first quarter of 2011 was $21.8 million, or $0.48 per diluted share, compared to $1.5 million, or $0.04 per diluted share, for the first quarter of 2010. Adjusted net income for the first quarter of 2011 was $26.8 million, or $0.59 per diluted share, compared to $6.1 million, or $0.18 per diluted share, for the first quarter of 2010. A reconciliation of GAAP net income to adjusted net income and the related per diluted share amounts is included with this press release.

Net sales of Xyrem® (sodium oxybate) oral solution increased 49 percent to $42.8 million for the first quarter of 2011, compared to net sales of $28.7 million for the first quarter of 2010. Net sales of once-daily Luvox CR® (fluvoxamine maleate) were $7.1 million for the first quarter of 2011, compared to $5.5 million for the prior year period, an increase of 29 percent.

“Our first quarter results reflect strong sales momentum for Xyrem,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “We are committed to helping patients suffering from narcolepsy.”

Selling, general and administrative expenses for the first quarter of 2011 were $19.9 million, compared to $16.8 million for the first quarter of 2010, primarily due to higher headcount related expenses, including stock based compensation, and legal and information technology expenses. Research and development expenses for the first quarter of 2011 were $3.7 million, compared to $6.2 million for the first quarter of 2010, reflecting lower product development spending.

Interest expense for the first quarter of 2011 was $0.8 million, compared to $5.8 million for the prior year period. As of March 31, 2011, cash and cash equivalents were $65.1 million, an increase of 45 percent from $44.8 million at December 31, 2010.

Pipeline Developments

Jazz Pharmaceuticals is also providing an update on its JZP-6 and JZP-8 development programs:

The company has decided that it will not proceed with the additional clinical studies to support the development of JZP-6 (sodium oxybate) in fibromyalgia requested by the Food and Drug Administration (FDA) in its October 2010 complete response letter. This decision follows an internal analysis of the cost, development time and likelihood of regulatory success associated with further clinical development.
Given the estimated costs, development timeline and competitive environment for JZP-8 (intranasal clonazepam), the company is reevaluating whether or how to proceed with additional development.

Narrower Loss at BioMarin

BioMarin Pharmaceutical Inc.’s (BMRN – Analyst Report) first quarter 2011 loss of $0.04 per share was narrower than the Zacks Consensus loss estimate of $0.10 per share. The narrower-than-expected loss was attributable to higher-than-expected revenues recorded by BioMarin in the first quarter of 2011. The company reported break-even earnings (on an adjusted basis) in the year-ago quarter.

Total revenues climbed approximately 28.9% to $109.5 million in the reported quarter. Revenues surpassed the Zacks Consensus Estimate of $104 million. Revenues were boosted by higher sales of the key products at BioMarin.

Net product revenues in the reported quarter climbed approximately 29.7% to $109.1 million. Naglazyme, approved for treating MPS-VI, a rare genetic enzyme deficiency disorder, contributed the bulk of the net product revenues recorded in the quarter. Revenues from the drug climbed 24.7% to $60.6 million. Naglazyme revenues were boosted by the receipt of an order from the Brazilian government in the quarter.

Net product revenues from Kuvan tablets, indicated for treating mild-to-moderate forms of phenylketonuria (PKU), grew 25.9% to $26.7 million. The increase was attributable to the higher demand for commercial tablets in the US. Revenues for BioMarin from another enzyme replacement therapy, Aldurazyme, increased 31.7% over the prior-year quarter to $18.7 million. BioMarin co-markets the drug with Sanofi-Aventis (SNY – Analyst Report).

In addition to the above-mentioned products, BioMarin possesses the rights to Firdapse through its acquisition of Huxley Pharmaceuticals in October 2009. Net revenues from Firdapse, currently marketed in Europe, were $3.1 million in the quarter. Firdapse was launched in April 2010, in the European Union, for treating patients suffering from Lambert Eaton Myasthenic Syndrome (LEMS) – a rare autoimmune disorder.

2011 Guidance

Apart from announcing financial results, BioMarin also provided guidance for 2011. The lower ends of the guidance range for total revenue and net product revenue have been raised. Total revenues are expected in the range of $422 million-$452 million (old guidance $417 million-$452 million). Net product revenues are expected in the range of $416 million- $446 million (old guidance $411 million-$446 million).

Revenue guidance for the marketed products at BioMarin is as follows: Naglazyme – $211 million-$225 million (old guidance $206-$225 million); Kuvan – $112-$120 million (unchanged); Aldurazyme – $79–$83 million (unchanged); and Firdapse – $14-$18 million (unchanged). The outlook for selling, general and administrative expenses and research & development expense remained unchanged at $164-$174 million and $195-$205 million respectively.

Perrigo Q3 Profit Rises; Lifts FY11 Earnings View – Update

Perrigo Co. (PRGO: News ), Monday reported an increase in profit for the third quarter, driven mainly by higher sales, reflecting the acquisitions of PBM Holdings and Orion Laboratories. The pharmaceutical and nutritional products maker also raised its full-year 2011 earnings guidance.

Perrigo’s net income for the quarter was $89.09 million or $0.95 per share, compared to $62.18 million or $0.67 per share last year.

Income from continuing operations for the quarter improved to $91.53 million or $0.98 per share from $61.54 million or $0.66 per share in the year-ago quarter. Excluding few one-time charges, adjusted income from continuing operations for the quarter rose to $100.21 million or $1.07 per share from $75.43 million or $0.81 per share in the prior year.

Analysts polled by Thomson Reuters expected the company to report earnings of $0.97 per share for the quarter. Analysts’ estimate typically excludes special items.

Net sales for the quarter grew 29 percent to $691.56 million from $537.63 million last year, mainly helped by the acquisitions of PBM Holdings and Orion Laboratories, as well as $44 million in new product sales.

Analysts expected the company to generate revenues of $687.93 million for the quarter.

Gross margin for the quarter improved to 34.3 percent from 33.3 percent last year.

Consumer Healthcare segment net sales for the quarter advanced 13 percent to $425 million from last year, reflecting nearly $36 million in additional existing product sales as well as $9 million from new product sales and $7 million of incremental sales from the acquisition of Orion.

Nutritionals segment net sales for the quarter more than doubled to $124 million from $59 million last year, mainly helped by additional sales of almost $81 million attributable to the acquisition of PBM Holdings.

The Rx Pharmaceuticals segment third-quarter net sales grew 66 percent to $84 million from last year, due primarily to new product sales of $23 million related to the authorized generic of Aldara and the generic version of Xyzal.

Looking forward, the company raised its fiscal year 2011 guidance for earnings from continuing operations to a range of $3.43 to $3.53 per share, from previous range of $3.28 to $3.43 per share.

Excluding one-time items, fiscal year 2011 earnings from continuing operations are now expected in the range of $3.90 – $4 per share, from the previous range of $3.75 to $3.90 per share.

Analysts currently expect earnings of $3.89 per share for the full year.

PRGO is currently trading on the Nasdaq at $87.48, down $2.50 or 2.78%, on a volume of 1.19 million shares.

Optimer Pharmaceuticals Expands Senior Management Team

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced the appointment of Nancy Ruiz, M.D., as Senior Vice President of Research and Development, Cynthia Schwalm as Senior Vice President of International and Kasia Petchel, M.D., as Senior Vice President of Pharmacovigilance. These newly created positions will strengthen the senior management team as the Company prepares for the potential launch of its lead product candidate, DIFICID™, while seeking to build its hospital specialty products capability and pipeline.

“With the recent FDA Advisory Committee’s unanimous vote in favor of market approval of DIFICID for the treatment of Clostridium difficile infection, we are taking additional steps to build a powerful team that will contribute to a successful product launch and long term company growth,” said Pedro Lichtinger, Optimer’s President and CEO. “These additions to our senior management team will support the safety and risk management of DIFICID, maximize our international business, and improve our capability to build our product pipeline.”

Dr. Ruiz joins Optimer with more than 20 years of Phase 1 through Phase 4 clinical research experience in infectious diseases and immunology, which includes more than 15 years in the pharmaceutical industry. She joins Optimer from Merck Research Laboratories (formerly Schering-Plough Research Institute) where she served as Vice President, Project and Pipeline Management for Infectious Diseases. During that tenure she fulfilled several leadership and strategic roles, including Senior Project Leader of early and late development teams responsible for the C. difficile monoclonal antibody program, as well as the antifungal, antibacterial, vaccines, HIV and hepatitis C teams (including the development and recent filing of boceprevir). Previously, Dr. Ruiz held several leadership roles at Bristol-Myers Squibb, where she gained global early and late clinical development and medical affairs experience in infectious diseases (HIV- Sustiva®, Reyataz®; hepatitis B-Baraclude®) and immunology (rheumatoid arthritis- Orencia® and transplant- belatacept). Prior to initiating her career as a clinician and clinical investigator, Dr. Ruiz received her B.A. at Temple University in Philadelphia and her M.D. at the Ponce School of Medicine in Puerto Rico. She is a Diplomat of the American Board of Internal Medicine and the American Board of Infectious Diseases and a Fellow of the American College of Physicians and Fellow of the Infectious Diseases Society of America.

Ms. Schwalm brings a strong track record of growth and development in hospital and specialty markets during her 30 years of experience in the fields of pharmaceuticals, biotechnology, medical devices and health care delivery. She joins Optimer from Eisai Pharmaceuticals, Inc., the U.S. commercial arm of Tokyo-based Eisai Co., LTD, where she served as President. Ms. Schwalm had full operating responsibilities for Eisai Pharmaceuticals where she led commercial, medical and manufacturing functions. Her team built independent commercial capabilities for Eisai and drove double digit top line and bottom line P&L growth during her tenure. She came to Eisai in 2008 from Amgen Inc. where, over the course of her five-year tenure, she rose to Vice President and General Manager of the U.S. oncology business. Under her leadership, the unit’s annual revenues tripled to over $5 billion, as she directed approximately 500 people in all areas of oncology strategy and commercialization. Prior to Amgen, she spent 18 years at Johnson & Johnson holding positions of increasing responsibility, culminating in her appointment as the managing director of Ortho-Biotech UK & Ireland. At Johnson & Johnson Ms. Schwalm also led worldwide franchise development for two franchises in the pharmaceuticals division. Ms. Schwalm is a member of Harvard JFK School of Public Policy Women’s Leadership Board and the International Women’s Forum, a merit-based organization of the highest ranking women in business. In April 2009, she was recognized as one of New Jersey’s Top 50 Women in Business by NJ Biz. Ms. Schwalm also serves on the boards of the Sarah Cannon Research Institute, The Children’s Aid and Family Services Organization of Bergen County, NJ and Beth Abrahams Family Services, NYC. She holds a B.S. degree in nursing from the University of Delaware and an M.B.A. from the Wharton School of Business.

Dr. Petchel joins Optimer with more than 20 years of pharmaceutical industry experience in safety science, pharmacovigilance and risk management. Prior to joining Optimer, Dr. Petchel was the Vice President, Global Head Drug Safety Risk Management at Roche. There she led the company’s Global Safety organization and initiated significant changes to advance into proactive benefit risk management. During this time, Dr. Petchel also chaired Roche’s Drug Safety Committee (DSC), the highest corporate body for all assessments of product safety. Prior to that, she served as an executive at Pfizer, Inc. from 1996 to 2006, most recently as the Vice President and Global Head Safety Surveillance Reporting, where she oversaw more than 500 staff in four global locations, focusing on long-term strategic planning for safety. Prior to her career at Pfizer, she worked at various positions in the pharmaceutical industry including late Phase 3 development activities, global medical affairs and drug safety, spanning companies such as Ciba-Geigy, Sanofi and Zeneca, with assignment locations in North America, Switzerland, Singapore and South East Asia. Dr. Petchel is a board-certified physician epidemiologist and received her M.D. at the University of Zagreb, Croatia and her postgraduate training at Harvard University. Dr. Petchel is also a founding board member and a past Vice President and President of the American Academy of Pharmaceutical Physicians.

About Optimer Pharmaceuticals

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has two anti-infective product candidates in development, DIFICID™ (fidaxomicin) and Pruvel™ (prulifloxacin). DIFICID is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company’s request for six-month Priority Review of Optimer’s NDA for DIFICID, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a MAA with the European Medicines Agency (EMA) for DIFICID. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea.

Forward Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the potential approval and commercial launch of DIFICID, Optimer’s establishment of a commercial organization, the potential growth of Optimer’s product pipeline and the future roles and contributions of Dr. Petchel, Ms. Schwalm, and Dr. Ruiz at Optimer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer’s business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product development efforts, the receipt of regulatory approvals, Optimer’s ability to recruit and retain a commercial sales force, Optimer’s ability to identify and develop additional product candidates and other risks detailed in Optimer’s filings with the Securities and Exchange Commission.

Government ‘politicising’ PBS process

Health groups say cancer patients and people with schizophrenia are among those who will be affected by the Federal Government’s decision to delay subsidising some medicines.

The Government has delayed putting several medicines on the Pharmaceutical Benefits Scheme (PBS), against the advice of its Pharmaceutical Benefit’s Advisory Committee (PBAC), as it tries to find budget savings.

The Consumers Health Forum’s Carol Bennet says the Government has politicised the process and it is a false economy.

She says the Government is ignoring the advice of independent experts.

“The impact on the health system is likely to be far greater than the short-term financial gain that may be made by not listing these drugs,” she said.

“We’re concerned because this politicises what was previously a very good process that had integrity, that had independence from Government, and already takes into account the cost effectiveness of the medications that the PBAC recommends.”

Federal Health Minister Nicola Roxon says the decision to delay giving subsidies for some medicines was about balancing priorities.

She says the Government is watching every dollar carefully.

“Those recommendations have always come to government for approval and government has always had to make choices whether to spend money on new listing of drugs or on other health priorities,” she said.

Ms Roxon is meeting concerned groups in Melbourne this morning, including the Australian Medical Association.

She says the independent assessments are detailed and the recommendations are taken seriously and there are other options for patients.

She says the Government is responsible to providing a broad range of health services, not just medicine.

“There are a range of other health needs that both they and other members of the community need in addition to access to medicines,” she said.

“Our Government is responsible for providing those as well and we need to be able to balance which is the most important priority at any particular time.”

EU Probes Teva, Cephalon Deal on Sleeping Drug

European Union antitrust regulators said Thursday they are investigating whether drug makers Cephalon and Teva were working to keep a generic version of sleep-disorder drug Provigil out of the European market.

U.S.-based Cephalon Inc. and Israel-based Teva Pharmaceutical Industries Ltd., one of the world’s largest generic drugs maker, in 2005 settled patent disputes relating to Provigil — which is also known as Modafinil — in the U.K. and the U.S.

As part of that deal, Teva agreed not to sell its generic version of Provigil in the EU as well as Iceland, Liechtenstein, and Norway before Oct. 2012, the EU’s competition watchdog said.

The European Commission is now probing whether that agreement broke EU competition rules and had the “object or effect” of keeping generic Provigil out of the European market.

So-called “pay-for-delay” deals between brand-name and generic drug makers have come under scrutiny from competition authorities on both sides of the Atlantic, who fear such agreements hurt consumers who have to pay much higher prices for the brand-name drugs even after patents expire.

The U.S. Federal Trade Association filed a lawsuit against Cephalon in 2008, alleging the company paid off potential competitors to keep a cheaper version Provigil off the market.

Provigil, which treats sleeping disorders such as narcolepsy and obstructive sleep apnoea, generated $1.12 billion in revenue for Cephalon last year.

Cardinal Health fiscal 3rd-quarter profit climbs 11 percent, boosted by pharmaceutical segment

DUBLIN, Ohio — Cardinal Health Inc. said Thursday its fiscal third-quarter earnings climbed 11 percent, as the health care products distributor saw a big jump in profitability from its pharmaceutical segment.

The Dublin, Ohio, company also raised its 2011 earnings forecast.

Cardinal Health earned $246 million, or 70 cents per share, up from $222.4 million, or 61 cents per share, in the same quarter last year. Revenue rose 7 percent to $26.07 billion.

Adjusted earnings — which exclude discontinued operations, restructuring costs and other items — were 75 cents per share.

Analysts surveyed by FactSet expected, on average, earnings of 69 cents per share on $25.97 billion in revenue.

Cardinal Health said pharmaceutical segment profit climbed 25 percent to $384 million, helped by its pharmaceutical distribution business and acquisitions completed earlier this year. Medical segment profit slipped less than 1 percent due to the impact of commodity price increases on the cost of products sold and sluggishness in surgical procedure volumes.

Distribution, selling, general and administrative expenses climbed 11 percent to $697.3 million.

The company now expects adjusted 2011 earnings per share of between $2.61 and $2.67, up from its previous forecast of between $2.54 and $2.60. Analysts expect, on average, earnings of $2.60 per share.

Cardinal Health shares fell 62 cents to close at $43.49.

UPDATE 1-Par Pharmaceutical settles drug pricing lawsuits

Says settlement will remove major damages and trials (Follows alerts)

(Reuters) – Par Pharmaceutical Cos Inc said it settled drug pricing lawsuits against it that allegedly caused government entities to pay inflated reimbursements for $153 million.

Par was named a defendant along with other pharmaceutical manufacturers in the lawsuits brought by Ven-A-Care of the Florida Keys Inc and attorney generals of Alaska, South Carolina, and Kentucky under state law.

The lawsuits claimed that these companies reported prices which made the government entities to pay inflated reimbursements for drugs under Medicaid or other programs.

The Woodcliff Lake, New Jersey-based company denied the allegations.

The settlement will eliminate majority of damages asserted and all trials scheduled to date, the company said.

Shares of the company closed at $34.54 on Wednesday on the New York Stock Exchange. (Reporting by Kavyanjali Kaushik in Bangalore;Editing by Vyas Mohan)

FDA Panel Unanimously Recommends Approval For New Hepatitis C Drug Boceprevir

In a unanimous vote today, an advisory committee to the United States Food and Drug Administration (FDA) recommended that boceprevir be approved for treatment of hepatitis C. Boceprevir is being developed by the U.S. pharmaceutical company Merck.

The FDA is expected to make a decision on boceprevir’s approval next month. Although the FDA is not required to follow the recommendations of its advisory committees, it usually does.

Boceprevir (or Victrelis, its proposed brand name) is one of two new hepatitis C virus (HCV) drugs being evaluated by the advisory committee this week. Boceprevir and telaprevir, made by Vertex Pharmaceuticals, are both HCV protease inhibitors, which work by inhibiting HCV replication in the body. The committee will decide on a recommendation for telaprevir tomorrow.

In the U.S., approximately 30 percent of people with HIV also have HCV. People with HIV are less likely to clear HCV than uninfected individuals, and HCV treatment is less effective in people with HIV (see related AIDS Beacon news).

Both boceprevir and telaprevir are meant to supplement the current standard treatment for hepatitis C, a combination of the drugs ribavirin (Rebetol, Copegus) plus Pegasys (pegylated interferon alfa-2a) or PegIntron (pegylated interferon alfa-2b).

The advisory committee raised a number of concerns regarding the safety of boceprevir, the manufacturer’s proposed dosing schedule for the drug, and whether African-Americans need longer treatment times (African-Americans typically do not respond as well to HCV treatment).

Nevertheless, the committee decided that the safety concerns – primarily involving anemia and related blood problems – were manageable and that its efficacy warrants FDA approval.

The committee was split on whether the drug should be recommended for so-called “null responders,” people with HCV who have only a minimal response to standard treatment. They were also split on whether certain populations, such as African-Americans, should take boceprevir longer.

In both cases, many panel members decided there was not enough information and recommended additional studies be conducted in null responders and African-Americans.

Supreme Court Justices Question Vermont Law Barring Rx Data Access

Vermont Law

Pharmacies are required by law to collect and maintain files about each prescription they fill and then can sell that information — including the prescribing doctor’s name and address, and the amount of drug prescribed — to data collection firms. Patient information is not included in the data.

The data mining firms then sell that information to drugmakers, which use it to market products to doctors.

A Vermont law requires doctors to grant consent before their prescribing information is sold and used for marketing.

Proponents of the law argue that it correctly prevents the commercial use of private health treatment decisions and protects physician privacy. Opponents believe it infringes upon freedom of speech protections in the First Amendment (iHealthBeat, 4/25).

The Vermont law permits other uses of the data, including by law enforcement, insurance companies and journalists. Drug companies also can continue to market directly to physicians but cannot use specific prescribing information to do so (Liptak, New York Times, 4/26).

Lawsuit Details

Three data collection firms — including IMS Health and the Pharmaceutical Research and Manufacturers of America — challenged the law.

A federal district court in Vermont initially upheld the statute, but an appellate court reversed the decision in November 2010. Vermont Attorney General William Sorrell (D) later petitioned the Supreme Court (iHealthBeat, 4/25).

Justices Weigh In

During arguments on the law, some justices indicated that the law is troubling because it appears to restrict brand-name drugmakers while sparing the state government, insurers or others that might favor cheaper generics (AP/San Francisco Chronicle, 4/26).

In developing the law, Vermont’s Legislature said there is a “massive imbalance in information presented to doctors” and “the marketplace for ideas on medicine safety and effectiveness is frequently one-sided.”

Some justices suggested that the point of the law was to protect doctors from hearing marketing pitches for more expensive drugs.

Chief Justice John Roberts said, “You want to lower your health care costs, not by direct regulation, but by restricting the flow of information to the doctors. To use a pejorative word, [the state is] censoring what [doctors] can hear to make sure they don’t have full information.”

Justice Ruth Bader Ginsburg noted that Vermont “is interested in promoting the sale of generic drugs and correspondingly to reduce the sale of brand-name drugs.” However, she added, “You can’t lower the decibel level of one speaker so that another speaker, in this case the generics, can be heard better” (New York Times, 4/26).

Justice Antonin Scalia said the purpose of the law is to make the marketing practices of pharmaceutical companies “less effective.”

Officials Defend Law

Vermont Assistant Attorney General Bridget Asay responded that “the purpose of the statute is to let doctors decide whether sales representatives will have access to this inside information” on the prescribing habits of physicians.

Alexion Pharmaceuticals: Expanding Markets Point to Bigger Profits

Biotechs are increasingly trying to boost drug pipelines by targeting rare diseases. Why? Because treatments command higher prices and generate bigger profits. One company buidling a billion dollar business in rare diseases is Alexion Pharmaceutical (ALXN).

Soliris, which accounts for all of Alexion’s revenue, treats PNH, an ultra-rare blood disease which damages red blood cells and vital organs. The market is small — affecting one to five of every million people — but lucrative, with Q1 net sales rising 41% to $166.1 million. Despite being approved in the U.S. and EU in 2007, Soliris’ momentum remains strong, with the company posting greater than 30% revenue and 25% earnings growth in every quarter since at least June 2009.

And this revenue is translating into robust cash flow, given that PNH is a chronic disease with the average person living 10-15 years following diagnosis. For 2011, Alexion is guiding for $2.28 per share in earnings, 28% higher than 2009. In 2012, the street expects earnings to expand an additional 33% to $3.04.

Expanding Soliris into new countries provides upside, but even greater opportunity exists in gaining approval to treat other diseases. In April, Alexion filed U.S. and EU Marketing applications for Soliris in the treatment of aHUS, an ultra-rare blood disease damaging kidneys, the heart and other vital organs.

Why is aHUS an important market for Alexion? Because 60% of aHUS patients require dialysis and/or a kidney transplant, or die within a year of diagnosis. Of those receiving donor kidneys, 90% experience failure. Like PNH, aHUS isn’t common, affecting about one in 500,000 in the U.S. But, given the nature of the disease and its prognosis, ALXN is modeling for priority review, which means a potential launch by year-end and significant sales upside in 2012 and 2013.

Additionally, Alexion is planning a study on the use of Soliris in treating Acute Humoral Kidney Rejection (AHR) in patients at elevated risk of antibody mediated rejection – another rare and potentially lucrative market. AHR occurs in about 20-30% of acute kidney rejections, with acute rejections occurring in 10-30% of all kidney transplants. It’s a small market, but another avenue of sales and profit growth, given there were 16,000 kidney transplants in the U.S. alone in 2008.

Alexion is also deploying its cash flow to expand its pipeline. In Q1, it acquired two developmental biotech companies: Taligen Therapeutics and Orphatec Pharmaceuticals. Taligen is a pre-clinical company seeking to treat ophthalmic diseases including age-related macular degeneration, which affects about 30% of those 75 or older, according to NIH. Orphatec has potential in treating an ultra-rare genetic disorder, MoCD Type-A, a fatal genetic deficiency fatal to newborns and currently untreatable.

The company boosted its guidance to $720-740 million for 2011 from $715-735 million, and has beaten the street in each of the past four quarters. Given Alexion’s balance sheet, with $348 million in cash exiting Q1, its strengthening cash flow and possibility of label expansion, Alexion offers investors a significant amount of future growth.