Pharmaceutical News

Watson Pharmaceuticals Incorporated (WPI) Shares Downgraded to “Neutral” by Citigroup (C) Analysts

Watson Pharmaceuticals Incorporated (NYSE: WPI) was downgraded by investment analysts at Citigroup (NYSE: C) from a “buy” rating to a “neutral” rating in a note issued to investors on Tuesday.

Separately, analysts at Goldman Sachs (NYSE: GS) reiterated a “conviction buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Monday. Analysts at Credit Suisse (NYSE: CS) cut their EPS estimates on shares of Watson Pharmaceuticals Incorporated in a research note on Monday. They now have an “outperform” rating and a $77.00 price target on the stock. Also, analysts at Needham & Company reiterated a “hold” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Monday.

Watson Pharmaceuticals, Inc. (Watson) is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution. It operates in international markets, including Western Europe, Canada, Australasia, Asia, South America and South Africa with its commercial market being the United States of America. As of December 31, 2010, it marketed approximately 160 generic pharmaceutical product families and approximately 30 brand pharmaceutical product families in the United States, and distributed approximately 8,500 stock-keeping units (SKUs) through its Distribution Division. In January 2010, the Company acquired 64% of Eden Biopharm Group Limited (Eden). In May 2011, it acquired Specifar Pharmaceuticals S.A.

Shares of Watson Pharmaceuticals Incorporated traded down 2.88% during mid-day trading on Tuesday, hitting $55.56. Watson Pharmaceuticals Incorporated has a 52 week low of $53.46 and a 52 week high of $73.35. The stock’s 50-day moving average is $61.05 and its 200-day moving average is $65.34. The company has a market cap of $7.065 billion and a P/E ratio of 39.35.

Formula Pharmaceuticals Appoints Martyn Greenacre to Board of Directors

Formula Pharmaceuticals, a privately-held oncology drug development company, today announced the appointment of Martyn Greenacre to the Board of Directors. Mr. Greenacre served as Chairman of BMP Sunstone Corporation, a pharmaceutical company recently acquired by Sanofi-Aventis.

“Martyn is a highly-valued addition to our Board of Directors,” said Maurits W. Geerlings, Chief Executive Officer of Formula Pharmaceuticals. “His proven leadership, coupled with his extensive business and corporate development experience in the pharmaceutical industry, will be invaluable to us as we advance our lead clinical-stage program.”

Previously, Mr. Greenacre served as Chief Executive Officer and Director of Delsys Pharmaceutical Corporation, a formulation and drug delivery system company, where he helped raise more than $50 million in equity and partnership financing and formed three development partnerships with leading pharmaceutical companies. Prior to that, Mr. Greenacre served as President and Chief Executive Officer of Zynaxis Inc., a biopharmaceutical company, where he was responsible for a critical acquisition, divesting a non-performing business and negotiating a strategic merger. Mr. Greenacre also held positions of increasing responsibility in the European division of SmithKline Beecham Pharmaceutical Company, rounding out his time there as Chairman, Europe.

“I am excited to join the Formula leadership team at a time when the company is moving its lead drug candidate, FPI-01, towards Phase 2 clinical development for the treatment of first-remission acute myeloid leukemia and other cancers,” said Mr. Greenacre. “I look forward to contributing my knowledge and expertise to supporting major milestones that are on the horizon for the company.”

Mr. Greenacre has also served on a number of start-up company Boards and currently serves as Chairman of the Board of Acusphere, Inc. (a drug delivery company), as Chairman of Life Mist Technologies, Inc. (a hospital biological decontamination company), and sits on the board of Curis, Inc. (a biotechnology company). Mr. Greenacre received a B.A. from Harvard College and an MBA from Harvard Business School.

About Formula Pharmaceuticals

Formula Pharmaceuticals, Inc. is a privately-held, oncology drug development company advancing novel medicines to address areas of unmet therapeutic need in cancer. Formula’s lead product candidate, FPI-01, is a first-in-class immunotherapeutic in clinical development for the maintenance of first-remission in acute myeloid leukemia (AML) and other cancers. Building upon deep industry expertise in identifying, licensing and developing novel medical approaches, Formula’s focus is on accelerating future life-saving cancer therapies.

Founded in late 2009 by Dr. Geerlings and Dr. Mosconi, Formula has assembled a world-class scientific, clinical development and business team well positioned to maximize the clinical and commercial value of promising drug candidates through excellence in drug development and strategic partnering.

Santhera and Ipsen Renegotiate Fipamezole Licensing Agreement

Santhera Pharmaceuticals (SIX: SANN) and Ipsen (Euronext: IPN, ADR: IPSEY) announced today that they have renegotiated their fipamezole licensing agreement. Santhera regains the worldwide rights to the development and commercialization of fipamezole, its first-in-class selective adrenergic alpha-2 receptor antagonist for the management of levodopa-induced Dyskinesia in Parkinson’s Disease. Under the renegotiated terms, Ipsen returns its rights for territories outside of North America and Japan in exchange for milestone payments and royalties based on future partnering and commercial success of fipamezole. Ipsen retains a call option for worldwide license to the program under certain conditions.

Thomas Meier, Chief Executive Officer of Santhera, commented: “Under the agreement reached with Ipsen, Santhera has regained global marketing rights for fipamezole, which we can further develop in line with the Company’s strategy. In the short term, the focus of our investments remains on our lead product Catena(R) and its multiple product opportunities in neuromuscular and mitochondrial orphan indications. However, fipamezole continues to be a valuable asset in Santhera’s late-stage clinical pipeline.”

Pierre Boulud, Ipsen’s Executive Vice-President, Corporate Strategy stated: “We are pleased that Santhera regains the worldwide rights to an agent like fipamezole. This new agreement will help to leverage the drug’s value on a global basis while allowing Ipsen to focus on its rich late stage development pipeline. With its important commercial overlap with movement disorders, Parkinson Disease remains an important area of commercial focus for Ipsen. Santhera’s commitment to this first-in-class drug has the potential to benefit levodopa-induced dyskinesia in Parkinson’s Disease patients in crucial need of better therapies.”

About the agreement
According to a licensing agreement signed in September 2010, Ipsen had acquired the rights to fipamezole outside the United States, Canada and Japan for an upfront payment of 13 million euros. Under the new agreement, Santhera regains full control over the development and commercialization of fipamezole, whilst Ipsen is entitled to receive milestone and royalty payments contingent upon the occurrence of certain events. Santhera is free to license the program to a third party whereby Ipsen is entitled to receive a percentage of any license income. In addition, the agreement includes a call option allowing Ipsen under certain circumstances to obtain an exclusive worldwide license. Should Ipsen exercise this call option, Santhera will receive milestone and royalty payments from Ipsen.

About Fipamezole
Fipamezole is widely perceived by clinicians as one of the most promising drug candidates to treat Dyskinesia in Parkinson’s Disease, the second most common and a severely debilitating neurodegenerative disorder. As a highly selective adrenergic alpha-2 receptor antagonist, fipamezole is an innovative, first-in-class drug in clinical development for the treatment of levodopa-induced Dyskinesia in Parkinson’s Disease. Santhera successfully completed two Phase II clinical studies which demonstrated efficacy and safety of fipamezole in the treatment of dyskinesia in Parkinson’s Disease. Fipamezole also showed attractive potential for the reduction of levodopa “wearing-off”, and demonstrated improvement in cognition and activities of daily living.

About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan neuromuscular and mitochondrial diseases, areas of high unmet medical with no current therapies. Santhera’s first product Catena(R) is currently marketed in Canada to treat Friedreich’s Ataxia. Catena(R) is also under review for marketing authorization by the European Medicine Agency as the first therapy for patients suffering from Leber’s Hereditary Optic Neuropathy.

Cubist Pharmaceuticals (CBST) Posts Quarterly Results

Cubist Pharmaceuticals (CBST) posted its quarterly earnings results on Thursday. The company reported $0.11 earnings per share (EPS) for the quarter, missing the Thomson Reuters consensus estimate of $0.31 by $0.20. The company’s quarterly revenue was up 31.6% on a year-over-year basis.

On a related note, analysts at Bank of America (NYSE: BAC) reiterated a “buy” rating on shares of Cubist Pharmaceuticals in a research note to investors on Wednesday, January 11st. Also, analysts at Jefferies Group (NYSE: JEF) reiterated a “buy” rating on shares of Cubist Pharmaceuticals in a research note to investors on Tuesday, January 10th. They now have a $48.00 price target on the stock.

Cubist Pharmaceuticals (CBST) traded down 1.51% on Thursday, hitting $40.40. Cubist Pharmaceuticals (CBST) has a 52-week low of $20.95 and a 52-week high of $42.10. The stock has a 50-day moving average of $39.19 and a 200-day moving average of $36.15. The company has a market cap of $2.487 billion and a price-to-earnings ratio of 71.22.

Cubist Pharmaceuticals, Inc. (Cubist) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The Company’s products are used primarily in hospitals, but also may be used in acute care settings, including home infusion and hospital outpatient clinics. Cubist’s owns CUBICIN (daptomycin for injection), which is a once-daily, bactericidal, intravenous (I.V.) antibiotic with activity against certain Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (S. aureus), (MRSA). During the year ended December 31, 2009, this product was used in the treatment of more than an estimated 880,000 patients. In December 2009, the Company acquired Calixa Therapeutics Inc.

Paula Deen says she has diabetes, will endorse pharmaceutical company

Paula Deen made waves this week when she announced that she’d be diagnosed with Type 2 diabetes.

Deen isn’t just any other American, though. She hosts a cooking show, renowned for its liberal use of fats, sugars and especially butter. And instead of announcing the diabetes to say she was going to change her ways, Deen went in a different direction.

She announced she was becoming a paid spokeswoman for pharmaceutical giant Novo Nordisk AS, which makes diabetes drugs such as Victoza. Deen said she was diagnosed three years ago but kept the matter private — seemingly until she could find a way to turn the diagnosis into a financial windfall.

Deen’s behavior has outraged some, particularly those who think lifestyle changes are important for dealing with, and potentially reversing, the effects of Type 2 diabetes.

Suzanne Vranica, a reporter for The Wall Street Journal who’s examined Deen’s announcement, said consumers think this Deen’s behavior is a complete sham.

“I think the real reason we’re seeing this problem is because she’s known for so long she’s had these problems and she’s done nothing in terms of her show and her books to promote a healthy lifestyle, which is needed when you’re combatting this sort of diabetes,” she sid.

Celebrity Chef Anthony Bourdain didn’t hold back in his criticisms either.

“Thinking of getting into the leg-breaking business, so I can profitably sell crutches later,” he tweeted.

Vranica described Deen’s problem as talking out of both sides of her mouth.

“The real crux of the problem is she’s basically tip-toed around this question about, “Well, on your show, will you now begin to promote healthier lifestyles.’ Although her spokespeople have said she’s in discussions to do that, it’s been slow going,” Vranica said.

They also point out that her son’s new show will feature healthier food.

But no matter how it turns out, Vranica said, there will be real ramifications for Deen and her brand because of this.

“Her brand was soaring up until now. What will happen to her book sales? Will people tune out,” Vranica said. “Given the reaction we’ve seen on social media sites, I anticipate there’s definitely going to be some financial fallout for her.”

China Health Resource Pharmaceutical Grade Gastrodia Product Line Expected to Contribute $8 Million in Revenue to 2011 Year End

China Health Resource, Inc. CHRI
+68.18% , announced
today that its pharmaceutical grade Gastrodia based product line has experienced double digit sales growth in 2011 with increased profit margins. The Gastrodia product line is expected to generate an estimated 50 million yuan (US$8 million) of revenue in 2011 for CHRI. The strength of the Company’s core product lines and rapid growth in newer higher margin products is expected to drive record revenue and earnings. The Company will confirm the disclosed preliminary figures at the time of disclosure of the annual report for 2011.

China Health Resource, Inc. entered into an exclusive agreement with a leading producer of Gastrodia in Pingwu, Sichuan in April 2011. The agreement gives CHRI leverage in the Traditional Chinese Medicine (TCM) marketplace in China, as the main controlling distributor and supplier of Gastrodia (also known as Tianma). Gastrodia currently retails for about 250~1,000 yuan/kg (US$38~150/kg) and is considered one of China’s highest value TCM drugs available in the market. This exclusive arrangement for the supply of Gastrodia is expected to generate an estimated combined total of 50 million yuan (US$8 million) of revenue for CHRI over the 2011-2012 period.

“Our core strength in establishing DAR as a standard has resulted in an enviable growth in revenues and margins in our DAR product line and the Gastrodia product line is the natural progression of CHRI product on large global markets with higher profit margins. We expect this will be reflected in our 2011 year in both revenues and earnings” stated Jiayin Wang, Chairman and CEO of CHRI.

“Gastrodia is an important herb with high margins and we expect it will add a significant contribution to our top and bottom line. As a TCM ingredient, it has pain relieving and anti-inflammatory properties, and it is used in the treatment of severe headaches and nervous fatigue. In time, we expect Gastrodia to have the same standard of acceptance as GAP DAR.” added Jiayin Wang.

Pharmaceutical M&A in the Asia Pacific Region

Slowing growth continues in major developed markets, prompted by generic erosion of branded sales and increasing regulatory and cost containment pressures. Expansion into emerging Asia Pacific (APAC) markets is appealing not only because of their rapid growth and sizeable patient populations, but also because operating environments are improving as these countries open up to global trade.

Features and benefits

* Overview of drivers, resistors and trends within the Asia Pacific M&A landscape.* Summary of geographic M&A activity on a regional and country-specific basis.* Analysis of the types of acquisitions and healthcare sectors targeted.* Examination of transaction values and leading dealmakers.

Highlights

India, Japan and Australia all continued to record frequent deal activity, although China increased its lead in terms of total deal numbers in 2010 and early 2011. However, Chinese companies continue to focus primarily on domestic transactions.Japanese companies still account for the majority of M&A deal value. The first half of 2011 has already surpassed previous peak M&A deal values in APAC, continuing the annual upward trend seen in transaction values when outlying multi-billion dollar deals are excluded.While most M&As involving APAC-based players target pharmaceutical and biological products companies, such as generics and active pharmaceutical ingredient (API) manufacturers, medical devices and equipment firms have recently taken over as the leading sector targeted for M&A.

Research and Markets: France Pharmaceuticals and Healthcare Report Q1 2012

Despite the government’s focus on fiscal consolidation – which includes various cost containment measures impacting the country’s healthcare and pharmaceutical spending – France will remain one of the most attractive pharmaceutical markets on a global scale. High usage of (especially patented) medicines on a per capita basis will continue to provide considerable commercial opportunities for multinational drug makers. While generic drugs will continue to increase their share of the total market’s value in the medium term, patented medicines are still expected to represent at least two-thirds the market by 2015, at a consumer price value of a significant EUR18.1bn (US$22.6bn).

Following cost-containment measures rolled out in 2010 and 2011, the authorities are poised to introduce further austerities in 2012. Proposed measures include savings of EUR910mn (US$1.23bn) achieved via price cuts on (mostly) generic medicines, and savings of EUR40mn (US$54mn) in reimbursement listings. The proposal sets the target annual growth in public expenditure on healthcare at 2.5% (from the previously proposed 2.8%) for each year from 2012 to 2015, which could see the pharmaceuticals industry more than EUR1bn worse off.

In October 2011, French pharmaceutical companies Servier and Hybrigenics signed a three year deal in the field of deubiquitinating enzymes to research first-in-class medicines to treat several diseases, particularly cancer. Under the licence and research collaboration agreement, Hybrigenics will get EUR4mn (US$5.5mn) from an up front fee and research funding, along with royalties on sales of diagnostic kits and EUR9.5mn (US$13.07mn) for each target successfully leading to registration.

Leading domestic drug producer Sanofi is expecting average annual growth of 5% from 2012- 2015, according to recent reports. The company aims to shift into new areas, including vaccines and animal health as sales of drugs like blood thinner Plavix (clopidogrel) and cancer drug Taxotere (docetaxel) are declining following the loss of patent protection. The company is also looking for extra cost savings of EUR2bn (US$2.8bn), as well as improving research and development capabilities to encourage sustainable growth.

Publication Overview:

Business Monitor International’s France Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on France’s pharmaceuticals and healthcare industry.

Astex Announces Early Transfer of Epigenetics Project to GSK

Astex Pharmaceuticals, Inc. ASTX
-0.02% today announced that the multi-year collaboration to
discover cancer therapeutics based on epigenetic targets entered into by SuperGen, Inc. and GlaxoSmithKline (GSK) in November 2009 is terminating and existing research work and assets generated under the CLIMB(TM) epigenetic collaboration will be transferred to GSK. Astex will have no further obligation to conduct additional research work on the program. This decision follows on from the review and rationalization of Astex’s internal pipeline and drug discovery programs as part of the recent merger of Astex Therapeutics Limited and SuperGen, Inc. to form Astex Pharmaceuticals, Inc., and discussions with GSK. As a result of the transfer, Astex will continue to be eligible to receive milestones and royalties under an asset transfer agreement. A separate Research and Development Collaboration and License Agreement which includes a multi-target drug discovery collaboration, entered into by Astex’s UK subsidiary, Astex Therapeutics Limited and GSK in November 2009 will continue as previously announced.

“The decision to transfer the CLIMB(TM) epigenetic program to GSK was based on our assessment of internal resources and discussions with GSK,” said Harren Jhoti, PhD, president of Astex Pharmaceuticals. “We continue to work closely with GSK on the discovery of molecules using our Pyramid(TM) fragment platform as part of our successful and ongoing collaboration against multiple targets of interest to GSK entered into in November 2009.”

About Astex Pharmaceuticals

Astex Pharmaceuticals is dedicated to the discovery and development of novel therapeutics with a focus on oncology. The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies. Astex Pharmaceuticals developed Dacogen(R) (decitabine) for Injection and receives significant royalties on global sales.

Swiss drug maker Novartis to cut almost 2,000 US jobs this year on patent expiry, failed trial

Drug maker Novartis will cut 1,960 jobs in the United States this year in anticipation of lower sales for two of its hypertension drugs, the Swiss company said Friday.

Basel-based pharmaceutical giant Novartis AG said the cuts will affect 1,630 sales positions in the field and 330 posts at its U.S. headquarters in New Jersey.

The restructuring was necessary because of the expiration of its patent for the best-selling hypertension drug Diovan and the failure of a clinical study into another hypertension drug, Tekturna, Novartis said.

“We recognize that the next two years will be challenging in the Pharmaceuticals Division and we are proactively making these changes to further focus our pipeline on the best opportunities and align our market position on our growth brands,” the head of Novartis’ pharmaceuticals division, David Epstein, said in a statement. “These are difficult but necessary decisions that will free up resources to invest in the future of our business which we view as well suited to bring new valuable therapies to patients and payors.”

In 2010 the company eliminated 1,400 U.S. sales jobs, followed by 900 U.S. development posts last October.

Novartis said the latest job cuts would save $450 million a year from 2013 after an initial charge of $160 million, to be booked in the first quarter of 2012.

Diovan contributed $1.43 billion to Novartis’ net pharmaceutical sales of $8.16 billion in the third quarter. Its patent expiry is likely to markedly increase competition from generic products.

Meanwhile, Novartis said a reassessment of the future sales potential of Tekturna, which is known as Rasilez outside of the U.S., will result in an exceptional charge of $900 million in the fourth quarter. The company said last month it had terminated a trial into the expanded use of Tekturna after it was found to cause increase complications in patients already taking other common hypertension drugs.

Two other experimental drugs will also be dropped, leading to one-off charges of $160 million in the fourth quarter, Novartis said.

In its statement, Novartis made no mention of a recent announcement that it was recalling several over-the-counter drugs in the United States following reports of a possible mix-up with powerful prescription pain medications at a Nebraska manufacturing plant.

Novartis shares closed 0.7 percent lower at 53.00 Swiss francs ($55.59) on the Zurich exchange Friday.

Savient Pharma Names David Veitch President Of Savient Europe – Quick Facts

Savient Pharmaceuticals, Inc. (SVNT) said it named David Veitch President of Savient Europe, effective January 16, 2012. Veitch will report directly to John Johnson, Chief Executive Officer and President of Savient. He will be responsible for establishing, building and leading Savient’s European regional organization to launch and drive the future growth of KRYSTEXXA.

Veitch has over 24 years of pharmaceutical industry experience.

Watson Pharmaceuticals Incorporated (WPI) EPS Estimates Cut by Goldman Sachs (GS)

Investment analysts at Goldman Sachs (NYSE: GS) lowered their EPS estimates on shares of Watson Pharmaceuticals Incorporated (NYSE: WPI) in a note issued to investors on Friday. They currently have a “buy” rating and a $78.00 price target on the company’s shares.

Separately, analysts at Jefferies Group (NYSE: JEF) reiterated a “hold” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday, December 20th. They now have a $70.00 price target on the stock. Analysts at Citigroup (NYSE: C) reiterated a “buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday, December 20th. They now have a $82.00 price target on the stock. Also, analysts at Canaccord Genuity reiterated a “buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday, December 20th.

Watson Pharmaceuticals, Inc. (Watson) is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution. It operates in international markets, including Western Europe, Canada, Australasia, Asia, South America and South Africa with its commercial market being the United States of America. As of December 31, 2010, it marketed approximately 160 generic pharmaceutical product families and approximately 30 brand pharmaceutical product families in the United States, and distributed approximately 8,500 stock-keeping units (SKUs) through its Distribution Division. In January 2010, the Company acquired 64% of Eden Biopharm Group Limited (Eden). In May 2011, it acquired Specifar Pharmaceuticals S.A.

Shares of Watson Pharmaceuticals Incorporated traded up 0.23% during mid-day trading on Friday, hitting $62.19. Watson Pharmaceuticals Incorporated has a 52 week low of $51.39 and a 52 week high of $73.35. The stock’s 50-day moving average is $62.05 and its 200-day moving average is $65.82. The company has a market cap of $7.908 billion and a price-to-earnings ratio of 42.68.

Bulgaria Pharmaceuticals and Healthcare Report Q1 2012

Business Monitor International’s Bulgaria Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on Bulgaria’s pharmaceuticals and healthcare industry.

BMI View: Out-of-pocket spending will continue to be the main driver behind the growth of Bulgaria’s pharmaceutical market, though this feature also makes the market highly vulnerable to the wider economic situation. In terms of absolute values, government funding for healthcare is expected to improve marginally, although its relative contribution to the overall healthcare spending in the country will continue to decline, partly due to the difficulties regarding the collection of insurance contributions.

Business Environment Rating: Despite its composite score being 1% lower on a quarter-on-quarter (qo- q) basis, Bulgaria remains 13th in BMI’s latest Pharmaceutical and Healthcare Business Environment Ratings (BERs) for emerging Europe. The lower composite score is due to a slight downgrade in its rewards component, which is still well below the regional average. Bulgaria also has relatively pronounced risks, scoring 56 out of 100 for this category, although it is on par with the regional average.

Fleming Pharmaceuticals Sells Ocean, Nephrocaps, Other Branded Products to Valeant

Fleming Pharmaceuticals announced today that, effective December 22, 2011, it has sold its rights to its branded Ocean®, Nephrocaps®, Magonate® and ProBarimin QT® products to Valeant International (Barbados) SRL (“Valeant”). Valeant has appointed its affiliate, Valeant Pharmaceuticals North America LLC, to act as distributor of these products in the U.S.

Fleming also manufactures contract products for a broad customer base, including the federal government. Fleming has retained rights to manufacture and market its widely-known product ThyroShield, one of two FDA-approved potassium iodide medicines used in nuclear emergencies to block the thyroid gland from absorbing radioactive iodine to avoid thyroid cancer. In addition, Fleming has retained its contract services business relating to the development, manufacture and testing for specialty pharmaceutical companies and its physical headquarters in St. Louis, Missouri.

Due to the excess capacity anticipated as a result of the sale of the announced four products, Fleming is now considering proposals from a number of pharma manufacturers for its Midwestern manufacturing capability. A private investment banking firm, Douglas Group, St. Louis, has been retained to facilitate consideration of potential merger or sale for the remaining Fleming operations.

Biotechnology Pharmaceutical Company Selects NewCardio’s QTinno for Thorough QT Trial

NewCardio, Inc., NWCI
+8.15% a
cardiovascular diagnostic solutions developer, announced today that a biotechnology pharmaceutical company, which is focused on discovering and developing small molecule therapeutics for disorders of the central nervous system (CNS), has selected QTinno®, NewCardio’s automated cardiac safety solution, for an upcoming Thorough QT trial. Fully automated ECG analysis, empowered by QTinno, will be delivered by the ECG core lab of a top 3 Clinical Research Organization (CRO) under the terms of an existing Master Services Agreement with NewCardio.

The current study timeline anticipates initiating the study in January, with completion in the April timeframe. QTinno was selected, and specifically written into the protocol by the drug development sponsor, based on its proven ability to enable the CRO to deliver high-quality results in a much more timely and cost effective manner than the current core ECG lab methodologies. It is anticipated that the study will generate approximately $250,000 in revenue for NewCardio.

Greg Sadowski, NewCardio’s Chief Operating Officer, commented, “We are excited to participate in this TQT trial for an emerging biotech with our CRO partner. QTinno’s selection for this study, based on the performance in prior studies, provides clear evidence of the pharmaceutical company’s confidence, not only in the accuracy and precision of QTinno’s fully automated ECG analysis, but also in the FDA’s willingness to accept drug safety data from properly validated technology such as QTinno.”

About QTinno Technology

NewCardio’s patented QTinno 3-D ECG software technology is a novel, fully automated program for evaluating QT and other timing intervals relevant for assessing drug cardiac toxicity in drug development. It provides fast, accurate and precise QT data from a broad range of challenging ECGs and enables reliable, automated identification of key cardiac events. Pharmaceutical sponsors and clinical research organizations, which are mandated by the FDA to test new drugs for potential cardiac toxicity, are expected to benefit from QTinno’s faster, more accurate and less expensive assessment of cardiac status.

Diplomat Specialty Pharmacy to Provide Specialty Pharmacy Services for EYLEA™ (aflibercept) Injection

Diplomat Specialty Pharmacy, the nation’s largest independent specialty pharmacy in the nation, announced today it has received limited distribution rights from Regeneron for its new drug EYLEA™ (aflibercept) Injection.

On November 18, 2011, EYLEA (aflibercept) Injection was approved by the Food and Drug Administration and is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). Macular degeneration is diagnosed as either dry (non-vascular) or wet (vascular) and is a leading cause of blindness in older adults. The wet form usually leads to more serious vision loss.

“EYLEA represents an important new therapy in the treatment of AMD,” said Phil Hagerman, president and CEO of Diplomat. “AMD is becoming more and more prevalent in Americans 60 years of age and older; Diplomat looks forward to providing services to help treat this growing population of patients to slow the progression of this disease.”

About Diplomat Specialty PharmacyMichigan-based Diplomat Specialty Pharmacy, founded in 1975, serves patients nationwide as the country’s largest privately held Specialty Pharmacy and focuses on complete medication management programs for patients with serious and chronic conditions. Diplomat’s business model creates unique partnerships around both distribution and services with industry stakeholders with Group Purchasing Organizations, Hospital systems, retail chains and managed markets, always focused on improving adherence and the patient experience.

How Oregon’s Death-Penalty Drugs Ended Up With a New York Firm

Since 1986, New York’s Devos, Ltd, has steadily built a business with an annual revenue of $32.2 million handling overstocked, expired, or recalled drugs on pharmacy shelves throughout the nation. Operating as Guaranteed Returns, Devos is the industry leader in a specialized business called reverse pharmaceutical distribution. Reverse pharmaceutical distribution comes out of the need to carefully navigate the minefield of state and federal regulations surrounding controlled substances, and the equally difficult task of complying with hundreds of manufacturers’ and wholesalers’ strict rules for properly returning or reselling goods that lose all value once improperly stored or tampered with.

After Oregon’s Department of Corrections (ODOC) got word of Governor John Kitzhaber’s November 2011 announcement that he’ll no longer enforce the state’s death penalty, its pharmacy unit rang up Guaranteed Returns, the reverse distributor of choice for most VA Hospitals. It’s unclear if the decision to return rather than destroy the drugs ever reached Governor Kitzhaber’s notice before being publicly reported in The Bend Bulletin on December 24. Once aware, the governor took no action and never acknowledged the glaring contradiction with his own recently announced stand against the death penalty, despite the fact that clamping down on America’s supply of these drugs is the crux of a new international strategy that puts pressure on death-penalty states.

Guaranteed Returns now possesses Oregon’s lethal cocktail mixers, the ODOC told me.

So deciding where to resell $18,000-worth of pentobarbital sodium, pancuronium bromide, and potassium chloride rests entirely with Guaranteed Returns and its CEO, Dean Volkes. Guaranteed Returns’s business model typically involves resale to a pharmaceutical wholesaler or return to the original manufacturer for those drugs with an applicable return policy. The company also incinerates drugs that are damaged, expired, or have no marketable value.

Guaranteed Returns has an opportunity to act responsibly where Oregon did not. Rather than laundering these drugs back to a manufacturer or wholesaler of the kind that saw no problem selling to Oregon’s Department of Corrections in the first place, the multi-million-dollar company can eat this $18,000 cost in the name of human rights and incinerate this supply of lethal injection medications. Alternatively, Guaranteed Returns can decide it will only sell to parties that will certify, in writing, that the drugs will not find their way into a death chamber.

New York carried out its last execution in 1963, and though capital punishment is still on the books, in 2008 its governor ordered the destruction of the remaining apparatus of death row and the death chamber. If Oregon’s Governor Kitzhaber has missed his chance to stop this outrage, New York’s Governor Andrew Cuomo is now in a position to fix things for him.

Governor Cuomo could ask New York-based pharmaceutical companies and distributors to certify that their medical products won’t land in the store rooms of government agencies who will use them to kill people. If these companies don’t heed such a warning, New York’s Division of Human Rights and its attorney general could serve the nation well by launching investigations into those Empire State corporations that mishandle controlled substances so grievously that they wind up stocking death-chamber drug cabinets.

Apeiron, GSK begin phase IIa trial in Acute Lung Injury patients

Apeiron Biologics announced that GlaxoSmithKline (GSK), that has licensed Apeiron´s new investigational recombinant human Angiotensin Converting Enzyme 2 (rhACE2, name: GSK2586881, formerly APN01), has commenced a phase IIa study in patients suffering from Acute Lung Injury.

The study being sponsored by GSK, will involve patients with a positive diagnosis of ALI and will be conducted throughout the US and Canada.

The efficacy of the enzyme was assessed in several preclinical animal models of ALI/ARDS.

A phase I study in healthy volunteers also investigated the safety, tolerability and pharmacology profile of rhACE2.

In January 2010, GSK acquired an exclusive license for the development and commercialization of GSK2586881 for EUR 230m, subject to reaching future development milestones in multiple indications.

Apeiron CEO Hans Loibner said the company is happy that their biologic APN01 is being tested by their licensee GSK in a multicentric phase II study in ALI patients.

“The study is designed to provide important information regarding the safety and pharmacologic profile of this recombinant enzyme in this severely diseased patient population, as well as first insights into its clinical efficacy,” Loibner added.

Valeant Pharmaceuticals to Hold Conference Call to Announce 2012 Financial Guidance

Valeant Pharmaceuticals International, Inc. VRX
+0.30% today announced that it will host a conference call and a
live Internet webcast along with a slide presentation on Friday, January 6, 2012 at 10:00 a.m. EST (7:00 a.m. PST) to announce 2012 financial guidance.

Piper Jaffray (PJC) Analysts Reiterate a “Neutral” Rating on Teva Pharmaceutical Industries Ltd (TEVA)

Teva Pharmaceutical Industries Ltd (NASDAQ: TEVA)‘s stock had its “neutral” rating reaffirmed by equities research analysts at Piper Jaffray (NYSE: PJC) in a research note issued to investors on Thursday. The analysts currently have a $45.00 price target on the stock.

Separately, analysts at Needham & Company reiterated a “buy” rating on shares of Teva Pharmaceutical Industries Ltd in a research note to investors on Thursday. Analysts at Deutsche Bank (NYSE: DB) raised their price target on shares of Teva Pharmaceutical Industries Ltd to $48.00 in a research note to investors on Thursday. They now have a “buy” rating on the stock. Also, analysts at Wells Fargo & Co. (NYSE: WFC) reiterated an “outperform” rating on shares of Teva Pharmaceutical Industries Ltd in a research note to investors on Wednesday.

Teva Pharmaceutical Industries Limited (Teva) is a global pharmaceutical and drug company. It develops, produces and markets generic drugs in all treatment categories. The Company has a pharmaceutical business, whose principal products include Copaxone and Azilect. Teva’s active pharmaceutical ingredient (API) business provides vertical integration to Teva’s own pharmaceutical production. The Company’s global operations are conducted from North and Latin America to Europe and Asia. As December 31, 2010, it had direct operations in approximately 60 countries, including 40 finished dosage pharmaceutical manufacturing sites in 19 countries, 28 pharmaceutical research and development (R&D) centers and 21 API manufacturing sites. On October 14, 2011, it acquired Cephalon, Inc.

Shares of Teva Pharmaceutical Industries Ltd opened at 41.76 on Thursday. Teva Pharmaceutical Industries Ltd has a 52 week low of $35.00 and a 52 week high of $57.08. The stock’s 50-day moving average is $40.22 and its 200-day moving average is $41.84. The company has a market cap of $36.958 billion and a price-to-earnings ratio of 12.43.

Sucampo Reports Conclusion of Arbitration Hearing

Sucampo Pharmaceuticals, Inc. SCMP
+0.72% announced
that the hearing on the Company’s claims in the demand for arbitration under the applicable provisions of the Collaboration and License Agreement with Takeda Pharmaceuticals Company Limited, or Takeda, dated October 29, 2004, have concluded within the expected timeframe and we look forward to the arbitrators’ decision in the first quarter of 2012.

Under the current agreement, Sucampo and Takeda jointly commercialize AMITIZA(R) (lubiprostone) in the United States for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) and are developing AMITIZA for other gastrointestinal indications.

Sucampo Pharmaceuticals, Inc., an international pharmaceutical company, focuses on the development and commercialization of medicines based on prostones. The therapeutic potential of prostones, which occur naturally in the human body as a result of enzymatic (15-PGDH) transformation of certain fatty acids, was first identified by Ryuji Ueno, M.D., Ph.D., Ph.D., Sucampo Pharmaceuticals’ Chairman and CEO. Dr. Ueno founded Sucampo Pharmaceuticals in 1996 with Sachiko Kuno, Ph.D., founding CEO and currently Executive Advisor, International Business Development and a member of the Board of Directors.

Cantor Fitzgerald Analysts Reiterate a “Buy” Rating on Salix Pharmaceuticals (SLXP)

Salix Pharmaceuticals (NASDAQ: SLXP)‘s stock had its “buy” rating reaffirmed by equities research analysts at Cantor Fitzgerald in a research note issued to investors on Tuesday.

Separately, analysts at Jefferies raised their price target on shares of Salix Pharmaceuticals to $50.00 in a research note to investors on Tuesday. Analysts at UBS AG (NYSE: UBS) reiterated a “neutral” rating on shares of Salix Pharmaceuticals in a research note to investors on Friday, December 2nd. Also, analysts at UBS AG (NYSE: UBS) raised their price target on shares of Salix Pharmaceuticals to $47.00 in a research note to investors on Friday, December 2nd.

Shares of Salix Pharmaceuticals traded up 6.38% during mid-day trading on Tuesday, hitting $45.99. Salix Pharmaceuticals has a 52 week low of $25.64 and a 52 week high of $49.05. The stock’s 50-day moving average is $38.78 and its 200-day moving average is $34.95. The company has a market cap of $2.720 billion and a price-to-earnings ratio of 33.25.

Jefferies Analysts Reiterate a “Hold” Rating on Watson Pharmaceuticals Incorporated (WPI)

Watson Pharmaceuticals Incorporated (NYSE: WPI)‘s stock had its “hold” rating reaffirmed by equities research analysts at Jefferies in a research note issued to investors on Tuesday. The analysts currently have a $70.00 price target on the stock.

Separately, analysts at Citigroup (NYSE: C) reiterated a “buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday. They now have a $82.00 price target on the stock. Analysts at Canaccord Genuity reiterated a “buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday. Also, analysts at Needham & Company reiterated a “hold” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday.

Watson Pharmaceuticals, Inc. (Watson) is a specialty pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of brand and generic (off-patent) pharmaceutical products. Watson operates manufacturing, distribution, research and development (R&D), and administrative facilities in the United States of America. Watson operates and manages its business as three operating segments: Generic, Brand and Distribution. As of December 31, 2009, the Company marketed approximately 170 generic pharmaceutical product families and 30 brand pharmaceutical product families and distributed approximately 8,000 stock-keeping units (SKUs) through its Distribution business in the United States. On December 2, 2009, Watson completed the acquisition of Robin Hood Holdings Limited and Cobalt Laboratories, Inc. On November 26, 2009, the Company acquired Arrow Group. Watson also acquired a 36% ownership interest in Eden Biopharm Group (Eden).

Shares of Watson Pharmaceuticals Incorporated traded up 1.93% during mid-day trading on Tuesday, hitting $60.80. Watson Pharmaceuticals Incorporated has a 52 week low of $50.47 and a 52 week high of $73.35. The stock’s 50-day moving average is $63.97 and its 200-day moving average is $66.1. The company has a market cap of $7.731 billion and a price-to-earnings ratio of 41.02.

AAIPharma Services Appoints Vice President of Packaging Services

AAIPharma Services Corp., a leading provider of pharmaceutical product development services, announced today that it has appointed Kevin Flanagan to vice president of packaging services, where he will oversee the company’s Packaging and Distribution functions at the Wilmington headquarters. Flanagan joins the firm from Compass Pharma Services, a ventured-backed pharmaceutical contract packaging firm, where he served as president.

“I am delighted to have an executive of Kevin Flanagan’s caliber join the AAIPharma team,” said Patrick Walsh, Chief Executive Officer of AAIPharma. “Kevin’s deep knowledge of the packaging industry, particularly in the design and distribution of pharmaceutical products, will be a huge asset to AAIPharma as we expand and enhance our business offerings.”

Flanagan brings more than 30 years of experience in the pharmaceutical packaging components and contract packaging services industries. He founded National Packaging Systems, a manufacturing company that specialized in the design, packaging and distribution of clinical trial supplies, in 1998. National Packaging Systems was acquired by Corning, Inc., where Flanagan became part of the group from Corning Pharmaceutical Services that formed Covance. Flanagan also held leadership roles at PA Early Stage Partners and Research Trials LLC.

Flanagan received his bachelor of arts from Villanova University. He is a recipient of both the Ben Franklin Technology Center Innovation Award for Entrepreneurial Achievement and the Greater Philadelphia Venture Group Entrepreneur of the Year Award.

Impax Pharmaceuticals Initiates Phase IIb Trial of IPX159 in Restless Legs Syndrome

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. IPXL
+0.11% , announced that it has initiated a Phase IIb trial of
its drug candidate IPX159 in patients with moderate to severe Restless Legs Syndrome (RLS).

“We are pleased to advance IPX159 to this Phase IIb study, which will help establish its clinical profile in moderate to severe RLS patients. We look forward to reporting the results from this study and providing an update on the program in mid-2013,” said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

The Phase IIb study is a multicenter, randomized, double-blind, placebo-controlled, safety and efficacy study to evaluate IPX159 in the treatment of moderate to severe RLS. The trial is expected to randomize approximately 120 adult subjects who will receive either IPX159 or placebo and will be treated for up to 11 weeks. The trial will be conducted at multiple sites in North America. The primary endpoint is the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale.

About IPX159

IPX159 is an oral controlled-release formulation of a small molecule that has an established pharmacological and safety profile for non-RLS use outside the U.S. and may represent a novel mechanism of action in RLS. Impax has previously completed a proof of concept study with the molecule in RLS patients.

About Restless Legs Syndrome

Restless Legs Syndrome (RLS) is a condition characterized by an irresistible urge to move ones’ limbs, most commonly the legs, to stop uncomfortable sensations. RLS symptoms generally worsen in the evening, are made worse by rest or inactivity, and commonly cause insomnia and involuntary leg movements during sleep. There are approximately 25 million RLS sufferers in the US.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax is headquartered in Hayward, California, with a full range of capabilities located in its Hayward, Philadelphia and Taiwan facilities.

Ohr Pharmaceutical Announces $1,100,000 Private Placement Led by Existing Investors

Ohr Pharmaceutical Inc. OHRP
0.00%
announced that on December 16, 2011 it sold 1,833,342 shares of its common stock to a group of institutional and accredited investors at a price of $0.60 per share, the closing bid price prior to the closing of the transaction. In addition, the investors will receive 916,678 warrants to purchase common stock exercisable at $0.65 for a five year period. The Company did not engage a placement agent for the transaction.

The estimated net proceeds to the Company from the offering were approximately $1.09 million. The Company intends to use the net proceeds from this offering to further the clinical development of its portfolio compounds, Squalamine eye drops and OHR/AVR118, and general corporate purposes.

“The Company’s ability to raise funds on favorable terms is a testament to the strong progress that has been made over the last year, highlighted by the successful reformulation of Squalamine for topical administration,” said Ira Greenstein, Chairman of the Board of Directors. “It is a very exciting time as the Company continues development on many fronts to address the needs of large patient populations.”

Dr. Irach B. Taraporewala, CEO of Ohr Pharmaceutical, added, “We are expecting an eventful 2012, with the initiation of a clinical trial of Squalamine eye drops for Wet Macular Degeneration and the completion of our Phase II OHR/AVR118 trial in cancer cachexia.”

Somaxon Pharmaceuticals Hires Financial Advisor to Assist in Seeking Strategic Alternatives

Somaxon Pharmaceuticals, Inc. SOMX
-15.17% , a specialty
pharmaceutical company, today announced that it has hired Stifel Nicolaus Weisel as a strategic advisor. Stifel will assist the company in identifying and evaluating various strategies to maximize stockholder value.

“We are committed to working with the Stifel team to evaluate strategies which will allow us to fully leverage our rights in our core asset — Silenor(R) for the treatment of insomnia characterized by difficulty with sleep maintenance,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “This process will focus on strategic alternatives, which may include one or more of a sale of the company or assets relating to Silenor, or partnering or other collaboration transactions relating to U.S. or ex-U.S. prescription or over-the-counter rights to Silenor.”

“While we are conducting this process, we will continue to market Silenor in the U.S. to existing prescribers through our 30-person sales force and non-personal promotion, and to protect the intellectual property position of the product,” continued Pascoe. “We will also undertake measures to minimize our cash burn rate, including through a reduction in force involving approximately 60% of our current non-field-based employees.”

The exploration of strategic alternatives may not result in any agreement or transaction and, if completed, any agreement or transaction may not be successful or on attractive terms. Somaxon does not intend to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or it enters into a definitive agreement for a specific, material transaction.

About Silenor(R)

Silenor is a low-dose (3 mg and 6 mg) oral tablet formulation of doxepin, and is the first and only non-scheduled prescription sleep medication approved to treat insomnia characterized by difficulties with sleep maintenance. Sleep maintenance is defined as waking frequently during the night and/or waking too early and being unable to return to sleep.