Pharmaceutical News

Endo, Biogen lead drug stocks north

BOSTON (MarketWatch) — Endo Pharmaceuticals Holdings Inc. and Biogen Idec Inc. helped lead drug stocks north Monday, as the broader market also moved into positive territory.

Shares of Endo (ENDP 41.34, +0.49, +1.20%) jumped 5% to $42.99 after the company
announced it was buying medical device maker American Medical Systems Holdings Inc. (AMMD 29.48, +7.15, +32.02%) for $30 a share in cash, or about $2.9 billion. Endo will
also assume $312 million in debt.

Endo said the deal will help it diversify into the medical devices and treatment services markets. American Medical specializes in urology and gynecology products. Read more on Endo bid.

American Medical shares soared 32% to $29.50. The stock closed at $22.33 on Friday.

Biogen Idec (BIIB 78.37, +5.08, +6.93%)
shares were up almost 6% at $77.35.

The biotech group released positive Phase III clinical data for its multiple sclerosis drug candidate BG-12 that showed it helped lower the rate of relapse in certain MS patients. Biogen is expected to release data from a second Phase III trial for the drug during the second half of the year.

Biogen already markets two of the most popular MS drugs, Avonex and Tysabri, which are both injected medications. BG-12 has been seen as an improvement on those two drugs in part because it is taken orally.

Biogen’s good news dinged shares of Israel’s Teva Pharmaceutical Industries (TEVA 49.09, -1.37, -2.72%) , which is also working on an oral MS drug. Teva markets
one of the leading MS drugs, Copaxone.

Teva shares were down 3% at $49.

Switzerland’s Novartis AG (NVS 55.24, -0.06, -0.11%) already markets an oral MS drug,
called Gilenya, which also had study results released Monday.

Shares of Idenix Pharmaceuticals (IDIX 3.23, +0.33, +11.21%) were on the rebound, up
9% after analysts at Bank of America-Merrill Lynch upgraded the stock to buy from neutral. Read more on Idenix stock offering.

Idenix shares slid 10% last Friday after the company priced a stock offering substantially below the previous day’s close.

The drug sector’s two leading indexes were also higher. The NYSE Arca Pharmaceutical Index (DRG 315.08, +1.39, +0.44%) climbed 0.5% to 315 and the NYSE Arca
Biotechnology Index (BTK 1,388, +4.38, +0.32%) rose 0.4% to 1,389.

Sun Pharma, Merck’s India Unit Form Joint Venture

India’s Sun Pharmaceutical Industries Ltd. and U.S.-based Merck & Co. said Monday they have formed a joint venture focused on emerging markets, the latest in a series of deals through which Western drug makers are looking at opportunities outside their traditional markets.

“This joint venture will focus on developing, manufacturing and commercializing innovative branded generic medicines,” Sun Pharma Chairman Dilip Shanghvi said at a news conference.

Alembic’s real estate arm gets listed

The real estate arm of city-based Alembic Limited has got listed while its pharmaceutical arm is expected to get listed after the third week of May. Brokerage firm – Angel Broking – said this on Monday.

It was in June last year that Alembic Limited, country’s oldest pharmaceutical company, had announced demerger of its core pharmaceutical business into a 100 per cent subsidiary company called Alembic Pharma Limited (APL).

Under the scheme, pharma business comprising the domestic formulation, international generic and active pharmaceuticals ingredients (API) businesses along with the manufacturing facility at Baddi, Panelav and Karakhadi will be transferred to APL.

Alembic Limited will retain its Vadodara manufacturing facility including the loss making Penicillin G business along with the power infrastructure used for internal consumption and 115 acres of land assets at Vadodara including 45 acres currently used for the Pen-G facility.

Under the arrangement, shareholders of Alembic would receive one equity share of APL in the ratio of 1:1.

The brokerage firm on a conservative basis has valued the real estate arm at Rs 33 per share while APL is valued at Rs 71 per share.

Company officials however declined to comment on this valuation.

“The demerger process is complete and the shares are trading ex-scheme from Monday,” Alembic’s CFO R K Baheti told TOI, adding that the company will now make allotments to all the shareholders of Alembic Limited]

GW Pharma signs Sativex deal with Novartis

Cannabis-based medicines group GW Pharmaceuticals (GW) could receive over $30m under a new licence agreement with pharmaceutical giant Novartis Pharma to commercialise GW’s spasticity treatment product.

Novartis will commercialise ‘Sativex’ in Australia, New Zealand, Asia (excluding Japan, China and Hong Kong), the Middle East (excluding Israel/Palestine) and Africa.

GW will collect an upfront payment of $5m and could receive additional payments totalling $28.75m if it hits certain approval and commercial milestones. It will also receive royalties on sales of the product.

“As one of the world’s leading pharmaceutical companies with a strategic focus in both MS and oncology, Novartis represents an excellent commercial partner for Sativex in these important and growing international markets,” said GW’s managing director Justin Gover.

After factoring in the payments to its forecasts, Peel Hunt has upped its target price for the group from 160p to 178p, and kept its ‘buy’ rating, seeing an “excellent buying opportunity given the recent share price weakness.”

SuperGen To Acquire Astex

Pharmaceutical company SuperGen Inc, released a statement on Thursday stating the company has agreed to purchasing British based drug company Astex Therapeutics Ltd.

SuperGen’s released partial terms of the deal stating that they will be acquiring the company from Astex for 25 million dollars in cash. Astex Therapeutics shareholders own 35% of the combined company at closing. SuperGen also stated that they will pay 30 million dollars in cash or stock, in addition to the 25 million dollars. The 30 million dollars will be compensated over a 30 month period.

The deal is awaiting approval from regulators as well as shareholders, however if it does pass approval the deal will completed in July. Once the deal is finalized, shares of the company combined will trade on the Nasdaq under the ticker “ASTX”.

SuperGen which is located in Dublin California develops drugs that fight tumors and blood disorders. One of the most well known drugs the company has made is the drug Dacogen. Dacogen is a drug used to treat myelodysplastic syndrome. Myelodysplastic syndrome is a condition in which bone marrow produces blood cells that are misshaped and thus cannot produce healthy blood cells. Astex is a private company that studies drugs used to treat cancer and other life threatening viruses.

SuperGen plans to rename Astex Therapeutics to Astex Pharmaceuticals.

Orndorff to lead bioscience association

Ariel Pharmaceuticals founder Steve Orndorff has been tapped to head the board of directors of the Colorado BioScience Association, an industry trade group with several Boulder Valley members.

Orndorff takes over the chairman duties from Rick Jory, chief executive officer of Sandhill Scientific in Highlands Ranch. Derek Cole is the newly named vice chairman of the board. Cole is vice president at Broomfield-based ARCA biopharma Inc., a company that makes therapies for heart failure.

Broomfield-based Ariel Pharmaceuticals is a startup pharmaceutical company focused on bringing three experimental neurological drugs to market. Orndorff previously was president and chief executive of Broomfield-based Accera Inc., an Alzheimer’s therapy company, which he started and ran. Before that, Orndorff held the same role at Broomfield-based Univera Pharmaceuticals Inc., a drug discovery company that focused on inflammation diseases.

Orndorff is a founding board member of the Colorado BioScience Association and the past president of the Society for Industrial Microbiology.

In addition, treasurer Norwood Robb, from the Denver School of Science and Technology, and secretary Linda Pryor, from Pfizer Inc., will continue as officers. Four new board members also have been approved by members.

Newly named CBSA board members include:
Jeff Castleberry, chief operating officer, EndoShape Inc., Boulder;
Joe Guiles, executive director, MicroRx, CSU Ventures, division of Colorado State University, Fort Collins;
Scott Hutton, senior director of global marketing, Medtronic Navigation, a sector of Medtronic Inc., Louisville;
David Mitchell, executive director, plant manager, Merck & Co. Inc., Boulder.

Reappointments of board members include:
John Dunning, president and chief executive, Clarimedix Inc., Boulder;
Rick Jory, president and chief executive officer, Sandhill Scientific Inc., Highlands Ranch;
Ruth Lytle-Barnaby, executive director, Poudre Valley Health System Community and Foundation Development, Fort Collins;
Will Vaughn, director of technology transfer, Colorado School of Mines, Golden
Michael Weiner, partner, Dorsey & Whitney LLP, Denver;
Jim Wilson, senior audit manager, Ernst & Young, Denver.

The group’s mission is to support the regional bioscience community through advocacy and to look for collaboration opportunities. It promotes the interests of more than 400 regional bioscience companies and an estimated 20,000 employees.

Transcept Pharmaceuticals to Present at Future Leaders in the Biotech Industry Conference on April 15, 2011

POINT RICHMOND, Calif., April 7, 2011 /PRNewswire/ — Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced that Transcept management is scheduled to present at the Future Leaders in the Biotech Industry Conference on April 15, 2011 at 10:00 a.m. ET.

About Transcept

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. The most advanced Transcept product candidate is Intermezzo® (zolpidem tartrate sublingual tablet). Transcept has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) that seeks approval of Intermezzo® as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. The FDA has assigned a date of July 14, 2011 for its completion of the Intermezzo® NDA review. Transcept and Purdue Pharmaceutical Products L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States. In March 2011, Transcept initiated a Phase 2 study of TO-2061, a low dose ondansetron augmentation therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to treatment with approved first-line pharmacotherapy.

Cancellation of Drug Licenses at the Manitoba Pharmaceutical Association

A 49-year-old woman has been charged of allegedly forging documents and extracting money from people. She was a former employee of the Manitoba Pharmaceutical Association.

The woman used to be in charge of the licensing and registration at the pharmaceutical agency. She apparently committed these crimes from the time period ranging from January 2009 to the August of the year 2010.

This was found out in a research conducted on the inside of the institution, which was conducted by officials from the Saskatchewan College of Pharmacists. Two pharmacists had their drug licenses cancelled as a result of the same review.

The investigation was brought into action after the officials of the firm has realized that there were missing funds in the August of last year.

There were reports coming up in this January about the criminal investigation that took place in the firm and it was found that there were issues in the licensing of the pharmacists documents and prevented him from working in the province.

According to the officials of the firm, there was no potential threat to the public by the actions of these lawbreakers and thieves working in the firm. It was just that the entity was facing losses due to their actions.

Questions raised about industry influence on anti-depressant studies

For more than two decades, researchers have been unable to settle an important question: Can anti-depressant medications stimulate the growth of breast and ovarian cancers?

Some studies pointed to a link, but others did not.

Now a re-examination of the available evidence has cast a new – and disturbing – light on the previous research. Many studies that seemed to absolve the drugs of blame were carried out by researchers with close ties to the pharmaceutical industry, according to a report published this week in the online journal PLoS (Public Library of Science) One.
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“I think that’s an important piece of information,” said the lead author of the paper, Lisa Cosgrove of the Edmond J. Safra Center for Ethics at Harvard University in Boston.

For the review, Dr. Cosgrove and colleagues amassed a total of 61 studies, which included both laboratory and epidemiological research.

They then conducted separate searches on the principal investigators for each of the studies, looking for drug-company connections. “It was a lot of legwork,” said Dr. Cosgrove, noting that, in the past, such ties were not always publicly reported.

A clear pattern emerged. “None of the researchers with industry affiliation reported a positive association” between antidepressants and the risk of cancer, she said.

There were more mixed findings among researchers free of corporate ties. “Approximately 43 per cent of researchers without industry affiliation reported a positive association.”

A closer examination of these studies – using meta-analysis, which pools the data – suggests the risk is real, but not very large. Women with a history of antidepressant use faced an 11-per-cent increased chance of developing breast and ovarian cancer, compared with those who had not taken these medications. In the case of breast cancer, that means taking antidepressants would raise an average woman’s lifetime risk to 13.8 per cent from 12.5 per cent, Dr. Cosgrove said.

The risk is primarily associated with just one class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, which includes Prozac (generic name, fluoxetine), Paxil (paroxetine) and Zoloft (sertraline). “All studies but one in the SSRI analysis found a positive association,” she said.

Tricyclics, an older class of drugs, don’t appear to be as problematic. “There was a slight increase in risk but it was not statistically significant,” she said.

“I wouldn’t want any woman who is taking an antidepressant to abruptly stop,” cautioned Dr. Cosgrove. “She should talk over that decision with her doctor.”

Although the drugs appear to boost the odds of getting cancer by only a small amount, she said women should at least be informed of the potential risk. And that risk doesn’t come to light in industry-connected studies.

“We are at a point where public trust in biomedicine is rapidly decreasing as a result of conflicts of interest.”

However, Dr. Cosgrove doesn’t believe there is some covert “Machiavellian” plot by industry to cover up all unfavourable study results. She noted that the vast majority of researchers who receive industry funding consider themselves to be unbiased.

Over time, though, close industry ties can have a “pernicious” effect on the attitudes and actions of doctors and scientists. “Researchers might not be aware of the subtle ways they can be influenced, “ she said.

Doctors could be allowed to prescribe cheap drugs

In a move that could benefit many patients currently denied expensive treatments, the regulator for the medical profession has said for the first time that GPs should be allowed to give out a less costly alternative even if it is not licensed for that condition.

The General Medical Council said that doctors must only check that the “off-label” drug is safe and effective, as well as telling their patients why they are prescribing it.

It could bring fresh hope to thousands of people who suffer from the leading cause of blindness, wet age-related macular degeneration (wet AMD), who are currently denied treatment because one drug is extremely costly and because pharmaceutical companies will not seek a licence for a cheap alternative.

The updated GMC guidance also warns GPs of the potential risks of prescribing treatments by telephone or over the internet, and tells them to consider raising concerns if they believe athletes are using performance-enhancing drugs.

Niall Dickson, the Chief Executive of the GMC said: “Between 1995 and 2009 the number of drugs prescribed by GPs tripled and it is clear that they remain a vital part of the medical armoury, bringing benefits to many patients.

“So it is vital that our guidance for doctors on prescribing and managing medicines is relevant and up to date.”

Drugs are licensed for specific conditions by one quango called the Medicines and Healthcare products Regulatory Agency, and then another body called the National Institute for Health and Clinical Excellence (Nice) draws up guidelines on whether or not they should be recommended for general use of the NHS.

But pharmaceutical firms have been accused of failing to seek additional licences for products that can treat more than one condition, in order to protect their profits.

In the case of wet AMD, with which 20,000 people are diagnosed every year in Britain, there is a licensed and recommended treatment called Lucentis that costs around £750 a dose.

Another drug called Avastin, which can cost as little as £50 a dose, is also effective in stopping sufferers losing their sight, yet is licensed for bowel cancer but not for wet AMD.

Some health trusts in England have already started using Avastin instead of Lucentis for the eye condition, and now the GMC has suggested that it is willing to allow all doctors to do so.

Its new draft guidance states: “You should usually prescribe licensed medicines for their licensed uses; but you may prescribe off-label or unlicensed medicines outside an approved research protocol if there is no appropriately licensed alternative available or you are satisfied, on the basis of authoritative clinical guidance, that it is as safe and effective as an appropriately licensed alternative.”

The GMC highlights two drugs effective for treating anxiety and pain, for which “there are licensed alternatives, but they are not considered by Nice to be as cost-effective”.

The document also raises concerns about the increasing number of doctors prescribing drugs “remotely” – by phone or online – although it does not outlaw the practice .

It states: “You should prescribe only when you have adequate knowledge of the patient’s condition, and are satisfied that the medicines serve the patient’s needs.

“You should consider the limitations of the medium through which you are communicating with the patient, the need for physical examination or other assessments and whether you have access to the patient’s medical records.”

The consultation document goes on: “Many respondents to the scoping consultation to develop this draft were in favour of a ‘ban’ on doctors prescribing remotely (particularly online) for patients they had not met and whose records they did not have access to, especially without liaison with the patients’ general practitioners.

“Others questioned the evidence of harm arising from online and other remote prescribing practices. A few were concerned about the impact any ‘ban’ might have on patients’ access to the medical care of their choosing and their rights to control information about themselves.”

New drugs from mutant bugs

Working with Japanese pharmaceutical company Daiichi-Sankyo, and funded by the UK Biotechnology and Biological Sciences Research Council (BBSRC), the researchers’ work paves the way for the creation of new hybrid antibiotics that may help to solve the growing problem of bacterial infections that are resistant to essentially all antibiotics.

The research is published online in the journal PLoS ONE.

The team, comprising microbial geneticists from Birmingham and chemists from Bristol, determined the sequence of the complete DNA content of the marine bacterium that produces the new antibiotic, thiomarinol, owned by Daiichi-Sankyo. They then identified the genes responsible for making the antibiotic on the basis of their similarity to genes that make the related but less potent antibiotic, mupirocin, which is currently used to combat MRSA (methicillin resistant Staphylococcus aureus).

They found the genes are on a relatively small, separate DNA molecule called a plasmid, which is just big enough to carry the genes for making the antibiotic plus genes to allow the plasmid to replicate autonomously in the bacterium. The plasmid thus carries genes that make both the mupirocin-like antibiotic as well a second antibiotic, holomycin, and a gene responsible for joining both antibiotics together, forming a more potent molecule.

Tests showed that by joining the antibiotics together the resulting chemical is able to inhibit the growth of MRSA strains that have become resistant to mupirocin. ‘This shows how mupirocin can be modified to make it more potent and suggests that related molecules could be used against the increasingly problematic Enterobacteriacae like Escherichia coli and Klebsiella pneumoniae,’ says University of Birmingham research lead Professor Chris Thomas.

By using mutant strains that were unable to make either the mupirocin part or the holomycin part the team was able to feed alternative compounds to the bacteria – so-called mutasynthesis – so that a family of novel molecules was created, and tests showed some of these had biological activity. ‘This provides hope that the system will allow the production of new antibiotics that may help to combat the growing problem of antibiotic resistance in pathogenic bacteria,’ adds University of Bristol research lead Professor Tom Simpson.

Merck Sees Inspiration in Eye Care

Mergers and acquisitions continue in the pharma sector with Merck (MRK – Analyst Report) recently announcing its intention to acquire specialty pharma company Inspire Pharmaceuticals, Inc. (ISPH – Snapshot Report). The companies have entered into a definitive merger agreement which has been approved by the boards of both companies. Moreover, Warburg Pincus Private Equity IX, L.P., which owns 28% of Inspire Pharma’s shares, has agreed to tender all of its shares.

Deal Valued at $430 Million

Per the terms of the deal, Merck will pay $5 per share in cash to Inspire Pharma shareholders. The price represents a 26% premium to Inspire Pharma’s closing price on April 4, 2011. The entire deal has been valued at $430 million.

Inspire Pharma’s shares plunged more than 55% in early Jan 2011 when the company announced disappointing top-line results on its phase III cystic fibrosis candidate, denufosol. Since then, the shares have been struggling to regain lost ground and have been trading in a tight range.

Deal Makes Sense for Both Merck and Inspire Pharma

The deal makes sense for both Inspire Pharma and Merck. Inspire Pharma has been struggling following the late-stage failure of its cystic fibrosis candidate. The acquisition is a decent deal for Inspire Pharma’s shareholders. Inspire Pharma was left with a weak pipeline following the termination of the development of the cystic fibrosis program. The company also faced a setback with another phase III ophthalmology candidate, Prolacria, whose development is on hold for now.

Meanwhile, Merck has been working on expanding its ophthalmology product portfolio. The company currently has a glaucoma candidate, Saflutan, under US Food and Drug Administration (FDA) review. Saflutan became a part of Merck’s pipeline following the company’s April 2009 worldwide licensing agreement with Santen Pharmaceutical Co., Ltd.

Other candidates in Merck’s ophthalmology portfolio include Cosopt/Trusopt. However, US marketing exclusivity on both products have expired with sales declining 4% in 2010 to $484 million. While Trusopt has already lost marketing exclusivity in several European markets, Cosopt is slated to lose market exclusivity in several major European markets in March 2013.

With the Inspire Pharma acquisition, Merck will gain access to AzaSite, which is approved for bacterial conjunctivitis. AzaSite revenues increased 22% to $42.7 million in 2010. AzaSite is also being developed for blepharitis.

Besides AzaSite, Merck will be entitled to receive co-promotion revenues/royalties on two other eye care products, Elestat and Restasis, from Allergan, Inc. (AGN – Analyst Report). Additional royalties will come from Santen Pharma on Diquas sales in Japan.

Neutral on Merck

We currently have a Neutral recommendation on Merck supported by a Zacks #3 Rank (short-term Hold rating). Merck is currently facing issues such as patent expirations of key drugs, EU pricing pressure, US health care reform and pipeline setbacks. We believe the company will have to resort to cost-cutting initiatives to drive the bottom-line. Meanwhile, some of the company’s recent launches should start contributing significantly to the top line in the forthcoming quarters.

FDA Panel Recommends Approval of C. Diff-Fighting Drug

The FDA panel, in a 13-0 vote, agreed the drug fidaxomicin was safe and effective in treating C. diff. However, there was disagreement among the panelists over whether the drug was able to prevent infections in the future, according to the news report. The panelists also said the drug should include a warning label mentioning potential risks to patients who are pregnant or have weak immune systems, according to the news report.

Despite the panel’s unanimous backing, the FDA is not obligated to fully approve the drug. The FDA is expected to make a decision about the drug’s final clearance by May 30.

Dealtalk: Valeant bid wakes up market to drugmaker targets

(Reuters) – Valeant Pharmaceutical International’s (VRX.TO) $5.7 billion bid for Cephalon Inc (CEPH.O) challenges the industry wisdom that a drugmaker about to lose patent protection for top products does not make an attractive buyout target.

That could open the door for takeover proposals for companies such as Endo Pharmaceuticals Holding (ENDP.O) and Forest Laboratories Inc (FRX.N), which face patent threats to top products in the coming years that could seriously hurt their revenues.

Since Valeant announced its unsolicited bid on March 29, Endo shares have climbed 16 percent, while shares of larger Forest are up 6 percent as analysts say takeover premiums are building into the stocks.

“You’ve got a lot of these companies that are facing big patent expiries, not just in Big Pharma. A lot of these companies are bloated as well,” Jon LeCroy, an analyst with Hapoalim Securities said in an interview this week.

“They spend a lot on R&D, they don’t get much out of it. For what they trade at, if another company can get in there and really chop costs it makes a lot more sense than leaving these companies on their own.”

The Valeant announcement also has sparked Wall Street enthusiasm for other stocks, such as Medicis Pharmaceuticals Corp (MRX.N), up more than 9 percent in the past week.

“Some of these stocks that have what people view to be similar profiles and relatively attractive valuations, now they say, ‘If this M&A market is really that hot, then how do you not own some of these stocks,’ ” said Gary Nachman, an analyst with Susquehanna Financial Group.

PHARMA’S PATENT CLIFF

The bid for Cephalon underscored a new potential dynamic for the pharmaceutical industry’s much-discussed “patent cliff,” under which many of the industry’s biggest-selling drugs will lose exclusivity and see revenues fall due to generic competition over the next few years.

Many large drugmakers have looked to fill those revenue gaps with deals for companies with either promising experimental medicines or new biotechnology drugs that do not face impending patent issues.

The most prominent recent example is Sanofi-Aventis’ (SASY.PA) $20 billion bid for rare-disease drug specialist Genzyme Corp (GENZ.O).

By that logic, Cephalon would seem an unlikely takeover candidate. It faces the U.S. patent expiry in 2012 for its Provigil sleep disorder drug, which amounted to about 40 percent of its revenue last year. But the U.S. drugmaker made an alluring target for Valeant and the Canadian company’s low-cost operating structure.

“A patent cliff is not something that happens in a vacuum. A patent cliff, and a major earnings gap associated with it, happens when there’s a lot of spend,” said David Amsellem, an analyst with Piper Jaffray.

“In the case of Cephalon, why did they make an interesting target? Because there was enormous amounts of cash flow generation that could be unlocked if they took a more careful look at their spend.”

Some see the potential for replicating that situation with other companies that have products with strong cash flow.

“You end up with situations where a strategic acquirer says, ‘I can harvest more value from that asset than current management has so I am going to take my case to the shareholders’.” Drew Burch, head of healthcare mergers and acquisitions for Barclays Capital Burch told the Reuters Global M&A Summit this week.

Like Cephalon, Forest Labs faces a daunting patent cliff. The company, with a market value of $9.5 billion, is set to lose exclusivity next year over its top-seller, the anti-depressant Lexapro, while Alzheimer’s drug Namenda is expected to lose protection in 2015.

Compared with Cephalon, Amsellem said Forest’s business model involves promotion-sensitive products that may make it more difficult to find savings.

“Forest has a lot of primary-care-focused products that are going to require significant spend in order to drive adoption so that kind of goes against the whole idea of slashing costs,” Amsellem said.

Forest is on the larger end of specialty drugmakers and also could be a buyer, along with Allergan Inc (AGN.N) and Shire Plc (SHP.L) — two companies that also have been long-mentioned as potential prey for large pharmaceutical companies.

But the most likely company to follow Valeant’s lead could be Valeant itself. Acquisitions are a clear part of Valeant’s strategy, which also involves a low tax base as well as minimal research and promotional spending.

Some analysts see Valeant as a unique acquirer because of the savings and benefits it appears to be able to wring out of deals.

Valeant has vowed to be disciplined with its Cephalon bid and move on quickly if shareholders show no interest, leaving analysts to speculate who else could be in the company’s cross-hairs.

Endo, which has major pain franchises, and Medicis, which sells the Solodyn acne drug, could be targets for Valeant, according to Piper’s Amsellem.

Susquehanna’s Nachman said Medicis or Jazz Pharmaceuticals (JAZZ.O), which sells neurology products, could fit with Valeant.

“We don’t know if it is a done deal with Cephalon…Obviously (Valeant is) hungry, they’re looking for deals,” Nachman said. “There’s definitely some of that built into the stocks now, there’s no question.”

New drugs from bugs

Scientists from the Universities of Bristol and Birmingham have discovered how marine bacteria join together two antibiotics they make independently to produce a potent chemical that can kill drug-resistant strains of the MRSA superbug.

Working with Japanese pharmaceutical company Daiichi-Sankyo, and funded by the UK Biotechnology and Biological Sciences Research Council (BBSRC), the researchers’ work paves the way for the creation of new hybrid antibiotics that may help to solve the growing problem of bacterial infections that are resistant to essentially all antibiotics.

The research is published online in the journal PLoS ONE.

The team, comprising chemists from Bristol and microbial geneticists from Birmingham, determined the sequence of the complete DNA content of the marine bacterium that produces the new antibiotic, thiomarinol, owned by Daiichi-Sankyo. They then identified the genes responsible for making the antibiotic on the basis of their similarity to genes that make the related but less potent antibiotic, mupirocin, which is currently used to combat MRSA (methicillin resistant Staphylococcus aureus).

They found the genes are on a relatively small, separate DNA molecule called a plasmid, which is just big enough to carry the genes for making the antibiotic plus genes to allow the plasmid to replicate autonomously in the bacterium. The plasmid thus carries genes that make both the mupirocin-like antibiotic as well a second antibiotic, holomycin, and a gene responsible for joining both antibiotics together, forming a more potent molecule.

Tests showed that by joining the antibiotics together the resulting chemical is able to inhibit the growth of MRSA strains that have become resistant to mupirocin.

Professor Chris Thomas, lead researcher from the University of Birmingham, said: “This shows how mupirocin can be modified to make it more potent and suggests that related molecules could be used against the increasingly problematic Enterobacteriacae like Escherichia coli and Klebsiella pneumoniae.”

By using mutant strains that were unable to make either the mupirocin part or the holomycin part the team was able to feed alternative compounds to the bacteria – so-called mutasynthesis – so that a family of novel molecules was created, and tests showed some of these had biological activity.

Professor Thomas added: “This provides hope that the system will allow the production of new antibiotics that may help to combat the growing problem of antibiotic resistance in pathogenic bacteria.”

Online Exclusive: UW researchers’ high ties to big pharmaceuticals

The Milwaukee Journal Sentinel recently ran an investigative piece on a University of Wisconsin research group called UW Pain and Policy Studies Group. The investigation found the group repeatedly advocated against stricter regulations in the use of painkillers known as opioids. Perhaps the most notable of these painkillers is OxyContin, which is manufactured by Purdue Pharma, a company that has given the research group $1.6 million over the past decade. The story went on to point out the intricate and often undisclosed financial relationship between pharmaceutical companies and researchers, showing the research group received more than $2.5 million in funding from pharmaceuticals.

Pharmaceuticals are big business, I know, not exactly a shocker. Purdue Pharma alone pulled in $3 billion in revenue last year, with sales skyrocketing after the FDA approved the use of OxyContin in the United States.

There are two main problems this story reveals that need to be addressed for the improvement of health care in this country.

The first is the separation of researcher and manufacturer. The university had some answers when asked by the Sentinel about the relationship between these two entities. UW spokesperson Lisa Brunette said the money given was in educational grants with no strings attached and that the group did no direct work for the company. But businesses don’t make investments without cause, and the financial advantages to the researchers of producing favorable results appear to be a theme in the Sentinel’s investigation.

I don’t believe anything in the past was done illegally necessarily, but I think the positions taken by these individuals in medical journals greatly benefited the companies who had helped fund the research. At the same time, it provided the researchers themselves with easy money, while the proliferation of these drugs led to a sharp increase in related deaths.

A study presented by the U.S. Centers for Disease Control and Prevention linking deaths from narcotic painkiller abuse and a 500 percent increase in these drugs prescriptions highlights this correlation. These drugs present a real risk of dependence and long-term addiction, and a concerted effort to combat stricter regulations seems a dangerous, albeit profitable position to take.

My own solution to this conflict of interest would be to prevent pharmaceuticals from funding researchers, but obviously every company has the right to research its own products. But doctors need an unbiased opinion off of which they can base their prescription decisions. The government needs to step in and provide the increased research, providing these groups the educational grants they need to better understand the effects of new drugs.

The second problem I see is just the mind-boggling amount of money these companies make. We sit here and yell back and forth about health care reform, but it seems to me we would be better served addressing specific problems within that system. One problem: Prescription drugs cost a hell of a lot of money. Why? The most expensive drugs are rarely the ones that cost the most to produce. Instead, the most expensive drugs are the ones that fill a new niche in the market or have almost no competitors.

Then, when manufacturers and insurance companies sit down, there is very little to guide the negotiation. That certainly seems to make it a great investment to have a research group like UW Pain promoting the inclusion of opioids into the market when you have a pill ready to fill that niche. Yes, new drugs cost a lot of money to bring to market, but after that there is absolutely no relationship between what it costs to make an individual pill and what it sells for. The result puts both manufacturers and insurance companies in the drivers seat and leaves the average patient facing constantly rising costs and potentially unnecessary prescriptions.

I understand that the people working in our research facilities need funding, and outside of that researchers are looking for opportunities to profit from their knowledge. But is it really in the best interest of the patient to essentially have a company’s product rubber stamped by a research team? Watchdog journalism like the work done in this Sentinel piece can help highlight these conflicts of interest, but structural changes need to be made to ensure that new drugs are being created to better service the needs of the patient, not the bank accounts of the manufacturers.

Consumers Urged to Take Action to Stop the White House from Blocking Access to Low Cost Medicine from Pharmacies Abroad

The White House, through its Office of the Intellectual Property Enforcement Coordinator, is taking actions that could block access by Americans to safe, low cost medicine from online pharmacies in Canada and elsewhere. Americans are being urged to contact the President and their Congressional representatives to stop this action from affecting properly credentialed pharmacies that safely sell geniune medication for use by patients that have prescriptions. Twenty-five million Americans already forgo their medicine due to cost according to the Centers for Disease Control.

Pharmacy students learning in a virtual world

The group has created a virtual island called ‘Pharmatopia’, which is divided into four zones, each with specific teaching and learning objectives including a manufacturing zone, clinical zone, community zone and industrial zone.

UQ Pharmacy lecturers, Ms Jacqueline Bond and Dr Sally Firth, who have been involved in the development of ‘Pharmatopia’, introduced UQ’s first-year pharmacy students to ‘Pharmatopia’ for the first time this semester as part of a virtual laboratory class.

Ms Bond said the virtual reality resource allowed students to practice pharmaceutical calculations required for the compounding process.

“Calculations are presented as prescriptions from virtual patients, phone enquiries or ‘chats’ with virtual nurses, doctors and patients,” Ms Bond said.

“Students select the required ingredients from an extensive selection of drugs and raw materials and measure out the correct amount or provide other dosage related data as prompted.

“It’s a much more fun way to learn calculations than the way we were traditionally taught and it’s been a very exciting project to develop.”

The ‘Pharmatopia’ project brings together expertise from each of the university collaborators in a shared practice model, in which each university builds a teaching module on the virtual world, and then shares it with the rest of the ‘Pharmatopia’ community.

UQ’s contribution to ‘Pharmatopia’ is a virtual compounding dispensary located in the manufacturing zone.

Lecturer at the School of Pharmacy, Dr Sally Firth, said she saw great potential in the virtual reality resource assisting her students in their studies.

“The virtual environment provides real-time feedback on a student’s progress, and allows students to practice an exercise many times without consuming actual resources, occupying laboratory space or needing the guidance of a tutor,” Dr Firth said.

“The online platform also allows for communication between students within the virtual environment, providing an opportunity to work together to solve problems.

“The project is currently in its Beta phase, and will continue to expand as new practice environments are added, but it seems that the sky is the limit for this revolutionary new learning model.”

Fourth year honours student Ms Helender Singh is conducting an evaluation of Pharmatopia as part of her Honours project.

“One of the real strengths of the UQ Pharmatopia compounding laboratory is that students can work in whatever location they choose,” Ms Singh said.

“Whether this is in the classroom, library or home, students can complete as many exercises as they want in a safe, anonymous and non-judgemental environment.”

Monash University is the project leader for ‘Pharmatopia’ and collaborators also include, University of Sydney; University of London (UK), Nottingham University (UK), University of Keele (UK), Uppsala University (Sweden); University of Copenhagen (Denmark); University of North Carolina (USA); University of Kansas (USA)

Rexahn Pharmaceuticals to Present at Needham & Company’s 10th Annual Healthcare Conference

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it will present at Needham & Company’s 10th Annual Healthcare Conference on Wednesday, April 6, 2011, at 2:40 p.m. EDT in New York City.

Rexahn’s President and Chief Operating Officer, Rick Soni, and Chief Financial Officer, Ted Jeong, will provide a strategic business overview of the Company, including a discussion of its R&D pipeline.

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to developing and commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. Rexahn currently has three drug candidates in Phase II clinical trials, Archexin®, Serdaxin®, and Zoraxel™ – all potential best in class therapeutics – and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders. Rexahn also operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms.

BioSante Pharmaceuticals to Host LibiGel® R&D Event in New York City

BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will host a review of female sexual dysfunction (FSD) and the safety of testosterone in women by independent experts, as well as an update of the LibiGel (testosterone gel) development program, for institutional investors and analysts on Thursday, April 7, 2011 in New York City. LibiGel is in Phase III clinical development for the treatment of FSD, specifically, hypoactive sexual desire disorder (HSDD) in menopausal women. Data from both LibiGel Phase III efficacy trials is expected in Fall 2011.

The LibiGel R&D Event will include presentations by independent experts in the fields of FSD and testosterone therapy, and BioSante’s management will speak about the LibiGel Phase III clinical development progress. The independent experts’ presentations include:

“Hypoactive Sexual Desire in Postmenopausal Women,” by Sheryl Kingsberg, PhD – Chief, Division of Behavioral Medicine, University Hospitals Case Medical Center, MacDonald Women’s Hospital; Professor of Reproductive Biology and Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio.

“Update on Testosterone Safety in Women,” by Glenn D. Braunstein, MD – Chairman, Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.

MonoSol Rx Issued Strategic US Patent Governing the Production of Pharmaceutical Films Containing Specific Drugs and Drug Classes

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in proprietary pharmaceutical film products, today announced that it has been granted U.S. patent No. 7,897,080 from the United States Patent and Trademark Office (USPTO). The patent provides intellectual property protection for the Company’s methods of pharmaceutical film preparation along with the incorporation of specific drugs and polymer components.

Among the active categories covered in the patent are opiate and opiate derivatives such as buprenorphine and naloxone, anti-emetics such as ondansetron and granisetron hydrochloride, analgesics such as fentanyl, anti-migraines such as triptans, and anti-diabetics. Polymer components covered by the patent include carboxymethylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose and polyethylene oxide.

A. Mark Schobel, president and chief executive officer of MonoSol Rx, stated, “This latest patent provides undeniable affirmation that MonoSol Rx has the leading IP position in the development of pharmaceutical films and that our PharmFilm® technology is the industry standard for film drug delivery. Not only does this patent cover numerous actives and polymer components, but it also ensures that MonoSol Rx has process protection for the manufacturing of single and multi-layer films delivering a wide range of drug classifications through buccal and sublingual administration.”

Mr. Schobel continued, “Coupled with our prior patents, MonoSol Rx’s growing intellectual property portfolio offers clear competitive advantages to our current and prospective partners who view PharmFilm® as an ideal vehicle for delivering small or large molecules as well as sensitive prescription drug targets.”

About MonoSol Rx

MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary PharmFilm® technology to deliver drugs in films. PharmFilm® is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company’s leadership in film drug delivery is supported by strong intellectual property, a portfolio of commercialized prescription and over-the-counter (OTC) drug products, a pipeline of prescription formulations based on PharmFilm® technology, and two recent FDA approvals – Zuplenz® (ondansetron) oral soluble film 4 mg and 8 mg, the first approved prescription oral soluble film for the prevention of chemotherapy-induced, radiotherapy-induced, and postoperative nausea and vomiting, and Suboxone® (buprenorphine and naloxone) sublingual film 2 mg/0.5 mg and 8 mg/2 mg CIII, the first sublingual film product for the treatment of opioid dependence.

MonoSol Rx’s commercialization strategy for all PharmFilm® products is to partner with the innovator or other specialty pharma companies that can sell-in and manage product sales and marketing. PharmFilm® is also a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).

Procter & Gamble (NYSE:PG) Expands With Teva

According to Cincinatti.com, Consumer products company Procter & Gamble (NYSE:PG) announced that it will make a partnership agreement with Israeli pharmaceuticals firm Teva Pharmaceutical Ltd. to promote growth in its over-the-counter drug business outside North America.

The deal will enhance the business of Procter & Gamble (NYSE:PG)’s health care brands like Vicks, Pepto-Bismol, Metamucil and Prilosec.

Procter & Gamble (NYSE:PG) is expecting to generate $4 billion in the coming years.

Procter & Gamble (NYSE:PG) chief financial officer Jon Moeller said, “We see this partnership as a breakthrough we’ve been working toward for several years to expand sales of health care brands.”

Govt settles Pan lawsuit for $67.5m

An eight-year long case between Pan Pharmaceuticals and the Federal Government has finally concluded in the Federal Court in Sydney.

Customers of Pan Pharmaceuticals have been awarded $67.5 million in compensation.

That comes on top of a $55 million payout to Pan’s founder Jim Salim in 2008.

However, today’s settlement does not include any admission of wrongdoing by the Government.

It was a brief end to a very long case – Federal Court Judge Justice Geoffrey Flick simply acknowledged the settlement was finalised.

He did not read out the entire judgement, nor the compensation figure.

Instead the details were relayed by the lawyer representing the class action, Andrew Thorpe.

“This morning the Federal Court approved a compensation package for the group members of the Pan class action of $67.5 million,” he told reporters.

“That compensation package was negotiated without admissions of wrong doing by the Government.”

Mr Thorpe says it ends a long running saga that began in late April, 2003.

That is when Pan Pharmaceuticals went into voluntary administration after a Commonwealth agency – the Therapeutic Goods Administration – recalled all of Pan Pharmaceutical’s products after complaints its travel sickness medicine had caused people to hallucinate.

“On that day hundreds of people lost their jobs, $350 million was wiped off the Sydney stock exchange, and scores of feeder businesses, customers and service provides of Pan were very badly affected,” Mr Thorpe said.

“We also saw the largest ever recall in the history of the planet. I think it is fair to say that the industry descended into a state of chaos from which it has never really fully recovered.

“Thus began the lone fight of Mr Salim, which culminated in Australian legal history in August 2008 when the Government capitulated, awarded him a judgement and paid him $55 million dollars.”

One of the major stakeholders in the class action is complementary health care company Pharmacare.

“There has been mixed reaction for the few people that I have spoken to,” said Michael Halter, Pharmacare’s group operations manager.

“Some think the outcome has been reasonable. Others think it is not enough because of the loss they’ve suffered, but that’s the way the judicial system works, and that is the outcome that we have.”

He says the cumulative losses suffered by the 170 members of the class action were far in excess of the settlement.

“I don’t think the payment by the Commonwealth represents the loss, the sum loss that everyone suffered, so the collective figure was more than two times the sum that was paid,” he explained.

He says he is puzzled why the Commonwealth has paid out so much compensation, but has not admitted fault.

“It is interesting that the Commonwealth has paid an awful lot of money both to this case and also to Jim Salim’s case without admitting guilt,” he commented.

“It is a big sum of money, it is a substantial sum of money, and the fact that they still believe that they are not at fault is an interesting quandary, isn’t it?”

He says he is happy to be able to move on with his life.

“I hope so. I have been fighting this case for eight years and I’m over it so, yes, I hope it is over,” he added.

The compensation will be shared between 170 members of the class action.

Biostar Pharmaceuticals’ shares up 23% as Q4 profit triples

Biostar Pharmaceuticals (NASDAQ:BSPM) said Friday its fourth quarter profit more than tripled due to strong sales of its flagship hepatitis B drug, prompting a huge spike in the company’s share price.

For the fourth quarter ending December 31, the China-based pharmaceutical drug manufacturer reported net income of $6.1 million, or 22 cents per diluted share, up from $1.7 million, or 7 cents per diluted share, in the year ago period.

On an adjusted basis, earnings for the quarter were 24 cents per diluted share, beating analyst estimates of 22 cents a share.
Revenue rose 66% to about $28.2 million, exceeding analyst estimates of $27.6 million.

The increase in revenue was helped by 57% sales growth from the company’s Xin Aoxing hepatitis B drug, which accounted for two-thirds of the period’s revenue.

Sales of the company’s Gan Wang cold treatment drug also improved by 37% to $2.2 million.

Biostar continued to expand its distribution channel in Chinese rural communities during the quarter, with its products now being sold at 10,000 locations. The company expects that number to grow to 13,000 in 2011, it said.

For the full year, earnings rose 66% to $17.4 million, or 63 cents per diluted share, from $10.5 million, or 32 cents per diluted share, in 2009. Revenues soared 50% year-over-year to $80.2 million.

Since the announcement, the company’s shares jumped nearly 23% to trade at $2.72 as of 12:22 pm EST.

Lexicon Pharmaceuticals Appoints Dr. Pablo Lapuerta Chief Medical Officer

THE WOODLANDS, Texas, March 24, 2011 /PRNewswire/ — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that Pablo Lapuerta, M.D. has joined the company as its chief medical officer, responsible for directing clinical development of Lexicon’s drug candidates from Phase 2 proof-of-concept through Phase 3 and approval. Dr. Lapuerta has 15 years of pharmaceutical industry experience in a variety of leadership roles in drug development, global medical affairs and outcomes research strategy across multiple therapeutic areas, including cardiovascular disease, endocrinology, gastroenterology, and neurology. Most recently, Dr. Lapuerta served as vice president at Bristol-Myers Squibb where he was responsible for global development of an Alzheimer’s disease drug candidate with the associated use of an innovative biomarker.

“Dr. Lapuerta’s extensive experience in clinical development, regulatory strategy, and medical affairs are especially valuable as we progress the four programs we currently have in mid-stage clinical studies,” said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. “His breadth of knowledge in multiple therapeutic areas meshes well with Lexicon’s broad pipeline in drug discovery and development.”

Dr. Lapuerta obtained his undergraduate degree from Harvard College and his medical degree from Harvard Medical School. He completed his training in internal medicine at the University of North Carolina at Chapel Hill followed by a post-doctoral research fellowship at the University of California at Los Angeles in neuroscience. He served as assistant professor at the University of Southern California School of Medicine for several years. He has published more than 50 scientific articles on a wide range of topics including clinical trials, drug safety, epidemiology, health economics, and quality of care.

About Lexicon

Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has four drug candidates in mid-stage development for diabetes, irritable bowel syndrome, carcinoid syndrome and rheumatoid arthritis, all of which were discovered by Lexicon’s research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs.

Safe Harbor Statement

This press release contains “forward-looking” statements, including statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to successfully conduct preclinical and clinical development of its potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2010, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Trading Idea – Endo Pharmaceuticals Broke Resistance, What to Expect?

New York, March 24th – Shares of Endo Pharmaceuticals Holdings Inc. closed the trading session at $35.34 just above calculated resistance at $35.31 moving to what appears to be a new range, as this move will clearly raise the attention of momentum buyers.

Endo Pharmaceuticals Holdings Inc. is a specialty pharmaceutical solutions company, focused on high-value branded products and specialty generics. The company delivers an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology.

Endo’s stock was trading in a well defined range with support at $33.46 and resistance at $35.31, given that this range was broken traders will be closely monitoring the stock?s price action for clues of direction.

From a technical perspective it can be expected that previous resistance becomes support, as the new range gets defined, however, given that Endo’s stock is still near the broken resistance level, traders will be focusing on $35.31 to see if the stock holds the breakout without rolling over.

TDAP urges pharmaceutical cos to apply for WHO

KARACHI: Trade Develo-pment Authority of Pakistan (TDAP) asked pharmaceutical companies to apply for World Health Organization (WHO) pre-qualification to avail huge export opportunities.

At a seminar country advisor, WHO said pre-qualification procedures and export opportunities would be opened for the pharmaceutical companies after qualifying WHO pre-qualification.

The WHO country advisor said due to the lack of WHO pre-qualification, national companies are unable to participate in $110 million bids, which are appropriated for drugs’ supply to Pakistan by the WHO.

There was a dire need of awareness about WHO pre-qualification program for national pharmaceutical industry as there is no single pharmaceutical company in Pakistan which is WHO pre-qualified.

It is observed national companies despite having high level of technical expertise are devoid of any international accreditations.

It was said WHO and PPMA would ensure by the end of 2015, there would be at least 10 WHO pre-qualified companies in Pakistan.

Director general TDAP, head pharma cell TDAP besides members Pakistan Pharmaceutical Manufacturers Association attended the event.

NHS could publish prescription details for every GP practice

Information on the 900million medicine prescriptions written out each year by England’s doctors, currently only seen by certain NHS staff, could be made available to the public online.

A little-noticed section of HM Treasury’s Plan for Growth discloses the move as part of initiatives to improve research and health by providing more detailed evidence of illness and treatment.

In a one-line section headed “Opening up prescription data”, the document states: “Government will look to publish prescribing data at practice level subject to an evaluation and impact assessment by the NHS Information Centre.”

But the NHS Information Centre, which publishes statistics on the health service, ruled out the idea just two years ago.

Consultation documents state that the issue was raised after “a number of requests for such data from commercial companies”.

Local data on prescriptions is already collected in order to reimburse chemists and dispensing doctors for the £8billion of medicines they prescribe each year.

But only Primary Care Trusts, the tier of management currently above GPs, can access figures for surgeries in their area, and only the total number of prescriptions for each practice is made public, not the nature of the drugs given out.

The NHS Information Centre said in 2008 that “commercial companies will have significant potential benefits in obtaining access to this data”, by analysing it then presenting it to managers “at a cost to the NHS”.

But it warned of several possible risks, including the identification of practices “providing services for ‘sensitive’ conditions such as emergency hormonal contraception, HIV, drug addiction, Alzheimer’s disease, schizophrenia etc”.

This could lead to “lobbying by patient support groups” and “the pharmaceutical industry”.

Publication of data in remote areas could even lead to the identification of individual GPs or patients with rare conditions.

Patients would also be able to compare the number of highly sought-after treatments such as IVF prescribed in different areas, prompting claims of a postcode lottery.

The consultation goes on: “Practices, prescribers and the NHS may face increased targeting from the pharmaceutical industry.”

It says “it may not be in the best interests of the NHS or the public to disclose raw data due to the potential for it to be misleading”.

In 2009 the Information Centre decided “that open release of detailed practice level data is inappropriate and not permitted”, after NHS respondents to the consultation said there was “no need” for wider distribution.

It is possible the Department of Health will refine its plans to make the data available only to researchers.

A separate section in the Plan for Growth says the NHS “could offer unique opportunities for this country’s international competitiveness in health research” by using “anonymised data sets and aggregated prescription data linked down to GP practice level” in a “secure data service”.

It concedes: “That can happen only if there is robust protection for individual patients’ confidentiality and privacy.”

Former mayor sentenced for online pharmaceutical drug sales

A well-known Miami-Dade lawyer who pleaded guilty to selling tens of millions in pharmaceutical drugs without prescriptions on an Internet site serving buyers across the country was sentenced to 40 months by a federal judge in California on Thursday.

Robert Smoley, a former mayor of North Bay Village who has represented numerous high-profile clients during his career, admitted he and others distributed in excess of $48 million worth of drugs through his company, United Mail Pharmacy Services.

Federal agents say the 59-year-old attorney set up an elaborate distribution network from a warehouse in Florida, where he and others shipped drugs after taking orders over the Internet and call centers in Costa Rica and the Dominican Republic. Smoley admitted to selling more than seven million pills through more 17 online pharmacy sites – with most of the orders between 2001 and 2008.

‘CHOSE PROFITS’

“The Smoley drug trafficking organization fed the habits of drug seekers while its members chose profits over the health and well-being of those customers,” said DEA special agent Anthony Williams after Smoley’s guilty plea.

The onetime mayor took orders from customers who filled out online orders for medications, but no effort was made to ensure the information they provided was accurate, the plea agreement says.

The orders were then reviewed by doctors who were paid between $2 and $5 per order, with some doctors approving up to 500 orders per day.

Smoley admitted to encouraging doctors to review as many orders as possible each day, knowing they did not conduct physical exams – or review medical paperwork – for his customers.

For years, he managed to conceal the millions his organization reaped by shifting the money through various accounts set up at U.S. banks, court records state.

CAUGHT IN 2008

Though he had been under investigation for several years by federal agents in California, he was finally caught in early 2008 when he ordered more than half a million drugs from an undercover DEA agent.

He pleaded guilty before federal Judge Jeffrey White in San Francisco in November to conspiracy to distribute schedule III and IV controlled substances and conspiracy to launder money.

A practicing attorney since 1978, Smoley served as mayor of North Bay Village from 1980 to 1982, but left office after a controversial term in which citizens waged a recall effort against him and two commissioners.

His most high profile case came in 1991 when he represented Jeff and Kathy Willets, the Fort Lauderdale couple who made international news when they set up a $2,000 a week sex business out of their home, servicing the city’s vice mayor and others.

HIGH-PROFILE CLIENTS

Over the course of his 33-year career, he also represented several high-power officials, including Dade Circuit Court Judge Alfonso Sepe during a bitter judicial race in 1982.

Miami lawyer Richard Sharpstein, who represented Smoley during his drug case, said his client opened his business “fully believing that the Internet pharmacy was legal. Unfortunately for him, over the past five years the government has reversed its position and he was caught in the web.”

Canada Drugs Online and Online Pharmacy Coupons Team-up for Best Drug Prices

The most influential decision-making factor in purchasing is the cost. Businesses apply various strategies to lower down their material, machine, manpower and methodology costs. In lieu, Six Sigma and Lean Manufacturing have risen from such needs. Simultaneously, marketing strategies especially in the internet have been maximized further – Search Engine Optimization (SEO), Social Media Marketing (SMM), Search Engine Marketing (SEM), etc. to attract more clients and increase sales the same way low retail price does.

Canada Drugs Online together with Online Pharmacy Coupons managed to serve customers better. With this partnership, best, low, competitive, reasonable, marked-down (whatever you call it) prices are in store for you in every drug and pharmaceutical purchase that you make with Canada Drugs Online.

Are you new on using Online Pharmacy Coupons? You don’t know exactly how it works? Canada Drugs Online makes sure you understand its procedure in order to enjoy safe and effective drugs and other pharmaceutical products at its super best price.

Through Phone or Fax
If you prefer to use the telephone which is by far the easiest, fastest and most popular way in using Online Pharmacy Coupons, call Canada Drugs Online’s customer service agent upon ordering and mention the coupon code and name so that they will automatically deduct the amount of the coupon from your total order amount.

But if your preference is to fax an order form, simply write “Coupon Code” together with the name of the coupon on the order form and similar to phone processing, the coupon’s amount will be subtracted from your total payable.

Through Canada Drugs Online Website
An electronic way of using Online Pharmacy Coupons is by ordering using Canada Drugs Online’s shopping cart. Upon completion of your online order, state the coupon code and they will process your order with pleasure.

Through Email
You can also email your order form to Canada Drugs Online and specify the coupon code and name in the form. Or, after placing an online website order (using the shopping cart) you can send a separate email to the customer service personnel stating the coupon code and name, you order number, customer number and name for fast and easy processing. You are assured that the coupon savings are applied unto your order prior it is sorted out.

Reminder
Use savings and/or promo coupons as soon as you find them to avoid expiration. And, always make sure that coupons are properly encoded into your order form, and that our customer service representative has confirmed and approved the authentication and application of your coupon code and name. Coupons are not applicable to your past orders and orders that have been billed and/or invoiced already.

Bottom line is if you are in a tight budget, and needs a number of vitamins, supplements, medicines, beauty products, home health care goods, and the like, Canada Drugs Online is the best choice. Do not wait for tomorrow what you can do for today – sign up and be a member now with Canada Drugs Online!

For more information on “Canada Drugs Online and Online Pharmacy Coupons Team-up for Best Drug Prices”, make sure to follow the link in the resource box below.

Research and Markets: 2011 Global Contract Manufacturing Market Analysis

The global pharmaceutical contract manufacturing industry has registered strong growth during the past few years. The outsourcing of drugs manufacturing provides many advantages to the pharmaceutical companies, such as improved production capacity, quicker time to market drugs, and low scale up cost. With the help of contract manufacturing, pharmaceutical companies will be able to meet growing demand for new drugs and improve their core competencies. All these factors supported the contract manufacturing market to generate revenue worth around US$ 22.5 Billion at the end of 2009.

According to this new research report, demand for contract manufacturing services has been continuously soaring due to the rising cost pressure on pharmaceutical companies. Besides, the recent global economic slowdown was a major factor for the adoption of the contract manufacturing model. The leading pharma companies in the market are also looking at this model as a means to expand into the biosimilars and generics segments. With the changing economic scenario and the pressure of reducing drugs manufacturing cost, the global contract manufacturing market is expected to grow at a CAGR of around 11% during 2011-2013.

The publisher has also found that countries, such as India, China, Singapore, Russia, and Brazil are considered as the developed markets for contract manufacturers. The economic conditions of these countries are providing immense opportunities to the pharmaceutical manufacturers to expand their businesses. Countries, like Vietnam, South Korea, and Bangladesh are rapidly emerging among other contract manufacturing destinations. Majority of the drugs exported from these countries are destined to the American and European markets. In this regard, this research report provides complete information regarding the export of drugs from these countries.

The report provides an extensive research and prudent analysis of the global contract manufacturing industry. It gives an insight into the current and future market trends. The report has also studied the key contract manufacturers in all the countries to help clients understand the overall market dynamics. The report will work as an investment guide for the clients looking to invest or outsource their manufacturing in these markets.

Big Pharma compensation plans ‘flawed’ – study

Drug majors’ continued dependence on traditional executive compensation plans threatens to work in opposition to the culture of innovation which is needed to restore the sector’s health, a new study warns.

Mexican online pharmacy

While sustained transformation and performance in the pharmaceutical sector will require a level of risk-taking and change to the way that companies define, measure and reward performance, new research shows that executive compensation programmes at Big Pharma companies are still oriented towards rewarding compliance and near-term financial outcomes. Yet these are often the wrong approach in an industry with very long, multi-year product development pipelines, says management consultants Hay Group.

80% of metrics used by large drugmakers to determine incentives are financial, while only 12% are related to drug development and commercialisation, according to Hay Group’s new research, which is based on data from 50 publicly-traded US pharmaceutical companies, both big and small.

For at least a decade, pharmaceutical industry sales and R&D functions have operated on the premise that activity yields results, but that formula does not work anymore, says Ian Wilcox, vice president and global sector leader for life sciences at Hay Group. “The industry now has to turn itself inside out and focus on investments that produce results for customers,” he advises.

In a scorecard on the state of affairs within the industry, Big Pharma “would probably be at the bottom of the class,” says the firm, while in contrast, biotechnology and biopharmaceutical companies are innovators not only in the technology and products coming out of their laboratories, but also in how they measure and reward their executives.

As well suggesting that companies ask themselves whether short-term incentives should continue to play such an important role for senior executives in an industry with “incredibly long” product development cycles, Hay Group also finds problems with the industry’s long-term incentives. Ideally, these should link executives’ interests with the health of the company, but the research finds that, currently, 80% are based on financial data points, and only 20% are related to pipeline development and the commercialisation of innovative new therapies.

Another way to think of this is that financials are a lagging indicator, it suggests; while the last decade has been tough, the next will contain even more pitfalls, with Big Pharma collectively standing to lose revenues totalling as much as $150 billion annually over the next few years as valuable blockbusters fall over the patent cliff. And the situation could get much worse before it gets better, it warns.

Companies’ compensation committees cannot themselves re-fill the firm’s pipeline with novel products, but they can implement programmes and practices to encourage executives to place innovation much higher on their list of priorities, the firm suggests. “That’s the game in early biotech and emerging biopharmas – not just pay for financial ‘performance’ but pay for new and innovative technologies which are the lifeblood of these new companies,” it adds.

Specifically, while Big Pharma has continued to lean heavily on financial performance measures to drive compensation plans, the mid-size pharmas and small biotech firms that “live and die” based on whether their drugs are approved have been much more creative in weaving pipeline and R&D measurements into their incentives strategies, says Hay Group, and it advises Big Pharma, rather than seeking to “re-invent the wheel,” to look to biotech, or even other industries that have demonstrated track records in product development and innovation, for the way forward.

Pharmaceutical industry working to curb drug abuse

Recent articles in this newspaper have explored a serious and widespread problem in Kentucky: prescription drug abuse and misuse.

As chief medical officer for the pharmaceuticals business within Covidien, a health-care products company and the largest supplier of opioid pain medications in the United States, I understand raising awareness about prescription drug abuse is a critically important public service.

Kentucky consistently ranks among the top five states in prevalence of prescription drug abuse and misuse. This is especially true for pain medication misuse, which in recent years has been highest among young people ages 18 to 25.

Kentucky is also struggling with budget cuts, an issue plaguing every state as a result of the economic downturn. From New York to California, states are facing what The Washington Post recently called “the most severe budget crisis since the great depression.” As budgets diminish, funds to support lifesaving abuse prevention and treatment programs are quickly disappearing.

The budget crunch in Florida, for example, contributed to the elimination of the Office of Drug Control, the agency focused on drug abuse and coordination of the numerous state entities affected by this issue. Similar cuts have occurred in states like Ohio and cities like Seattle, Washington.

As state-level resources diminish, drug manufacturers, prescribers, pharmacists, patients and caregivers play an even greater role in improving patient safety. One way we do this is by working with the U.S. Food and Drug Administration as it develops a set of strategies recommending all drug manufacturers provide education on the safe use of long-acting (or extended-release) opioid pain medications.

Last summer, the FDA held its first-ever advisory committee hearing to discuss these proposed strategies. The result of this hearing will be an industry-wide Risk Evaluation and Mitigation Strategy (REMS) requirement for drugs in this class.

Covidien commends the FDA for taking this important first step toward addressing abuse and misuse, but we know our commitment must go above and beyond the REMS requirements. We are doing this by adding voluntary tools and resources for our products that follow an evidence-based evaluation of their individual risks and benefits.

In addition, Covidien is focused on taking collaborative steps to stem the growing epidemic and provide useful information to prescribers, patients, caregivers and community leaders to help them take action against the problem. In September 2010, we launched the C.A.R.E.S. (Collaborating and Acting Responsibly to Ensure Safety) AllianceSM — a coalition that seeks to reduce opioid pain medication misuse and abuse and increase responsible prescribing and safe use of all these medications, regardless of manufacturer, by collaboratively developing and sharing tools and resources for health=care professionals, patients and community and health care organizations.

The C.A.R.E.S. Alliance was born out of the realization that while government-mandated approaches to tackling prescription drug abuse were on target — they were only a start. We saw the need for a voluntary effort that truly engages every sector.

As the C.A.R.E.S. Alliance grows, we plan to add more information and resources for groups in all aspects of health care.

The C.A.R.E.S. Alliance recognizes that a problem this big can be solved only if we all work together. Prescribers, pharmacists, regulatory bodies, caregivers and patients all have a responsibility to patient safety — and we look forward to collaborating with all these groups, at the national, state and local levels, to end this growing public health concern.