Posts Tagged ‘Pfizer’

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Pipeline Checkup: Pfloundering Pfizer

Saturday, September 4th, 2010

Pfizer (NYSE: PFE) has had quite a few pipeline failures lately (see exhibits one, two, and three for instance). Individually, it’s easy to blow them off. No one drug is going to make or break a drugmaker the size of Pfizer.

But collectively they can be a problem. Perhaps today more than at any time in its past, Pfizer needs big hits from its pipeline. Megablockbuster Lipitor is on the decline and will hit free fall in a little more than a year. It’s doubtful that any single drug will replace Lipitor completely, but a few solid new drugs could help soften the blow.

At its last update, Pfizer had 133 programs in its pipeline, with 34 in the most critical phase 3 stage testing 24 different molecules. Here’s a highlight of a few that investors should be keeping an eye on.

I heart this drug
Pfizer’s apixaban, which is partnered with Bristol-Myers Squibb (NYSE: BMY), has the potential to knock off

long-used, but long-hated generic warfarin. Doctors don’t like the latter drug because the dose range that works for patients is narrow and foods that patients eat can change that window.

The duo has already shown that apixaban works better than aspirin at reducing strokes and blood clots, but the true test of the potential blockbuster is a head-to-head trial against warfarin. That trial is scheduled to be completed next year.

A tiny number times a really big one can sometimes work out
Pfizer has a couple of drugs in its pipeline that won’t be used on very many people but could still bring in a decent amount of revenue because they’ll be priced extremely high.

Taliglucerase alfa, which Pfizer licensed from Protalix BioTherapeutics, treats a rare disease called Gaucher disease. Genzyme‘s (Nasdaq: GENZ) floundering in its manufacturing of Cerezyme, which also treats the disease, has opened the door for the duo. The FDA already has the marketing application in its hands and is expected to hand down a decision in February.

Pfizer also has a lung cancer drug, crizotinib, in the pipeline that only treats a subset of patients with a certain mutation. Fortunately, crizotinib seems to treat them very well and should have an easy time gaining FDA approval for the hard-to-treat population.

Don’t forget about these
The Alzheimer’s disease market is wide open with the current offering doing little to help slow down the debilitating disease. Any drug that can show a reasonable efficacy is sure to be an instant blockbuster.

Pfizer has two shots at making its mark. Actually, maybe it’s more like one and a half.

Dimebon, which is partnered with Medivation (Nasdaq: MDVN), already flunked one of its phase 3 trials. The duo is testing Dimebon in combination with Eisai and Pfizer’s Aricept and Forest Labs‘ (NYSE: FRX) Namenda, which might show an effect, but the first trial shouldn’t give investors a whole lot of confidence.

Pfizer’s other shot at conquering Alzheimer’s disease comes from bapineuzumab. Pfizer owns half of the drug with the remaining split between Johnson & Johnson (NYSE: JNJ) and Elan (NYSE: ELN). The phase 2 results were confusing, to say the least, making bapinezumab’s success very hard to handicap. (There are a few others, but they’re in earlier phases of development.)

Opportunity to grow
Of the drugs I’ve highlighted, all but one came to the company through a licensing deal. Pfizer needs those kinds of deals to grow its pipeline further.

While Pfizer made a fairly large acquisition last year that I wasn’t all that fond of, the drugmaker was smart enough to fund much of Wyeth’s purchase with shares and loans. At the end of the first quarter, Pfizer still had more than $17 billion in the bank to acquire additional drugs.

As long as it uses the money to continue licensing drugs and doesn’t go off and buy a medium-sized drugmaker with drugs already on the market, the company’s pipeline should do just fine.

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Studies of promising Pfizer pain reliever halted

Tuesday, August 31st, 2010
Some taking tanezumab needed joint replacements

At the request of the U.S. Food and Drug Administration, Pfizer Inc. has halted mid-stage clinical studies of what would have been the world’s first biologic pain reliever for back and diabetes-related discomfort.

The news about the once-heralded drug tanezumab, released Monday shortly after the stock market closed, is yet another blow for Pfizer’s new-drug pipeline as the company faces the November 2011 expiration of the patent on Lipitor, the world’s leading medicine, with sales of more than $11 billion last year. It also is disappointing news to Pfizer’s drug-development team in New London, which has been involved in setting up and analyzing tanezumab’s clinical studies.

Just last month, Pfizer had presented positive data on tanezumab, demonstrating the injectable antibody’s effect on reducing knee pain in osteoarthritis patients. A week later, New York-based Pfizer, which has its biggest worldwide research site in Groton, announced that the FDA had asked it to stop a late-stage study of tanezumab in osteoarthritis patients because some people using the experimental drug wound up needing joint replacements.

The FDA’s latest request “follows further consideration of reports of adverse events in osteoarthritis patients,” Pfizer said in a statement, citing “the agency’s concerns regarding the potential for such events in other patient populations in which the compound is being studied.”

Pfizer said it continues to study tanezumab as a pain reliever for cancer patients and in other groups with unmet medical needs.

Pfizer’s stock price was down 18 cents, or about 1.2 percent, at the end of trading Monday, finishing at $14.55 a share.

The latest drug-testing closure for Pfizer follows several years of bad luck and bad decisions regarding some of the company’s most-promising medicines.

Among the most spectacular failures have been heart medication torcetrapib, once heralded as a potential successor to Lipitor but, after an $800 million investment in research during clinical trials, found to result in excessive deaths; the inhaled insulin Exubera, which never caught on with patients and cost the company nearly $3 billion, and the Russian-born antihistamine Dimebon, which had shown excellent results in midstage trials on Alzheimer’s disease but utterly failed in clinical tests that ended earlier this year and cost Pfizer at least $300 million.

Tanezumab was one of the most promising drugs being developed by San Francisco-based Rinat Neuroscience Corp. when Pfizer bought the company four years ago for a reported $500 million. A pipeline review announced by Pfizer just last year put tanezumab as among its top drug prospects.

Earlier studies of the drug showed significant pain relief and no major health risks.

“Repeated dosing with this compound gives sustained pain relief,” Northwestern University researcher Thomas Schnitzer told the website MedPage Today last fall.

But naysayers have questioned the potential market for tanezumab, wondering if an injectable biologic pain reliever would be embraced. Biologic medicines are made with live organisms.

Pfizer indicated it has not given up on tanezumab. It said the shutdown of its latest clinical trials would have no effect on the employment of local scientists.

“Pfizer will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab,” the company said.

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Drug Helps Brain Grow New Cells

Tuesday, August 24th, 2010

Researchers have found a drug that can help the brain grow new cells, and they said their study may lead to ways to improve experimental Alzheimer’s drugs.

The researchers’ work, done on rodents, builds on findings that all mammals, including humans, make brain cells throughout their lives. Most of these die, but this drug helps more of the baby cells survive and grow to become functioning brain cells.

“We make new neurons every day in our brain,” Andrew Pieper of the University of Texas Southwestern Medical Center in Dallas who worked on the study, said in a telephone interview. “What our compound does is allow more of them to survive.”

The compound is called P7C3 for now, and the researchers have already started tweaking it to make it more effective. They said it seems safe and appears to work even when taken as a pill.

The compound is similar to Medivation and Pfizer experimental Alzheimer’s drug, Dimebon, and may provide ways to improve its effects, Pieper and colleagues reported in the journal Cell.

It is also similar to some compounds owned by Serono, the researchers said.

Dimebon, originally a Russian-made antihistamine also known as latrepirdine, failed in a clinical trial for Alzheimer’s disease in March.

“For the sake of patients suffering from Alzheimer’s disease, it is hoped that the apparently marginal clinical utility of Dimebon might be enhanced by improvements in both its potency and ceiling of proneurogenic, neuroprotective efficacy,” the researchers wrote.

“If so, our work offers concrete assays for the development of improved versions of these neuroprotective drugs.”

Alzheimer’s gradually destroys the brain and affects 26 million people globally. Drugs, such as Pfizer’s Aricept, improve symptoms only minimally.

The researchers went through 1,000 representative compounds from 300,000 chemicals, pooled them, and administered them to mice. They then dissected the brains to see whether any of the mice had made new cells in the hippocampus, a region of the brain associated with learning and memory.

They eventually narrowed the field to P7C3.

When they gave it to old rats for two months, the elderly rodents did far better than other old rats in learning their way around a water maze.

When dissected, the treated rats turned out to have three times the usual number of newborn neurons in a brain region called the dentate gyrus.

They made a derivative of P7C3 called A20 that worked even better

When the researchers tested Dimebon and the Serono compounds, they found these drugs also stimulated the growth of new brain cells. Being able to target their effects could lead to better drugs to treat Alzheimer’s and perhaps other diseases that destroy brain cells like strokes and amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease.

“This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease,” said Dr. Thomas Insel, director of the National Institute on Mental Health, which helped pay for the study.

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A pill to make you smarter? Drug grows brain cells

Tuesday, August 10th, 2010

Researchers have found a drug that can help the brain grow new cells and said their study may lead to ways to improve experimental Alzheimer’s drugs.

The researchers’ work, done on rodents, builds on findings that all mammals, including humans, make brain cells throughout their lives. Most of these die, but this drug helps more of the baby cells survive and grow to become functioning brain cells.

“We make new neurons every day in our brain,” Andrew Pieper of the University of Texas Southwestern Medical Centre in Dallas who worked on the study, said in a telephone interview. “What our compound does in allow more of them to survive.”

The compound is called P7C3 for now, and the researchers have already started tweaking it to make it more effective. They said it seems safe and appears to work even when taken as a pill.

The compound is similar to Medivation Inc (MDVN.O) and Pfizer Inc’s (PFE.N) experimental Alzheimer’s drug, Dimebon, and may provide ways to improve its effects, Pieper and colleagues reported in the journal Cell.

It is also similar to some compounds owned by Serono, the researchers said.

Dimebon, originally a Russian-made antihistamine also known as latrepirdine, failed in a clinical trial for Alzheimer’s disease in March.

“For the sake of patients suffering from Alzheimer’s disease, it is hoped that the apparently marginal clinical utility of Dimebon might be enhanced by improvements in both its potency and ceiling of proneurogenic, neuroprotective efficacy,” the researchers wrote.

“If so, our work offers concrete assays for the development of improved versions of these neuroprotective drugs.”

Alzheimer’s gradually destroys the brain and affects 26 million people globally. Drugs, such as Pfizer’s Aricept, improve symptoms only minimally.

OLD RATS, NEW TRICKS

The researchers went through 1,000 representative compounds from 300,000 chemicals, pooled them and administered them to mice. They then dissected the brains to see whether any of the mice had made new cells in the hippocampus, a region of the brain associated with learning and memory.

They eventually narrowed the field to P7C3.

When they gave it to old rats for two months, the elderly rodents did far better than other old rats in learning their way around a water maze.

When dissected, the treated rats turned out to have three times the usual number of newborn neurons in a brain region called the dentate gyrus.

They made a derivative of P7C3 called A20 that worked even better.

When the researchers tested Dimebon and the Serono compounds, they found these drugs also stimulated the growth of new brain cells. Being able to target their effects could lead to better drugs to treat Alzheimer’s and perhaps other diseases that destroy brain cells like strokes and amyotrophic lateral sclerosis, also know as ALS or Lou Gehrig’s disease.

“This striking demonstration of a treatment that stems age-related cognitive decline in living animals points the way to potential development of the first cures that will address the core illness process in Alzheimer’s disease,” said Dr. Thomas Insel, director of the National Institute on Mental Health, which helped pay for the study.

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Pfizer names new head of worldwide research

Tuesday, July 20th, 2010

Longtime executive Mackay departing for job with AstraZeneca

In a major shake-up of Pfizer Inc.’s management structure, longtime executive Martin Mackay has left the company, and Wyeth Pharmaceuticals holdover Mikael Dolsten has assumed sole control of worldwide research.

Mackay, a native Scotsman who lives in Salem and spent 15 years with Pfizer, is departing the company immediately and has taken the job of R&D president for English drug-maker AstraZeneca. His new duties start July 1, according to the company.

Mackay’s position with AstraZeneca is newly created, the company said; previously, separate executives led discovery and drug development efforts.

“Martin has impeccable scientific and leadership credentials, combined with extensive experience of the pharmaceutical industry,” said AstraZeneca chief executive David Brennan in a statement.

This was the second top Pfizer executive AstraZeneca has snatched from the region in recent days. Earlier this month, Menelas Pangalos of Old Lyme, head of Pfizer’s neuroscience research unit, joined AstraZeneca as head of drug discovery.

Pfizer has major research-and-development sites in Groton and New London. The company employs nearly 5,000 people locally.

Company spokesman Ray Kerins declined to say whether Mackay’s exit was related to Pfizer’s decision to name Dolsten as its top R&D executive, or whether the company restructured the research division in response to Mackay’s departure. He said Rod MacKenzie, head of worldwide discovery research for Pfizer, will take over some of Mackay’s responsibilities.

Pfizer’s research division has been under the gun lately because of the need to replace lost sales from blockbuster cholesterol medication Lipitor when it faces generic competition a year and a half from now. Pfizer’s drug pipeline also has taken hits because of a rash of spectacular failures of experimental therapies in clinical trials over the past few years, including disappointing results from studies of the Alzheimer’s treatment Dimebon.

Les Funtleyder, a health care analyst for Miller Tabak & Co. in New York City, said he’s not sure what led to Mackay’s departure, though he called the research-head position “a bit of a thankless job” in that drug-target decisions made today won’t see any results for several years.

“It’s a little bit like a head coach’s job,” he said. “It’s not always the head coach’s fault, but somebody has to take the blame.”

Mackay did not return a phone call seeking comment.

Kerins said the R&D management change takes Pfizer to “the next level of overall integration of the company” after its takeover of Wyeth. He did not foresee the shake-up resulting in any changes at Pfizer’s sites in Groton or New London, other than altered reporting structures as those who previously reported to Mackay will now report to Dolsten.

Dolsten will have an office at the company’s world headquarters in New York City but will spend time in many of Pfizer’s R&D sites, Kerins said.

Kerins said Pfizer has a “deep history” in developing the traditional medicines in pill form that the local campuses focus on, and he didn’t see that the ascension of the company’s lead biotech researcher would change the pharmaceutical giant’s priorities. Biotechnology uses living organisms to create new medicines, while traditional research manipulates chemical entities.

“With this appointment, Dr. Dolsten will now lead all of research at Pfizer, as well as development of all compounds through Phase 2, or ‘proof of concept,’” New York-based Pfizer said in a statement Wednesday. In Phase 2, the middle stage of drug development, clinical trials with small numbers of patients help show whether a basic concept works, according to predetermined criteria called biomarkers; later trials demonstrate the effectiveness and safety of experimental therapies.

The company said late-stage clinical development will continue to be led by teams associated with Pfizer’s various business units.

Mackay, a member of the company’s Executive Leadership Team, headed Pfizer’s R&D division from October 2007 until its merger with Wyeth in October of last year. Dolsten had led Wyeth’s R&D division before the merger with Pfizer.

After the $67 billion acquisition of Wyeth, Pfizer split its R&D management into two separate divisions: the PharmaTherapeutics group, which did small-molecule research and was headed by Mackay; and the BioTherapeutics group, led by Dolsten, which was charged with finding and developing large-molecule drugs and vaccines.

But with Mackay’s resignation, announced Wednesday, Dolsten will now head all aspects of Pfizer’s drug research in a newly renamed division called Pfizer Worldwide Research & Development.

“Having all of Pfizer’s research conducted under Mikael’s leadership will enrich the alignment between our research programs and commercial teams to address important unmet medical needs and deliver the next generation of medicines,” Pfizer chairman and chief executive Jeffrey B. Kindler said in a statement.

Kindler said Pfizer implemented the two-headed research model as an interim device to help speed the integration of two large companies. Now that much of the integration has been completed, he said, the consolidation of the two research groups into one division could be accomplished.

“Since closing the Wyeth acquisition we have rapidly advanced integration, completing the pipeline portfolio review, finalizing decisions regarding our R&D network very quickly after close, and more steadily progressing the pipeline,” Kindler said. “Rapid integration has been enhanced by strong and steady collaboration between the two legacy R&D groups – making the consolidation under one leader a natural and progressive step to take at this point.”

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Pfizer partners with university to develop new uses for drugs

Saturday, July 17th, 2010

Eager to make the most of current products even as its pipeline of new drugs has setbacks, Pfizer Inc. announced Monday a first-of-its-kind collaboration to find new uses for familiar remedies.

The collaboration, which begins this week and is covered in a five-year agreement, will give researchers at Washington University in St. Louis unprecedented access to information about Pfizer’s products. The company said it’s likely scientists at Pfizer laboratories in Groton will be among those exchanging information with university researchers.

“We expect certain investigator proposals to be of relevance and interest to research colleagues in Groton, which may lead to collaborations,” said Pfizer spokeswoman Anne Wilson in an e-mail. “Neuroscience and anti-bacterial colleagues in Groton already have relationships with some investigators at Washington University.”

Pfizer will provide $22.5 million to researchers at the university’s medical school, along with extensive data about 500 of its drugs, which it will make available to key researchers through a special online portal. Previously, drug companies had been reluctant to share proprietary information about their drugs with outsiders.

“By sharing Pfizer’s data on existing compounds, researchers will not have to replicate extensive preclinical studies, thereby shaving years off the time it takes to evaluate new uses for existing drugs,” Pfizer said in a release.

The agreement comes at a key time for Pfizer, which is within a year and a half of losing exclusivity in the United States for its blockbuster cholesterol medication Lipitor, with about $13 billion in worldwide sales last year. Pfizer also has faced a rash of drug-trial failures in recent months, most notably for Dimebon, a hoped-for Alzheimer’s remedy.

Pfizer said it plans to investigate, through the Washington University collaboration, the uses for drugs already marketed as well as those whose development has been stalled. As new uses for remedies are found, the company said, Pfizer and the university will negotiate terms to allow drug commercialization to proceed.

The collaboration – which will focus on a range of diseases, including Alzheimer’s, cancer, asthma and diabetes – builds on previous agreements between the two organizations. Pfizer and university scientists will sit on an advisory committee to evaluate proposals for new research, and the project is being headed by company executive Don Frail.

Pfizer said the potential for success in what is known as indications discovery has increased over the years. That’s because scientists understand more about how diseases progress at a molecular level and how patients respond to medications based on their genetic makeup, Pfizer said.

“Those drugs that do succeed typically have multiple uses,” Frail, chief scientific officer in Pfizer’s indications discovery unit, said in a statement. “The collaboration seeks to discover entirely new uses for these compounds in areas of high patient need that might otherwise be left undiscovered.”

Pfizer, which has its largest worldwide research-and-development contingent in Groton and New London, plans to move its indications discovery laboratories from Chesterfield, Mo., to a biotech corridor adjacent to Washington University, the company said.

“This is a tremendous opportunity for both partners,” Jeffrey Gordon, director of the university’s Center for Genome Sciences, said in a statement. “By creating this innovative new framework, academic and pharmaceutical researchers can collaborate in ways that are mutually advantageous for the university, Pfizer and society to meet the needs of patients.”

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Pfizer gets ‘bearish’ review

Wednesday, June 30th, 2010

Activity in Pfizer Inc. stock has reached bearish proportions, according to Sarah Wasserman, a blogger for Schaeffer’s Options Center.

Wasserman said so-called “put options,” which indicates a downward stock trend, had been more than double its daily average Monday. She also noted Pfizer’s nearly yearlong losing streak as the company’s stock has dropped 7.6 percent.

Wasserman offered no analysis of Pfizer’s current stock woes, although a series of pipeline failures – including the sudden end of a trial involving the promising Alzheimer’s drug Dimebon – has been cited by others.

“Skepticism toward (Pfizer) among near-term traders is quickly mounting,” Wasserman said.

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Sphera Health Fund Shuns Teva Shares for ‘Cheap’ Pfizer, Sanofi

Tuesday, June 22nd, 2010

Sphera Global Healthcare Fund, an Israeli hedge fund that’s beaten the market since its founding in 2007, is avoiding shares of local generic-drug maker Teva Pharmaceutical Industries Ltd., which has given investors a 105 percent return over the past five years.

Instead, Sphera is building a stake in Teva’s arch-rival Pfizer Inc., the world’s biggest pharmaceutical company, which has lost 20 percent in that time including dividends. New York- based Pfizer, selling for 7.4 times estimated earnings, is the least expensive of the 10 largest drugmakers. Teva, at 12.6 times profit, is the most expensive.

“As long as something is cheap, we’ll hold it,” said Ori Hershkovitz, 36, who’s a partner in the Tel Aviv-based fund and the head of research, in an interview last month. “As long as something is expensive, we’ll short it.”

That contrarian strategy has paid off. The $120 million fund returned 17 percent since inception in March 2007, compared with a loss of 0.4 percent for a Standard & Poor’s index of global health-care stocks. Now, Hershkovitz and says Pfizer

shares are attractive because of its diversified product portfolio, presence in fast-growing emerging markets and 4.2 percent dividend yield. The New York-based company probably will get positive clinical trial results by September for the tanezumab pain treatment, he said.

Not only is Pfizer a good value now, “but also we have a short-term catalyst,” he said. The fund increased its Pfizer holding this year. The company accounts for 15 percent of Sphera Global Healthcare’s assets, up from 12 percent previously, even as growth for makers of lower-priced generic medicine outpaces that of branded drug companies.

Pfizer’s Forecast

Pfizer shares declined more than warranted because its 2012 forecast in February disappointed investors and because of setbacks with cancer drug Sutent and Alzheimer’s drug Dimebon, he said. Pfizer is “poorly regarded by the market,” said Hershkovitz.

Started with capital from Mori Arkin, the Israeli entrepreneur who led Agis Industries Ltd. until its 2005 takeover by Perrigo Co., the Sphera health fund began accepting external investors in March 2007. The fund taps a network of Israeli doctors for opinions on new drugs and hired a veteran Teva patent lawyer to analyze prospects for generic challengers, said Hershkovitz, who joined at the fund’s inception after working as an analyst for Leader & Co. Investment House Ltd.

Arkin, Hershkovitz and two other partners seek companies whose shares are temporarily depressed by bad news, or whose stock may benefit from catalysts such as drug approvals within two years.

Generic Growth

Sphera Global Healthcare is avoiding Teva, the world’s biggest generic-drug company, even as growth of lower-priced copied medicines outpaces that of branded pharmaceuticals. Pfizer is preparing to lose most of the $11.4 billion in 2009 sales for Lipitor, the top-selling medicine, starting next year when cheaper copies enter the market from companies such as Teva.

Teva, based in the Tel Aviv suburb of Petah Tikva, was the fund’s biggest holding when it started four years ago, and comprised as much as 15 percent of its holdings until Sphera sold the shares in 2008. The drugmaker in January told investors it’s aiming to more than double sales to $31 billion by 2015, and last month agreed to buy Germany’s Ratiopharm GmbH, snatching it away from Pfizer in an auction.

While Sphera missed out on Teva’s last rally, the company’s American depositary receipts probably won’t budge much from about $65 in the next several months, said Hershkovitz. Teva has advanced 41 percent in the past year to close yesterday at $63.51 on the Nasdaq Stock Market.

“Looking back I think of course we could have done it differently,” the fund manager said. “Right now, if you look long term, you can find opportunities that are 20 percent to 30 percent cheaper.”

Sanofi Slump

Sanofi-Aventis SA is one of them, he said. The fund added to its stake in the Paris-based company this year as the shares slumped on the prospect of a generic competitor in the U.S. to Sanofi’s Lovenox anti-clotting drug, he said. Sanofi fell from a 52-week high of 58.90 euros on Jan. 20 to as low as 51.68 euros two weeks later after Novartis AG said Jan. 22 it planned to sell a version of the drug as soon as it obtains U.S. Food and Drug Administration approval.

The sell-off wiped 9.52 billion euros ($12.7 billion) off Sanofi’s market capitalization, more than Lovenox contributes in earnings, he said. “The stock grossly overreacted,” said Hershkovitz. Sanofi now sells for 8.5 times this year’s estimated earnings, compared with an average price-earnings ratio of 11 for the 10 largest drugmakers.

Sphera added to its stake in Pfizer and Sanofi this year after selling U.S. drugmaker Merck & Co. when shares peaked above $40 in January, Hershkovitz said.

Twelve percent of the fund is in Basel, Switzerland-based Novartis, which Sphera regards as the “best-managed company in our universe,” said Hershkovitz. Ten percent is invested in Novartis’s cross-town competitor Roche Holding AG, which he said has the best science.

California-based biotechnology companies Onyx Pharmaceuticals Inc. and NeurogesX Inc. account for about 9 percent of the fund. Onyx is working with Germany’s Bayer AG on the tumor-fighting drug Nexavar, while NeurogesX is developing a pain-treating patch. The fund views both companies as takeover targets, Hershkovitz said.

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Job Cuts at Medivation

Friday, June 18th, 2010

Medivation, Inc. (MDVN) recently announced that it intends to reduce its workforce by 20% or 23 people to save costs and focus its resources towards research and developmentmag glass 10x10 Job Cuts at Medivation activities related to dimebon and MDV3100.

Medivation also announced the departure of its senior vice president of clinical development and the vice president of commercial development. The companymag glass 10x10 Job Cuts at Medivation said that it is no longer looking for a new Chief Financial Officer (CFO) as this post will be filled by the current Chief Business Officer (CBO).

Medivation’s workforce reduction announcement comes on the heels of disappointing phase III results reported earlier this month on its lead pipeline candidate, dimebon. Dimebon, which is being developed for Alzheimer’s disease in collaboration with Pfizer, Inc. (PFE), failed to achieve both its primary and secondary endpoints in a phase III study (CONNECTION).

Dimebon was the most advanced pipeline candidate at Medivation, which has no marketed products in its portfolio. The successful development of dimebon would have been a major boost for the company. In addition to the Alzheimer’s indication, Medivation is also studying dimebon for Huntington’s disease.

Going forward, Medivation intends to focus on the further analysis of the CONNECTION data, which will help determine future development plans for the candidate. Dimebon is currently being studied in combination with Pfizer’s Aricept for the treatment of mild-to-moderate Alzheimer’s. Positive results from this study could allow the companies to push for approval of the product as a combination therapy.

Dimebon is also in another study which is being conducted in Huntington disease patients.

We currently have a Neutral recommendation on Medivation. The high profile phase III failure was a major setback for the company. Medivation could suffer another blow if Pfizer decides to pull out from the collaboration agreement for dimebon.

We note that Pfizer already has another Alzheimer’s candidate, bapineuzumab, in its portfolio that is being developed with Elan Corp (ELN) and Johnson & Johnson (JNJ). As such, Pfizer may decide to focus its efforts towards the development of bapineuzumab.

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Pfizer Drug Filings on Track Despite Setbacks

Monday, June 7th, 2010

LONDON (Reuters) – It’s been a bad month for Pfizer’s research labs but its head of R&D says the world’s biggest drugmaker is on track to hit earlier targets for new drug filings despite the setbacks.

“We have had some disappointments, there is no getting away from it,” Martin Mackay told Reuters during a visit to Britain.

Dimebon’s lack of efficacy in Alzheimer’s disease was “extremely disappointing,” although Mackay said it was “a wee bit early” to say the drug, which Pfizer has developed with Medivation , was now dead.

Pfizer has also seen failures this month with Sutent in breast cancer and figitumumab in lung cancer.

have plenty more big drugs coming down the pipeline, even though cutbacks in the research budget are planned in the wake of the Wyeth merger.

“It (R&D spending) will drop somewhat over the next two years in line with the commitments we’ve made to savings,” he said. “But if we can’t come up with great medicines with a budget of $8 billion or $9 billion, shame on us.”

Some analysts have worried that these problems mean the company will no longer meet its goal of filing 15 to 20 new drugs or new indications for regulatory approval between 2010 and 2012 — a target that was set in March 2008.

Mackay denied this was the case.

“When we had the three failures I went straight to the data and looked at it again to make sure that we could still be on target. And clearly the 15 to 20 was already attrition-adjusted, so we are still within that range,” he said.

While the goal was set before Pfizer bought Wyeth last year, Mackay stressed it still referred only to legacy Pfizer products and any filing contributions from Wyeth would be in addition to this total.

$9 BILLION R&D BUDGET

Like many major drugmakers, Pfizer has struggled in recent years to get a decent return out of its vast R&D machine, which currently spends more than $9 billion a year in the hunt for new medicines.

Yet, despite disappointing productivity, Mackay said the science had never been better and he remains confident that Pfizer will always remain here.

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