Dimebon Over Counter Treatment Alzheimer Alzheimer's

Feb. 2 (Bloomberg) — Doctors may learn next month that Dimebon, a 27-year-old hay fever treatment and one of the most mysterious compounds yet tried to fight dementia, is poised to become their newest and perhaps best weapon against Alzheimer’s.

Medivation Inc., the start-up that persuaded Pfizer Inc., the world’s biggest drugmaker, to help develop Dimebon, may be ready to release new research data during the first week of March, said Bengt Winblad, head of Alzheimer’s research at the Karolinska Institute in Stockholm and a leader of the European trials for the product. The study may confirm a 2008 finding in Russia that patients functioned better and thought more clearly after swallowing Dimebon tablets three times a day.

Pfizer, which hasn’t brought a new drug to market that generates more than $1 billion a year since the pain pill Lyrica won U.S. clearance in 2004, has pinpointed Alzheimer’s as one of six focuses of research. Doctors say millions of patients may benefit.

The 183-patient Russian study, reported in the Lancet in July 2008, “showed the most effective and sustained benefit that we’ve ever seen in Alzheimer’s,” Samuel Gandy, associate director of the Alzheimer’s Disease Research Center at Mount Sinai School of Medicine in New York, said in a telephone interview. “There is nothing that’s currently approved that compares to it and nothing else really in the pipeline that compares to it.”

Drug Failures

Some patients were better after taking the drug for 18 months than they were at the start of the trial, something never previously seen with the progressive disease. Gandy, who wasn’t involved in the research, said the drug stands to win approval even if the next study “is only half as good as the original.”

Few Alzheimer’s candidates beat the odds. There hasn’t been a new drug for the disease since Namenda, from New York-based Forest Laboratories Inc., was approved in 2003, and almost a dozen drugs in mid- to late-stage testing have failed since then, according to data compiled by Bloomberg.

Drugs that looked exciting in early studies have turned into disappointments, while others that appeared less promising ended up successful, said Constantine Lyketsos, chair of psychiatry at Johns Hopkins Bayview Medical Center in Baltimore.

“Ultimately with Dimebon, the data will speak,” Lyketsos said. “Even if it was hugely promising and exciting, it would be a little while before it ends up on the market. My patients and families need realistic hope at this point and I’m not sure that’s realistic hope at this point.”

Stock Ratings

Now valued at $1.13 billion, Medivation may plunge 35 percent in Nasdaq trading if the study fails, said Ian Sanderson, an analyst at Cowen & Co. in Boston. Success may propel the stock to rise 20 percent, he said. Sanderson rates the shares “neutral.” Seven other analysts say investors should buy Medivation and one has a “sell” opinion, according to Bloomberg data.

Medivation rose $1.88, or 5.6 percent, to $35.70 at 4 p.m. in Nasdaq Stock Market composite trading. The shares have gained 80 percent in the last 12 months before today as investors anticipate the study results. Pfizer shares rose 45 cents, or 2.4 percent, to $19.24, and have climbed 29 percent in the past 12 months in New York Stock Exchange composite trading.

Positive results would usher Dimebon into a $4 billion a year market that may almost triple by 2018, said Matthew Winton, an analyst at Decision Resources Inc. in Waltham, Massachusetts, in a telephone interview.

‘Very Excited’

Analysts said they expect Medivation and New York-based Pfizer to file for regulatory approval of Dimebon in 2011. Results from the 525-patient Connection study could move that date forward, company officials said.

“We’re all very excited that we will reproduce exactly what was seen in the other trial,” said Briggs Morrison, senior vice president of Pfizer’s primary-care development group, in a telephone interview. “If that data comes together and in our conversations with regulators they feel that it’s a strong package worthy of filing, we all have a passion to get these important medicines to patients.”

In its initial studies, Dimebon was effective in all five areas examined and the improvements lasted longer than the effects seen in separate research on rival therapies. If the results are confirmed, the drug may generate at least $1.6 billion in annual sales by 2015, Sanderson said. The top spot in the market is now held by Pfizer and Tokyo-based Eisai Co.’s Aricept, which generates $2.5 billion a year.

Russian Researchers

Medivation acquired Dimebon, which has been used since 1983 to treat hay fever in the former Soviet Union, from a company formed by Sergey Bachurin, a researcher at the Institute of Psychologically Active Compounds, in Chemogolovka, Russia.

The drug was first identified as a possible way to protect neurons when the Russian Academy of Science, in Chernogolovka, Russia, started in the early 1990s to screen libraries of compounds for their ability to block a key brain receptor. Belief in the drug was bolstered when researchers found it improved learning in brain-damaged rodents.

If Dimebon beats the 70 percent failure rate seen in drug development, the results — and clearances from the U.S. Food and Drug Administration and its European counterparts — may arrive before scientists pinpoint how the product works.

What Patients Want

Investigators once thought Dimebon combined the activity seen with the two types of drugs already approved for Alzheimer’s disease: medicines such as Pfizer’s Aricept that increase levels of a brain chemical that helps transmit messages between nerves, and drugs such as Forest’s Namenda, that block the absorption of toxic levels of another neurotransmitter. Studies dispelled that hypothesis, and what Dimebon does inside the brain remains unknown.

Patients don’t care why a drug works — only if it does.

“Many of my patients or their spouses say, ‘If I could at least keep my husband or wife as she is now, I would be very happy,’ ” said Karolinska’s Winblad. “In a way, that’s what you do with this drug. You prolong the time to the decline.”

Dimebon is one of five Alzheimer’s medicines that may reach the market in the next decade, Winton said. The drugs, including products from Johnson & Johnson in New Brunswick, New Jersey; Elan Corp. in Dublin; Pfizer; Baxter International Inc. in Deerfield, Illinois; and Eli Lilly & Co. in Indianapolis, may spur an $11 billion market by 2018 as prices and the number of patients climb, Winton said.

Approved Drugs

Most of the potential Dimebon competitors reduce levels of amyloid plaque, a substance that builds up in the brain of people with Alzheimer’s. The four approved drugs, which ease symptoms for as much as six months, generated $6.3 billion in the 12-months ended Sept. 30, according to IMS Health Inc., a research company in Norwalk, Connecticut.

Scientists have now focused on Dimebon’s effect on mitochondria, so-called power plants that generate energy in cells, with laboratory studies showing it improves cells’ function and helps them withstand stress.

“The data is really clear, but it is in cell culture,” Maria Ankarcrona, a Karolinska researcher, said in an interview. “Stressed cells respond more to Dimebon than normal cells.”

Alzheimer’s is a progressive disease that starts with mild forgetfulness and eventually robs patients of memories and independence. It afflicts 30 million people worldwide, a number that may exceed 100 million by 2050, according to Alzheimer’s Disease International, an advocacy group based in London.

Losing Lipitor

Pfizer, with revenue of $48.3 billion in 2008, needs new medications to replace the sales it will lose when its biggest- selling drug, the cholesterol-lowering drug Lipitor, loses patent protection in 2011. The patent on Aricept expires at the end of this year.

Pfizer paid Medivation $225 million in September 2008 to help develop Dimebon for Alzheimer’s and Huntington’s disease, and may pay an additional $500 million as the drug proceeds through the regulatory process. Pfizer is covering 60 percent of the development costs in the U.S. and will get a like portion of the profits.

The Medivation development program includes five pivotal trials of Dimebon, for use alone and in combination with existing drugs, and for patients with disease ranging from mild to severe. The 183 volunteers in the first such study, in Russia, were given either Dimebon or a placebo for six months, while other anti-dementia drugs weren’t allowed.

Additional Research

The researchers evaluated the last patient enrolled in the 525-patient Connection study in December and are now starting to analyze the findings, Winblad said. The results should be available by early March, and Medivation and Pfizer may be able to release the findings by then, he said.

Pfizer’s Morrison and Medivation CEO David Hung said the data will be released by July.

“The Connection study is an important study, but it’s only one of a number of studies,” Hung said. “We have a lot of shots on goal.”

The data augur a make-or-break moment for San Francisco- based Medivation, which has no products on the market and has recorded losses exceeding $150 million since 2003.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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For Pfizer Inc., the stock market is a fickle mistress.

The pharmaceutical giant, whose campuses in Groton and New London employ nearly 5,000 people, reported Wednesday a 34 percent increase in fourth-quarter 2009 revenues compared with the same period the previous year, and the company said profits nearly tripled over the same period.

Those numbers would normally dazzle. On Wednesday, they merely elicited a muffled yawn, as Pfizer stock fell more than 2 percent, closing the day at $18.62.

Stock analysts focused on earnings per share that were lower than expected and a forecast that this year’s earnings will be as much as 17 cents a share below traders’ expectations.

“Pfizer’s business update was not what we hoped for,” said Leerink Swann analyst Seamus Fernandez, who had been recommending buying the company’s stock. “That being said, Pfizer’s still attractively valued.”

Les Funtleyder, a health care analyst for Miller Tabak & Co. in New York City, said the earnings per share of 49 cents, after excluding one-time expenses, were off 1 cent from Wall Street expectations, though revenues were higher than anticipated.

“We think the Street will be a bit disappointed but we think half a quarter is not enough time to judge the success of the now combined Pfizer-Wyeth,” Funtleyder said in a commentary.

Pfizer’s profits were significantly higher in the fourth quarter compared with the previous year partially because of the first-time contribution to the budget of newly acquired Wyeth Pharmaceuticals, which added $3.3 billion in revenues.

The company also saw profits increase because it took a one-time charge of $2.3 billion in the fourth quarter of 2008 to settle a U.S. Justice Department investigation of off-label product promotions, while its legal expenses for the same period last quarter were only $124 million.

In addition, Pfizer saw a $419 million increase in sales of the company’s legacy products as well as a $469 million jump tied to favorable foreign-exchange rates related to a weaker dollar.

For the year, Pfizer finished with $50 billion in revenues, a 4 percent increase from 2008. Net income for the year was up 7 percent.

“The operational improvements were driven partially by the reduction in workforce as well as manufacturing and research and development site exits,” Pfizer said in a statement.

Pfizer said it took on more than 40,000 workers when it acquired Wyeth but has reduced the combined staff by about 4,200 since the October megamerger. The company at the end of the year had a work force of about 116,500. “We are pleased with the rapid pace of the integration and our ability to quickly realize the benefits of our combined organization,” Jeffrey B. Kindler, Pfizer’s chairman and chief executive, said in a statement.

What’s more, Pfizer management was upbeat about its pipeline of experimental medicines, including the Alzheimer’s drug Dimebon and its JAK-3 cancer treatment. Kindler said 34 of the company’s current 133 compounds in development have reached the final stage of development.

“We are more enthusiastic about our late-stage pipeline than we have been in years,” Kindler said in a Webcast conducted a few hours after Pfizer’s earnings were released.

The company also is talking up its ability to weather the loss of patent protection for Lipitor, the world’s leading medicine, when it faces generic competition in November 2012.

“We are structured for a post-2012 world,” said Ian Read, president of worldwide pharmaceutical operations for Pfizer. “We are adding field force as fast as we can … in China and Brazil and some of the other markets.”

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TheStreet’s Adam Feuerstein offers a compelling look at the fate that awaits Medivation (MDVN) and anyone bold enough to invest in its stock right now. The developer is looking at a first-half announcement on its Phase III results for Dimebon, a closely tracked new therapy for Alzheimer’s.

With standard Alzheimer’s therapies woefully inadequate, the five million Americans and 30 million people worldwide who suffer from this terrible disease would be likely candidates for any promising new therapy. In short, a successful Phase III would position Dimebon for an FDA approval and a blockbuster launch. The effect on Medivation shares: Feuerstein expects the shares would rocket from around $33.12-yesterday’s close-to the $65 to $75 range.

Then there’s the down side, or perhaps we should call it the cliff. A failure would send this stock into the tank. Feuerstein estimates a gut-wrenching drop to $10 to $15 a share, a drop of more than half.

Mid-stage data for Dimebon “rocked,” says the analyst. But there are plenty of doubters who suspect that the Phase II numbers were too good to be true. But TheStreet’s resident skeptic is giving Medivation the benefit of some optimism this morning, offering 60-40 odds in favor of a positive outcome. About the only thing guaranteed here, though, is that some people–and this biotech company–will either win big or lose big. There’s no breaking even.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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Prioritized Pipeline Marks Important Milestone for Company’s New Global R&D Organization

Company Meets Key Late-Stage Development Commitments Made to Investors

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. today provided an update to its pipeline for the first time since the close of the acquisition of Wyeth in October, 2009. The new development pipeline, composed of assets from both legacy companies, includes 133 programs from phase 1 through registration, and shows growth and increased diversity in each of the areas where the company invests in research and development.

“This pipeline of investigational medicines represents the strong future of Pfizer,” said Martin Mackay, president, PharmaTherapeutics Research and Development. “Since the closing of the Wyeth transaction late last year, we have made strategic decisions about our R&D resources, global footprint and high-priority projects. Our focus now turns to delivery of these health solutions for patients around the world.”

Pfizer has identified six “Invest to Win” areas of research where there exist significant opportunities for innovation and market leadership: oncology; pain; inflammation; Alzheimer’s disease; psychoses; and diabetes. The new pipeline demonstrates focused investment in these areas of significant unmet medical need as well as growth in the critical technologies of vaccines and biologics.

Following the acquisition of Wyeth, the combined company pipeline had 600 projects ranging from discovery through registration. The new prioritized portfolio contains about 500 projects across a broad range of diseases, with a focus on the “Invest to Win” areas, as well as vaccines and biologics. Approximately 70% of Pfizer’s research projects and 75% of the late-stage portfolio are focused on these areas.

The growth in vaccines and biologics is reflective of Pfizer’s goal of becoming a top-tier biotherapeutics company by 2015. The company’s pipeline now includes a total of 6 vaccines and 27 biologics in development, up from 1 vaccine and 16 biologics at the last pipeline update in March 2009.

“Through the acquisition of Wyeth, Pfizer has become a leading biotherapeutics company, and we are well positioned to pioneer the next generation of high-potential medicines,” said Mikael Dolsten, president, BioTherapeutics Research and Development.

Pfizer’s portfolio now includes:

• 30 compounds in development for various oncology indications, including PF-02341066, a c-MET-ALK inhibitor in Phase 3 for the treatment of non-small cell lung cancer, and axitinib, a VEGF inhibitor in Phase 2 for lung, gastrointestinal, thyroid, and breast cancer and Phase 3 studies for renal cell carcinoma (RCC). Pfizer has two pan-HER/erbB targeted agents in Phase 3 studies, including PF-00299804 for non-small cell lung cancer and Neratinib for metastatic breast cancer. In addition, Pfizer has therapeutic targets in hematology with compounds in Phase 3 development, such as bosutinib, for the treatment of chronic myelogenous leukemia (CML), in addition to compounds in earlier development, such as inotuzumab ozogamicin for the treatment of Non-Hodgkin’s Lymphoma. Last month, a supplemental new drug application (sNDA) seeking FDA approval for Sutent for the treatment of pancreatic neuroendocrine tumors was filed. Sutent is an oral multi-kinase inhibitor approved for the treatment of advanced / metastatic renal cell carcinoma (RCC) and the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.
• 10 compounds in development for Alzheimer’s disease, representing a range of mechanisms Pfizer is evaluating for the treatment of this illness. These include Latrepirdine (Dimebon), being developed by Pfizer and Medivation, and bapineuzumab, being developed by Pfizer and Janssen, both in Phase 3 development for the treatment of Alzheimer’s disease.
• 8 compounds in development for pain, including tanezumab, a novel injectable biotherapeutic compound which targets nerve growth factor. The Phase 3 program studying tanezumab in osteoarthritis initiated in November, 2008, with more than 5,000 patients planned to be treated with this potential new medicine.
• 11 compounds in development for inflammation, including tasocitinib (CP-690,550), Pfizer’s JAK-3 inhibitor in development for the treatment of rheumatoid arthritis (RA). Pfizer initiated a global Phase 3 clinical program in RA for tasocitinib (CP-690,550) in February 2009, with five Phase 3 studies ongoing.
• 6 vaccines and 27 biologics in the development pipeline, including Prevnar 13, a vaccine designed to prevent pneumococcal disease in infants and young children. Prevnar 13 has been approved for infants and young children in 34 countries, including in the EU and Canada, and is under regulatory review in many other countries, including the U.S. Prevenar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.

By the end of 2009, Pfizer as a stand-alone company met three late-stage development commitments made to investors in March 2008. It met a commitment to initiate 10-12 Phase 3 starts between March, 2008 and March, 2009, and it met commitments to initiate 15 Phase 3 starts in the 2008-2009 period and to have 24-28 new molecular entities and new indications in the Phase 3 pipeline by the end of 2009. The new combined company pipeline has 34 new molecular entities and new indications in Phase 3.

Pfizer also announced that it has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Lyrica for the adjunctive treatment of generalized anxiety disorder (GAD).

In November, 2009, Pfizer announced that it would reduce its global R&D square footage by 35 percent. Consequently, R&D activities will be conducted at five main sites and nine specialized units around the world as compared with 20 R&D sites upon closing the acquisition of Wyeth on October 15, 2009.

Detailed information about Pfizer’s pipeline is available at www.pfizer.com/pipeline. Accompanying information includes compound name, target disease, phase of development and, for late-stage programs, mechanism of action.

Dimebon Alzheimer’s Disease

http://www.dimebonalzheimers.com

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