Vienna (July 12, 2009) - Pfizer (NYSE: PFE) and Medivation, Inc. (Nasdaq: MDVN) today announced that new Phase 1 data showed that the investigational drug dimebon (latrepirdine)* was well tolerated when used in combination with donepezil HCI tablets, the leading Alzheimer's disease (AD) medication worldwide, in patients with mild-to-moderate Alzheimer's disease. The Phase 1 data were presented today at the 2009 Alzheimer's Association International Conference on Alzheimer's disease (ICAD 2009) in Vienna, Austria.
There were no serious adverse events reported in the study and most adverse events were mild to moderate. The therapy was well tolerated, and all patients completed the treatment period except for one placebo patient. There were no remarkable changes to vital signs, electrocardiograms or laboratory values associated with dimebon treatment.
"Every patient is uniquely affected by Alzheimer's disease and management is often complex. Combination therapy may be needed to maximize clinical benefit, but limited treatment options are available currently," said Pierre N. Tariot, M.D., one of the study's investigators and Director, Memory Disorders Center, Banner Alzheimer's Institute. "The Phase 1 data are encouraging, and serve as the foundation for the ongoing Phase 3 CONCERT study, which recently started enrollment in the U.S. and internationally."
The CONCERT study is a 12-month clinical trial designed to evaluate the safety and efficacy of dimebon (latrepirdine) when added to ongoing treatment with donepezil in patients with mild-to-moderate AD. CONCERT is designed to complement previous and ongoing studies by further evaluating the efficacy of dimebon and benefits in Alzheimer's disease.
*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.
About the Study
The placebo-controlled, Phase 1 study was designed to evaluate the safety and tolerability of dimebon in Alzheimer's patients treated with donepezil. In the trial, 24 patients with mild-to-moderate Alzheimer's disease stable on donepezil for at least 60 days were randomized to receive dimebon or placebo for two to four weeks.
The most commonly reported adverse events compared to placebo were fatigue (dimebon, n=3/15, placebo, n=0), abdominal distension (dimebon, n=2/15, placebo, n=0), fall (dimebon, n=2/15, placebo, n=0), hyperkalemia (dimebon, n=2/15, placebo, n=1/9) and nightmare (dimebon, n=2/15, placebo, n=0). These events were mild to moderate and resolved with continued treatment.
About Dimebon
Dimebon (latrepirdine) is an investigational drug currently in Phase 3 development for the treatment of Alzheimer's disease and in clinical development for Huntington disease (HD). The comprehensive Phase 3 clinical development program for Alzheimer's disease is evaluating the potential for dimebon to be used in broad applications including use as first-line monotherapy, in combination with existing medications and in patients at all stages of the disease.
Dimebon (latrepirdine) has a unique mechanism of action, distinct from currently available treatments. In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain cell survival, potentially by stabilizing and improving mitochondrial function.
About the Pfizer/Medivation Dimebon Collaboration
Medivation and Pfizer have a global collaboration to develop and commercialize dimebon for the treatment of Alzheimer's disease and Huntington disease. Under the terms of the agreement, the companies are working in partnership to bring dimebon to market in the United States. In addition, following FDA approval, Medivation will co-promote dimebon to specialty physicians in the U.S. Pfizer has responsibility for development, regulatory and commercialization outside of the U.S.
For more information about Pfizer, visit www.Pfizer.com.
For more information about Medivation, visit www.Medivation.com
Forward-Looking Statements
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of July 12, 2009. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about certain potential indications for dimebon, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any new drug applications that may be filed for such indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such indications; and competitive developments.
A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.
MEDIVATION DISCOSURE NOTICE: This press release contains forward-looking statements, including statements regarding potential clinical indications for dimebon, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation's actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation's clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation's clinical trials, partnering of Medivation's product candidates, manufacturing of Medivation's product candidates, competition with Medivation's product candidates should they receive marketing approval, the adequacy of Medivation's financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation's filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended March 31, 2009 filed on May 11, 2009, with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
1ICAD Submitted Abstract #P1-254. A safety, tolerability and pharmacokinetic study of dimebon in patients with Alzheimer's disease already receiving donepezil. Poster Session. July 12, 2009: 12:30-3:00 p.m. P Tariot - Presenter. 2009 International Conference on Alzheimer's Disease (ICAD), Vienna, Austria. July 11-16, 2009