Healthcare Industry News: Dimebon
News Release - March 1, 2006
Medivation Receives FDA Comments on Huntington's Disease INDSAN FRANCISCO--(HSMN NewsFeed)--March 1, 2006--Medivation, Inc. (OTCBB:MDVN ) today announced that late yesterday it received telephonic comments from the FDA regarding the Company's investigational new drug application (IND) filed on January 31, 2006 to begin human clinical development of Dimebon for Huntington's disease. In the call, the FDA stated Medivation would be required to conduct additional toxicology studies prior to receiving approval to start its proposed human clinical trial. The FDA also informed Medivation that it would be sending a written comment letter shortly.
David Hung, M.D., President and Chief Executive Officer of Medivation, stated: "We have not yet received the FDA's comment letter or had the opportunity to discuss our IND with the FDA staff. Once we receive the letter and have the opportunity to consult with the FDA staff, we will formulate a plan in consultation with the staff. Based on the information we have from FDA thus far, we believe we can complete the requested studies in a few months. Obviously our Huntington's disease program will be delayed somewhat and, if resource reallocation is required, our prostate cancer program may also be delayed. We remain on track for the previously disclosed milestones for our lead clinical program in Alzheimer's disease."
Medivation, Inc. acquires promising pharmaceutical and medical device technologies in the late preclinical development phase, develops those technologies quickly and cost-effectively through human first proof-of-efficacy studies (generally the end of Phase 2 clinical trials), and seeks to sell or partner successful programs with larger pharmaceutical, biotechnology and medical device companies for late-stage clinical studies and commercialization. The Company intends to build and maintain a portfolio of 4 to 6 development programs at all times, targeting technologies with the potential to generate returns on investment of at least 6 fold within 3 years.
Medivation's current portfolio consists of small molecule drugs in development to treat 3 large, unmet medical needs -- Alzheimer's disease, Huntington's disease and hormone-refractory prostate cancer, the last two of which are likely Orphan Drug indications. Dimebon(TM), with a 20-year record of human use and demonstrated efficacy in animal studies of both Alzheimer's disease (AD) and Huntington's disease (HD) and in a pilot clinical study of AD, is in a randomized, double-blind, placebo-controlled Phase 2 study in AD patients in Russia, the results of which are expected to be available in Q3 2006. Medivation also expects to initiate a U.S. Phase 1-2 study of Dimebon in HD patients. The MDVN 300 series compounds are in development for the treatment of hormone-refractory prostate cancer. Further information about Medivation can be found on its website (www.medivation.com).
Safe Harbor Statement
This press release contains forward-looking statements, including statements regarding the anticipated timing of regulatory and clinical milestones on the Company's Dimebon Alzheimer's disease and Huntington's disease programs, and the Company's MDVN300 family of small molecules for the treatment of hormone-refractory prostate cancer, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from those projected. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-KSB for the year ended December 31, 2004 and our Quarterly Reports on Form 10-QSB for the quarters ended March 31, 2005, June 30, 2005, and September 30, 2005 include more information about factors that could affect our financial and operating results.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.