SAN FRANCISCO, CA and TOKYO--(Marketwire - June 04, 2011) - Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. today announced preliminary results from an ongoing study conducted at MD Anderson Cancer Center that provides additional evidence of the clinical effects and tolerability of MDV3100 in patients with advanced prostate cancer. MDV3100 is a triple-acting, pure androgen receptor antagonist in clinical development to treat advanced prostate cancer.
The study is evaluating 58 heavily pre-treated advanced prostate cancer patients at a dose of 160 mg/day, the dose being studied in all ongoing MDV3100 trials. Patients had a particularly high disease burden, with 70 percent having 20 or more bone metastases. Bone marrow biopsies were taken in this study to determine the impact of MDV3100 on tumors that had metastasized to the bone marrow.
"The preliminary results from this study confirm MDV3100's anti-tumor effects and tolerability profile seen in our previously reported Phase 1-2 trial and provides further support for the selection of 160 mg per day as the optimal Phase 3 dose," said Lynn Seely, M.D., chief medical officer of Medivation. "The bone marrow biopsy data also confirm for the first time in man that MDV3100 inhibits nuclear translocation of the androgen receptor, a critical step in the growth of prostate cancer."
The oral presentation will be presented by Eleni Efstathiou, M.D., Ph.D., assistant professor, University of Texas, MD Anderson Cancer Center, during the Clinical Science Symposium: Translational Science Advancing Androgen Receptor Targeting in Prostate Cancer at the ASCO Annual Meeting in Chicago on Saturday, June 4, 2011, from 1:15 to 2:45 p.m. CT.
Preliminary Study Results
Of the 55 evaluable patients enrolled thus far, 45 percent experienced at least a 50 percent reduction in prostate-specific antigen (PSA) levels. Tissue analyses from bone marrow biopsies showed that response to MDV3100 was associated with decreased levels of androgen receptor in the cell nucleus where it can promote cancer growth.
Overall, MDV3100 was generally well tolerated. The most common adverse event was fatigue, with 24 percent of patients experiencing Grade I/II fatigue and 3 percent of patients experiencing Grade III fatigue.
About MDV3100
MDV3100 is an investigational therapy in clinical development for advanced prostate cancer. In a Phase 1-2 trial in 140 patients with advanced prostate cancer published in The Lancet, encouraging antitumor activity was noted with MDV3100 across endpoints. In preclinical experiments published in Science in April 2009, the triple-acting, oral androgen receptor antagonist provided more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions -- MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation) and inhibits binding to DNA. In the preclinical experiments published in Science, MDV3100 was superior to bicalutamide in each of these three actions.
About Prostate Cancer
Prostate cancer is the second most common non-skin cancer among men in the world and it is the sixth leading cause of cancer death among men worldwide. Patients whose prostate tumors have stopped responding to, or are growing despite the use of, active hormone treatment strategies are considered to have advanced prostate cancer. These patients have a poor prognosis and few treatment options.
About the Medivation/Astellas Collaboration
In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize MDV3100. The companies are collaborating on a comprehensive development program that includes studies to develop MDV3100 across the full spectrum of advanced prostate cancer disease states. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. and Astellas will have responsibility for commercializing MDV3100 outside the U.S. Medivation received a $110 million up-front payment upon entering into the collaboration agreement, and is eligible to receive up to $335 million in development milestone payments, up to $320 million in commercial milestone payments, 50% of profits on sales in the U.S., and tiered, double-digit royalties on sales outside the United States.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimer's disease. For more information, please visit us at www.medivation.com.
About Astellas Pharma Inc.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. Astellas has approximately 16,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology & Infectious Diseases, Neuroscience, DM complications & Metabolic Diseases and Oncology. For more information on Astellas Pharma Inc., please visit our website at www.astellas.com/en.
MEDIVATION DISCLOSURE NOTICE: This press release contains forward-looking statements, including statements regarding the continued clinical development of Medivation's product candidates, the therapeutic and commercial potential of MDV3100, potential future clinical trial results, potential regulatory approval and commercialization of MDV3100, and the continued effectiveness of, and continuing collaborative activities under, Medivation's collaboration agreements with Pfizer and Astellas, 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, including the risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of Medivation's product development activities, the risk that positive results from early clinical trials may not be predictive of results obtained in later and larger clinical trials, and the risk that alternative life-prolonging treatments could prevent ongoing or planned MDV3100 trials from succeeding or could reduce any potential survival benefit that may be shown in these trials even if they do succeed, enrollment of patients in Medivation's clinical trials, partnering of Medivation's product candidates, including Medivation's dependence on the efforts of and funding by Astellas for the development of MDV3100, the achievement of development, regulatory and commercial milestones under Medivation's collaboration agreement with Astellas, the manufacturing of Medivation's product candidates, 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, 2011, filed on May 6, 2011 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.
