TOKYO and SAN FRANCISCO, CA--(Marketwire - May 09, 2011) - Astellas Pharma Inc. and Medivation, Inc. (NASDAQ: MDVN) today announced treatment of the first patient in the second new Phase 2 clinical trial of the investigational drug MDV3100, a triple-acting oral androgen receptor antagonist. This trial is evaluating MDV3100 monotherapy as the first hormonal treatment of patients with prostate cancer. Enrolled patients would not have had any previous hormonal therapies for the treatment of prostate cancer. This is the first trial to examine the effects of MDV3100 without a background of medical or surgical castration.
“This is the second of two Phase 2 trials that we and our partner Medivation have initiated this year to evaluate the potential benefit of MDV3100 in both advanced and earlier stage prostate cancer patients,” said Steven Ryder, M.D., president, Astellas Pharma Global Development. “Investigating MDV3100 monotherapy is the next important step to potentially providing a new option for prostate cancer patients with earlier stage disease.”
The open-label, single-arm Phase 2 trial is planned to enroll approximately 60 patients in Europe. The primary endpoint of the trial is prostate-specific antigen (PSA) response. The trial will evaluate MDV3100 at a dose of 160 mg taken orally once daily for 24 weeks. Information about patient eligibility and enrollment can be obtained by calling 800-888-7704 ext. 5473 or e-mailing clintrials.info@us.astellas.com.
MDV3100 Clinical Development Program
In addition to this trial, MDV3100 is currently being evaluated in the TERRAIN study, a Phase 2 trial comparing MDV3100 with bicalutamide, a commonly used anti-androgen, in the treatment of advanced prostate cancer patients who have progressed while on LHRH analogue therapy or following surgical castration. TERRAIN is expected to enroll approximately 370 patients in North America and Europe. The primary endpoint of the trial is progression-free survival. Information about patient eligibility and enrollment can be obtained by calling 800-888-7704 ext. 5473 or e-mailing clintrials.info@us.astellas.com.
MDV3100 is also being evaluated in two global Phase 3 studies in patients with advanced prostate cancer.
The randomized, double-blind, placebo-controlled Phase 3 AFFIRM trial completed enrollment in November 2010. This trial of 1,199 patients with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy is evaluating 160 mg/day of MDV3100 versus placebo. The primary endpoint is overall survival.
A second Phase 3 clinical trial of MDV3100 in advanced prostate cancer, the PREVAIL trial, is currently enrolling patients. This randomized, double-blind, placebo-controlled, multi-national trial of approximately 1,700 men with advanced prostate cancer who have not yet received chemotherapy is evaluating MDV3100 at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care. The co-primary endpoints of the trial are overall survival and progression-free survival. Information about patient eligibility and enrollment can be obtained by calling the PREVAIL study hotline toll-free at 1-888-243-4363.
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 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.
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, the planned initiation of additional clinical trials 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, 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 agreements, 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 annual 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.
