Medivation and Astellas Complete Enrollment in Phase 3 AFFIRM trial of MDV3100 in Advanced Prostate Cancer
By Astellas Pharma Inc. And Medivation Inc., PRNEMonday, November 29, 2010
SAN FRANCISCO and TOKYO, November 30, 2010 - Medivation, Inc. (Nasdaq: MDVN) and Astellas Pharma Inc. today announced
that patient enrollment was completed on November 15, 2010 in the Phase 3
AFFIRM study of the investigational drug MDV3100, a novel, triple-acting oral
androgen receptor antagonist, in patients with advanced prostate cancer who
have previously been treated with chemotherapy.
"There has been a lot of positive news for advanced prostate cancer
patients over this past year, and the completion of patient enrollment in
AFFIRM is yet another significant achievement in the development of new
therapies to treat this devastating disease," said Lynn Seely, M.D., chief
medical officer of Medivation.
"While AFFIRM is focused on patients with the most advanced stage of
disease, earlier stage prostate cancer patients are also in need of new
treatment options," said Steve Ryder, MD, president, Astellas Pharma Global
Development."The first step in our expanded development of MDV3100 into
earlier stage patients is our ongoing Phase 3 PREVAIL trial, in which we are
studying advanced prostate cancer patients who are chemotherapy naïve. In
addition, Medivation and Astellas plan to initiate two Phase 2 trials in
earlier stage prostate cancer early next year."
The randomized, double-blind, placebo-controlled Phase 3 AFFIRM study
enrolled 1,199 patients. The trial is evaluating 160 mg/day of MDV3100 versus
placebo. The primary endpoint is overall survival, and secondary endpoints
include progression-free survival, safety and tolerability. The AFFIRM study
is being conducted at sites in the United States, Canada, Europe, Australia,
South America and South Africa.
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 for both early-stage and advanced prostate cancer. 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 U.S.
About MDV3100
MDV3100 is an investigational therapy in clinical development for
advanced prostate cancer. The novel, triple-acting, oral androgen receptor
antagonist has been shown to slow growth and induces cell death in
bicalutamide-resistant cell-lines 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. Preclinical data comparing
MDV3100 and bicalutamide in each of these three actions was published in
Science in April 2009.
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 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 Pfizer and Astellas,
Medivation currently has investigational drugs in Phase 3 development to
treat advanced prostate cancer, mild-to-moderate Alzheimer's disease and
Huntington 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 Medivation's
product candidates, the planned initiation of additional clinical trials and
the continued effectiveness of, and continuing collaborative activities
under, Medivation's collaboration agreement with 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 quarterly report on Form 10-Q for the
quarter ended September 30, 2010, filed on November 5, 2010 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.
Contacts: Medivation, Inc. Red Door Communications Astellas Patrick Machado Arran Attridge Mindy Dooa Chief Business Officer +1(415)829-4101 +44-208-392-8040 +44-1784-419-408
Medivation, Inc. Patrick Machado, Chief Business Officer, +1(415)829-4101, Red Door Communications, Arran Attridge, +44-208-392-8040, Astellas, Mindy Dooa, +44-1784-419-408
Tags: Astellas Pharma Inc. And Medivation Inc., california, Japan, November 30, San Francisco And Tokyo