Total operating expenses increased to $33.8 million for the year ended December 31, 2007, from $16.1 million for the same period in 2006.
Medivation ended 2007 with $43.3 million in cash and equivalents, plus a remaining capacity of $78.8 million under its committed equity line of credit facility. The Company expects total operating expenses in 2008 to increase significantly beyond 2007 levels, due primarily to further expansion of Dimebon and MDV3100 development, including the upcoming confirmatory pivotal Phase 3 trial of Dimebon in AD and the expanded dosing groups in the ongoing Phase 1-2 trial of MDV3100 in HRPC.
2008 Corporate Milestones
"In 2008, we plan to begin multiple AD clinical trials for Dimebon,
including our confirmatory pivotal Phase 3 trial. We also look forward to
presenting a steady stream of data across all of our programs in 2008 --
including top-line results from our ongoing Phase 2 trials in Huntington's
disease and hormone-refractory prostate cancer," continued Dr. Hung.
During 2008 Medivation intends to:
-- Initiate a second, confirmatory pivotal Phase 3 trial of Dimebon in AD
in the second quarter with the goal of completing the trial and
applying for U.S. and European marketing approval in 2010.
-- Conduct multiple clinical trials of Dimebon in AD for marketing and
reimbursement purposes and to provide a safety database of
approximately 1,500 patients as part of its marketing application. In
the second quarter of 2008, the Company plans to begin the first of
these trials -- a 20 patient Phase 1 trial to evaluate the safety and
tolerability of Dimebon when given to AD patients who are also taking
Aricept(R), the leading AD treatment on the market.
-- Complete the ongoing Phase 2 study of Dimebon in Huntington's disease
in the second quarter.
-- Begin global Phase 3 clinical studie
|SOURCE Medivation, Inc.|
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