Medivation Management Discusses Q2 2012 Results - Earnings Call Transcript

In addition to our prepared remarks, we may make forward-looking statements in response to questions, including, for example, statements regarding our current and potential future collaboration and our future financial position and results. Any statements made in this call are not -- 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, the risks and uncertainties detailed in Medivation's Form 10-Q for the quarter ended June 30, 2012, filed today with the SEC. All forward-looking statements made during this call are based on information available to us as of today, and we assume no obligation to update these statements as a result of future events or otherwise.

With that, I'll turn the call over to Dr. David Hung, President and CEO of Medivation. David?

David T. Hung

Thanks, Anne. Thank you all for joining us today. 2012 has been an eventful year for Medivation. I'd like to start the call with some exciting recent developments, and Pat will review second quarter 2012 financial results. And after that, we'll open the call up for Q&A.

Just a little over 2 weeks ago, we achieved a major corporate milestone, when the FDA notified us that our NDA for enzalutamide for the post-chemotherapy indication was accepted for filing and granted priority review designation, which is reserved for drugs that offer a significant improvement in treatment or provide treatment where no satisfactory alternative therapy exists. This acceptance triggers a $10 million milestone payment to Medivation under our collaboration agreement with Astellas.

In addition, on June 26, Astellas submitted an MAA to the EMA seeking approval to market enzalutamide in Europe for the post-chemo indication. Also in June, new data from our Phase III AFFIRM trial was highlighted at ASCO, where Dr. Johann de Bono, co-principal investigator of the trial from The Institute of Cancer Research and Royal Marsden Hospital, presented data showing that patients treated with enzalutamide reported significantly higher response rates and health-related quality-of-life measures compared to placebo, as measured by the FACT-P questionnaire, a validated measure of patient function.

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