Medivation CEO Discusses Q3 2010 Results - Earnings Call Transcript
Medivation, Inc. (
)
Q3 2010 Earnings Call Transcript
November 5, 2010 4:30 pm ET
Executives
Joey Fleury – WCG
David Hung – President and CEO
Pat Machado – Chief Business Officer and CFO
Lynn Seely – Chief Medical Officer
Analysts
Kim Lee – Global Hunter
Andrew Vaino – Roth Capital Partners
Nathan Kelly – Noble Finance
John Aschoff – Brean Murray
Howard Liang – Leerink Swann
Presentation
Operator
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Thank you for joining Medivation’s Third Quarter 2010 Financial Results Conference Call. This conference is being recorded. At the end of the presentation we will have a question and answer session will be given instructions at that time on how to signal for question.
I would now turn the call over to Joey Fleury.
Joey Fleury
Thank you and welcome to Medivation’s third quarter 2010 financial results conference call. On the call today from Medivation are Dr. David Hung, President and CEO, Patrick Machado, Chief Business and Financial Officer, Dr. Lynn Seely, Chief Medical Officer and Rohan Palekar, Chief Commercial Officer. We issued a press release earlier today, a copy of which can be found at www.medivation.com in the “News” section.
Before we begin I would like to remind you that various remarks that we make on this call contains forward looking statements, including statements regarding the timing of clinical trial initiation, enrollment and data, potential future clinical trial event, the therapeutic and commercial potential of our products candidate and their continued development, regulatory and intellectual property matters, our collaboration, the sufficiency of our cash resources and statements above our future opportunities which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.
Any statements contained in this call that are not statements of historical facts 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 press related progress, timing and result of Medivation’s clinical trial, difficulties as a ways in obtaining regulatory approval, difficulties or delays in enrolling and retaining patients in Medivation’s clinical trials, partnering of Medivation’s product candidate, manufacturing of Medivation’s product candidate, competition with Medivation’s product candidate should they receive marketing approval, the adequacy of Medivation’s financial resources unanticipated expenditures or liabilities, intellectual property matters and other risks and uncertainties 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
th
2010, filed today 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 call. Medivation disclaims any obligation or undertaking to update or revise any forward looking statements contained in this conference call.
With that, I will now turn the call over to Dr. David Hung, President and CEO of Medivation.
David Hung
Thank you all for joining us today. I’ll begin the call with an update on our programs including recent developments. I will then review third quarter financial results and I’ll conclude with an outline of our near-term company milestone.
Let’s begin with the Medivation 3100 program. We and our partner, Astellas, expect to complete enrollment in our ongoing Phase III AFFIRM trial on November 15, just a little more than a week from now. AFFIRM is a randomized double-blind placebo-controlled multinational study that is expected to enroll approximately 1200 patients with advanced prostate cancer who have previously failed docetaxel-based chemotherapy.
Primary end point of the AFFIRM trial is overall survival. All patients in AFFIRM represent the most advanced prostate cancer population we are targeting MDV3100. Patients with earlier stage prostate cancer also need a new treatment option. Therefore, our goal is to develop MDV3100 for the broadest possible spectrum of disease stage.
In the third quarter, we began the expansion to earlier stage patients with the initiation of our second phase retrial known as PREVAIL. PREVAIL is a randomized double-blind placebo-controlled multinational study that is expected to enroll approximately 1700 patients with advanced prostate cancer who have chemotherapy naïve. The co-primary end points of the trial are overall survival and progression free survival.
Secondary endpoints include time to first related event in time to initiation of different chemotherapy. Both of our Phase III prostate cancer trail AFFIRM and PREVAIL are valuating MDV3100 at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care.
We and our partner, Astellas also remain on track to initiate two new trials in even earlier stage prostate cancer this year. A Phase 2 head to head trial comparing MDV3100 with bicalutamide and a Phase 2 trial in hormone-naïve patients. Our partner, Astellas bears two-thirds of the development cost of our ongoing Phase 3 AFFIRM and PREVAIL trial as well as our upcoming Phase 2 trial.
As you know, there has been a lot of good amount of news over the past several months focused on the prostate cancer space. Most recently, Abiraterone, a compound development by J&J for advanced prostate cancer announced positive data from the interim analysis demonstrating an overall survival benefit in post-chemo patients. The same population we are studying in our ongoing AFFIRM trial.
We believe these data are net positive for MDV3100 as they represent total clinical validation for the androgen receptor signaling pathway in the treatment of advanced prostate cancer.
We are also encouraged by the fact that the Phase 1-2 efficacy data published to-date for Abiraterone and MDV3100 are quite similar.
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