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Medivation Management Discusses Q2 2012 Results - Earnings Call Transcript

Patients also demonstrated a significantly longer median time to occurrence of the first skeletal-related event compared to placebo. Our Phase III AFFIRM trial has provided us with a very rich data set, and we look forward to presenting additional data from this trial at future medical meetings.

As you know, if enzalutamide receives marketing approval, Medivation will provide 50% of the sales and medical affairs field forces supporting enzalutamide in the U.S. Since our last quarterly call, we've completed the build-out of our sales and medical affairs field forces, and we are in the final stages of preparing for launch. We continue to expect to receive FDA approval and to launch enzalutamide for our post-chemo patients in the U.S. this year. Given its potential benefits across a wide variety of prostate cancer disease states and long patent life, we and our alliance partner, Astellas, are all conducting a broad clinical development plan for enzalutamide, which we further expanded this quarter with the addition of several new trials.

As background for understanding the various patient populations we are studying in these trials, let me begin by providing a brief overview of the various prostate cancer disease states and current therapies.

Upon initially being diagnosed with prostate cancer, many men opt for what is known as definitive treatment, either surgical removal of the prostate or radiation to the prostate. In most instances, these procedures successfully eradicate all the cancer cells and, thus, are curative. However, unfortunately, a significant number of these procedures fail, and the prostate cancer continues to progress, as typically evidenced by a rising PSA level. Men whose prostate cancer has progressed following definitive treatment are said to have advanced prostate cancer. Because prostate cancer is fueled by the male sex hormone, testosterone, the initial treatment for men with advanced prostate cancer is castration, either medically, through the use of drugs known as LHRH analogs, or surgically. These treatments reduce serum testosterone to castrate levels, which generally slows disease progression for a period of time. However, in virtually all cases, the cancer will continue -- will eventually continue to progress. Men whose prostate cancer has progressed following either medical or surgical castration are said to have castration-resistant prostate cancer or CRPC. These patients typically are given hormonal therapy with an anti-androgen, such as bicalutamide, and then move on to chemotherapy once their disease continues to progress.

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