Medivation has been here before and apparently likes the terrain. In a deal similar to last year's partnership with Pfizer on Dimebon , the company announced on Oct. 27 that it will receive a $110 million upfront payment to collaborate with Astellas on the development and commercialization of its Phase III prostate cancer candidate MDV3100.

The significant upfront payment is not the only similarity between the Dimebon (latrepirdine) and MDV3100 deals. Medivation also will share in U.S. development and commercialization costs, as well as profits, and will retain the option to co-promote the drug in the U.S.

In an investor call on Oct. 27, Medivation's chief executive and President David Hung, said the structure of the deal will further "our strategic goal of becoming a fully integrated U.S. specialty pharmaceutical company while retaining significant economic participation in MDV3100's ultimate commercial success." Also appealing - Astellas wants to develop a global oncology portfolio.

For Dimebon, a Phase III Alzheimer's disease and Phase II Huntington's disease candidate, Pfizer paid $225 million upfront, taking on 60 percent of U.S. development and commercialization costs, while also sharing profits with Medivation in a 60/40 split ([See Deal]). Biobucks in the Dimebon deal included up to $500 million in potential development and regulatory milestones, plus undisclosed commercial milestones and tiered royalties on ex-U.S. sales.

In its collaboration with Astellas, Japan's top-selling drug maker, Medivation could earn up $335 million in development and regulatory milestones, along with up to $320 million in commercial milestones. The companies will evenly split U.S. development and commercialization costs, as well as profits, with Astellas responsible for full development and commercialization costs outside the U.S. Medivation will receive tiered double-digit royalties on ex-U.S. sales of the drug.

Medivation's U.S. co-promotion option for '3100 allows it to choose between 20 percent and 50 percent of the combined U.S. sales and medical affairs field personnel, with a focus on urologists and oncologists. For any trial that will be useful for both U.S. and international approval processes, such as the ongoing Phase III AFFIRM trial, Astellas will cover two-thirds of development costs.

In a release, Astellas Chief Executive Masafumi Nogimori cited the drug's potential to establish a new treatment approach for prostate cancer and said the deal would expand his firm's urology franchise while helping it to establish a base in oncology.

Astellas' urology acumen, similar development goals led to deal

Medivation's Hung said the deal resulted from a competitive process. Besides the financial and co-promotion facets of the transaction, he said Medivation chose Astellas because of its global experience marketing urology drugs such as Flomax and Vesicare .

He added that the two companies also share a similar view on the best strategy to advance '3100, which is currently being studied in late-stage, castration-resistant prostate cancer patients who did not respond - or no longer respond - to therapy with Taxotere (docetaxel). Medivation and Astellas plan to conduct at least one other Phase III trial with an intention of expanding the drug's use to earlier-stage prostate cancer, he explained.

Hung also said Astellas' stated determination to develop a significant global oncology portfolio convinced Medivation that '3100 would be a high-priority program for the Japanese firm.

MDV3100 could compete with Cougar/J&J compound

MDV3100 is one of two late-stage compounds seeking approval in the currently unmet need of late-stage prostate cancer that is resistant to hormone therapy and castration (Also see "Several Prostate Cancer Drug Candidates Heading Into Home Stretch" - Pink Sheet, 9 March, 2009.). Cougar Biotechnology, purchased by Johnson & Johnson earlier this year, has advanced abiraterone, a cytochrome P450c17 inhibitor, to a pair of Phase III trials. One trial is in treatment-naive patients and the other in patients who failed docetaxel therapy, with final data expected in 2010 ([A#14090522006]).

Like abiraterone, which is a once-daily oral compound that targets androgen signaling, '3100 uses a triple mechanism of action to prevent and/or fight prostate cancer. It blocks movement of a cell's androgen receptor from moving from the cytoplasm to the nucleus, where it could contribute to tumor growth. The drug also blocks testosterone binding to the androgen receptor and inhibits binding to DNA.

In testing against AstraZeneca's blockbuster Casodex (bicalumatide), '3100 blocked the androgen receptor with greater affinity than the comparator and induced cell death in previously resistant prostate cancer tumor cells, an effect not seen with Casodex, Medivation said.

The AFFIRM trial, which enrolled its first patient last month, is slated to be a 1,200-patient, randomized, placebo-controlled, double-blind study testing a 160 mg dose of '3100 in patients with castration-resistant prostate cancer who previously received docetaxel.

Medivation has not provided guidance on when it expects final data from the trial, which has a primary endpoint of overall survival. Secondary endpoints include progression-free survival, safety and tolerability, according to the company.

MDV3100 also is being studied in an ongoing Phase I/II open-label trial in both treatment-naive and post-chemotherapy patients. Measuring levels of circulating tumor cells, the trial showed that 73 percent of treatment-naive and 40 percent of post-chemo participants improved from unfavorable to favorable levels of CTCs.

During the investor call, Medivation chief medical officer Lynn Seely said the company believes '3100 can win FDA approval for late-stage prostate cancer with just the one Phase III trial. Future Phase III study would be to expand the drug's label, she added.

-Joseph Haas (jh.haas@elsevier.com)

Medivation Gets $110M Upfront From Astellas In Prostate Cancer Collaboration

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