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Jun 24, 2013
 |  BioCentury  |  Product Development

ARrangement for antagonism

J&J deal for Aragon challenges Astellas-Medivation's Xtandi in CRPC

Johnson & Johnson's acquisition of Aragon Pharmaceuticals Inc. is reminiscent of its deal for Cougar Biotechnology Inc.: roughly $1 billion for an androgen deprivation therapy for castration-resistant prostate cancer based on promising PSA reductions but pending survival benefit. The deal gives the pharma a second-generation androgen receptor antagonist that could have the edge in efficacy over Xtandi enzalutamide from Astellas Pharma Inc. and Medivation Inc.

The acquisition also gives J&J a compound to potentially combine with its Zytiga abiraterone, which faces U.S. patent expiration in 2016.

Under last week's deal, J&J will pay $650 million in cash up front and up to $350 million in development milestones. J&J will gain Aragon's androgen receptor programs including lead compound ARN-509, which is in Phase II testing to treat castration-resistant prostate cancer (CRPC), and the biotech's Selective Androgen Receptor Degrader (SARD) program, which is in discovery. The deal is slated to close next quarter.

J&J bought Cougar for $1 billion in cash in 2009, bringing in Zytiga. At the time, the cytochrome P450 17 alpha-hydroxylase/C17, 20 lyase (CYP17) inhibitor was in Phase III testing for CRPC.

FDA and EMA approved Zytiga in 2011 to treat metastatic CRPC patients who received prior docetaxel chemotherapy. Last year, FDA approved an expanded label that includes chemotherapy-naïve patients, while EMA expanded the label to include chemotherapy-naïve patients who are asymptomatic or mildly asymptomatic after failing androgen deprivation therapy.

Xtandi's U.S. launch in September 2012 gave patients with metastatic CRPC an alternative androgen deprivation therapy with a new profile: Xtandi is indicated after docetaxel but does not require concomitant prednisolone. In April, EMA's CHMP recommended approval of the drug.

J&J reported $961 million in 2012 sales for Zytiga, and $344 million in sales in 1Q13. Astellas reported sales of ¥12.2 billion ($146 million) for Xtandi in the U.S. for FY12 ended March...

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