Astellas Pharma, Inc.’s (ALPMY) shares gained 2.5% following the company’s update on its pipeline. The company also provided a comprehensive overview of its initiatives towards innovation, research and development and its corporate strategy.
Astellas is currently focused on the development of its oncology pipeline. In May 2014, Astellas and partner Medivation (MDVN) received priority review status for Xtandi from the FDA for the treatment of patients suffering from advanced prostate cancer who are chemotherapy-naive. A response from the FDA should be out by Sep 18, 2014.
Xtandi is already approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC) patients who have been treated with Taxotere previously. In 2013, U.S. net sales for Xtandi were $392.4 million.
According to Medivation, there is stronger-than-expected demand in the market for post-chemotherapy treatment for mCRPC patients. On its first quarter call, Medivation said that a majority of physicians consider Xtandi as the preferred choice of treatment in the post-chemo setting. Approval for Xtandi for chemotherapy-naive advanced prostate cancer patients will expand the eligible patient population and boost Xtandi’s sales significantly.
Additionally, in a phase II study roxadustat showed efficacy in anemia correction and maintenance in dialysis as well as non-dialysis patients suffering from chronic kidney disease. Roxadustat is currently in a phase III study for this indication in Europe. Astellas’ VESIcare/Myrbetriq combination is also in a phase III study for the treatment of overactive bladder.
Meanwhile, the company is preparing to initiate a phase III program on ASP015K for the treatment of rheumatoid arthritis.
We note that Astellas has a collaboration agreement with Amgen (AMGN) for the development and commercialization of five of Amgen’s candidates in Japan, which includes rilotumumab (gastric cancer), evolocumab (hyperlipidemia) and romosozumab (osteoporosis).
Astellas carries a Zacks Rank #4 (Sell). A better-ranked stock in the health care sector is Synergy Pharmaceuticals, Inc. (SGYP), carrying a Zacks Rank #1 (Strong Buy).
(We are reissuing this article to correct a mistake. The original article, issued July 16, 2014, should no longer be relied upon.)
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