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Bayer's Xofigo Data Published - Analyst Blog

By: Zacks.com
Posted: 7/19/2013 4:48:00 PM
Referenced Stocks: BAYRY;JAZZ;JNJ;MAA;MDVN

Bayer 's ( BAYRY ) HealthCare segment recently announced that positive data from the phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study on Xofigo (radium 223 dichloride) was published in the New England Journal of Medicine (NEJM).

Results from the randomized, double-blind, placebo-controlled international study revealed that treatment with Xofigo resulted in a 44% improvement in overall survival and caused a 30.5% reduction in the risk of death compared to patients in the placebo arm. Moreover, in January this year, a licensing decision on the medical use of Xofigo was issued by the US Nuclear Regulatory Commission.

We note that the US Food and Drug Administration (FDA) approved the drug in May 2013 for the treatment of patients suffering from castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease, based on the positive results from the ALSYMPCA study. The New Drug Application (NDA) for Xofigo, submitted in Dec 2012, was reviewed by the FDA on a priority basis. Following the approval, the drug is marketed in the US under the trade name Xofigo.

Xofigo is co-promoted by Bayer and Algeta US, LLC in the US as per a 2009 agreement. Bayer however has the rights to commercialize the product worldwide.

Bayer is also seeking European approval of the candidate. In Dec 2012, the company had submitted a Marketing Authorization Application (MAA) for radium 223 dichloride to the European Medicines Agency (EMA) for the treatment of CRPC patients with bone metastases.

We note that the prostate cancer market already has companies like Johnson & Johnson ( JNJ ) and Medivation Inc. ( MDVN ).

Bayer presently carries a Zacks Rank #4 (Sell). Meanwhile, stocks such as Jazz Pharmaceuticals Public Limited Company ( JAZZ ) currently look more attractive with a Zacks Rank #1 (Strong Buy).



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