Credit: Shutterstock photoThe HealthCare segment at Bayer ( BAYRY ) received encouraging news when the European Commission (EC) cleared its oncology drug, Xofigo. Xofigo was approved in the EU for treating adults suffering from castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
The European approval of Xofigo does not come as a surprise, as in September this year the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) rendered a positive opinion on the approval of Xofigo.
The EU approval of Xofigo was based on positive results from the phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study. Results from the 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.
We remind investors that the U.S. Food and Drug Administration (FDA) approved the drug in May 2013 for the above indication, based on positive results from the ALSYMPCA study. Xofigo is co-promoted by Bayer and Algeta U.S., LLC in the U.S. as per a 2009 agreement. Bayer however has the rights to commercialize the product worldwide.
We are encouraged by Bayer's progress on Xofigo. However, the prostate cancer market already has companies like Johnson & Johnson ( JNJ ) and Medivation Inc. ( MDVN ).
Bayer presently carries a Zacks Rank #2 (Buy) and so does Johnson & Johnson. Stocks such as Actelion Ltd. ( ALIOF ) currently look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
