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Bayer/Amgen's Nexavar Fails in Late-Stage Study

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The HealthCare segment at Bayer (BAYRY) and partner, Amgen Inc. (AMGN), announced disappointing results from a phase III STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) study on Nexavar.

The study was evaluating the clinical benefit of Nexavar compared to placebo as an adjuvant treatment for patients suffering from hepatocellular carcinoma who had no detectable disease following surgical resection or local ablation.

Bayer stated that Nexavar failed to meet the primary objective of the study of improving recurrence-free survival. However, the companies mentioned that the safety findings were consistent with Nexavar’s known profile.

We are disappointed with the study outcome. Bayer’s shares went down slightly following the news. Bayer is, however, not losing hope and stated in its press release that it will continue to explore the full potential of Nexavar in all stages of liver cancer. As per company sources over 780,000 liver cancer patients are diagnosed each year worldwide.

Nexavar is already a key oncology product at Bayer and is approved in over 100 countries around the globe. In the U.S., the drug is approved for the treatment of patients suffering from locally recurrent or metastatic, progressive, differentiated thyroid cancer (:DTC) that is refractory to radioactive iodine treatment.

In the EU, the drug is approved for two other indications – for the treatment of patients suffering from hepatocellular carcinoma and suffering from advanced renal cell carcinoma who have had unsuccessful interferon-alpha or interleukin-2 based therapy.

Bayer reported Nexavar sales of €771 million in 2013, up 3.3% year over year on an adjusted basis. Bayer and Amgen are evaluating Nexavar in several other indications as well. We expect Nexavar sales to be boosted with further label expansions. However, the oncology market is extremely competitive given the presence of companies like Roche (RHHBY).

Bayer presently carries a Zacks Rank #4 (Sell). Some better-ranked stocks include Alexion Pharmaceuticals, Inc. (ALXN). Alexion carries a Zacks Rank #1 (Strong Buy).

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