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Gilead's Sovaldi in Focus on Bradyarrhythmia Concerns

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Concerns related to Gilead Sciences Inc .'s GILD Sovaldi have surfaced after a letter to the New England Journal of Medicine reported three cases of severe bradyarrhythmia during treatment with Sovaldi plus Daklinza, Olysio or ribavirin out of 415 patients treated in Hopital Cochin's hepatology and cardiology group in Paris last year.

Gilead clarified that the company had reported these three cases of bradyarrhythmia mentioned in the published letter to the FDA and the European Pharmacovigilance Risk Assessment Committee earlier this year.

We remind investors that Gilead's HCV drugs have already been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from the year-ago figure owing to the availability of newer HCV therapies. Another new HCV drug, Harvoni, witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. Meanwhile, Gilead is working on developing several Sovaldi-based regimens. In this scenario, if the product is found to be associated with a risk of severe bradyarrhythmia, it could prove to be a major setback for the company.

The report of potentially severe bradyarrhythmia being associated with Sovaldi came close on the heels of the FDA issuing a warning related to AbbVie Inc.'s ABBV HCV drugs, Viekira Pak and Technivie. The FDA stated that both HCV drugs can cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (read more: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs ).

Meanwhile, competition in the HCV market is intensifying as several companies including Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.

Gilead currently carries a Zacks Rank #3 (Hold). Anika Therapeutics Inc. ANIK is a better-ranked stock in the health care sector. The stock sports 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.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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