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Positive Data on Gilead's Sovaldi

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Gilead Sciences, Inc. (GILD) announced positive results from three phase III (ION-1, ION-2 and ION-3) studies (n= 1,952) on its potential blockbuster drug, Sovaldi, in combination with ledipasvir alone or with ledipasvir plus ribavirin. Gilead is evaluating the combination therapies (over 8, 12 or 24 weeks) for the treatment of genotype 1 chronic hepatitis C virus (:HCV) infection.

Gilead announced results from the 12-week arms of the ION-1 study and all arms of the ION-2 and ION-3 studies. Results revealed that around 95.9% of the treatment-naïve patients achieved the primary efficacy endpoint of sustained virological response (SVR12). Results further revealed that a lower rate of adverse events was observed in the study arms without ribavirin compared to the study arms with ribavirin.

Gilead expects to have the results from the 24-week arms of the ION-1 study in the first quarter of next year. The company also intends to file for approval of the Sovaldi/ledipasvir combination at that time.

Earlier in the month, Gilead gained U.S. and Canadian approval for Sovaldi as a combination therapy for treating patients suffering from chronic HCV, the primary reason behind liver cancer and liver transplantation in the U.S. Sovaldi is currently under review in the EU, Australia, New Zealand, Switzerland and Turkey.

Our Take

We note that Sovaldi is an important product not only for Gilead but also for HCV patients who have postponed treatment in the hope of a better therapy. Gilead’s shares gained more than 5% after the positive results from the ION studies were announced. Sovaldi has many factors that should work in its favor – high cure rates, a short treatment period and reduction/elimination of the need for interferon injections. It has the potential to change the treatment paradigm in the HCV market. We expect investor focus to remain on the performance of the drug.  

Gilead, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space include Actelion Ltd. (ALIOF), Jazz Pharmaceuticals (JAZZ) and Vanda Pharmaceuticals Inc. (VNDA). All these stocks carry a Zacks Rank #1 (Strong Buy).

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