Gilead Sciences, Inc.
) 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.
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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
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
Vanda Pharmaceuticals Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).