In a bid to strengthen its product portfolio further,
Gilead Sciences, Inc.
) has submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) seeking approval to market the
fixed-dose combination of ledipasvir ( a NS5A inhibitor: 90 mg)
and sofosbuvir: 400 mg for treating adults with chronic hepatitis
C virus (HCV) genotype 1 infection. Gilead filed the marketing
application on the basis of encouraging data from three phase III
studies (ION-1, ION-2 and ION-3).
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The studies evaluated the combination with or without ribavirin
in almost 2000 genotype 1 chronic hepatitis C patients. The
approval of the combination would not only reduce the treatment
duration of chronic hepatitis C genotype 1 infection to as low as
eight weeks but also eliminate the need for interferon injections
or ribavirin which have significant side effects. Gilead stated
that 75% of the HCV affected population in the U.S. suffers from
the genotype 1 version.
We note that the combination has been granted breakthrough
therapy designation by FDA. The designation, which was enacted as
part of the 2012 Food and Drug Administration Safety and
Innovation Act, should help fasten the development and review
process for the candidate.
Gilead also intends to get the candidate approved in other
territories across the globe. Gilead has already filed an
application to the European Medicines Agency (EMA) for
accelerated assessment of the combination. Acceptance of the
request could reduce the EMA's review period of the application
by two months.
We note that one of the components of the combination -
sofosbuvir- is already approved in the U.S. (Dec 2013) and the EU
(Jan 2014) under the trade name Sovaldi. Sovaldi is off to a
strong start and recorded U.S. sales of $136.4 million in the
fourth quarter of 2013. Sovaldi, with its high cure rates, a
short treatment period and reduction/elimination of the need for
interferon injections, has the potential to change the treatment
paradigm in the HCV space.
Approval of the all oral ledipasvir/ sofosbuvir combination would
further strengthen Gilead's product portfolio. We note that
) is also aiming to bring an all-oral, interferon-free therapy
into the market for treating genotype 1 HCV.
Gilead, a biopharmaceutical company, carries a Zacks Rank #2
(Buy). Better-ranked biopharma stocks include
Alexion Pharmaceuticals, Inc.
). Both companies carry a Zacks Rank #1 (Strong Buy).