Good news flowed in for
Gilead Sciences, Inc.
) from Europe as the European Commission cleared the company's
potential blockbuster drug Sovaldi (sofosbuvir) as a combination
therapy for treating adults suffering from chronic hepatitis C
virus (HCV), a major cause of liver cancer and liver
transplantation in Europe. The approval of the all-oral HCV
treatment in the EU with a broad label does not surprise us as
its clearance was recommended by the European Medicines Agency's
(EMA) Committee for Medicinal Products for Human Use (CHMP) in
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Gilead gained the European approval for Sovaldi on the basis of
encouraging data from four phase III studies - NEUTRINO, FISSION,
POSITRON and FUSION. Gilead had submitted the marketing
application to the EMA in April last year. Moreover, the EMA also
considered data from two other phase III studies (VALENCE and
PHOTON-1) while assessing the application on an accelerated
The approval of Sovaldi is a big positive for HCV patients as it
would not only bring down the duration of therapy to a minimum of
12 weeks but also eliminate/reduce the duration of peg-IFN
injections depending on the genotype of the disease. Currently,
HCV therapy includes up to 48 weeks of treatment with a regimen
inclusive of injectable peg-IFN. Moreover, the current standard
of care comes with several side effects, which make it difficult
for patients to remain on treatment.
The EC cleared the drug as an all-oral therapy for treating
patients affected with genotypes 1, 2, 3, 4, 5 or 6 of the virus.
Sovaldi in combination with ribavirin can also be used to treat
chronic HCV patients awaiting liver transplantation to prevent
the recurrence of the virus after transplant.
The European approval of Sovaldi would not only boost Gilead's
top line but also strengthen its position in the lucrative HCV
market. Approximately 9 million people are estimated to be
affected by chronic HCV in Europe alone. However, the treated
population is much lower. This leaves the field open for new
treatments. We expect uptake in Sovaldi sales to be rapid, given
its broad label and the pent-up demand for new HCV therapies.
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.
Sovaldi is also approved in the U.S. and Canada. Gilead is also
seeking approval of the drug in countries such as Australia, New
Zealand, Switzerland and Turkey.
Many companies are targeting the lucrative HCV market.
Johnson & Johnson
) Olysio in combination with peg-IFN and ribavirin for treating
chronic HCV patients was cleared in the U.S. late last year.
Moreover, companies such as
Bristol-Myers Squibb Company
) are developing therapies to combat HCV.
Gilead, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). A better-ranked stock in the biopharma space includes
), which carries a Zacks Rank #1 (Strong Buy).