Pipeline updates are highly awaited events in the
pharma/biotech sector as they play an important role in deciding
whether or not to invest in a particular company. These updates
provide information on experimental drugs and sometimes give an
insight into the commercial potential of the candidate once it is
successfully developed and commercialized.
Earlier this week,
Gilead Sciences, Inc.
) announced that Health Canada has issued a Notice of Compliance
for its chronic hepatitis C virus (HCV) drug, Sovaldi. In May
this year, Sovaldi's marketing authorization application was
submitted in Canada for the treatment of adults suffering from
compensated liver diseases like cirrhosis. The indication also
includes treatment of genotype 1 or 4 chronic hepatitis C (CHC)
infection in combination with pegylated interferon and ribavirin
and also genotype 2 or 3 CHC in combination with ribavirin.
Sovaldi is currently going through a reimbursement review process
in Canada. Gilead expects to launch the drug in Canada early next
Current HCV therapy in Canada includes treatments of up to 48
weeks with a pegylated interferon/ribavirin-containing regimen.
Sovaldi's approval will bring down the duration of therapy to a
minimum of 12 weeks. Approximately 250K people are estimated to
be affected by chronic HCV in Canada alone.
The Notice of Compliance from the Canadian health authority came
shortly after Gilead gained U.S. 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.
Sovaldi is an important product not only for Gilead but also for
HCV patients who have postponed treatment as they await the
launch of a better therapy. 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
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).
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