Gilead Sciences, Inc.
) recently settled its dispute with
Teva Pharmaceutical Industries Limited
) regarding the former's antiviral drug Viread. Viread is
marketed for treating HIV infection as well as chronic hepatitis
B. Following the agreement, Teva can launch its generic version
of Viread on Dec 15, 2017.
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We remind investors that Gilead received a notice in Jan 2010
that Teva had filed an Abbreviated New Drug Application (ANDA)
with the US Food and Drug Administration (FDA), seeking to market
a generic version of Viread. Gilead challenged the application in
By filing the patent infringement lawsuit, within the required
45-day period, Gilead ensured a 30-month stay. The stay
prevented the FDA from clearing Teva's ANDA during that time
period under the Hatch Waxman Act. The 30-month stay came to an
end in Jul 2012.
However, due to the court's scheduling orders, Teva was
prohibited from launching at risk its generic version of Viread
following the expiry of the 30-month stay. With the settlement
agreement being announced, the trial, which was scheduled to
commence on Feb 20, 2013 in the US, was adjourned. We are
positive on Gilead's settlement of its dispute with Teva since
Viread is one of the key drugs in the former's product portfolio.
We note that apart from its settlement with Teva, Gilead was in
the news recently when it presented encouraging phase III data on
its chronic hepatitis C virus (HCV) candidate sofosbuvir. Gilead
intends to seek regulatory approvals for the candidate in the US
and EU in the second quarter of 2013.
Successful development of sofosbuvir would not only boost
Gilead's top line, but also would strengthen its position in the
lucrative HCV market. A huge population suffers from HCV
infection across the world. However, the treated population is
Gilead, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Biopharma stocks, which are presently well
). Both stocks carry a Zacks Rank #2.