Teva Pharmaceutical Industries Ltd.
) recently received good news on the Copaxone front with the US
District Court for the Southern District of New York ruling in the
company's favor in its patent infringement lawsuit. Teva had filed
a patent infringement lawsuit against
Momenta Pharmaceuticals, Inc
)/Sandoz Inc. and
)/Natco Pharmaceuticals, who were looking to launch their generic
versions of Copaxone.
Copaxone is approved for the reduction of the frequency of
relapses in relapsing-remitting multiple sclerosis (RRMS),
including patients who have experienced a first clinical episode
and have MRI features consistent with multiple sclerosis.
The court ruled that the claims made by Momenta/Sandoz and
Mylan/Natco about the Copaxone patents being invalid and
unenforceable were unfounded. Moreover, the court ruled that the
generic versions for which the companies were seeking Food and Drug
Administration (FDA) approval would infringe the Copaxone
Impact of the Ruling
With this ruling, Copaxone should be protected from generic
competition in the US until May 24, 2014, when the Orange Book
patents are scheduled to expire. Teva believes that the protection
could extend up to September 1, 2015, when the process patent is
slated to expire.
The favorable ruling is a major positive for Teva. With Copaxone
contributing 19.5% to total revenues in 2011, the
earlier-than-expected entry of generic versions of Copaxone would
have been a major setback for the company. Teva can now focus on
extending Copaxone's life cycle.
The company recently announced positive top-line results on
Copaxone from a phase III study, GALA, which was conducted to
evaluate the efficacy, safety and tolerability of Copaxone (40mg)
administered thrice a week compared to placebo in patients with
RRMS. The 40mg dose being evaluated in the GALA study is a higher
strength compared to the 20mg dose currently available (daily
injection). Results showed that Copaxone 40mg significantly
reduced disease activity. The safety and tolerability profile was
also found to be favorable.
The positive ruling has removed a major overhang on the shares.
We currently have a Neutral recommendation on Teva, which carries a
Zacks #3 Rank (short-term 'Hold' rating).
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