Patients Enrolled for Teva Study - Analyst Blog
June 03 2011 - 11:15AM
Zacks
Teva Pharmaceutical Industries Ltd. (TEVA)
recently finished enrolling patients for the GALA (Glatiramer
Acetate Low-frequency Administration) study which is being
conducted with Copaxone.
The phase III study is being conducted to evaluate the efficacy,
safety and tolerability of a 40mg dosage (thrice-weekly) of
Copaxone compared to placebo in relapsing-remitting multiple
sclerosis (RRMS) patients.
More than 1,400 patients have been recruited for the study,
whose primary endpoint is the total number of confirmed relapses
during a 12-month placebo-controlled phase. The study design
includes an open-label extension phase which will commence
following the 12-month placebo-controlled phase.
Copaxone, which is Teva’s lead branded product, is currently
available in a 20mg formulation which is injected daily. It is
approved for the treatment of RRMS and for patients presenting with
clinically isolated syndrome (CIS).
However, the product faces intense competition in the multiple
sclerosis market. Moreover, Copaxone could face generic competition
as companies like Sandoz, Momenta Pharmaceuticals
(MNTA), and Mylan (MYL) are all seeking to bring
their generic versions of Copaxone to market. With Copaxone
contributing 20.5% to total revenues in 2010, the earlier than
expected entry of generic versions of Copaxone would be a major
setback for Teva.
Teva is looking to drive growth for Copaxone by expanding the
label. Results from the GALA study should be out in the second
quarter of 2012. Positive data could result in the thrice-weekly
formulation entering the market in mid to late 2013.
Neutral on Teva
We currently have a Neutral recommendation on Teva, which
carries a Zacks #3 Rank (short-term Hold rating). Teva’s upcoming
acquisition of Cephalon, Inc. (CEPH) should help
the company expand and strengthen its branded and specialty pharma
business.
CEPHALON INC (CEPH): Free Stock Analysis Report
MOMENTA PHARMA (MNTA): Free Stock Analysis Report
MYLAN INC (MYL): Free Stock Analysis Report
TEVA PHARM ADR (TEVA): Free Stock Analysis Report
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