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.
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