Teva-Active Biotech Start Phase II on MS Drug - Analyst Blog

Teva Pharmaceutical Industries Ltd. TEVA and Active Biotech announced that they have started patient enrollment in a multinational, multi-center, randomized, double-blind, parallel-group, placebo-controlled phase II study on its once-daily, oral candidate laquinimod for the treatment of primary progressive multiple sclerosis (PPMS).

The primary endpoint of the study (A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes (ARPEGGIO)) is to measure the percentage of brain volume change in the patients through MRI analysis.

Teva will present additional details on the study design at the AAN Annual Meeting to be held in Washington D.C. on Apr 23, 2015.

According to the company, PPMS affects nearly 15% of all patients suffering from multiple sclerosis. Given that no drug has yet been approved for the treatment of this disease, there is significant unmet need in the market for PPMS.

We note that Teva is currently going through a rough patch following the recent FDA approval of Momenta MNTA/Novartis’ NVS generic version of Teva’s Copaxone (20 mg/mL daily). In order to boost its multiple sclerosis franchise, Teva has to successfully develop and commercialize new products. Copaxone is approved for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis (RRMS).

In order to solidify its position in the market for multiple sclerosis Teva is working on shifting patients from the daily formulation of Copaxone (20 mg/ml) to a higher dose three-times-a-week version of the drug. Earlier this week, Teva presented new 36-month data from a study evaluating the efficacy and safety of three-times-a-week Copaxone (40 mg/mL) in patients suffering from RRMS. Results showed that patients benefited from an early beginning of treatment with the three-times-a-week Copaxone.

Copaxone (40 mg/mL), which is already commercially available in the U.S. since Jan 2014, is expected to be launched in select European countries through 2015.

Teva carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Mallinckrodt plc MNK, carrying a Zacks Rank #1 (Strong Buy). Momenta holds a Zacks Rank #2 (Buy).


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