Teva begins new double-dose Copaxone trial

Teva expects results from the trial in the second quarter of 2012.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has completed patient enrollment in a new international Phase III clinical trial of its 40mg dosage of Copaxone for the treatment of multiple sclerosis - double the 20 mg dosage currently marketed. The trial will include over 1,400 patients at 180 sites in the US, Europe, and Israel. Teva expects results from the trial in the second quarter of 2012.

The GALA (Glatiramer Acetate Low-frequency Administration) trial will examine the efficacy, safety and tolerability of the drug when administered three times a week compared with a placebo. The trial's primary endpoint is the total number of confirmed relapses during a 12-month placebo-controlled phase, which will be followed by an open-label extension phase.

Teva said that Copaxone was currently approved in over 50 countries worldwide, and has a global market share of 31%. It is Teva's leading product with over $3 billion in annual sales, and reportedly accounts for a third of the company's net profit.

Investors are worried about a decline in Copaxone's standing due to the introduction of generic versions of the drug and oral treatments for multiple sclerosis, and have driven Teva's share price down sharply in recent months. Teva actions to reduce its dependency on Copaxone, including the acquisition of Cephalon Inc. (Nasdaq: CEPH) and a joint venture with Proctor & Gamble (NYSE: PG) have been favorably received, and the share price has been climbing.

Teva's share price rose 0.4% in premarket trading on Nasdaq today to $50.18, giving a market cap of $47 billion, but it fell 1.6% on the TASE to NIS 170.

Published by Globes [online], Israel business news - www.globes-online.com - on June 2, 2011

© Copyright of Globes Publisher Itonut (1983) Ltd. 2011

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