The safety profile of Teva Pharmaceutical Industries Ltd's (Nasdaq: TEVA; TASE: TEVA) intravenous treatment for multiple sclerosis, Copaxone, is again center stage, after Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) announced that a US patient died after starting a regime of its oral treatment Gilenya. Novartis is investigating the case, and Novartis spokesman Eric Althoff said that whether Gilenya played a role in the patient’s death could not be excluded or confirmed.
Novartis launched European sales of Gilenya in March, and sales have totaled €480 million to date. The US Food and Drug Administration (FDA) approved Gilenya in 2010. At the launch, some analysts feared that it would win substantial market share from Copaxone, fears which have not yet materialized.
Althoff said that the death of the patient, a 59-year old American who had had multiple sclerosis for ten years, was the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug. The death occurred on November 23, a day after starting the regime, and successfully completed six hours of post-dose observation without incident. Since Gilenya slows the heart rate, the death could be cardiovascular in nature.
Novartis said that it was working with the FDA on the case and had provided findings from the initial tests.
Teva's rose 2.2% by early afternoon to NIS 154.40, after rising 1.1% on Nasdaq yesterday to $40.66, giving a market cap of $36 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on December 13, 2011
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