Professional conferences often provide a stage for drug companies to announce results of clinical trials. So it was this week, at the Annual Meeting of the American Academy of Neurology conference of the in Seattle. Teva presented data on its two original drugs for treatment of multiple sclerosis Copaxone and Laquinimod. At the same time, Merck presented data on its treatment for the disease, Cladribine.
As far as Teva's flagship drug Copaxone is concerned, a long term study found that patients using it experienced an improvement in functionality, and that it helps to protect brain tissue from harm in relapsing-remitting multiple sclerosis (RRMS) patients. Annual Copaxone sales amount to $2 billion.
Copaxone is administered by injection, but in collaboration with Active Biotech of Sweden, Teva is also developing an orally ingested drug for multiple sclerosis Laquinimod, which is already in clinical trials. Data presented at the conference indicate that the new drug impacts RRMS by modulating key processes of the immune system.
Laquinimod recently received Fast Track designation from the US Food and Drug Administration (FDA), which may allow the drug to enter the market as soon as late 2011. However, even Fast Track designation will not it seems enable Laquinimod to become the first oral treatment for multiple sclerosis. Merck's Cladribine achived positive results several months ago in Phase III clinical trials.
Merck presented detailed results of the trial at the conference, and on the basis of these results the company plans to apply for marketing approval for the drug in mid-2009 in both the US and Europe. The application is being made by the Merck-Serono division, which also has substantial activity in Israel.
In further news about Teva, the US Supreme Court has dismissed the appeal by Sanofi-Aventis over the cancellation of its patent on blood thinner Lovenox, which has annual sales of $3.6 billion, two thirds of which is in the US. Despite the win by Teva and US company Amphastar in the case, they have still not received FDA approval to distribute their generic versions of the drug.
Published by Globes [online], Israel business news - www.globes.co.il - on April 30, 2009
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