Teva Pharmaceutical Industries suffered a blow in its attempt to enter the Alzheimer's treatment market in the United Statesy. The U.S. Food and Drug Administration ruled yesterday that Indian drug company Ranbaxy had 180-day exclusive rights to sell its generic version of Aricept, an Alzheimer's treatment originally made by the Japanese pharmaceutical firm Eisai.
The patents on Aricept expire on November 25. Teva's request to market its own generic version was reclassified by the FDA from "approved" to "tentatively approved," meaning it will only be able to compete 180 days after Ranbaxy's launch.
The worldwide market for Aricept was $3.2 billion in the last 12 months, $1.9 billion of which was in the U.S.
Analysts expect he exclusivity period to be worth some $300 million in profit to Ranbaxy.
Teva shares rose 1.8% in Tel Aviv yesterday.
In other Teva news, the company reported positive findings Monday after completing the extension phase of its 36-week clinical trials for Laquinimod, its oral treatment for multiple sclerosis.
The test results were released just one day before the U.S. Food and Drug Administration was expected to announce Novartis' Gilenia drug had been approved for use, which would make it the first orally-administered multiple sclerosis treatment available.
Patients who received placebos in the first phase of trials were split randomly into two groups, and given 0.3 milligram or 0.6 milligram doses of the drug, Teva said.
Patients who had been receiving Laquinimod from the start continued to do so throughout the 36-week extension phase.
According to Teva, patients who received a placebo in the first phase and Laquinimod in the second experienced an average decrease of 52% in the number of brain lesions - an indicator of the disease's activity level - while patients who got the drug throughout both phases of the tests maintained the reduction in the disease's activity.
Milan's San Raffaele University neurological department chief Professor Giancarlo Comi, who led the trial, said the findings substantiate the claim that the drug provides a balance of efficiency, safety and passivity. Results from the drug's third and decisive clinical testing stage will become known in 2011, he added.
Laquinimod was fast-tracked by the FDA in February 2009. Teva already has completed recruiting participants for the two global studies to be performed in the final phase of testing.
The drug is an experimental immunomodulator.
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