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Teva, Lundbeck stop oral MS drug Copaxone development
Jerusalem | Thursday, March 23, 2006, 08:00 Hrs  [IST]

Teva Pharmaceutical Industries has halted development of an oral version of its popular multiple sclerosis drug Copaxone.

Teva and its partner, Denmark's Lundbeck A/S began Phase II clinical trials of oral Copaxone in late 2004 but results have never lived up to its expectations, report says.

"Nevertheless, Teva is considering future development of Copaxone in various non-parenteral formulations and will make its decision in the context of its entire MS portfolio," the company said in the SEC filing.

Teva began clinical trials of oral Copaxone in 2000 but the results were not "statistically significant," the company said.

Laquinimod is currently in Phase II trials. Teva said in its SEC filing that the trial has shown a 0.3 mg daily dose of the drug "is well tolerated and effective in surpressing development of active MRI lesions in patients with relapsing MS."

More updated results are expected later in 2006, while analysts believe the drug should be ready for a market launch in late 2009 to early 2010 along with six or seven other MS treatments slated to hit the market starting in late 2008.

In the meantime, Teva's injectible version of Copaxone has become very popular. Copaxone had sales of $1.18 billion in 2005, of which $782 million were in the United States where Copaxone increased its market share to more than 34 percent of new prescriptions, Teva said citing IMS data.

Sales of Copaxone grew 26 percent globally in 2005. Copaxone is co-marketed by Sanofi-Aventis.

Copaxone competes with MS treatments from Switzerland's Serono, Biogen and Germany's Schering AG.

Teva and Lundbeck are also collaborating on a treatment for Parkinson's disease called Azilect. The drug has been launched in Europe but it has not yet received US regulatory approval. Teva has said it was working with the US Food and Drug Administration to resolve outstanding issues, the report added.

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