nani
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| Tue Apr 11, 2006 7:54 pm back to the drawing board |
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Teva, Lundbeck Halt Development Of Oral MS Drug
By Peter Loftus, Of DOW JONES NEWSWIRES
Dow Jones
Teva Pharmaceutical Industries Ltd. (TEVA) and H. Lundbeck A/S (LUN.KO) have halted development of an oral version of a top-selling drug for multiple sclerosis.
Israel-based Teva said in an annual report filed Monday with the Securities and Exchange Commission that the decision was based on results from Phase II studies of an oral version of Copaxone, which is currently sold as an injectable medication.
Teva didn't say what the Phase II results were or elaborate on its reasons for halting the program; a spokesman at its North American unit declined immediate comment.
Lundbeck spokeswoman Caroline Broge said there had been "technical difficulties" in the trial.
Teva is considering future development of Copaxone in various non-injectable formulations, and will make its decision in the context of its entire portfolio of treatments for MS, the company said in its SEC filing.
Copaxone is designed to reduce relapses in people with MS, an auto-immune disease affecting the central nervous system. Copaxone sales were about $1.2 billion in 2005.
Teva has had trouble in past attempts to develop an oral version of Copaxone. One version was tested in a large clinical trial from 2000 to 2002, but the results weren't statistically significant.
In late 2004, Teva and Denmark-based Lundbeck began two pilot Phase II studies with two doses of an oral formulation of Copaxone.
Most other disease-modifying MS treatments are administered either by injection or intravenous infusion. These include one of the newest treatments, Tysabri, which U.S. regulators recently allowed back on the market after it was withdrawn last year amid safety concerns. Tysabri is co-marketed by Biogen Idec Inc. (BIIB), of Cambridge, Mass., and Elan Corp. (ELN) of Ireland.
Other companies including Serono SA (SRA) and Novartis AG (NVS), both of Switzerland, are developing oral versions of MS treatments.
Teva's Nasdaq-traded shares were up 30 cents at $42.83 Tuesday.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com |
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