is getting a second shot at life.
Battered last June when a drug partnership with
went bust, Indevus reported positive, late-stage test results Tuesday for Trospium, an experimental drug to treat overactive bladder.
Based on these results, the company says it hopes to file an approval application with the Food and Drug Administration for Trospium in the second quarter of 2003. If approved, Trospium would be Indevus' first marketed drug in the U.S.
Shares of Indevus jumped 29 cents, or 25%, to $1.45 in early Tuesday trading. The stock, which closed Monday at $1.16, fell to these depressed levels in June, after Pfizer
gave up on a partnership with Indevus to develop the antianxiety drug Pagoclone. Indevus is seeking a new pharmaceutical partner for the drug.
With Pagoclone on the shelf, Indevus' near future became dependent on Trospium. Tuesday, the company said the drug was effective in helping patients reduce the frequency of urination and episodes of incontinence associated with overactive bladder syndrome -- the two primary goals of a 523-patient, phase III clinical study.
"We are extremely pleased that the positive data from this trial met both primary endpoints," said Indevus CEO Glenn Cooper in a statement. "To our knowledge, this is the first clinical trial of a drug to treat
overactive bladder that has achieved both of these important, pre-specified primary endpoints."
Cooper added that the Trospium's safety profile appears to be as good, or better, than competing drugs.
Indevus will submit Trospium to the FDA in the second quarter of 2003, contingent on the outcome of discussions with the agency regarding the drug's stability and manufacturing issues, the company said. Indevus's manufacturing partner for Trospium is currently undergoing an FDA review of its plant to meet U.S. quality standards.
About 17 million Americans, overwhelmingly women, suffer from bladder control problems, which can lead to urinary incontinence, according to the American Urological Association. The market for this condition is expected to reach about $1 billion in 2003, according to Indevus.
Detrol is one of the leading drugs currently used to treat overactive bladder, racking up 2001 sales of $617 million, a 43% increase over 2000 sales.
Trospium is currently marketed in Europe. Indevus licensed U.S. rights to the drug from German drugmaker
, in 1999.