UPDATE 1-Sirtris: FDA grants orphan status for red-wine compound
Wed Apr 2, 2008 9:50am EDT
April 2 (Reuters) - Sirtris Pharmaceuticals Inc (SIRT.O: Quote, Profile, Research) said the U.S. health regulators granted orphan drug status for resveratrol, a compound derived from red wine, to treat a fatal muscular disorder.
The biopharmaceutical company uses resveratrol to develop drugs to treat diseases related to aging. Resveratrol has been shown in several studies to prolong the life of mice and reduce the advance of age-related disease.
Sirtris' formulation of resveratrol, SRT501, is currently in an early-stage trial for MELAS syndrome and targets SIRT1, a gene tied to the aging process and improved mitochondrial function.
MELAS syndrome is a progressive muscular disorder caused by DNA mutations in mitochondria, the parts of cells which supply energy.
Early symptoms of MELAS syndrome include muscle weakness and fatigue. As the disease progresses, patients can suffer from seizures, dementia and impaired muscular function.
Orphan drug designation for resveratrol in MELAS syndrome would provide the company with seven years of marketing exclusivity upon approval for the indication.
Sirtris said it plans to seek orphan drug status, which is given to drugs that have the potential to treat rare diseases, for SRT501 in Europe.
Shares of Sirtris were down more than 5 percent at $13.15 in early morning trade on Nasdaq, after opening higher at $14.15. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)