GenVec Inc. (Nasdaq: GNVC) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to TNFerade, GenVec’s newest and most promising anti-cancer drug for the treatment of pancreatic cancer.
The FDA grants orphan drug designation to drugs that could possibly provide a significant therapeutic advantage over existing treatments, and specifically target conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug designation allows the development company potential financial and regulatory incentives including various favorable grants and credits such as, study design assistance, waiver of FDA user fees, tax credits, and up to seven years of market exclusivity, contingent upon marketing approval.
The company said it the agency’s decision is a significant development with several market advantages.
“Orphan drug designation is a critical step for the development of TNFerade and will strengthen the TNFerade program at GenVec by offering potential clinical development and commercialization benefits,” Dr. Paul Fischer, GenVec’s president and CEO stated in the press release.
TNFerade has also been granted Fast Track product designation by the FDA for its proposed use in the treatment of locally advanced pancreatic cancer.
Upon hearing the news investors plunged into GenVec shares, driving the share price up more than $.20 per share, or almost 20%, to an intra-day high of $1.01.
Popularity: unranked [?]
