The drug: NV1FGF
The disease: Critical limb ischemia
The companies: Sanofi-Aventis and Vical
Sanofi-Aventis had high hopes for NV1FGF and the Tamaris Phase III study was designed to show that it was better than a placebo in preventing death and disease from critical limb ischemia. More than 500 patients were enrolled to see if investigators could find statistically significant signs that the drug could spur the growth of new blood vessels, helping patients with limbs damaged by embolism or thrombosis.
Vical, which had handed off the development of the drug to Sanofi in a licensing agreement, saw its shares plummet by 32 percent in September. Even Sanofi shares were dinged by the "disappointing" outcome.
When Sanofi stepped in, its researchers had solid mid-stage data in hand indicating that the drug could help prevent the more than 150,000 amputations that occur every year in the U.S. and Europe due to critical limb ischemia. Next months, they'll get a chance to explain what went wrong at the American Heart Association Congress.