In a surprising turn of events, Shire ($SHPGY) announced late yesterday it is jerking its application for Replagal, the rare genetic disorder drug the FDA had pushed to get on the market as Genzyme sorted out its high-profile manufacturing problems. The reason for the sudden reversal? The FDA is indicating the need for new clinical studies before it stamps an OK on the Fabry disease treatment. And that put any approval off to "the distant future," the company said.
The news was a big reversal for Shire, which had submitted a BLA last fall after the agency had repeatedly encouraged it to push ahead. It's also a clear boost for Sanofi ($SNY), which acquired Genzyme and recently announced its FDA-approved Fabrazyme was once again fully available after a new plant in Framingham, MA, had begun to produce new supplies.
"Shire has had a close partnership with the global Fabry patient community for over 10 years, and we are extremely disappointed that we feel compelled to make this decision," said Sylvie Grégoire, the president of Shire HGT.
Welford analysts called the move "a surprise setback for Shire," according to Bloomberg. A new trial, they added, "would take at least two years and is probably not economically justifiable."
- check out Shire's release
- here's the story from Bloomberg