There's a big sigh of relief coming from Wyeth and Progenics today as the FDA approved Relistor, a subcutaneous injection for opioid-induced constipation in patients with advanced illness who are receiving palliative care. Back in January the FDA added an additional three months of review time so that it could study the drug's side effects. Though European regulators gave a thumbs up to the drug on Thursday, some U.S. analysts doubted Relistor would gain FDA approval. The FDA came through though, and Progenics' stock shot up on the news. The approval triggers a $15 million milestone payment from Wyeth.
"The approval of Relistor is a transformative event for Progenics Pharmaceuticals," says Paul J. Maddon, CEO of Progenics. "This is our first U.S. product approval.
- see the release on Relistor [1]
- read TheStreet report [2]
Related Articles:
FDA wants time to ponder Progenics, Wyeth drug [3]
Wyeth, Progenics drug gets fast-tracked [4]
Wyeth stumbles badly trying to develop new drugs [5]
Links:
[1] http://www.fiercebiotech.com/press-releases/progenics-and-wyeth-announce-fda-has-approved-relistor
[2] http://www.thestreet.com/s/fdas-ok-of-relistor-bodes-well-for-progenics/newsanalysis/biotech/10413740.html?puc=googlefi&cm_ven=GOOGLEFI&cm_cat=FREE&cm_ite=NA
[3] http://www.fiercebiotech.com/story/fda-wants-time-ponder-progenics-wyeth-drug/2008-01-10?utm_medium=rss&utm_source=rss
[4] http://www.fiercebiotech.com/story/spotlight-wyeth-progenics-drug-gets-fast-tracked/2006-07-17
[5] http://www.fiercebiotech.com/story/wyeth-stumbles-badly-trying-develop-new-drugs/2007-08-13