Relistor is expected to reach the market by early June.
FDA gave Progenics Pharmaceuticals and Wyeth Pharmaceuticals the go-ahead to market Relistor™ for opioid-induced constipation. Under the agreement established between the companies in December 2005, Progenics will receive $15 million.
Progenics’ board approved a share-repurchase program to acquire up to $15 million of its outstanding common shares using this milestone fee. The company’s stock jumped 26.79% to open trading today at $13.44.
The drug, which should be available in the U.S. by early June, according to Wyeth, represents Progenics’ first U.S. approval. The subcutaneous injection may be used in patients with advanced illness when response to laxative therapy has not been sufficient.
Wyeth owns the worldwide rights to the therapy, while Progenics retains an option to copromote the product in the U.S. Wyeth will pay royalties on worldwide sales and copromotion fees within the U.S.
Wyeth notes that this is its third new drug that the FDA has sanctioned this year. In January the company reported U.S. launch of a generic version of Protonix, its own GERD therapy. A month later, the firm won two approvals: Xyntha for hemophilia A and Pristiq for major depressive disorder.
Relistor has already obtained Canadian marketing approval. Additionally, the European Committee for Medicinal Products for Human Use gave the treatment a positive opinion as well.
Relistor is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain, the companies explain.
