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TARRYTOWN, N.Y., July 14, 2014 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) chief executive officer Mark Baker will comment on the FDA's Relistor
® Appeal Response in a
conference call this morning, Monday, July 14, at 8:30 a.m. Eastern Time.
More information concerning the Appeal Response is available in the joint press release issued this morning with the Company's collaboration partner, Salix Pharmaceuticals (Nasdaq:SLXP).
To participate in the call, please dial (877) 250-8889 (domestic) or (720) 545-0001 (international) and reference conference ID 74147589. A live webcast will be available on the Media Center of the Progenics website,
www.progenics.com, and a replay will be available there for two weeks.
Progenics has exclusively licensed development and commercialization rights for its first commercial product, Relistor, to Salix Pharmaceuticals, Ltd. Relistor (methylnaltrexone bromide) subcutaneous injection is a first-in-class treatment for opioid-induced constipation approved in more than 50 countries for patients with advanced illness.
Important Safety Information for subcutaneous Relistor
Relistor is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of Relistor beyond four months has not been studied.
Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with Relistor and consult their physician. Use of Relistor has not been studied in patients with peritoneal catheters.
Safety and efficacy of Relistor have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).