Progenics Gets $40M Milestone on FDA Approval of Relistor

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The approval of Relistor (a subcutaneous injection for the treatment of opioid induced constipation in patients with chronic non-cancer pain) by the FDA last week, triggered a $40 million milestone payment in favor of Progenics Pharmaceuticals, Inc. (PGNX) from partner, Salix Pharmaceuticals, Inc. (SLXP).

Progenics’ association with Salix goes back to 2011 when the companies had entered into a license agreement for the development and commercialization of Relistor. As per the deal, Progenics is entitled to receive commercialization milestone payments of up to $200 million. The company is also eligible to receive up to $50 million upon U.S. approval of an oral formulation of Relistor. Under the deal, Progenics is also entitled to 60% of revenues earned by Salix from ex-U.S. sublicensees of Relistor.

Relistor is already approved in the U.S. for the treatment of OIC in patients with advanced illness who are under palliative care, when response to laxative therapy has not been sufficient. Relistor is also approved in several countries around the globe, including the EU, for the same indication.

Meanwhile, Progenics is working with Salix to seek regulatory approval for an oral formulation of the drug, which has already completed a phase III study.

We are pleased with the company’s progress with its pipeline. Late last month, Progenics reported positive long-term follow-up data from a pivotal phase II study on its ultra-orphan radio-therapeutic candidate, Azedra, in patients suffering from malignant pheochromocytoma.

We expect investor focus to remain on the commercialization of Relistor for the recently approved indication.

Progenics currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Actavis plc (ACT) and Mallinckrodt plc (MNK). Both hold a Zacks Rank #1 (Strong Buy).

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