On July 26, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported that it has received a $50 million milestone payment from its worldwide collaboration partner, Valeant Pharmaceuticals International, Inc. (NYSE:VRX), resulting from the US Food and Drug Administration’s marketing approval last week of RELISTOR Tablets for the treatment of opioid-induced constipation in adults with chronic non-cancer pain (Press release, Progenics Pharmaceuticals, JUL 26, 2016, View Source [SID:1234514031]).

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"We are pleased that our partner Valeant can now offer RELISTOR in a more convenient tablet form to patients in need," said Mark Baker, Chief Executive Officer of Progenics. "This and other sales milestone payments that we may receive from sales of RELISTOR provide an important source of non-dilutive financing for our Company as we approach topline, registrational data on AZEDRA and advance our diverse pipeline of prostate cancer imaging agents and therapeutics."

Under a 2011 collaboration with Salix Pharmaceuticals, Inc. (acquired by Valeant in April 2015), Progenics is also entitled to receive up to $200 million of sales milestone payments based on specified U.S. sales targets. The sales milestone payments range from $10 million when calendar-year U.S. net sales first exceed $100 million, to $75 million when such sales first exceed $1 billion. Each sales milestone payment is payable one time only, and one or more, or all, sales milestones could become payable within the same calendar year if the specified sales levels are met. Progenics also earns tiered royalties on total RELISTOR U.S. net sales, as follows: 15% on U.S. net sales up to $100 million, 17% on the next $400 million in U.S. net sales, and 19% on U.S. net sales over $500 million. Outside of the U.S. Progenics is entitled to receive 60% of any up-front milestone, royalty and other revenue, net of certain costs, as specified in our license agreement with Valeant.

About RELISTOR

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant. RELISTOR Tablets (450 mg once daily) is approved in the United States for the treatment of OIC in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for opioid-induced constipation approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.

Important Safety Information about RELISTOR

RELISTOR (methylnaltrexone bromide) Tablets is contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

Cases of gastrointestinal perforation have been reported in adult patients with OIC and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR.

Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia. Take into account the overall risk-benefit profile when using RELISTOR in such patients. Monitor for adequacy of analgesia and symptoms of opioid withdrawal in such patients.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The most common adverse reactions (≥ 12%) in adult patients with opioid-induced constipation and chronic non-cancer pain receiving RELISTOR tablets were abdominal pain, diarrhea, headaches, abdominal distention, hyperhidrosis, anxiety, muscle spasms, rhinorrhea, and chills. Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal.

Please see complete Prescribing Information for RELISTOR at valeant.com. For more information about RELISTOR, please visit www.relistor.com.