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Progenics Pharmaceuticals, Inc.

Partner : Valeant

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Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR
-Agency requests standard three-month extension to review additional solicited information-

-New PDUFA date set for July 19, 2016-

LAVAL, Quebec and TARRYTOWN, N.Y., April 4, 2016 /CNW/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Oral RELISTOR (methylnaltrexone bromide) new drug application (NDA) by three months to July 19, 2016. The FDA extended the action date to allow for a full review of Valeant's responses to recent information requests from the FDA.
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Source: press release, 4/04/16. http://ir.progenics.com/releasedetail.cfm?ReleaseID=963260

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Oral RELISTOR Remains On-track for April 19, 2016 PDUFA. Progenics anticipates an FDA decision April 19, 2016 on the NDA submission for oral RELISTOR. If approved, Progenics would be entitled to a $50 million milestone payment and subsequent sales royalties and commercial milestones from Valeant.
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Source: press release, 3/11/16. http://ir.progenics.com/releasedetail.cfm?ReleaseID=960135

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September 8, 2015
/C O R R E C T I O N -- Valeant Pharmaceuticals International, Inc./
In the news release, Valeant And Progenics Announce FDA Acceptance Of NDA Submission For Oral RELISTOR®, issued 08-Sep-2015 by Valeant Pharmaceuticals International, Inc. over PR Newswire, we are advised by the company that the first paragraph, last sentence, should read "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 19, 2016." rather than "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 16, 2016." as originally issued inadvertently. The complete, corrected release follows:

Valeant And Progenics Announce FDA Acceptance Of NDA Submission For Oral RELISTOR®

LAVAL, Quebec and TARRYTOWN, N.Y., Sept. 8, 2015 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Valeant's New Drug Application for RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 19, 2016.

RELISTOR is a peripherally acting mu-opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation without affecting the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and was approved in 2014 for the treatment of OIC in patients with chronic non-cancer pain.
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Source: press release, 9/08/15. http://ir.progenics.com/releasedetail.cfm?ReleaseID=930553

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September 8, 2015
Valeant And Progenics Announce FDA Acceptance Of NDA Submission For Oral RELISTOR®
LAVAL, Quebec and TARRYTOWN, N.Y., Sept. 8, 2015 /CNW/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Valeant's New Drug Application for RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of April 16, 2016.

RELISTOR is a peripherally acting mu-opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation without affecting the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and was approved in 2014 for the treatment of OIC in patients with chronic non-cancer pain.
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Source: press release, 9/08/15. http://ir.progenics.com/releasedetail.cfm?ReleaseID=930457

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June 23, 2015

Valeant and Progenics Announce the Submission of U.S. New Drug Application for Oral RELISTOR®

LAVAL, Quebec and TARRYTOWN, N.Y., June 23, 2015 /CNW/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that Valeant submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

RELISTOR is a peripherally acting mu-opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation without affecting the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and was approved in 2014 for the treatment of OIC in patients with chronic non-cancer pain.
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Source: press release, 6/23/15. http://ir.progenics.com/releasedetail.cfm?ReleaseID=919083

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Mark R. Baker, Chief Executive Officer, commented on the regulatory outlook for the Oral Relistor product. He stated, "Our marketing partner, Salix, was just acquired by Valeant in April. To date, we have been impressed with Valeant's commitment to this franchise, and we look forward to having them as a partner in marketing to the broader chronic pain indication received in the U.S. last September and to working with them as we approach the filing, potential approval and commercial launch for oral Relistor. Valeant recently reported that they are creating a new pain sales force, which will promote Relistor in addition to some other Valeant products to the pain specialist market, offering additional support to this product. In addition, in our conversations with Valeant, they have reiterated that they intend to file an NDA for the oral formulation midyear, so we are confident and optimistic in the upside potential for this program."
Source: Q1 2015 earnings conference call, 5/06/15.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Relistor Methylnaltrexone (Oral) OIC CPGastroenterologyOpioid induced constipation (chronic pain)Opioid receptor modulatormu-opioid receptors peripheral

Mechanism of action: Relistor Methylnaltrexone (Sq), a SM-inhibitor, relieves the side effects associated with prolonged opioid exposure by blocking peripheral mu-opioid receptors with a methylated (unable to cross the BBB) version of the known opioid receptor antagonist naltrexone.

Phase of Development: III

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-07-19

Results:

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July 19, 2016
Valeant and Progenics Announce FDA Approves RELISTOR® Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-cancer Pain
Sales of RELISTOR tablets are expected to commence in the Third Quarter 2016
LAVAL, Quebec and TARRYTOWN, N.Y., July 19, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration has approved RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Valeant expects to commence sales of RELISTOR Tablets in the U.S. in the third quarter of 2016.

"Opioid-induced constipation represents a long-lasting and potentially debilitating side effect of opioid therapy for millions of patients suffering from chronic pain," commented Joseph C. Papa, Chief Executive Officer of Valeant. "We believe Oral RELISTOR represents a new alternative treatment for OIC, and we look forward to introducing the more convenient oral formulation as soon as practicable."

"We are delighted that this milestone for RELISTOR has been achieved, and that patients suffering from OIC will have this new treatment option," said Mark Baker, Chief Executive Officer of Progenics. "We expect the market to be receptive to a more convenient oral tablet formulation of RELISTOR's well-established subcutaneous preparation. We would like to thank, in particular, Dr. Tage Ramakrishna and Dr. Robert Israel of Valeant for their work over many years in the clinical development of RELISTOR."

"RELISTOR has a unique mechanism of action that binds to mu-opioid receptors without impacting the opioid-mediated analgesic effects on the central nervous system," said Richard L. Rauck, MD, Medical Director, Center for Clinical Research, President, Carolinas Pain Institute, President of the Sceptor Pain Foundation of which he is a founding member, and Immediate Past President of the World Institute of Pain. "This represents a true breakthrough in the treatment of OIC, and addresses a large and growing need in the field of pain management."

Today, the FDA approved RELISTOR Tablets (450 mg once daily) for the treatment of OIC in adults with chronic non-cancer pain. Previously, RELISTOR Subcutaneous Injection (12 mg and 8 mg) was approved in 2008 for the treatment of OIC in adults with advanced illness who are receiving palliative care and in 2014 for the treatment of OIC in adults with chronic non-cancer pain.
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Source: press release, 7/19/16. http://ir.progenics.com/releasedetail.cfm?ReleaseID=980238

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