Full Press Release Details
SAN FRANCISCO , Sept. 26, 2014 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR ) reported today that partner AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of MOVENTIG® (naloxegol) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives. MOVENTIG is an investigational, peripherally-acting mu-opioid receptor antagonist (PAMORA).
OIC is a condition caused by prescription opioid pain medicines. Opioids work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC.
The positive opinion was reached after a review of comprehensive data from the KODIAC clinical program, which was comprised of four studies assessing the safety and efficacy of MOVENTIG.
Today's announcement follows the approval on September 16, 2014 , of MOVANTIK™ (naloxegol) tablets by the U.S. Food and Drug Administration (FDA) as the first once-daily PAMORA for the treatment of OIC in adult patients with chronic non-cancer pain.
About MOVENTIG® (naloxegol) MOVENTIG is an investigational PAMORA specifically designed for the treatment of OIC in adult patients on prescription opioid pain medicines. In Phase III clinical studies, MOVENTIG was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal (GI) tract.
The KODIAC clinical program was comprised of KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were identically-designed, placebo-controlled, double-blind, 12-week studies assessing safety and efficacy. KODIAC-7 was a 12-week safety extension to KODIAC-4, and KODIAC-8 was a 52-week long-term safety study.
MOVENTIG is part of the exclusive worldwide licence agreement announced on September 21, 2009 , between AstraZeneca and Nektar Therapeutics. MOVENTIG was developed using Nektar's oral small molecule polymer conjugate technology.
About Nektar Nektar Therapeutics has a robust R&D pipeline of potentially high-value therapeutics in pain, oncology, hemophilia and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for MOVANTIK TM , the first FDA-approved once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. The AstraZeneca agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of MOVANTIK and an opioid. NKTR-181, a wholly-owned mu-opioid analgesic molecule for chronic pain conditions, has completed Phase 2 development. NKTR-171, a wholly-owned new sodium channel blocker being developed as an oral therapy for the treatment of peripheral neuropathic pain, is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer. In hemophilia, BAX 855, a longer-acting PEGylated Factor VIII therapeutic is in Phase 3 development conducted by partner Baxter . In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia.
Nektar's technology has enabled nine approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including AstraZeneca's MOVANTIK, UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia.
Nektar is headquartered in San Francisco, California , with additional operations in Huntsville, Alabama and Hyderabad, India . Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com .
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Contact: INVESTORS Jennifer Ruddock of Nektar Therapeutics 415-482-5585
MEDIA: Nadia Hasan of WCG Group 212-257-6738
SOURCE Nektar Therapeutics