SAN FRANCISCO, June 11, 2014 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR), a biopharmaceutical company developing novel pain and cancer therapeutics, today announced that NASDAQ has halted trading of the company's common stock.
The U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) is meeting on June 11-12, 2014 to discuss potential cardiovascular risk associated with peripherally-acting opioid receptor antagonists which includes MOVANTIK TM (naloxegol oxalate), an investigational treatment for opioid-induced constipation (OIC). The AADPAC will consider the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class for the proposed indication of opioid-induced constipation in patients taking opioids for chronic pain.
The AADPAC meeting is scheduled for 8:00 a.m. ET. The briefing materials can be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm390304.htm.
MOVANTIK is being developed by Nektar partner AstraZeneca. The Prescription Drug User Fee Act (PDUFA) date set by the FDA for MOVANTIK is September 16, 2014. MOVANTIK is also under regulatory review with health agencies in the European Union and Canada.The FDA is not required to follow the guidance of an advisory committee when rendering its final decisions on pending applications and other public health matters. About Nektar Nektar Therapeutics has a robust R&D pipeline of potentially high-value therapeutics in pain, oncology and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for MOVANTIK, an investigational drug candidate, which has been filed for regulatory approvals in the U.S., Europe and Canada as a once-daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of MOVANTIK and an opioid. NKTR-181, a novel mu-opioid analgesic molecule for chronic pain conditions, has completed Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-171, a 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 and is also in Phase 2 studies for the treatment of ovarian, colorectal, lung and brain cancers. 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. Additional late-stage development candidates that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a longer-acting PEGylated rFVIII therapeutic, which is in Phase 3 clinical development for patients with hemophilia A. Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including 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. Cautionary Note Regarding Forward-Looking Statements
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