Nektar Therapeutics (NKTR) announced that most of the members of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) have recommended that no cardiovascular outcomes study is required for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes Movantik (naloxegol oxalate).
Movantik is being developed for the treatment of opioid-induced constipation (OIC) for patients suffering from chronic non-cancer pain. The committee however suggested that post-approval cardiovascular safety data collection for this class of candidates will continue.
The favorable voting comes as a huge relief for Nektar. Additional cardiovascular outcomes studies would have significantly spiked the company’s research and development expenses. We note that Nektar’s stock trading was halted yesterday before the advisory committee meeting. We expect the news to positively impact Nektar’s shares.
Nektar has a worldwide licence agreement with AstraZeneca (AZN) for Movantik. Movantik is under review in the U.S. for the chronic non-cancer pain indication. A final decision from the FDA on the approval of Movantik is expected by Sep 16, 2014. We note that although the FDA is not bound to follow the advisory committee’s opinion, but it generally does so. Movantik is also under review in the EU and Canada for the same indication.
Nektar also has NKTR-181 in its portfolio being developed for the treatment of chronic pain. The company is in discussion with the FDA regarding the design of a phase III study on NKTR-181 in chronic pain patients.
Nektar has progressed well with its pipeline in the last few quarters and is awaiting several pipeline related events in the coming quarters.
Nektar currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. (GILD) and Ariad Pharmaceuticals Inc. (ARIA). While Gilead carries a Zacks Rank #1 (Strong Buy), Ariad holds a Zacks Rank #2 (Buy).
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