Nektar Therapeutics’ (NKTR) shares gained more than 9% on Mar 18, after the U.S. Food and Drug Administration (:FDA) notified the company and its partner AstraZeneca (AZN) that the Anesthetic and Analgesic Drug Products Advisory Committee meeting on mu-opioid antagonists, including naloxegol, is tentatively scheduled for Jun 11-12, 2014.
Naloxegol is being developed for the treatment of opioid-induced constipation. If approved, naloxegol would be the first once-daily oral treatment for patients with chronic OIC.
The advisory board meeting was originally scheduled on Mar 10-11, 2014, but had to be rescheduled due to some conflicts. The agenda of the meeting will be to discuss the cardiovascular safety and potential additional safety study requirements of the mu-opioid antagonists.
As per a 2009 agreement, AstraZeneca was granted worldwide and exclusive rights to develop, market and sell naloxegol and naloxegol fixed-dose combination program. We note that naloxegol is under review in the U.S. for the treatment of opioid induced constipation. A final decision on the approval of the candidate is expected by Sep 16, 2014. Naloxegol is also under review in the EU and Canada for the same indication.
Upon approval and launch of naloxegol, Nektar is entitled to up to $175 million in milestones from AstraZeneca. If naloxegol is approved without the need for a significant additional safety study, Nektar will receive $35 million. The company will receive $100 million in the U.S. upon launch, and $40 million upon launch in Europe.
Nektar currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Alexion Pharmaceuticals (ALXN) with a Zacks Rank #1 (Strong Buy).
(We are reissuing this article to correct a mistake. The original article, issued Wednesday, March 19, 2014, should no longer be relied upon.)