) shares gained more than 9% on Mar 18, after the U.S. Food and
Drug Administration (FDA) notified the company and its partner
) 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.
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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
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
Nektar currently carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the same sector include
) 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.)