Nektar Therapeutics (NKTR) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for naloxegol (NKTR-118) for treating adults suffering from opioid-induced constipation (OIC) with chronic non-cancer pain. The FDA acceptance of the NDA has triggered a $70 million milestone payment to Nektar from partner, AstraZeneca (AZN). The payment is supposed to be made within five business days of the NDA acceptance.
The NDA for naloxegol, submitted in mid-Sep 2013, was based on positive results from the phase III KODIAC program. The program consisted of four studies namely KODIAC-04 (n=652), KODIAC-05 (n=700), KODIAC-07 (an extension of KODIAC-04) and KODIAC-08 (n= 534). The studies evaluated the safety and efficacy of naloxegol in treating patients suffering from OIC.
In Sep 2013, the European Medicines Agency (EMA) accepted the Marketing Authorisation Application (MAA) of naloxegol for the treatment of OIC in adults. The MAA filling was also based on positive results from the KODIAC program. Nektar received a $25 million milestone payment from AstraZeneca during the third quarter of 2013 following the MAA acceptance.
Nektar’s pipeline currently looks promising. It includes candidates like NKTR-102 (breast cancer), NKTR-181 (chronic pain) and NKTR-192 (chronic pain). We expect investor focus to remain on Nektar’s pipeline going forward.
We are impressed by Nektar’s progress with naloxegol. However we remain concerned as the constipation market currently looks extremely crowded with the presence of companies like Forest Laboratories (FRX).
Nektar currently carries a Zacks Rank #3 (Hold). Stocks like Actelion Ltd. (ALIOF) look better positioned with a Zacks Rank #1 (Strong Buy).
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