AstraZeneca plc (AZN) recently announced the initiation of patient enrollment in a late-stage trial of NKTR-118, being studied for the treatment of opioid-induced constipation (OIC) or opioid bowel dysfunction. The phase III study aims to evaluate the safety and efficacy of the candidate as a treatment for OIC.
This study will consist of two 12-week trials, both of different doses of NKTR 118 and will enroll about 630 patients each. The studies will compare response rates among placebo and two different doses of the candidate with primary endpoint at 4 weeks. There will be a three-month safety extension trial after one of the two 12-week studies.
NKTR-118 is originally Nektar Therapeutics’ (NKTR) product, which was out-licensed along with NKTR-119 to AstraZeneca in September 2009. Per the terms of the license agreement, AstraZeneca will develop and commercialize NKTR-118 and NKTR-119 worldwide. NKTR-119, a combination of various opioids and NKTR-118, is currently in early stage development.
As part of the agreement, Nektar Therapeutics is eligible to receive payments on the achievement of certain development and sales milestones. Nektar Therapeutics can also receive double-digit royalty payments on sales of NKTR-118 and NKTR-119.
According to the American Pain Society and IMS Health, annual worldwide sales of opioids exceed $10 billion. Constipation occurs in up to 90% of patients taking opioids and, at present, there is no drug approved for the treatment of OIC.
We currently have Neutral recommendations on both AstraZeneca and Nektar Therapeutics, supported by a Zacks #3 Rank (short-term Hold rating).
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
NEKTAR THERAP (NKTR): Free Stock Analysis Report
Zacks Investment Research
