AstraZeneca (AZN) recently announced long-term safety data from a phase III study (KODIAC-08) evaluating the use of naloxegol (25 mg once daily) in non-cancer related pain and opioid-induced constipation (OIC).
The open-label, randomized, 52-week, long-term safety study, compared naloxegol with the usual care, a currently available laxative for OIC. No significant difference was found between naloxegol and usual care in terms of serious side effects. However, adverse events like abdominal pain, diarrhea, nausea and headache were found to be more frequent in patients on naloxegol.
In Nov 2012, the company presented data from two randomized, placebo controlled phase III KODIAC studies (KODIAC-04 and -05) and an open-label, randomized, placebo-controlled long-term safety study (KODIAC-07).
In KODIAC-04, both naloxegol doses (12.5 mg and 25 mg) achieved the primary endpoint. However, in KODIAC-05, although the 25 mg dose achieved the primary endpoint, the 12.5 mg dose failed to do so. The candidate was found to be safe.
AstraZeneca plans to submit regulatory applications for naloxegol in the US and EU in the third quarter of 2013. AstraZeneca had licensed the candidate from Nektar Therapeutics (NKTR) in Sep 2009.
We believe that AstraZeneca’s pipeline must deliver since many of its drugs are facing/likely to face generic competition. Generic competition has adversely impacted AstraZeneca’s revenues over the past few quarters. 2013 is expected to be a challenging year for AstraZeneca. The company expects mid-to-high single-digit decline in revenues in 2013 primarily due to generic erosion of Seroquel IR and Crestor (in Canada) revenues.
AstraZeneca carries a Zacks Rank #3 (Hold). However, other large cap pharma stocks such as Bayer (BAYRY) and Eli Lily and Company (LLY) currently look more attractive with a Zacks Rank #2 (Buy).
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