Back to top

Analyst Blog

AstraZeneca (AZN - Analyst Report) 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 - Analyst Report) 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 - Analyst Report) and Eli Lily and Company (LLY - Analyst Report) currently look more attractive with a Zacks Rank #2 (Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
UTD THERAPE… UTHR 117.83 +28.51%
TRIQUINT SE… TQNT 20.67 +6.52%
RF MICRO DE… RFMD 12.47 +6.04%
VASCO DATA… VDSI 14.77 +4.68%
BANCO DO BR… BDORY 15.53 +3.95%