AstraZeneca's Severe Asthma Drug Positive In Phase III

AstraZeneca plc (NYSE:AZN) announced positive data from two pivotal phase III studies – SIROCCO and CALIMA – on its respiratory disease candidate, benralizumab, for the treatment of severe asthma.

These randomized, double-blind, parallel-group, placebo-controlled studies evaluated the safety and efficacy of benralizumab as an add-on therapy in the treatment of severe uncontrolled asthma with eosinophilic inflammation in patients aged 12 years and older.

The study met its primary endpoint. Data demonstrated significant reduction in the annual asthma exacerbation rate compared to placebo. The candidate was generally well tolerated too. Full results from the studies will be presented at a medical conference later.

AstraZeneca expects to file for regulatory approval in both the U.S. and the EU in the second half of 2016.

Benralizumab is also being evaluated in the phase III VOYAGER program for the treatment of patients with severe chronic obstructive pulmonary disease (COPD).

We remind investors that AstraZeneca has in-licensed the drug from BioWa, Inc., a subsidiary of Kyowa Hakko Kirin Co., Ltd., in all countries except Japan and certain other Asian countries. In Jul 2015, AstraZeneca inked an agreement with Kyowa Hakko Kirin for an exclusive option to commercialize the candidate in Japan, in both asthma and COPD indications.

Benralizumab is expected to face competition from GlaxoSmithKline plc’s (NYSE:GSK) Nucala and Teva Pharmaceutical Industries Limited’s (NYSE:TEVA) Cinqair once it hits the market.

As per the company’s press release, about 315 million individuals in the world suffer from asthma, which will likely increase to 400 million by 2020.

AstraZeneca carries a Zacks Rank #3 (Hold). Bristol-Myers Squibb Company (NYSE:BMY) is a better-ranked stock in the health care sector with a Zacks Rank #1 (Strong Buy).


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