AstraZeneca’s (AZN) Respiratory Drug Approved in the EU

Zacks

AstraZeneca’s (AZN) Duaklir Genuair has been approved in the EU as a maintenance bronchodilator treatment to relieve the symptoms of adults suffering from chronic obstructive pulmonary disease (COPD).

Duaklir Genuair is a fixed-dose combination of Eklira, a long-acting muscarinic-antagonist, and Mylan, Inc.’s (MYL) Perforomist (formoterol fumarate), a long-acting beta-agonist. Both are individually approved for the maintenance treatment of COPD.

Duaklir Genuair’s approval came on the basis of results from 11 clinical studies conducted in over 29 countries around the globe. Duaklir Genuair showed statistically significant and sustained improvement in lung function as compared to monotherapy.

We note that Duaklir Genuair became a part of AstraZeneca’s portfolio from its acquisition of Almirall’s respiratory franchise last month for an upfront payment of $875 million along with development, launch and sales-related milestones of up to $1.22 billion.

Symbicort is already an approved product in AstraZeneca’s COPD franchise. The company is also developing benralizumab for the treatment of COPD. Currently, the lucrative COPD market is heavily crowded with the presence of companies like GlaxoSmithKline (GSK) among others.

Our Take

We note that AstraZeneca is under severe pressure as it is facing generic competition in several key franchises. Moreover, another key product, Nexium, which generated more than 15% of AstraZeneca’s total revenues last year, is expected to go generic soon. The company’s pipeline needs to deliver significantly to offset these loses.

AstraZeneca carries a Zacks Rank #3 (Hold). Stocks that are worth considering in the health care sector include Allergan Inc. (AGN). Allergan sports a Zacks Rank #1 (Strong Buy).

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