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AstraZeneca’s COPD Drug Succeeds in Label Expansion Study

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AstraZeneca AZN announced positive top-line data from a phase IV study evaluating its marketed drug, Tudorza Pressair (aclidinium bromide 400 mg, twice-daily), for an expanded indication.

The phase IV ASCENT was conducted to expand the label Tudorza to include patients with chronic obstructive pulmonary disease (“COPD”) with cardiovascular risk factors. The post-marketing requirement (PMR) study was requested by the FDA and was conducted on a total of 3630 patients. The study met its both primary efficacy and safety endpoints. Data from the study demonstrated that treatment with Tudorza led to a statistically significant reduction in the annual rate of moderate or severe COPD exacerbations compared with placebo.

Notably, Tudorza is a long-acting muscarinic antagonist (LAMA) which is also marketed under the brand name Eklira and Bretaris for treatment of COPD in more than 50 countries globally including the United States.

AstraZeneca’s shares have outperformed the industry year to date. The stock has rallied 17.7% compared with the industry’s gain of 15.5% in the same time frame.


A full evaluation of the ASCENT data is underway and further results will be presented at a forthcoming medical meeting. Based on positive ASCENT data AstraZeneca expects to submit a supplemental new drug application (NDA) to the FDA to expand the label of Tudorza.

The potential label expansion of Tudorza will provide the company with access to a wider patient-population base suffering from COPD.

We remind investors that in March 2015, AstraZeneca acquired the rights to Allergan's AGN branded respiratory business, which added Tudorza in its portfolio.

In April, the company entered into a strategic collaboration with Circassia Pharmaceuticals Plc for development and commercialization of Tudorza and another COPD drug Duaklir in the United States.

AstraZeneca’s COPD products in the market include Symbicort, Pulmicort et al. Sales of its respiratory portfolio have declined 5% in the first nine months of the year due to pricing pressure and competition in the United States and the EU.

Importantly, the company’s promising respiratory treatments in the pipeline include tralokinumab in phase III studies for severe asthma and PT010, also in phase III studies for treating COPD. AstraZeneca expects to launch four new respiratory medicines between 2017 and 2020.

It remains to be seen if these candidates can improve the company’s respiratory sales upon approval.

Per the company’s press release, COPD is a progressive serious lung disease, commonly found to affect approximately 329 million people worldwide. Moreover, cardiovascular risks are seen to have the biggest effect on patients with COPD, representing a significant need for such therapies.

Zacks Rank & Key Picks

AstraZeneca carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are Corcept Therapeutics Incorporated CORT and Achillion Pharmaceuticals, Inc. ACHN, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Corcept’s earnings per share estimates have moved up from 77 cents to 88 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 14.32%. Share price of the company has skyrocketed 129.8% year to date.

Achillion’s loss per share estimates has narrowed from 66 cents to 63 cents for 2017 and from 75 cents to 67 cents for 2018 over the last 60 days. The company came up with positive earnings surprises in two of the trailing four quarters with an average beat of 4.51%.

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