AstraZeneca's $1.2B COPD drug comes through in Phase III

AstraZeneca's headquarters in London--Courtesy of AstraZeneca

The star of AstraZeneca's ($AZN) $1.2 billion acquisition of Pearl Therapeutics hit its main goals in two late-stage COPD trials, the company said, clearing the way for regulatory filings and what the drugmaker hopes will be blockbuster sales.

The drug, PT003, is a twice-daily combo inhalant designed to improve lung function. In a pair of late-stage trials on more than 2,000 patients, the drug charted a statistically significant improvement in how much air COPD sufferers could exhale in one second compared to each of its two components alone and placebo, AstraZeneca said. On the safety side, adverse effects were similar across all four treatment groups, according to the company, with the most common including colds, upper respiratory tract infections and shortness of breath.

Now AstraZeneca is on track to file U.S. and European applications for the drug this year, hoping to crack a crowded market for newfangled COPD therapies.

Last year, during its long and ultimately successful struggle to shake off Pfizer's ($PFE) M&A advances, AstraZeneca unveiled a slew of ambitious revenue goals for its pipeline medicines, predicting peak sales of $4 billion a year for PT003. To get there, it'll have to beat out GlaxoSmithKline's ($GSK) new Anoro Ellipta, which uses similar active ingredients and has thus far failed to live up to prelaunch expectations. Meanwhile, Boehringer Ingelheim is awaiting approval for a competing combo, and Novartis ($NVS) is already on the market in Europe with its own COPD cocktail.

The disease affects about 27 million people in the U.S. alone, and Citigroup estimates the market for treatments will jump from just over $10 billion last year to $14 billion in 2018.

AstraZeneca is betting big on respiratory drugs as a growth driver moving forward, laying out up to $2.1 billion last year for Almirall's inhalables business and netting three marketed drugs and a handful of pipeline assets. The company is also at work on benralizumab, a Phase III antibody treatment for severe asthma and COPD from which AstraZeneca expects $2 billion in peak sales.

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