Boehringer Ingelheim met its main goals in a late-stage study on a new COPD treatment, clearing the way for regulatory approvals and a bout with rival GlaxoSmithKline ($GSK).
The inhaled treatment combines olodaterol, approved in July as Striverdi, with tiotropium, on sale as Spiriva. In two 52-week Phase III trials on more than 5,500 COPD patients, the two drugs in tandem better improved lung function than each agent on its own, all with a similar adverse event rate across each group.
Olodaterol is a long-acting beta2 agonist (LABA), while tiotropium is a long-acting muscarinic antagonist (LAMA), and the tandem is designed to ease airway muscles and relieve symptoms of COPD. The combination is part of a new wave of COPD cocktails that analysts expect to eventually dominate the market.
Now Boehringer is awaiting final word from the FDA, which accepted its application for the fixed-dose combo last month. The company hasn't disclosed when it expects to win approval, but the agency sets a 10-month cap on its reviews.
Meanwhile, GSK is already on the market with Anoro Ellipta, which combines proprietary LABA and LAMA treatments. And, thanks to its checkbook, AstraZeneca ($AZN) is not far behind, spending $1.5 billion on Pearl Therapeutics and up to $2.1 billion on Almirall's respiratory business to get its hands on some Phase III COPD combos of its own. Novartis' ($NVS) fixed-dose LABA/LAMA, dubbed Ultibro Breezhaler, won European approval last year.
But despite trailing in the COPD combo race, Boehringer believes its contender can stand out in the crowded space, carving out a substantial share of a market expected to jump from $10 billion in 2013 to $14 billion in 2018.
And while GSK is the first mover, the company has so far struggled to live up to analysts' expectations with Anoro and the recently launched Breo Ellipta, therapies it hopes will eventually make up for Advair's roughly $8 billion in annual revenue.
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