Can Boehringer carve out space in a crowded COPD market with new approval?

The COPD market has its fair share of contenders, but that's not stopping Boehringer Ingelheim from joining the party. The German drugmaker has nabbed FDA approval for its own entrant, which will go up against the likes of Glaxo's ($GSK) aging giant Advair in a market-share showdown. But despite the competition, BI is hoping it can still find its corner.

Though Boehringer's newcomer, Striverdi Respimat (olodaterol), earned an FDA panel's recommendation last year based on safety and efficacy, little distinguished it from its competitors, the experts noted. Among those competitors: a trio of meds from GlaxoSmithKline, the world's respiratory leader.

The British drugmaker boasts market-leader Advair, which raked in more than $8 billion in 2013 sales. It's also flaunting a pair of newly approved next-gen meds, Breo and Anoro, meant to fill in for off-patent Advair as its top line wanes.

Does that mean there's no room for Boehringer to sneak in? Not necessarily. COPD affects about 27 million U.S. patients, with Citigroup estimating the market for therapies to climb from $10 billion in 2013 to $14 billion in 2018. Advair's decline is on--and fast--with Glaxo reporting a Q2 sales drop of 24%. And new launches Breo and Anoro so far haven't seen the uptake analysts expected--with some pointing fingers at GSK's revamped, quota-free sales model.

Of course, there are plenty of other rivals out there. AstraZeneca ($AZN), for one, has aggressively discounted blockbuster Symbicort to grab a piece of Advair's market share, and this week it hatched a $2 billion-plus deal for Almirall's respiratory portfolio--including a pipeline combo for COPD. Merck's ($MRK) Dulera has been increasing its piece of the pie as of late, too. And then there are the generics, which will compete with Striverdi in Europe: AirFluSal Forspiro, an Advair knockoff from Novartis' ($NVS) Sandoz that hit the scene last December, and Teva's ($TEVA) DuoResp, a Symbicort copy due to roll out on the continent in the near future.

But Boehringer may soon have another weapon if the FDA approves its combo drug, which packages olodaterol with LAMA bronchodilator tiotropium (known on its own as Spiriva). May Phase III results revealed that at 6 weeks, the combo had beat out placebo, as well as each drug on its own, at improving lung function.

- read the FDA's statement
- read FierceBiotech's take

Special Report: The 10 best-selling drugs of 2013 - Advair/Seretide

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