When Boehringer Ingelheim's COPD drug Stiolto Respimat won U.S. approval early last month, the company's head of pharma marketing and sales, Allan Hillgrove, acknowledged that payer arm-twisting happening stateside may make pricing tough. But now, the German drugmaker has nabbed some European approvals that should give the drug a lift.
|Boehringer Ingelheim CMO Klaus Dugi|
Dubbed Spiolto Respimat in Europe, the therapy has won go-aheads from Croatia, the U.K., Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain, and the company anticipates more approvals on the continent in the coming months, CMO Klaus Dugi said in a statement.
The combo therapy--which pairs tiotropium, the active ingredient in the company's Spiriva Respimat, and olodaterol, the active ingredient in its Striverdi Respimat--should help the company build on sales of best-seller Spiriva, which raked in €3.2 billion last year. As a LAMA/LABA combo, Stiolto/Spiolto provides "significant improvements in lung function, breathlessness, quality of life and rescue medication use over Spiriva right from the initial stages when patients need maintenance therapy," Boehringer said.
That's good news for the company, with a U.S. Spiriva patent expiration approaching in 2018. Though EU rollouts tend to be slower than those in the U.S., with each country sporting its own reimbursement gatekeepers and pricing negotiations, the U.S. respiratory market has been more of a free-for-all lately, full of formulary battling and major discounting. Newly aggressive payers have hurt many respiratory meds' sales as of late--including those of Spiriva, whose sales took an 8.1% tumble last year.
But Europe does feature more competition. Novartis ($NVS), for one, is vying for market share in Europe with its Ultibro Breezhaler--a LAMA/LABA product that's awaiting FDA approval in the U.S. That's on top of competition from respiratory behemoth GlaxoSmithKline ($GSK), which has its LAMA/LABA combo Anoro on the market on both sides of the pond.
- read Boehringer's release
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