|GSK CEO Andrew Witty|
GlaxoSmithKline's ($GSK) respiratory unit is gearing up for a sunnier 2016--one that includes stellar coverage for its meds and a slowdown on Advair's price decline, CEO Andrew Witty said Wednesday. It's also ready to add a U.S. launch for new product Nucala to that list, and it'll find out soon whether it has the green light to do just that.
The British pharma giant is expecting word from the FDA on Nucala, an injectable treatment for severe asthma with eosinophilic inflammation, by Nov. 4, and as Witty told investors on Glaxo's Q3 conference all, the company is prepared to get going with the rollout.
"We've already built the Nucala sales force and it's ready to go," he said.
And if an FDA advisory panel vote from this June is any indication, it'll get its chance--at least in adults. Experts voted 14-0 in favor of approval in adults, though they split, 10-4, over whether to recommend the prospect for asthmatics between the ages of 12 and 17.
While Nucala, if approved, won't boast a huge patient population--the company estimates that around 300,000 to 400,000 severe asthma patients in the U.S. will meet prescribing recommendations--it has an opportunity to get that pool all to itself.
Right now, severe asthma patients are treated with Novartis' ($NVS) Xolair, but that med--indicated for patients with moderate to severe allergic asthma--doesn't directly address eosinophilic inflammation, a condition GSK says affects 60% of severe asthma patients. Nucala targets that inflammation directly.
"You need to make sure you get exactly the right product for the person in that severe population. That's where Nucala is really a strong scientific story more than anything," Deborah Waterhouse, GSK's SVP of primary care, told FiercePharmaMarketing in a recent interview.
Meanwhile, Glaxo is expecting a brighter 2016 for its other respiratory meds, too. 2016 will hold "probably the best coverage we've ever had for our respiratory portfolio," Witty said on the conference call. And while securing that coverage has required more price cuts on Advair, "the rate of decline is decelerating."
The company is also bulking up its U.S. sales force for the aging giant, though "not massively"--and it's doing the same for slow-starting new products Breo and Anoro, Witty said. Most of that "has come from internal redeployment," but GSK has supplemented it with CRO resources.
So far, it's "seeing good returns from that investment," Witty said.
- read the call transcript
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