GSK's Arnuity approval adds another rebuilding block to respiratory franchise

GlaxoSmithKline ($GSK) has rolled out a slew of respiratory meds lately, looking for newcomers to take up the torch as Advair sales fade. After notching three approvals on the COPD side, now, the pharma giant has a brand new asthma treatment on its hands in Arnuity.

The med, which nabbed FDA approval Wednesday, is a once-daily inhaled corticosteroid for patients 12 and older, and it joins Breo, Anoro and Incruse on the list of recent approvals delivered through Glaxo's Ellipta inhaler.

"The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio," Darrell Baker, head of the British drugmaker's global respiratory franchise, said in a statement. Arnuity "enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients."

Together, that group is looking to fill the gaping $8-billion-a-year-plus hole in GSK sales that asthma/COPD giant Advair will leave when generic copycats take it down--a decline that's already begun. Second-quarter sales of the drug sank 19% in constant currencies, a showing that dragged down the company's overall top-line haul and prompted it to cut its earnings guidance for the year.

And it won't be getting any easier from here on out. While branded and generic rivals--like AstraZeneca's ($AZN) Symbicort and Merck's ($MRK) Dulera--ramp up competition in the U.S., copycats, like Novartis' ($NVS) AirFluSal Forspiro, are gaining ground elsewhere. That drug grabbed its first Latin American approval Thursday with a nod in Mexico, adding to a green-light list comprising four European countries and South Korea.

So GSK's freshman class has its work cut out for it. And considering the slow starts for Breo and Anoro, Glaxo could use a strong launch from Arnuity to pick up some of the slack. Those drugs--both of which have been tabbed by analysts as potential blockbusters--pulled in a combined £10 million in Q2. That's "really way under what analysts expected," Sphera Funds Management analyst Ori Hershkovitz told Bloomberg in July. 

- read the release

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