With aging top dog Advair losing ground to generic and branded competitors alike, GlaxoSmithKline ($GSK) is grooming a lineup of respiratory up-and-comers to step in with their own blockbuster sales. And new study results comparing Advair with not-yet-launched Anoro Ellipta could help the fledgling COPD treatment do just that.
On Friday, Glaxo and partner Theravance ($THRX) announced positive data from three Phase III studies examining the safety and efficacy of Anoro and Advair--known as Seretide outside the U.S. and Canada--in COPD patients with no moderate to severe exacerbations in the last year. Anoro impressed in all three 12-week trials, achieving a statistically significant improvement in lung function of the 2,100 participants across the studies.
"We are pleased to communicate these data comparing the effect of these treatments on the lung function of patients with COPD who do not have a history of exacerbations," Darrell Baker, SVP and head of GSK's global respiratory franchise, said in a statement. "These findings add to the existing body of evidence and our understanding of the efficacy and safety" of Anoro, he said.
It's good news for the British pharma giant, which will be relying more and more on its new products--including Anoro and Breo, also approved last year--in years to come. Advair has long been off patent, but its difficult-to-copy Diskus inhaler technology has largely kept rivals at bay. The FDA, however, is working with competitors to help get generic treatments to the U.S. market, which would compromise a hefty piece of the drug's $8 billion-plus sales haul--one that Anoro and Breo, with combined peak sales of $2.4 billion, won't be able to recoup.
In the meantime, Seretide sales are already slipping in the EU, dipping 2% last year as rival treatments like AstraZeneca's ($AZN) Symbicort made their mark. And things may get dicier for Glaxo going forward: After nabbing its first approval in December, a new generic from Novartis' ($NVS) Sandoz unit is making the regulatory rounds, now boasting nods in a handful of EU countries.
- read the release
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