GlaxoSmithKline's ($GSK) Advair is one step closer to getting some unwanted company--and so are Mylan ($MYL) and Novartis' ($NVS) Sandoz.
On Friday, Vectura Group said it had wrapped up clinical trials for an Advair generic dubbed VR315, which could take on GSK's respiratory behemoth in early 2018. Now, the Chippenham, U.K.-based company--and its partner Roxane Labs, the generic arm of respiratory heavyweight Boehringer Ingelheim--will "look forward to submission of the file, positioning VR315 competitively in what will be a major value opportunity," Vectura chief James Ward-Lilley said in a statement.
That major value opportunity is still intact in the U.S., despite several years off-patent for Advair. The GSK drug netted $8.25 billion in 2013 revenue, before formulary pressure and European knockoffs began taking a serious bite out of sales. So far, copying the drug's Diskus inhaler technology has foiled other drugmakers, generics leader Teva ($TEVA) among them.
The same could still happen to Vectura and Roxane, Bernstein analyst Ronny Gal notes; the partners might fall short at the FDA after a first review. It's "tough" to see such a "complex drug-device" as a first-round approval, he wrote in a Monday note to clients. "We model 1Q18 entry (but could be surprised)," he said.
A slowdown for Vectura would obviously be good news for Glaxo, whose pharma unit has been battered lately by its respiratory troubles. While CEO Andrew Witty has insisted 2016 would mark a turning point--with its respiratory unit fielding the "best coverage we've ever had" from payers--slow-starting respiratory newcomers Breo and Anoro are limping into the new year after their script numbers dropped significantly around the Christmas holidays, Gal wrote recently.
Meanwhile, Glaxo's not the only company that would feel the pain if Vectura does bring a version of Advair to market. Mylan and Novartis' Sandoz unit are already submitting their own copies, and more competition means they would get a smaller piece of the pie. Vectura's progress represents a hit of about 16 cents to GSK's 2018 earnings, Gal figures.
- read Vectura's release
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