And so it ends.
After multiple delays, Mylan has won FDA approval for a generic version of Advair, GlaxoSmithKline’s mega-blockbuster asthma/COPD drug.
This is not one of your run-of-the-mill stories about generics.
Advair has continued to pump billions into GSK long after the patent expiration, helping to mask the pharma giant’s deep problems with R&D productivity. CEO Emma Walmsley brought in the renowned Hal Barron specifically to shake up the lackluster research arm of the company and get it pointed at cancer and other diseases where the prospects of major returns — in the not-too-distant future — are much, much better.
Company execs haven’t exactly embraced Axel Hoos’s remarks recently that GSK is walking away from respiratory diseases. But the company’s lack of impact in the field in recent years with largely sub-blockbuster offerings hasn’t gone unnoticed either. The cancer research chief got that part exactly right.
To be sure, GSK won’t just abandon Advair. As Umer Raffat has just noted, the company has been scrambling to lock in payers with some deep discounts. In an email with the subject line ‘Godot is finally here,’ Leerink notes:
Our model currently assumes a February launch and ~$170M in 2019 with a 75% PoS, which comprises $0.17 of our current $5.00 2019 EPS estimate. Revising the PoS to 100% with the approval would raise the contribution in 2019 to ~$230M and add $0.05.
The clock has really begun ticking now for GSK R&D to get its act together. The safety net is gone.
Image: Emma Walmsley. GSK
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