GlaxoSmithKline ($GSK) faces some major regulatory decisions this year that will shape the future of the drug giant for years to come. And Bloomberg took the pulse of how industry watchers have harbored angst about the big year ahead for GSK and gathered insights from the company's pharma R&D boss, Patrick Vallance.
For all the celebration surrounding its embrace of R&D data sharing last year, the London-based pharma group has been underperforming its European peers and turning in lackluster profit and revenue numbers, the news service points out. Where things get potentially exciting--or scary depending on your attitude--is the high degree to which GSK could alter its circumstance based on its rich late-stage pipeline and 5 drugs up for regulatory approvals this year.
"Glaxo will seal its fate in 2013," Philippe Lanone, an analyst at Natixis Securities in Paris, told Bloomberg. "If the new products fail to make it, the company will be in big trouble."
Vallance highlighted the importance of two GSK meds facing regulatory decisions, the respiratory drug Relvar and the HIV med dolutegravir. As a potential heir to the GSK's Advair throne, Relvar has garnered intense scrutiny among investors for how well differentiated it is from the aging blockbuster. Advair has made the respiratory business the largest of all at the drug giant, and Relvar along with other pipeline contenders could make that business hum or stall depending on their success.
Glaxo is already studying Relvar/Breo in a real-world setting in the U.K. to gauge benefits of the once-daily drug. Advair is taken twice per day to improve breathing, leaving one more chance per day for patients to miss a dose.
Still, some investors and analysts are uneasy about GSK banking on its pipeline to engineer a turnaround. "You've still got this legacy over the last 10 years where pipelines haven't really delivered," Dan Mahony, of GSK investor Polar Capital, said, as quoted by Bloomberg. "There's a general amount of skepticism as to whether any of these companies are going to come up with any products."
- check out Bloomberg's article
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