Novartis move clears threat to Advair

The folks at GlaxoSmithKline must be celebrating today: Rival Novartis has handed back U.S. rights to a drug that might have become a copycat version of the GSK blockbuster Advair. That move gives Glaxo one less problem to worry about.

GSK chief Andrew Witty has been pooh-poohing the potential of generic rivals to that best-selling lung drug, which accounted for $7.6 billion in 2009 sales. The inhaled drug isn't easy to make, Witty has said, making it even tougher to copy. For that reason, it called on the FDA to set strict standards for any generic form of the drug.

Nonetheless, Novartis and others have been working on their versions; after all, even a daunting task is worth it when billions in sales are at stake. With Novartis handing the rights to an experimental compound--presumed to be copycat Advair--back to Vectura Group, that removes one potential rival; analysts say Vectura doesn't have the resources to come up with copycat Advair on its own.

Despite the news, Vectura expressed confidence this morning. "Regaining complete ownership of the VR315 U.S. program is in line with this strategy and offers Vectura significant financial advantages. We are confident that we have the high level of expertise required to develop and successfully commercialise inhaled products, and with a robust balance sheet, we believe we have the ability to gain an enlarged share of a major market opportunity," Chris Blackwell, chief executive of Vectura, says in a statement.

And it could be a sign that others will eventually give up, too. "For Sandoz (Novartis' generic arm) to hand back development of what could be a potentially significant generic immediately questions whether it views taking a generic of this type to the U.S. market as viable," Jeffries International analyst Jeffrey Holford writes to investors (as quoted by Bloomberg). "Although the risk of Advair generics is not fully mitigated, this can now be assumed greatly reduced," another analyst writes. Understandably, GSK's shares are up on the news.

- read Vectura's announcement
- read the Bloomberg piece
- see the story from Reuters

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.