Biotech Values

[DewDiligence]

Sorry about the venting, Januvia vs. Galvus is a sore point with me.

No problem—I expected you to chime in on cue :- )

Bottom line is NVS realized that Galvus could still be a blockbuster based on Europe and the rest of world… I believe at last count Galvus has been approved in approximately 40 countries.

69 countries as of Oct 2009 (http://www.novartis.com/newsroom/media-releases/en/2009/1349248.shtml ).

They decided not to fight the FDA when they were apparently picking favorites.

As you know from our prior exchanges, I don’t think the FDA played favorites with respect to Galvus and Januvia; rather, I think there’s an unpredictable element in regulatory approvals and sometimes companies get the short end of the stick. If the review teams for Galvus and Januvia had been reversed, perhaps the outcomes would have been different—the luck of the draw does play a role to some extent.

I fear the FDA could do the same thing in the COPD market.

If you subscribe to my thesis above, the FDA is no more likely to be prejudiced against NVS than against any other applicant. We know that the QAB149/NVA237/QVA149 program has some warts (#msg-60613283), so an FDA rejection or qualified approval would not be hugely surprising.