Is GSK's Top R&D Deal Linked to Its "Undisclosed" FDA Application?

(MoneyWatch)  GlaxoSmithKline was involved in three of the five biggest R&D collaborations of 2008, indicating that CEO Andrew Witty's plan to outsource GSK's R&D functions is well under way. The stats were assembled by Gen News, an R&D publication.

(BNET readers are already familiar with the theory that internal R&D at GSK is shrinking as GSK looks to outside companies to provide it with new drugs.)

This was the number one deal:

GlaxoSmithKline's deal with Actelion valued at CHF 3.3 billion, or almost $3.2 billion, is the front-runner for alliances forged this year. The company put down 4.45% of this headline-making figure, or CHF 150 million, for exclusive, worldwide rights (excluding Japan) to Actelion's late-stage drug for insomnia. If the treatment successfully completes the recently begun Phase III trials and wins approval, Acetelion will earn CHF 415 million. The clincher will be the further development of this compound in two other indications, with milestones reaching CHF 2.735 billion.

This is a huge, huge gamble, as the insomnia market is oversaturated with generics and new branded drugs like Lunesta that have not been big sellers. This deal actually threatens GSK's existing insomnia pill deal with Sepracor.

In that deal, GSK gets to distribute Lunesta/Lunivia in "all markets worldwide (excluding the U.S., Canada, Mexico and Japan)." Which happen to be mostly the same markets covered by the Actelion deal.

The Lunesta deal is a curious one because some patients find it tastes disgusting or robs them of their sense of taste completely. By amazing coincidence, as BNET readers know, GSK is trying to get an "undisclosed" application through the FDA right now for a process that disguises bad drug tastes. It begs the speculation: Are the Sepracor, Actelion and "undisclosed" deals in some way related?