End of Sepracor-GSK Deal Raises Question in Lunesta Patent Fight

Last Updated Jun 13, 2009 6:51 PM EDT

Here's something that few noticed in Sepracor's Q1 2009 earnings announcement: The company's $155 million marketing deal for insomnia drug Lunesta/Lunivia with GlaxoSmithKline in Europe fell through.

The collapse of the deal was predictable. I noted in July 2008 that GSK's subsequent $3.3 billion deal with Actelion for its sleeping pill eclipsed the Sepracor deal, making it either pointless or a giant conflict of interest on GSK's part:

GSK is now touting [Actelion's] almorexant as "first-in-class," which raises a question about how serious GSK's commitment to Lunesta is, especially as both drugs have yet to be approved in Europe.
So Sepracor could be better off without the promiscuous GSK as its European muse. Also, note that GSK paid Sepracor $17 million on the collapse of the deal. That seems to be on top of $20 million when the deal opened.

But it's not all money-for-nothing at Sepracor. The silver has a cloudy lining. The deal was nixed because although EMEA approved Lunesta/Lunivia in Europe, it did so "without designating it as a new active substance."

That's a problem for Sepracor because its patents on Lunesta are the subject of a legal fight with Mylan and Alphapharm. Those companies will doubtless be interested in the Europeans' notion that Lunesta isn't "new."