What's Next for Celgene?

First a confession. I (correctly but timidly) voted for "someone else" in the IN VIVO blog poll on the next biopharma acquisition target. That said, I certainly never would have picked Pharmion.

Celgene, on the other hand, would definitely have been one of my choices.

No, we don't have any good scuttlebutt to base that on. Its just that we've been writing and thinking a lot about the impact of the new drug safety legislation--and especially the new authority given to the Food & Drug Administration to impose risk management plans. You can't think about the impact of tighter post-marketing safety regulation and restricted distribution programs without thinking a lot about Celgene.

The company's STEPS program for Thalomid is routinely cited by FDA as one of the few, clear successes of the restricted distributuion regulatory model. It is also a clear commercial success, helping both Thalomid and the follow-on Revlimid make it to market and generate a nice healthy revenue stream--despite onerous monitoring and surveillance burdens for the sponsor.

Not only that, Celgene has a patent on the STEPS program, carving out an unusual and now unusually valuable intellectual property position for a biopharma company. So, as the rest of the industry wrestles with how to make money under the new regulatory order, I expect a lot of people will be taking a close look at Celgene.

If you are looking for a place to start, try a story from The RPM Report's Kate Rawson: "Building a Business in Drug Safety." When Celgene pioneered that business model, it looked like a clever niche strategy for a specialty pharma business. In the new drug safety era, it may become more like business as usual.