How will Cephalon shift patients to Nuvigil?

Shifting patients from a soon-to-go-off-patent blockbuster to its tweaked successor is old hat in the pharma biz. Ever since drugmakers figured out that adding a time-release coating or other slight improvement could earn it a new round of patent protection, they've been developing strategies for competing against their own meds. Raising the price [1] of the old version to get patients to switch to the new brand, hoping they'll stick when the old one goes generic? Done. Touting the slight improvement as if it's a major advance? Also done.

If you're interested just what Cephalon might bring to its follow-up party, check out its Q2 earnings call. Jim Edwards at BNET Pharma did, and found that it's eyeing new indications--and a new focus on recently won indications--as a Nuvigil switching strategy. According to the call transcript, it's also using price breaks: free samples, a seven-days-free coupon, co-pay assistance of up to $50 per scrip. It's offering deals to insurance plans and managed care companies. All to capture brand business before the wakefulness med Provigil goes off patent, sometime before 2012.

But more about those new indications. At the end of June, Cephalon asked FDA to approve Nuvigil for jet lag disorder. It's studying Nuvigil as a treatment for sleepy brain-injury patients. It's plotting two Phase III trials of Nuvigil as an add-on for bipolar depression [2]. It's enrolling for a IIB study in schizophrenia. And it's in the early stages of developing Nuvigil as a treatment for chemotherapy-related fatigue.

That's quite a range of uses. And at least in the case of jet lag disorder, one might argue--as BNET does in relation to Nuvigil's shift-work fatigue indication--that jet lag is a natural physical response that Type A business travelers hate. And those travelers would be quick to ask for Nuvigil even if their jet lag isn't extreme enough to be disorderly. That's all good for Nuvigil sales, of course. And Provigil and Nuvigil together account for half of Cephalon's recent revenues. Stay tuned.

- read the BNet post [3]
- check out the Cephalon call transcript [4]