Will new blockbusters follow a new model?

Should pharma-watchers be worried about Eli Lilly and Bristol-Myers Squibb? After all, they both launched blockbuster hopefuls--the clot-buster Effient for Lilly, the diabetes remedy Onglyza for Bristol--but haven't racked up the kind of early numbers that the drugs-that-would-be-blockbusters did in the past.

But as In Vivo points out, times are changing. With insurers steering patients toward generics, patients worrying about drug risks, and these particular drugs facing some heavy-hitting competition, the quick uptake once expected of blockbuster meds may not be in the cards for most drugs, no matter how successful they may be in the long term

Effient is covered by a risk-management plan, which effectively slows down any launch, In Vivo says. Plus, it's chasing Plavix, the world's No. 2 drug. Onglyza enters a diabetes drug market shaken by Avandia safety concerns. Its marketing materials still aren't FDA-approved, which has got to slow down sales efforts. And Onglyza will be competing against Januvia and Janumet, which have been romping and stomping for Merck.

So maybe the sales model should be like Prozac, which built sales slowly, then became a breakout success. In Vivo argues that regulators want new meds like Effient and Onglyza to be slow out of the gate. After all, some fast-growing meds proved not so safe when administered to thousands of new patients not hand-picked by clinical trial committee. What do you think?

- see the In Vivo piece

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