Tuesday, August 4, 2009

FDA Sees Elevated Cancer Risk in Juvenile Arthritis Drugs -- Incuding Remicade and Simponi


This news has been a while in the making, but it will affect the worldwide Schering-Plough franchises in Remicade and Simponi, without regard to the ultimate outcome of the pending J&J arbitration:

. . . .The Food and Drug Administration warned Tuesday that several of the leading biologic medications used to treat rheumatoid arthritis can increase the risk of cancer when used by children and adolescents. The drugs, which belong to a class called TNF-blockers, include the following: Remicade and Simponi, marketed by Johnson & Johnson and [short-term?] partner Schering-Plough. . . .

Stay-tuned, but recall that I have earlier suggested the arbitrators will likely allow in extrinsic evidence of what a "small c" change of control might mean -- to experienced practicioners, in this securities law/distribution agreement context.

And, that would be very bad news for the Merck and Schering-Plough lawyers. The arguable gaffe in Section 8.2(c), then:
. . . .from such notification, to notify in writing the party subject to the change of Control of the termination of the Agreement taking effect immediately. . . .

We'll keep an eye on it, here.

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