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Roche Holding AG

Drug Names(s): mycophenolate mofetil, R99

Description: Mycophenolate mofetil (CellCept)—MMF—was approved in the United States in May 1995 and then in Europe in 1996. It is approved for use as prophylaxis of organ rejection in renal and cardiac transplant recipients and is being investigated for the prevention and treatment of rejection in other organ transplants. MMF is a prodrug that reversibly binds and inhibits inosine monophosphate dehydrogenase (IMPD). IMPD is an enzyme essential for the conversion of inosine monophosphate to xanthine monophosphate, which is a precursor of guanine nucleotides. Thus this agent results in an inhibition of de novo purine nucleotide synthesis, inhibiting DNA and RNA synthesis and subsequent synthesis of T and B cells. MMF may be an improvement on the antimetabolite azathioprine, in that it is almost five times more potent on targeting the type II isoform, which is associated with stimulated rather than resting lymphocyte. Moreover, to some extent, this agent is cell-type specific.

Deal Structure: Revenue splits for this drug are BioMedTracker estimates.

In October 2003, Aspreva Pharmaceuticals and Roche announced a partnership agreement on Cellcept. Under the terms of the deal, Aspreva Pharmaceuticals has obtained exclusive worldwiderights to develop and commercialize CellCept in all autoimmune disease applications. Roche will maintain the rights to CellCept's transplanation market while extending the potential benefits of CellCept to autoimmune disease patients. Roche will register and invoice such sales as may result and will share the proceeds with Aspreva.

Pursuant to the collaboration agreement with Roche, Aspreva is entitled to a royalty based on an equal sharing of incremental net sales of CellCept in non-transplant indications above a negotiated baseline less a distribution fee, payable on a quarterly basis. This baseline is subject to an annual price index adjustment and Roche and Aspreva agreed that the baseline for 2006 would be Swiss Francs (CHF) 130.5...See full deal structure in Biomedtracker

Partners: The Galenica Group Chugai Pharmaceutical Co., Ltd.

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