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EMEA recommends generic copies of Roche's CellCept

The EMEA recommends approval of Teva's generic versions of Swiss pharmaceutical company Roche's anti-rejection drug CellCept

A Reuter's report has revealed that the European Medicines Agency (EMEA) has recommended approval of Teva Pharmaceutical's generic versions of Swiss pharmaceutical company Roche's anti-rejection drug CellCept (mycophenolate mofetil).

The generic copies of CellCept, Myfenax and mycophenolate mofetil Teva, are indicated for preventing acute transplant rejection in patients receiving kidney, heart, or liver transplants.

Roche's CellCept was approved by the EMEA in 1996. The Reuters report noted that marketing recommendation by the EMEA's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the EU Commission within a few months.

Pacific Growth Equities analysts have projected flat CellCept sales for Roche until the US patent expiration in 2009. They also noted CellCept's failure in a phase III clinical trial for lupus nephritis. The 370-patient, 24-week, randomised, open-label study failed to prove that CellCept was superior to intravenous cyclophosphamide (IVC).

The analysts added that US payers might push back on the USD 7,000 per year price of CellCept, compared with the USD 1,000 per year price of IVC.

17th December 2007


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