Aspreva, Roche receive orphan-drug designation for CellCept in rare autoimmune disease

By Elaine Rigoli

Tampa, Fla., June 6 - Aspreva Pharmaceuticals Corp. and Roche have received orphan-drug designation from the Food and Drug Administration for CellCept (mycophenolate mofetil) in the treatment of pemphigus vulgaris (PV).

Aspreva is evaluating CellCept for the treatment of PV in a global phase 3 study.

"Pemphigus vulgaris is a painful and sometimes life-threatening skin-blistering disease for which there are currently no adequate treatment options. Successful completion of our phase 3 clinical study of CellCept in PV will support our sNDA filing, and once approved will have the potential to provide a new treatment option for patients suffering from this debilitating condition," Richard Glickman, Aspreva's chairman and chief executive officer, said in a news release.

The randomized, double-blind, placebo-controlled comparison study is investigating the efficacy and safety of CellCept in 77 patients with active PV over a treatment period of 52 weeks. The primary end-point encompasses both minimal disease activity defined as no new persistent lesions, with a low steroid dose.

Aspreva is an emerging pharmaceutical company based in Victoria, B.C.

Basel, Switzerland-based Roche is a research-focused pharmaceuticals and diagnostics company.

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