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Genzyme and Bayer Schering begin phase III for MS treatment

US-based Genzyme and Germany-based Bayer Schering Pharma have treated their first patient in the first of two planned phase III trials examining the safety and efficacy of MabCampath (alemtuzumab) for the treatment of multiple sclerosis (MS).

US-based Genzyme and Germany-based Bayer Schering Pharma have treated their first patient in the first of two planned phase III trials examining the safety and efficacy of MabCampath (alemtuzumab) for the treatment of multiple sclerosis (MS).

The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomised, rater-blinded study, will compare alemtuzumab to Serono's Rebif (interferon beta-1a) in patients with relapsing- remitting multiple sclerosis (RRMS). Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but who have not yet begun treatment with any MS drug.

Initiation of this programme follows the successful completion of the initial treatment period in the phase II trial. Interim results showed that alemtuzumab-treated patients experienced a statistically significant reduction compared with Rebif-treated patients in the risk for sustained accumulation of disability and the risk for relapse for 24 months.

The phase III CARE study will enroll up to 525 patients at approximately 60 medical centers throughout North America, Australia, Latin America, and the EU, and will again compare alemtuzumab-treated patients with Rebif-treated patients according to two co-primary endpoints: the time to sustained accumulation of disability; and the yearly relapse rate. Alemtuzumab-treated patients will continue to have safety evaluations for at least three years after the last course of treatment. The companies anticipate filing for marketing approval of alemtuzumab for the treatment of MS in 2011.

MabCampath was licensed in the US as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside the US for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The product was launched in its oncology indication in 2001 in the US, where it is marketed by Bayer HealthCare Pharmaceuticals as Campath, and in Europe, where it is named MabCampath. On 20 September, the FDA approved a supplemental application for Campath in the treatment of B-CLL that will allow it to be used to treat patients earlier in the course of the disease.

The MS market was worth nearly USD 5bn in FY06 with a growth rate of 8.9 per cent year-on-year. It is the fifth largest segment of the CNS market and has attracted much R&D investment from big pharma, biotechnology companies and specialty pharma. The market is being driven by the use of six disease-modifying agents: Avonex (Biogen Idec), Betaseron/Betaferon (Schering), Copaxone (Teva), Novatrone (Schering), Rebif (Serono/Pfizer) and Tysabri (Biogen Idec/Elan).

Sales growth will be driven by current drugs gaining broader indications, MS medicine being prescribed earlier in treatment in clinically-defined multiple sclerosis patients and the longer-term use of combination therapies as more classes of drug become available.

Genzyme and Bayer Schering Pharma are co-developing alemtuzumab in oncology, MS and other indications. Bayer Schering Pharma holds exclusive worldwide marketing and distribution rights to the molecule.

26th September 2007

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