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NICE recommends Tysabri for multiple sclerosis

Elan and Biogen have received a recommendation for its multiple sclerosis drug Tysabri from NICE

Irish pharmaceutical company Elan and US partner Biogen have received a recommendation for its multiple sclerosis drug Tysabri (natalizumab) from the UK's National Institute of Clinical Excellence (NICE).

NICE, which assesses the cost-effectiveness of drugs and other medical treatments, recommended Tysabri for the treatment of a severe form of MS known as highly active relapsing remitting MS.

Elan shares were up EUR 0.53 to reach EUR 16.66 in Dublin in pm trading on 3 July.

Tysabri will be competing with Teva's established MS therapy, Copaxone (glatiramer acetate). In FY06, in-market global sales of Copaxone reached USD 1.4bn, an increase of 20 per cent on FY05 figures. Sales of Copaxone in the EU increased 26 per cent to reach USD 498m, driven by significant sales increases in the UK, France and Germany, which are the largest MS markets in Europe.

Teva still has not developed an effective oral version of Copaxone, but is in clinical trials with the oral MS drug, laquinimod, in partnership with Sweden-based Lundbeck.

Tysabri, which was developed by Biogen and Elan, was launched in November 2004. However, in February 2005, it was banned not only for use, but also from clinical trials after being implicated in the development of a fatal cerebral viral infection, known as progressive multifocal leukoencephalopathy (PML). Two MS patients taking Tysabri also died after developing progressive multi-focal leucoencephalopathy, a neurodegenerative disease.

Despite the study results, Tysabri fought off the negative press, based on its efficacy and ease of use. Copaxone and other MS treatments are usually administered by injection on a daily basis, while Tysabri is given as a monthly infusion. In June 2006, US regulators reinstated Tysabri's marketing license, with certain caveats imposed.

Tysabri has new labelling warning that it increases the risk of developing PML, which is described as an opportunistic viral infection of the brain that usually leads to death or severe disability.

The new labelling also notes that the known cases of PML were limited to patients with recent or concomitant exposure to immunomodulators or immunosuppressants, which left them more vulnerable to infections. There were not enough cases, however, to rule out the possibility that PML may occur with Tysabri monotherapy.

4th July 2007

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