Cambridge Labs announces Spanish approval of Tetrabenazine

Dec 8 2008

Cambridge Laboratories Limited has announced that its flagship product Tetrabenazine, (known as NITOMAN in Germany and other key European territories and XENAZINE in the UK, U.S. and other markets) has received marketing approval in Spain from the Agencia Espanola de Medicamentos y Productos Sanitarios.

The Company also announces that it has recently signed distribution agreements for Tetrabenazine in Finland and Taiwan, and renewed existing arrangements in Australia and New Zealand.

Tetrabenazine will be marketed as NITOMAN in Spain by Cambridge's marketing partner UCB upon successful completion of all related procedures. It has been approved for the treatment of movement disorders associated with Huntington's disease, a condition for which there is major unmet medical need.

Cambridge has recently renegotiated its agreements with UCB in Spain and Portugal, giving UCB ten year exclusive marketing rights to Tetrabenazine in Spain. UCB, a global biopharmaceutical company, is focused on severe diseases in three therapeutic areas - inflammation, oncology and neurology. The renegotiated terms follow UCB's acquisition of Celltech, Cambridge's former partner in Spain and Portugal, and the more recent merger of UCB with Schwarz Pharma.

UCB is currently in the process of applying for price and reimbursement in Spain and expects to have this procedure completed in the first half of 2009.

Mark Evans, CEO of Cambridge, said: "The granting of a license for Tetrabenazine in Spain follows a series of launches in key global territories, most notably the US where the product was launched last month and completes the approval process in the major 5 EU territories. The continued worldwide rollout of Tetrabenazine, with new agreements signed in Finland and Taiwan is affirmation of Cambridge's commitment to providing Huntington's disease patients with this important treatment. We are particularly pleased to have partnered in Spain with UCB, one of Europe's leading neurology players."

A spokesperson from UCB said: "Our expertise within the CNS arena will allow us to maximize the value of this potential new therapy for patients, physicians and our shareholders."