Healthcare Industry News: Nitoman
News Release - December 8, 2008
Cambridge Laboratories Announces Approval of Tetrabenazine in SpainMarketing Partner UCB Expects to Receive Completed Price and Reimbursement Approval for Tetrabenazine in H1 2009
Exclusive Distribution Rights Granted in Finland (MediFront) and Taiwan (Giddi Pharma); Distribution Contracts Renewed in Australia and New Zealand
DUBLIN and NEWCASTLE, England, December 8 -- (Healthcare Sales & Marketing Network) -- Cambridge Laboratories Limited ("Cambridge" or "the Company"), the privately-owned specialty pharmaceutical company, today announces that its flagship product Tetrabenazine, (known as Nitoman® in Germany and other key European territories and XENAZINE® in the UK, US 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."
Further details in connection with the new licensing deals in Finland and Taiwan and the renewal of existing arrangements in Australia and New Zealand are set out below:
- In Finland, Cambridge announced that it has granted exclusive rights to MediFront to market and distribute Tetrabenazine. Medifront has been distributing Tetrabenazine on a named patient basis in Finland for five years and will have responsibility for obtaining a marketing authorisation in Finland.
- Cambridge has signed a marketing and distribution agreement with Giddi Pharma of Taiwan. Under the terms of the agreement Giddi will have exclusive rights to market and distribute Tetrabenazine in that territory, and will also be responsible for obtaining a marketing authorisation.
- Cambridge has renewed its distribution agreement with its Australian partner, Orphan Australia, for the exclusive marketing and distribution rights for Tetrabenazine.
- In New Zealand, Cambridge has renewed its contract with AFT Pharmaceuticals, a privately owned company with a focus on the Pharmaceutical Rx/OTC market, giving them a further 5 year term with Tetrabenazine (marketed as XENAZINE®).
About Cambridge Laboratories (Ireland) Limited
Cambridge is a fast growing, dynamic and entrepreneurial pharmaceutical company with extensive product development and commercialisation expertise focused on innovative products to treat diseases of the central nervous system. Cambridge has an exciting portfolio of products, both on the market and in development, derived from its proprietary discovery efforts and a carefully constructed network of international partnerships for research, development, sourcing and global commercialisation. Utilising this unusual business model, Cambridge is dedicated to delivering significant value to patients, physicians and partners around the world.
UCB, Brussels, Belgium (http://www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing around 12 000 people in over 40 countries, UCB achieved revenue of 3.6 billion Euro in 2007. UCB is listed on Euronext Brussels (symbol: UCB).
Source: Cambridge Laboratories
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