Cambridge Labs debuts Nitoman in Germany

Cambridge Laboratories, the privately-owned UK specialty pharmaceutical company, says that its distribution partner in Germany, Temmler Pharma, has now launched Nitoman (tetrabenazine, also known as Xenazine in the USA and certain other markets) following its approval from the Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM) on January 19. The product has been approved for use in Germany for the treatment of chorea associated with Huntington's disease and moderate to severe tardive dyskinesia, both conditions for which there is major unmet medical need.

Nitoman is a dopamine depleting agent that was exclusively licensed by Cambridge to Temmler Pharma in 2006 for commercialization in Germany and Austria. Germany is the second of the key mainland European markets to launch the drug, following the product's introduction in France in 2006. Temmler will now be seeking approval in Austria.

Last month, a Complete Response was submitted to the US Food and Drug Administration in respect of an application for marketing approval for Xenazine for the treatment of chorea associated with Huntington's disease.