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|  |  OPi receives marketing authorisation for Xenazine® 25 mg in FrancePress Release November 3, 2005 November 3, 2005 Lyon, France and Dublin, Ireland (November 3, 2005). OPi SA and Cambridge Laboratories Ltd announce today that OPi has received marketing authorisation for Xenazine® 25 mg (INN: tet rabenazine) from the "Agence Française de Sécurité Sanitaire des Produits de Santé" (AFSSaPS), the French regulatory authority. The product has been approved for use in the treatment of movement disorders associated with Huntington's disease and in the treatment of hemiballism. Xenazine® 25 mg is a neuroleptic-like agent developed by Cambridge Laboratories. In 2003, Cambridge Laboratories and OPi entered into a partnership agreement, whereby Cambridge Laboratories granted an exclusive license to OPi for the commercialization of Xenazine® in France. Since then, both partners have been actively collaborating to gain the French marketing authorisation. "This important regulatory achievement illustrates OPi's commitment and capabilities to make new treatments available for patients suffering from rare and severe diseases, as well delivering milestones in our partnership agreements", said Gilles Alberici, President and Founder of OPi SA. "Thanks to this approval and in close collaboration with Cambridge Laboratories, we are currently working to obtain pricing approval and are looking forward to launching Xenazine® 25 mg in France before the end of this year". Mark Evans, President and CEO, Cambridge Laboratories, commented: "We are delighted that OPi has received the approval for Xenazine in France which is the first approval for Xenazine in Europe outside of the UK and Denmark. This is a landmark decision for the future treatment of Huntington's disease and hemiballism in France and provides hope for patients with debilitating chorea." Thanks to its original mechanism of action based on the selective pre-synaptic depletion of monoamines and particularly dopamine in the central nervous system, by selectively inhibiting Vesicular Monoamine Transporter of Type 2 (VMAT2), Xenazine® 25 mg appears to be specifically suited for the treatment of movement disorders associated with Huntington's disease and of hemiballism. Approximately 6,000 patients suffer from Huntington's disease in France, a severe and debilitating neurodegenerative disease. In parallel with the progressive decline of their psychiatric and cognitive functions, all of these patients also develop hyperkinesia such as chorea (abnormal and involuntary movements), a disabling condition which dramatically alters their autonomy and social interactions and accelerates the need for institutionalisation. Hemiballism is another severe and rare hyperkinetic syndrome usually affecting patients with brain lesions following stroke. For complete information on Xenazine® 25 mg, please refer to the French Summary of Product Characteristics. About OPi SA Founded in 1999, OPi is a European integrated biopharmaceutical company whose mission is to develop and market pharmaceuticals (small molecules and biologicals) aimed at treating patients suffering from rare and severe diseases. OPi's primary focus is onco-haematology, with Kidrolase® and Erwinase®, an L-asparaginase franchise for the treatment of acute lymphoblastic leukaemia, and with a R&D portfolio of monoclonal antibodies at various stages of preclinical and clinical development. OPi is also active in other therapeutic areas, with hospital products targeting rare and severe diseases in neurology, metabolic diseases and clinical toxicology. Innovation and medical needs are the mainstays of OPi's approach. About Cambridge Laboratories Ltd Cambridge Laboratories is a fast growing, dynamic and entrepreneurial pharmaceutical company with extensive product development and commercialisation expertise focussed on innovative products in oncology and the 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. Utilizing this unusual business model, Cambridge is dedicated to delivering significant value to patients, physicians and partners around the world. For more information: OPi - Elisabeth Guichard; tel: + 33 (0)4 37 49 85 97; fax: + 33 (0)4 37 49 85 99 opi@orphan-opi.com - www.orphan-opi.com Cambridge Laboratories – Mark Evans, CEO; tel: + 353 1 631 9352; fax: + 353 1 631 9452 www.camb-labs.com
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