Healthcare Industry News:  tetrabenazine 

Biopharmaceuticals Neurology

 News Release - September 17, 2008

Cambridge Laboratories Announces New Marketing Arrangements for XENAZINE(R) in North America

Ovation and Biovail to Market First Treatment Licensed for Movement Disorders Associated With Huntington's Disease

DUBLIN, Ireland and NEWCASTLE, England, September 17 (HSMN NewsFeed) -- Cambridge Laboratories Group Limited ("Cambridge" or the "Company"), the privately-owned specialty pharmaceutical company, announces today that its product XENAZINEŽ (tetrabenazine), the first and only product for the treatment of chorea associated with Huntington's disease, will be marketed in the US by Ovation Pharmaceuticals, Inc. and in Canada by Biovail Corporation (NYSE/TSX: BVF).

The agreement follows the acquisition of Cambridge's original marketing partner Prestwick Pharmaceuticals by Biovail. XENAZINEŽ was approved by the Food and Drug Administration (FDA) in the US in August and the product's commercial launch is anticipated in late 2008. The FDA has also granted XENAZINEŽ orphan drug status, providing the product with seven years of market exclusivity from launch in the US.

Ovation is a leading biopharmaceutical company which develops and commercialises innovative medicines focused on diseases of the central nervous system (CNS), haematology and hospital-based products. Based in Deerfield, Illinois, Ovation has a history of successfully partnering with leading companies including Sanofi-Aventis, Merck and Abbot. Ovation will market XENAZINEŽ to US specialists through its 48-person sales force, who have considerable experience in CNS disorders, including epilepsy and Attention Deficit Disorder.

Biovail Corporation is Canada's largest publicly traded pharmaceutical company. Biovail will commercialise tetrabenazine tablets in Canada (marketed under the NitomanŽ brand name) through its specialist sales force. It will pay Cambridge Laboratories a variable supply price ranging from 50% to 67% of net sales. Biovail will also supply XENAZINEŽ to Ovation for a variable percentage of the product's annual net sales, and will in turn pay a supply price of 50% of net sales to Cambridge.

Mark Evans, CEO of Cambridge said: "We are delighted that XENAZINEŽ will be promoted in North America by Ovation and Biovail. Both are well established companies with specialist sales forces who we believe will be able to maximise XENAZINEŽ's potential in these two key markets. Ovation will launch the product in the US before the end of the year using its dedicated CNS sales force and enabling US patients to have access to this important new product as soon as possible."

Approximately 30,000 people suffer from Huntington's disease in the US alone, with the vast majority suffering from associated debilitating chorea. In a large Phase 3 study published in Neurology in 2006, XENAZINEŽ demonstrated its ability to significantly reduce patients' chorea burden without causing many of the side effects often seen with other unlicensed treatment strategies.

About Cambridge Laboratories Group Limited

Cambridge is a fast growing, dynamic and entrepreneurial pharmaceutical company with extensive product development and commercialisation expertise focussed on innovative products in 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.

About XENAZINEŽ

XENAZINEŽ is a highly selective and reversible dopamine depletor that works by inhibiting vesicular monoamine transporter 2 (VMAT2). XENAZINEŽ is the first product for treatment of chorea associated with Huntington's disease which has been approved by the U.S. Food and Drug Administration. Chorea, a debilitating feature of a number of neurological diseases, is characterized by excessive, involuntary, and repetitive movements, which may involve the face, limbs, or the entire body. In Huntington's disease, it is the result of over-activity of the neurotransmitter dopamine.

Cambridge has worldwide rights to tetrabenazine and markets the product through its own direct salesforce in the UK and Eire, and through marketing partners in Europe and other global markets. The product is available in most European markets, South Africa and New Zealand under the name XENAZINEŽ, as tetrabenazineŽ in Australia, and as NITOMANŽ in Canada and other key European territories including Germany.

In February 2006, Cambridge reported the results of a Phase III trial, published in Neurology, demonstrating that XENAZINEŽ significantly reduced patients' chorea burden without causing many of the side effects seen with other treatments. The 84 patient study was the largest Phase III trial ever undertaken in Huntington's chorea.


Source: Cambridge Laboratories

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