Healthcare Industry News:  XENAZINE 

Biopharmaceuticals Neurology FDA

 News Release - August 18, 2008

Cambridge Laboratories Announces FDA Approval of XENAZINE(R) (tetrabenazine) in the US

First Treatment Licensed for Chorea Associated With Huntington's Disease

LONDON, August 18 (HSMN NewsFeed) -- Cambridge Laboratories Group Limited ("Cambridge"), the privately owned specialty pharmaceutical company, announces today that XENAZINE® (tetrabenazine), the first and only product for the treatment of chorea associated with Huntington's disease, has received approval by the Food and Drug Administration (FDA) in the US. XENAZINE® will be distributed in the US by Cambridge's partner Prestwick Pharmaceuticals, Inc. ("Prestwick").

Today's announcement follows the FDA's Peripheral and Central Nervous System Drugs Advisory Committee's unanimous decision in December 2007 to recommend XENAZINE® for approval. 30,000 people suffer from Huntington's disease in the US alone, with the vast majority suffering from associated debilitating chorea. XENAZINE® is the first and only therapy approved by the FDA to treat chorea associated with Huntington's disease. In a large Phase 3 study published in Neurology in 2006, XENAZINE® demonstrated its ability to significantly reduce patients' chorea burden without causing many of the side effects often seen with other unlicensed treatment strategies.

Cambridge owns the worldwide rights to XENAZINE® and licensed the US and Canadian rights to Prestwick Pharmaceuticals in 2002 and 2004 respectively. The drug is marketed as NITOMAN® in Canada and is approved for the treatment of various hyperkinetic movement disorders, including chorea associated with Huntington's disease. It is also approved in 14 other countries, including the UK, France, Germany, Italy and Australia and recently approved territories, the Netherlands, Sweden and Switzerland.

Mark Evans, Chief Executive of Cambridge, said:

"We are delighted XENAZINE® has been approved by the FDA. It is the only approved product in the key US market for the treatment of chorea associated with Huntington's disease and we are pleased that physicians will soon have the benefit of being able to offer this product to patients who currently have nothing to alleviate the suffering from this extremely debilitating disease. XENAZINE® is Cambridge's lead product and continues to achieve great success outside of the US. Today's decision by the FDA is a significant milestone for our company and further underlines our strong dedication to both CNS and specialist secondary care. We look forward to working with our marketing partner Prestwick to drive XENAZINE's success as it enters the key US market place."

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 XENAZINE®

XENAZINE® is a highly selective and reversible dopamine depletor that works by inhibiting vesicular monoamine transporter 2 (VMAT2). XENAZINE® 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 XENAZINE®, as TETRABENAZINE® in Australia, and as NITOMAN® 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 XENAZINE® 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 Group

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