Cambridge Laboratories Announces Launch Of XENAZINE(R) (Tetrabenazine) In The US

Main Category: Huntingtons Disease
Article Date: 01 Dec 2008 - 3:00 PDT

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Cambridge Laboratories Group Limited ("Cambridge"), the privately-owned specialty pharmaceutical company, today announces that XENAZINE(R) (tetrabenazine), the first and only product approved for the treatment of chorea associated with Huntington's disease, has been launched in the US.

Following the US Food and Drug Administration's approval of XENAZINE(R) in August the product will be sold in the US by Ovation Pharmaceuticals, a leading biopharmaceutical company which develops and commercialises innovative medicines focused on diseases of the central nervous system (CNS), haematology and hospital-based products. Ovation will market XENAZINE(R) to US specialists through its 48-person sales force, who have considerable experience in CNS disorders.

The launch follows the acquisition of Cambridge's original marketing partner, Prestwick Pharmaceuticals, by Biovail in September this year. Under the agreement, Biovail will commercialise tetrabenazine in Canada (marketed under the Nitoman(R) brand name). Biovail will also supply XENAZINE(R) 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.

Ovation will distribute XENAZINE(R) via a specialty pharmacy network, designed to both help streamline prescription fulfilment and provide specialized assistance to healthcare professionals, patients and caregivers, including addressing questions about the appropriate use of XENAZINE(R).

Mr. Mark Evans, Chief Executive of Cambridge, commented: "The launch of XENAZINE(R) in the US is a significant milestone in Cambridge's history. We are delighted that XENAZINE(R) will be promoted in the US by Ovation, who we believe will be able to maximize XENAZINE(R)'s potential in this important market. This is the only treatment for what is a devastating disease and we are pleased that patients finally have a treatment to help alleviate their debilitating symptoms."

Huntington's disease is a hereditary and degenerative condition of the central nervous system (CNS) which carries a 50% risk of being inherited by the children of an affected parent. Huntington's disease affects a wide range of brain activities and symptoms gradually become apparent in middle age. Changes in personality or mood may be the earliest signs of the disease, followed by problems with memory and involuntary movements (chorea). 30,000 people suffer from Huntington's disease in the US alone, with the vast majority suffering from associated debilitating chorea.

XENAZINE(R) 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(R) 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 XENAZINE(R)

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

Cambridge Laboratories Group Limited