September 17, 2008
OVATION Pharmaceuticals Acquires Rights to Commercialize Xenazine(R) (Tetrabenazine) in U.S. For Chorea Associated With Huntington’s Disease
OVATION Pharmaceuticals, Inc. announced today that it has acquired from Prestwick Pharmaceuticals the exclusive license in the United States to commercialize Xenazine(R) (tetrabenazine), an orphan drug recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington's Disease (HD). Financial terms of the deal were not disclosed. Subsequently, Biovail Corporation, Canada's largest publicly traded pharmaceutical company, acquired Prestwick.
Under the terms of the agreement, Biovail and OVATION will jointly develop additional follow-on indications for Xenazine and related products in the U.S. in conjunction with Cambridge Laboratories Limited, the worldwide license holder of the drug. Xenazine is the first and only FDA-approved treatment for any HD-related disorders. OVATION expects to launch the product in the U.S. by the end of this year."Obtaining the rights to Xenazine in the U.S. adds another important growth driver to our series of multiple specialty product launches expected over the next several years," said Jeffrey S. Aronin, President and Chief Executive Officer of OVATION. "This drug represents a strong strategic fit and complements our existing portfolio of central nervous system products, in addition to continuing our business strategy of pursuing opportunities to bring important new medicines to severely ill patients with unmet medical needs."
Noting OVATION's strong commercial capabilities to support the launch of Xenazine, Aronin added, "We will be able to efficiently and effectively reach patients suffering from this devastating neurodegenerative and ultimately fatal disease. We are pleased that we can bring to these patients the first approved therapy to treat this disorder."
Chorea affects approximately 25,000 Americans, interfering with their ability to perform activities of daily living, including dressing, bathing and caring for themselves. Currently there are no treatments to stop or reverse the onset or progression of HD. Chorea is a debilitating movement disorder characterized by excessive, involuntary and repetitive movements which are the most visible and dangerous manifestations of Huntington disease.
The precise mechanism by which Xenazine exerts its anti-chorea effects is unknown, but it is believed to be related to its effects as a reversible depletor of monoamines by inhibiting a molecule known as vesicular monoamine transporter 2 (VMAT2). Xenazine has been designated an orphan drug by the FDA.
The most frequent adverse events reported with Xenazine in a randomized, 12-week, placebo controlled clinical trial of HD subjects include sedation/somnolence, fatigue, insomnia, depression, akathisia and nausea. Xenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease and the drug is therefore contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression. Xenazine is also contraindicated in patients with impaired hepatic function and in patients taking monoamine oxidase inhibitors or reserpine. Although Xenazine has been shown to decrease the chorea of HD, it was also shown to cause slight worsening in mood, cognition, rigidity and functional capacity and prescribers should periodically re-evaluate the need for therapy.
About OVATION Pharmaceuticals
OVATION is a fast-growing biopharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system, hematology/oncology, and hospital-based therapies. The four new launches the company expects over the next three years will largely be fueled by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 "Pharma Company of the Year" award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at www.ovationpharma.com.