Paris and London, 13 June 2005 - Fournier Pharma and Xytis Pharmaceuticals Ltd. announced today that they have signed an agreement for the development and commercialisation of Anatibant (LF16-0687MS), a potential new medication for the treatment of traumatic brain injury, originating from Fournier Pharma's Research.
Fournier Pharma has granted Xytis an exclusive worldwide license for the development, manufacture and sale of the product containing its bradykinin B2 antagonist Anatibant for traumatic brain injury and possibly other indications. Fournier Pharma has retained full rights to manufacture the compound. The parties do not wish to disclose further details on the transaction.
Jean-Louis Junien, Chief Scientific Officer, Fournier Pharma, said: "Development in brain trauma is complex, but Anatibant is a very promising compound. Because its mechanism targets the treatment of cerebral edema, it should reduce early mortality, prevent long-term functional handicap and improve neurological outcome. I am pleased that this innovative compound from our Research Group is progressing into phase II with Xytis."
Sandrine Cailleteau, Vice President Business Development & Licensing, Fournier Pharma, commented: "This partnership is very positive as it allows us to optimize our R&D. We can concentrate our resources on metabolic diseases, our core business, while still being able to continue the development of Anatibant through Xytis' strong commitment."
Dr. Werner Tschollar, founder and CEO of Xytis Pharmaceuticals Ltd., said: "Traumatic brain injury is an area of high unmet medical need. Anatibant belongs to the therapeutic class of bradykinin B2 inhibitors, which has demonstrated in previous clinical and non-clinical studies a potential benefit for the prevention of secondary brain damage in traumatic brain injury. We believe that Anatibant has a very good chance of becoming the first ever marketed drug improving TBI patients' clinical outcome."
About Traumatic Brain Injury
Traumatic brain injury (TBI) is a major cause of disability and death and generates significant economic costs to our society. There is currently no effective therapy available to treat this condition. The incidence rate of moderate and severe TBI represents 300,000 new case per year in the US, Europe and Japan Severe TBI is often associated with permanent functional and cognitive disorders, learning disabilities and a range of behavioural and emotional problems.
The occurrence of TBI is highest among young and elderly people. The leading causes of TBI are motor vehicle accidents, firearms and accidental falls (the leading cause of brain injury in the elderly). TBI is also a major cause of hospitalisation in the military. The annual market potential for the first FDA-approved drug treating TBI in the U.S. alone is estimated above $500 million and the worldwide market potential above $1 billion.
About Anatibant (LF16-0687MS)
Anatibant is a new potent and selective non-peptide antagonist of the bradyknin B2 receptor. Phase-I clinical trials have evaluated the safety and the pharmacokinetics of the compound in both healthy volunteers and in patients with severe traumatic brain injury. The compound was shown to be well tolerated. Anatibant has received Fast Track designation and Orphan Drug status in the EU and in the US in January 2004 and April 2005.
About Fournier Pharma
Fournier Pharma is a pharmaceutical company with 30 years of experience in the study of lipid disorders and cardiovascular diseases. Its activities are focused on the treatment of metabolic diseases and the prevention of cardiovascular risk.
With spending on Research and Development accounting for 13% of turnover, Fournier Pharma is today working on the discovery of new drug targets and innovative drugs in the field of metabolic diseases, in particular for the treatment of diabetes, dyslipidemia and atherosclerosis.
With a total of 3 400 employees, Fournier Pharma reached sales of 593 million euros in 2004, of which 74% was generated outside France through subsidiary companies and partnerships. Today, Fournier Pharma has a direct presence in 30 countries worldwide including the main countries of Europe, the US, Canada, China, and South East Asia, and markets its products in more than 80 countries.
Please visit us at www.fournierpharma.com
About Xytis Pharmaceuticals Ltd.
Xytis Pharmaceuticals Ltd. is a start-up company focused on the in-licensing and the development of later stage CNS drug candidates. The company was founded by Dr. Werner Tschollar, a seasoned entrepreneur and pharmaceutical industry executive, who previously held senior R&D positions with Bristol-Myers Squibb, Schering Plough and Novartis. The company received financing from Atlas Venture and CDC Entreprises Innovation.
Xytis has started assembling a pipeline of novel compounds addressing major unmet needs in the psychiatric and neurological fields. The first product in-licensed by Xytis is neboglamine, a potential new anti-psychotic compound showing great potential to treat a variety of disorders, including negative symptoms of schizophrenia as well as depressive and cognitive disorders. Neboglamine will start Phase I in Europe in 2005.
Please visit us at www.xytis.com
For more information contact:
Lise LEMONNIERCorporate Communication ManagerFournier PharmaTel +33 3 80 44 73 86Email: firstname.lastname@example.org
Dr. Werner TSCHOLLARChief Executive OfficerXytis Pharmaceuticals Ltd.Tel: +41 22 994 2895Email: email@example.com
Jean-Noël ODIERChief Financial OfficerXytis Pharmaceuticals Ltd.Tel: +41 22 994 2892Email: firstname.lastname@example.orgPR representative:Christophe LAMPSRochat PartnersTel: +41 22 786 54 55Email: email@example.com