11th Dec 2006 07:00
Vernalis PLC11 December 2006 11 December 2006 Vernalis Plc Initiates a Phase I Trial of a Promising New Approach to Treating Obesity and Related Disorders - Including Type II Diabetes WINNERSH, U.K., December 11, 2006 -- Vernalis plc (LSE: VER, Nasdaq: VNLS) todayannounced that it has started a Phase I trial of V24343, a CB1 antagonist, as apotential treatment for obesity, type II diabetes and related disorders. Cannabinoid type 1 receptors, (CB1) are widely expressed both in peripheraltissues involved in lipid and glucose metabolism and in the brain regionscontrolling appetite. Blockade of these receptors by selective CB1 receptorantagonists causes weight loss and ameliorates risk factors for obesity relateddisorders such as cardiovascular disease and type II diabetes. The efficacy ofCB1 receptor antagonists in the treatment of obesity, type II diabetes andassociated disorders has been clinically demonstrated in recent trials ofRimonabant. Simon Sturge, CEO of Vernalis commented: "There are only two drugs approved in the United States for long-term treatmentof obesity; both of which are limited by side effects. The knowledge that CB1antagonists reduce weight and have the capability to improve glucose control indiabetics has led to this promising new approach. Prevalence of obesity in theUS and Europe has reached epidemic levels and there is a clear opportunity foran effective and well-tolerated anti-obesity drug." The Phase I double-blind, randomised, placebo-controlled study in overweight andmildly obese volunteers will be conducted in two parts; a single ascending dosefollowed by a multiple ascending dose and is expected to complete in mid-2007.The primary objectives of the Phase I programme are to evaluate the safety,tolerability and pharmacokinetics of single and multiple doses of V24343;however, having overweight and mildly obese subjects in the trial ensures thatthe evaluation of V24343 is carried out in clinically relevant subjects. -- ends -- Enquiries: Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerJohn Hutchison, Development DirectorJulia Wilson, Head of Corporate Communications Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroy Lazar Partners LtdGregory Gin 212-867-1762 Notes to Editors About Obesity Obesity, defined as a body mass index of greater than 30, arises from theaccumulation of excess fat in the body from over consumption of fatty foodsAccording to the American Obesity Association, obesity is a disease that affectsnearly one-third of the adult American population (approximately 60 million).The number of overweight and obese Americans has continued to increase since1960, a trend that is not slowing down. Today, 64.5 percent of adult Americans(about 127 million) are categorized as being overweight or obese. Each year,obesity causes at least 300,000 excess deaths in the U.S., and healthcare costsof American adults with obesity amount to approximately $100 billion. The WorldHealth Organisation state that obesity is a major contributor to the globalburden of chronic disease and disability and has reached epidemic proportionsglobally, with more than one billion adults overweight, at least 300 million ofthem being classed as clinically obese. People with obesity are at risk ofdeveloping one or more serious medical conditions, which can cause poor healthand premature death. Obesity is associated with more than 30 medicalconditions, and scientific evidence has established a strong relationship withat least 15 of those conditions. About Diabetes Diabetes is a disease whereby the body does not produce or properly use insulin.Insulin is a hormone that is needed to convert sugar, starches and other foodinto energy. The dramatic rise in the incidence of type II diabetes is thoughtto be largely due to the increased prevalence of obesity. Type I diabetesresults from the body's failure to produce insulin and it is estimated that5-10% of Americans who are diagnosed with diabetes have type I diabetes. Themore prevalent, type II diabetes results from insulin resistance (a condition inwhich the body fails to properly use insulin), combined with relative insulindeficiency and accounts for between 85 - 95% of all people with diabetes.According to the American Diabetes Association, there are 20.8 million childrenand adults in the United States who have diabetes. While an estimated 14.6million of these have been diagnosed almost one-third are unaware that they havethe disease. About Vernalis Vernalis is a speciality bio-pharmaceutical company focused on products marketedto specialist neurologists. The company has two marketed products, Frova(R) andApokyn(R), and a development pipeline focused on neurology and central nervoussystem disorders. The company has eight products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec and Serono. Vernalis has established a US commercial operation topromote Apokyn(R) and co-promote Frova(R) alongside its North American licensingpartner, Endo Pharmaceuticals, progressing the company towards its goal ofbecoming a sustainable, self-funding, R&D-driven, speciality bio-pharmaceuticalcompany. For further information about Vernalis, please visit: www.vernalis.com Product Indication Phase Phase Phase Marketing Rights I II III Registration Market Apokyn Parkinson's x North America(R) DiseaseFrova Migraine x US milestones &(R) royalties - Endo (EU - royalties)Frova Menstrual x US milestones &(R) Migraine royalties - Endo Prevention (EU - royalties)V1512 Parkinson's x World Wide Disease (excl. Italy)V10153 Ischaemic x World Wide strokeV1003 Acute Pain x US Profit share Option Reckitt BenckiserV3381 Neuropathic x World Wide PainV2006 Parkinson's x US Co-promotion Disease Biogen IdecMMPI Multiple x None - royalty Sclerosis (Serono)V24343 Obesity x World Wide Vernalis Forward-Looking Statement This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events including the clinicaldevelopment and regulatory clearance of the Company's products, the Company'sability to find partners for the development and commercialisation of itsproducts, as well as the Company's future capital raising activities.Forward-looking statements involve risks and uncertainties. Actual events coulddiffer materially from those projected herein and depend on a number of factorsincluding the success of the Company's research strategies, the applicability ofthe discoveries made therein, the successful and timely completion of clinicalstudies, the uncertainties related to the regulatory process, the ability of theCompany to identify and agree beneficial terms with suitable partners for thecommercialisation and/or development of its products, as well as the achievementof expected synergies from such transactions, the acceptance of Frova(R) andApokyn(R) and other products by consumers and medical professionals, thesuccessful integration of completed mergers and acquisitions and achievement ofexpected synergies from such transactions, and the ability of the Company toidentify and consummate suitable strategic and business combinationtransactions. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Vernalis PLC