Vernalis PLC Regulatory News (VER)

13 Sep 2007 07:01

Vernalis PLC13 September 2007 13 September 2007 VERNALIS ANNOUNCES STRIKING WEIGHT LOSS IN PHASE I STUDY WITH V24343 IN OVERWEIGHT AND MILDLY OBESE VOLUNTEERS Vernalis plc (LSE: VER) today announced the results of its Phase I programmewith the CB1 antagonist, V24343 which has completed two Phase I studies: asingle and multiple ascending dose study for up to 14 days, and a food effectstudy. • Striking weight loss over 16 days in overweight and mildly obese volunteers • Evaluated in a total of 66 volunteers • Generally well tolerated with no serious adverse events • Evidence of efficacy also demonstrated by clinically relevant reductions in body fat, energy intake and waist circumference • Pre-clinical data demonstrated significant safety differences from Sanofi-aventis CB1 antagonist, rimonabant. Simon Sturge, CEO of Vernalis commented "We are very excited by thesepreliminary results which, if confirmed over longer studies, will be ofsignificant benefit to overweight and obese patients. We stated from the outsetof this trial that it is our intention to seek a partner for this programme, aprocess which is enhanced by such promising data". Safety and Tolerability V24343 was generally well tolerated over the dose range with two patientswithdrawing due to adverse events (nausea and vomiting) in the highest dosecohorts. Other tolerability events were as expected for a CB1 antagonist. Therewere no serious adverse events. Efficacy Measures of efficacy were taken in the multiple ascending dose study in whichpatients were treated at 4 daily dose levels of 5mg, 15mg, 50mg and 100mg. Inthis trial, there were clear beneficial effects of V24343 at all dose levelsacross multiple parameters including weight loss, waist circumference, body fatand energy intake. Average weight loss after 16 days was 0.5kg for placebo, 2.6kg for 5mg V24343and 5.0kg for 100mg V24343. This compares very favourably with results forrimonabant in a similar trial in obese volunteers over 1 week, which showedplacebo-corrected weight loss of 0.7kg. Differentiation from Rimonabant The striking weight loss demonstrated in the Phase I study above gives furthercredence to the effectiveness of CB1 antagonists as weight loss agents. The U.S.Food and Drug Administration (FDA) advisory committee decision to not supportthe approval of rimonabant for a number of reasons, including risks associatedwith depression, may be relevant to this class of drug. However, the question asto whether or not other CB1 antagonists can achieve similar or improved efficacywithout major side effects remains open. Indeed, V24343 has shown a number ofdistinguishing features over rimonabant in pre-clinical studies including: •A markedly reduced propensity for neurological adverse events •Lower propensity to induce nausea and GI disturbance •Improved metabolic profile. More lengthy trials will be required to evaluate fully the long-term safety andefficacy of this product in the treatment of obesity and other indications suchas management of diabetes. -- ends --Enquiries: Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial Officer Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroyAlex Tweed Lazar Partners LtdGregory Gin +1 212-867-1762 Notes to Editors 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 seven products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec, Serono and Chiesi: Product Indication Phase I Phase Phase Registration Market Marketing Rights II IIIApokyn(R) Parkinson's X North America DiseaseFrova(R) Acute X US Co-promotion Migraine Endo (EU-royalties Menarini)Frova(R) Menstrual X US Co-promotion Migraine Endo Prevention (EU-royalties Menarini)V1512 Parkinson's X World Wide (excl. Disease Italy)V10153 Ischaemic X World Wide StrokeV3381 Neuropathic X World Wide PainV2006 Parkinson's X US Co-promotion Disease Biogen IdecV24343 Obesity X World WideHsp90 Cancer X Royalty (Novartis)MMPI Multiple X Royalty (Serono) Sclerosis Vernalis has established a US commercial operation to promote Apokyn (R) andco-promote Frova (R) alongside its North American licensing partner, EndoPharmaceuticals, propelling the company towards its goal of becoming asustainable, self-funding, R&D-driven, speciality bio-pharmaceutical company.For further information about Vernalis, please visit www.vernalis.com. About V24343 Scientists have long known that cannabis, which stimulates a receptor in thebrain called the CB1 receptor, also stimulates appetite as evidenced by thehunger pangs or "munchies" often experienced by cannabis smokers. Blockade ofthese CB1 receptors by products like V24343 has been shown to cause weight lossand may reduce risk factors for obesity related disorders such as cardiovasculardisease and type II diabetes. 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 including diabetes, heart disease and high blood pressure andscientific evidence has established a strong relationship with at least 15 ofthose conditions. 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 Exchange