Vernalis PLC Regulatory News (VER)

27 Jun 2005 07:00

Vernalis PLC27 June 2005 27 June 2005 Vernalis Reports Frovatriptan Interim Phase III Safety Data Frovatriptan well tolerated when used as six-day dosing regimen for up to six menstrual periods as preventive therapy for Menstrually Related Migraine Vernalis plc (LSE: VER, NASDAQ: VNLS) today announced six-month interim safetydata for frovatriptan, in development for the prevention of menstrually relatedmigraine (MRM) and marketed as Frova(R) in the U.S. by Vernalis' partner, EndoPharmaceuticals Inc. The data were presented at the 47th Annual ScientificMeeting of the American Headache Society which took place in Philadelphia June23-26, 2005. The interim data seem to indicate that frovatriptan is well-tolerated when usedas a six-day dosing regimen for up to six menstrual periods as preventivetherapy for MRM. No serious adverse events attributed to frovatriptan werereported. The trial is now nearing completion, with currently more than 300patients having received 12 months of treatment. This exceeds the studyobjective of treating 100 patients for 12 menstrual cycles. Migraine expert Dr Anne MacGregor commented, "This is a promising set of resultsin this population with MRM. Many women are disabled by menstrual attacks ofmigraine, which are often more severe and less responsive to existing treatmentsthan attacks at other times of the cycle. Hence there is a real need forwell-tolerated, effective and specific prophylactic treatments for thiscondition." "Frovatriptan's distinctively long half-life of 26 hours is a key element in ourinterest in determining whether it is an appropriate agent for migraineprophylaxis," said Simon Sturge, CEO of Vernalis. "The interim safety data fromthis study support our goal of seeking approval for frovatriptan for theprevention of MRM." - ends - Notes to Editors This safety trial is one of three required trials to complete the data packagefor a supplemental New Drug Approval (sNDA) application to market frovatriptanas a short-term prophylaxis for MRM in the U.S. The first, a 500-patientefficacy study, was completed in April 2003 and was reported in the journalNeurology in July 2004. The remaining two trials, the safety study and thesecond efficacy study, are ongoing, with regulatory submission expected in thefirst-half of 2006. • MRM Phase III Efficacy Study In October 2002, positive trial data were first presented from a study of morethan 500 menstrual migraine sufferers in the U.S., suggesting that short-termprophylaxis with frovatriptan was effective in preventing migraine headachestriggered by menstruation. The data demonstrated a highly statisticallysignificant improvement in the numbers of patients who were headache-free duringtheir menstrual cycles for both once and twice daily dose regimens offrovatriptan compared to placebo (p < 0.0001). These data were published in fullby a leading journal, Neurology (2004, 63: 261-269). • MRM Phase III Safety Study The 12 month, safety study, now fully enrolled, investigated the higher doseregimen that showed positive signs of efficacy in the initial efficacy studythat was published in Neurology in July 2004. In this safety study, femalepatients take frovatriptan tablets for six days each month (2 x 2.5 mg twicedaily on day 1, and 2.5 mg twice daily for five days) covering their menstrualcycles. The pre-specified safety review was planned to occur once 300 patientshad completed treatment for six menstrual cycles.The analysis was conducted on data from 442 patients, of whom 313 had completedata from at least six menstrual cycles. Any patient who had taken at least onedose of frovatriptan was included in the safety analysis. The mean age ofpatients was 37.5 years and the average duration of MRMs was 11 years. Theaverage number of MRMs experienced by patients in the previous year was 11.3. Amajority of the patients (83%) had experienced their migraines on the day ofmenstruation or up to two days beforehand, as previously reported. The trial is now nearing completion, with currently more than 300 patientshaving received 12 months of treatment. This exceeds the study objective oftreating 100 patients for 12 menstrual cycles. • Second MRM Phase III Efficacy Study A second, placebo-controlled, parallel group efficacy study began recruitment inOctober 2004 and is investigating the same dose regimen that was efficacious inthe initial study, published in Neurology in July 2004. Female patients takefrovatriptan tablets for six days each month covering their menstrual cycle.Around 600 patients whose menstrually related migraines are difficult to treatusing acute therapies are being enrolled and treated for three consecutivemonths. About Frova(R) Frova(R) was approved by the FDA on November 8, 2001 for the acute treatment ofmigraine attacks with or without aura (subjective symptoms at the onset of amigraine headache) in adults. Frova(R) is generally well tolerated, with aside-effect profile that is typical of the triptan class of drugs. Frova(R) isindicated for the acute treatment of migraine attacks with or without aura inadults where a clear diagnosis of migraine has been established. Frova(R) is notintended for the prophylactic therapy of migraine or for use in the managementof hemiplegic or basilar migraine. The safety and effectiveness of Frova(R) havenot been established for cluster headache, which is present in an older,predominantly male population. Frova(R) should not be given to patients with cerebrovascular syndromes,peripheral vascular disease, uncontrolled hypertension, ischemic heart disease,or to patients who have symptoms or findings consistent with ischemic heartdisease, coronary artery vasospasm, including Prinzmetal's variant angina orother significant underlying cardiovascular disease. Frova(R) should not begiven to patients within whom unrecognized coronary artery disease is predictedby the presence of risk factors without a prior cardiovascular evaluation.The most common adverse events (4%) include dizziness, fatigue, paresthesia,flushing, and headache. The FDA-approved dosing for Frova(R) is one 2.5 mg tablet up to three timeswithin a 24-hour period. Frova(R) has not been approved by the FDA for anyindications other than for the treatment of acute migraine headaches, and itssafety and efficacy in other indications have not been established.Frova(R) is licensed for this indication in the US. For other countries, checklocal prescribing information. Not necessarily licensed for this indicationoutside the US. Not for release in the UK. About MRM Menstrually Related Migraines (also known as MRM) can have a serious anddebilitating impact on women's lives because they last longer than non-menstrualmigraines, tend to be associated with severe pain and come back more often.Patients with MRM may suffer from migraines at any time, although their migraineis frequently linked to their menstrual cycle. Over 50 percent of migraines inwomen are associated with menstruation. Pain from these monthly migraines candisrupt a woman's ability to function for up to three days at a time. About Vernalis Vernalis is a UK-based biotechnology company with a marketed migraine product,frovatriptan, and a development pipeline focused on central nervous systemdisorders and oncology. The company has five products in clinical developmentand collaborations with leading, global pharmaceutical companies includingNovartis, Biogen Idec and Serono. Vernalis is establishing a US commercialoperation to co-promote frovatriptan alongside its North American licensingpartner, Endo Pharmaceuticals, propelling the company towards its goal ofbecoming a sustainable, self-funding, R&D-driven biotechnology company. Forfurther information about Vernalis, please visit www.vernalis.com Safe Harbour statement: this news release may contain forward-looking statementsthat reflect the Company's current expectations regarding future events.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 successfulintegration of completed mergers and acquisitions and achievement of expectedsynergies from such transactions, and the ability of the Company to identify andconsummate suitable strategic and business combination transactions. Enquiries: Vernalis plc +44 (0) 118 977 3133 Simon Sturge, Chief ExecutiveJohn Hutchison, Development DirectorJulia Wilson, Head of Corporate Communications Brunswick Group +44 (0) 20 7404 5959 Jon ColesWendel Verbeek This information is provided by RNS The company news service from the London Stock Exchange