Vernalis PLC Regulatory News (VER)

6 Sep 2005 07:00

Vernalis PLC06 September 2005 6 September 2005 Vernalis Reports Completion of Recruitment on Frovatriptan Phase III Efficacy Study Vernalis plc (LSE: VER, NASDAQ: VNLS) today announces that patient enrollmentfor the confirmatory Phase III efficacy study of frovatriptan for intermittent,short-term prevention of menstrually related migraine (MRM) has completed. Thestudy is investigating the potential of frovatriptan taken both once and twicedaily to prevent menstrual migraines. Top-line data from this trial and thefiling of a supplemental New Drug Application, to include data from the threePhase III trials undertaken by Vernalis, are on schedule for the first half of2006. Frovatriptan, marketed as Frova(R) in the U.S. by Vernalis' partner, EndoPharmaceuticals Inc., is a selective 5-HT1B/1D receptor agonist approved as anacute oral treatment for migraine headache and its associated symptoms. It isone of a class of prescription drugs called triptans that are approved for thisacute migraine indication. "We are pleased to have achieved this important milestone for the company," saidSimon Sturge, CEO of Vernalis. "Menstrual migraine is a form of migrainesuffered by approximately 60 per cent of female migraineurs in the UnitedStates, which represents approximately 12 million women. None of the triptanclass of drugs is currently approved for prophylactic use in menstrual migraineand, if the studies are positive, we look forward to submitting the full datapackage to the FDA in the first half of 2006." - ends - 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 Notes to Editors This efficacy trial is one of three required trials to complete the data packagefor a supplemental New Drug Approval (sNDA) application to market frovatriptanas an intermittent, short-term prophylaxis for MRM in the U.S. The first, a500-patient efficacy study, was completed in April 2003 and was reported in thejournal Neurology in July 2004. The remaining two trials, the safety study andthe second efficacy study, are ongoing, with regulatory submission expected inthe first-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 In this study, which investigated the higher dose regimens from the initialefficacy study, female patients took frovatriptan for six days each month (2 x2.5 mg twice daily on day 1, and 2.5 mg twice daily for five days) coveringtheir menstrual cycles. Six-month interim safety data were presented at the 47thAnnual Scientific Meeting of the American Headache Society, which took place inPhiladelphia in June 2005. These data indicated that frovatriptan iswell-tolerated when used as a six-day dosing regimen for up to six menstrualperiods as preventive therapy for MRM. No serious adverse events attributed tofrovatriptan were reported. All patients have now completed the study with morethan 300 patients receiving 12 months of treatment, exceeding the studyobjective of treating 100 patients for 12 menstrual cycles. • Second MRM Phase III Efficacy Study This placebo-controlled, parallel group efficacy study achieved its recruitmenttarget in August 2005. Over 550 patients who have been difficult to treat usingacute therapies have been included in the study, which is investigating the sameregimens that were found to be efficacious in the first study, published inNeurology in July 2004. Female patients are treated for six days each monthcovering their menstrual cycle starting two days before the expected onset ofheadache and are randomised to placebo, once a day dosing with frovatriptan andtwice a day dosing with frovatriptan. 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 six products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec and Serono. Vernalis is establishing a US commercial operation toco-promote frovatriptan alongside its North American licensing partner, EndoPharmaceuticals, propelling the company towards its goal of becoming asustainable, self-funding, R&D-driven biotechnology company. For furtherinformation 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. This information is provided by RNS The company news service from the London Stock Exchange