Vernalis PLC Regulatory News (VER)

20 Dec 2005 07:00

Vernalis PLC20 December 2005 20 December 2005 Vernalis Successfully Completes Frovatriptan Phase III Open Label Safety Study in Prevention of Menstrual Migraine Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced the successful completionof a long-term Phase III open-label safety study of frovatriptan administeredfor six days a month for 12 months in the prevention of migraine in patientswith migraines related to their menstrual cycles. In total, 525 patients enteredthe study and 308 (59%) completed all 12 treatment cycles with over 4,000peri-menstrual periods treated during the study. A minimum of 100 patientscompleting the study was required to fulfil the safety data objective. Theresults indicate that the long-term safety profile observed in this trial is inline with previous data from shorter-term studies. The full results of the studywill be presented at a scientific conference in due course. The treatment regimen for frovatriptan in this study was identical to the higherdose regimen in the initial efficacy study, namely 5 mg twice daily on day one,followed by 2.5 mg twice daily for the remaining five days. Patients wereinstructed to begin treatment two days before their anticipated day of migraineheadache. Simon Sturge, CEO of Vernalis, said, "We are delighted to see that the resultsof this long-term safety study for frovatriptan are in line with ourexpectations. We now look forward to completion of the ongoing Phase IIIconfirmatory efficacy trial in the first half of 2006 which, if positive, willbe closely followed by submission to the FDA." 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 acutemigraine indication. -- ends -- Enquiries: Vernalis plc +44 (0) 118 977 3133 Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial OfficerJulia Wilson, Head of Corporate Communications Brunswick Group +44 (0) 20 7404 5959Jon ColesWendel Verbeek Notes to Editors 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 60 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 specialty pharmaceutical company focused on products marketed tospecialist neurologists. The company has two marketed products, frovatriptan andApokyn(R), and a development pipeline focused on neurology and central nervoussystem disorders. The company has five products in clinical development andcollaborations with leading, global pharmaceutical companies including Novartis,Biogen Idec and Serono. Vernalis is establishing a US commercial operation topromote Apokyn(R) and co-promote frovatriptan alongside its North Americanlicensing partner, Endo Pharmaceuticals, propelling the company towards its goalof becoming a sustainable, self-funding, R&D-driven, specialty pharmaceuticalcompany. For further 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 expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions. This information is provided by RNS The company news service from the London Stock Exchange