Vernalis Reports Completion of Recruitment on Frovatriptan Phase III Efficacy Study
6 September 2005
Vernalis plc (LSE: VER, NASDAQ: VNLS) today announces that patient enrolment for the confirmatory Phase III efficacy study of frovatriptan for intermittent, short-term prevention of menstrually related migraine (MRM) has completed. The study is investigating the potential of frovatriptan taken both once and twice daily to prevent menstrual migraines. Top-line data from this trial and the filing of a supplemental New Drug Application, to include data from the three Phase III trials undertaken by Vernalis, are on schedule for the first half of 2006.
Frovatriptan, marketed as Frova® in the U.S. by Vernalis’ partner, Endo Pharmaceuticals Inc., is a selective 5-HT1B/1D receptor agonist approved as an acute oral treatment for migraine headache and its associated symptoms. It is one of a class of prescription drugs called triptans that are approved for this acute migraine indication.
“We are pleased to have achieved this important milestone for the company,” said Simon Sturge, CEO of Vernalis. “Menstrual migraine is a form of migraine suffered by approximately 60 per cent of female migraineurs in the United States, which represents approximately 12 million women. None of the triptan class of drugs is currently approved for prophylactic use in menstrual migraine and, if the studies are positive, we look forward to submitting the full data package to the FDA in the first half of 2006.”
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Enquiries:
Vernalis plc +44 (0) 118 977 3133
Simon Sturge, Chief Executive
John Hutchison, Development Director
Julia Wilson, Head of Corporate Communications
Brunswick Group +44 (0) 20 7404 5959
Jon Coles
Wendel Verbeek
Notes to Editors
This efficacy trial is one of three required trials to complete the data package for a supplemental New Drug Approval (sNDA) application to market frovatriptan as an intermittent, short-term prophylaxis for MRM in the U.S. The first, a 500-patient efficacy study, was completed in April 2003 and was reported in the journal Neurology in July 2004. The remaining two trials, the safety study and the second efficacy study, are ongoing, with regulatory submission expected in the first-half of 2006.
· MRM Phase III Efficacy Study
In October 2002, positive trial data were first presented from a study of more than 500 menstrual migraine sufferers in the U.S., suggesting that short-term prophylaxis with frovatriptan was effective in preventing migraine headaches triggered by menstruation. The data demonstrated a highly statistically significant improvement in the numbers of patients who were headache-free during their menstrual cycles for both once and twice daily dose regimens of frovatriptan compared to placebo (p ‹ 0.0001). These data were published in full by a leading journal, Neurology (2004, 63: 261-269).
· MRM Phase III Safety Study
In this study, which investigated the higher dose regimens from the initial efficacy study, female patients took frovatriptan for six days each month (2 x 2.5 mg twice daily on day 1, and 2.5 mg twice daily for five days) covering their menstrual cycles. Six-month interim safety data were presented at the 47th Annual Scientific Meeting of the American Headache Society, which took place in Philadelphia in June 2005. These data indicated that frovatriptan is well-tolerated when used as a six-day dosing regimen for up to six menstrual periods as preventive therapy for MRM . No serious adverse events attributed to frovatriptan were reported. All patients have now completed the study with more than 300 patients receiving 12 months of treatment, exceeding the study objective of treating 100 patients for 12 menstrual cycles.
· Second MRM Phase III Efficacy Study
This placebo-controlled, parallel group efficacy study achieved its recruitment target in August 2005. Over 550 patients who have been difficult to treat using acute therapies have been included in the study, which is investigating the same regimens that were found to be efficacious in the first study, published in Neurology in July 2004. Female patients are treated for six days each month covering their menstrual cycle starting two days before the expected onset of headache and are randomised to placebo, once a day dosing with frovatriptan and twice a day dosing with frovatriptan.
About Frova®
Frova® was approved by the FDA on November 8, 2001 for the acute treatment of migraine attacks with or without aura (subjective symptoms at the onset of a migraine headache) in adults. Frova® is generally well tolerated, with a side-effect profile that is typical of the triptan class of drugs. Frova® is indicated for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established. Frova® is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of Frova® have not been established for cluster headache, which is present in an older, predominantly male population.
Frova® 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 heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina or other significant underlying cardiovascular disease. Frova® should not be given to patients within whom unrecognized coronary artery disease is predicted by 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® is one 2.5 mg tablet up to three times within a 24-hour period. Frova® has not been approved by the FDA for any indications other than for the treatment of acute migraine headaches, and its safety and efficacy in other indications have not been established.
Frova® is licensed for this indication in the US. For other countries, check local prescribing information. Not necessarily licensed for this indication outside the US. Not for release in the UK.
About MRM
Menstrually Related Migraines (also known as MRM) can have a serious and debilitating impact on women’s lives because they last longer than non-menstrual migraines, tend to be associated with severe pain and come back more often. Patients with MRM may suffer from migraines at any time, although their migraine is frequently linked to their menstrual cycle. Over 50 percent of migraines in women are associated with menstruation. Pain from these monthly migraines can disrupt 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 system disorders and oncology. The company has six products in clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec and Serono. Vernalis is establishing a US commercial operation to co-promote frovatriptan alongside its North American licensing partner, Endo Pharmaceuticals, propelling the company towards its goal of becoming a sustainable, self-funding, R&D-driven biotechnology company. For further information about Vernalis, please visit www.vernalis.com
Safe Harbour statement: this news release may contain forward-looking statements that reflect the Company’s current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the successful integration 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.
