Healthcare Industry News: Frova
News Release - July 19, 2006
Endo Pharmaceuticals and Vernalis plc Announce the Filing of the Supplemental NDA for Frova(R) for Short-Term Prevention of Menstrual MigraineCHADDS FORD, Pa., and WINNERSH, England, July 19 (HSMN NewsFeed) -- Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP ) and Vernalis plc (LSE: VER, Nasdaq: VNLS) today announced that Endo has submitted to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application (sNDA) for FrovaŽ (frovatriptan succinate) 2.5 mg tablets for the short-term (six days per month) prevention of menstrual migraine (MM). This submission contains data from previously reported pivotal Phase III studies that met their primary efficacy endpoints of reduction in incidence in MM.
If the sNDA is approved by the FDA, FrovaŽ will be the only triptan indicated in the U.S. for the prevention of MM. Currently, FrovaŽ is FDA-approved for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established.
Approximately 21 million American women suffer from migraines. Of these female migraineurs, approximately 60 percent, or 12 million women, are estimated to suffer from menstrual migraines, a condition which can have a serious and debilitating impact. Compared to non-menstrual migraines, menstrual migraines can be more severe and are reported to be longer in duration, often lasting up to three days.
"Doctors and patients need to understand that menstrual migraine differs from other kinds of migraines. These differences need to be taken into consideration in order for the condition to be treated appropriately," said Stephen Silberstein, M.D., professor of neurology at the Jefferson Medical College of Thomas Jefferson University, director of the Jefferson Headache Center and lead investigator of the initial efficacy study of FrovaŽ for the short-term prevention of menstrual migraine. "The predictable nature of menstrual migraine supports the future use of preventative therapy for this disabling condition."
"Menstrual migraines disrupt the lives of millions of women, but currently no triptan is approved to prevent them," said Peter A. Lankau, president and chief executive officer of Endo, which markets FrovaŽ in the U.S. "If approved, FrovaŽ would provide a novel treatment approach to address this unmet medical need. We are pleased to be submitting this sNDA for FrovaŽ to the FDA and will work closely with the Agency throughout the review process."
Simon Sturge, chief executive officer of Vernalis, stated "The data confirm the potential of FrovaŽ for the prevention of menstrual migraine. Short-term prevention could be a major benefit for women who do not respond well to acute treatment. We continue to be impressed by the therapeutic potential of FrovaŽ."
The sNDA for FrovaŽ is supported by data from four studies, including two Phase III studies examining the efficacy and safety of once- and twice-daily dose regimens of FrovaŽ in the short-term prevention of MM, a pharmacokinetics and tolerability study of once and twice-daily dosing of FrovaŽ, and a 12-month open-label safety study evaluating a six-day dosing regimen of FrovaŽ in 525 women.
Important Information about FrovaŽ
FrovaŽ 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. FrovaŽ is generally well tolerated, with a side-effect profile that is typical of the triptan class of drugs. FrovaŽ is indicated for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established. FrovaŽ 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 FrovaŽ have not been established for cluster headache, which is present in an older, predominantly male population.
FrovaŽ 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. FrovaŽ 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 FrovaŽ is one 2.5 mg tablet up to three times within a 24-hour period. FrovaŽ is not currently 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.
FrovaŽ 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 Menstrual Migraine
Menstrual Migraine (MM) can have a serious 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 MM may suffer from migraines at any time, although their migraine is frequently linked to their menstrual cycle. Over 60 percent of migraines in women are associated with menstruation.
Endo Pharmaceuticals Holdings Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products. Through its Endo Pharmaceuticals Inc. subsidiary, the company researches, develops, produces and markets a broad product offering of both branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at www.endo.com.
Vernalis is a speciality bio-pharmaceutical company focused on products marketed to specialist neurologists. The company has two marketed products, FrovaŽ and ApokynŽ, and a development pipeline focused on neurology and central nervous system disorders. The company has seven products in clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec and Serono. Vernalis has established a US commercial operation to promote ApokynŽ and co-promote FrovaŽ alongside its North American licensing partner, Endo Pharmaceuticals, propelling the company towards its goal of becoming a sustainable, self-funding, R&D-driven, speciality bio-pharmaceutical company. For further information about Vernalis, please visit www.vernalis.com.
Endo Pharmaceuticals Inc. +1-610-558-9800
Bill Newbould, Vice President, Corporate Communications
Vernalis plc +44 (0) 118 977 3133
Simon Sturge, Chief Executive Officer
John Hutchison, Development Director
Julia Wilson, Head of Corporate Communication
GCI Group +1-212-537-8297
Brunswick Group +44 (0) 20 7404 5959
Endo Forward-Looking Statement
This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management's beliefs and assumptions, current expectations, estimates and projections. Statements that are not historical facts, including statements which are preceded by, followed by, or that include, the words "believes," "anticipates," "plans," "expects" or similar expressions and statements are forward-looking statements. Endo's estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Endo's current perspective on existing trends and information. Many of the factors that will determine the Company's future results are beyond the ability of the Company to control or predict. These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The Company undertakes no obligation to update any forward-looking statements whether as a result of new information, future events or otherwise. Several important factors, in addition to the specific factors discussed in connection with these forward-looking statements individually, could affect the future results of Endo and could cause those results to differ materially from those expressed in the forward-looking statements contained in this press release. Important factors that may affect future results include, but are not limited to: market acceptance of the Company's products and the impact of competitive products and pricing; dependence on sole source suppliers; the success of the Company's product development activities and the timeliness with which regulatory authorizations and product launches may be achieved; successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions; the availability on commercially reasonable terms of raw materials and other third party manufactured products; exposure to product liability and other lawsuits and contingencies; dependence on third party suppliers, distributors and collaboration partners; the ability to timely and cost effectively integrate acquisitions; uncertainty associated with pre- clinical studies and clinical trials and regulatory approval; uncertainty of market acceptance of new products; the difficulty of predicting FDA approvals; risks with respect to technology and product development; the effect of competing products and prices; uncertainties regarding intellectual property protection; uncertainties as to the outcome of litigation; changes in operating results; impact of competitive products and pricing; product development; changes in laws and regulations; customer demand; possible future litigation; availability of future financing and reimbursement policies of government and private health insurers and others; and other risks and uncertainties detailed in Endo's filings with the Securities and Exchange Commission, including its Registration Statement on Form S-3 filed with the SEC on March 21, 2006. Readers should evaluate any statement in light of these important factors.
Vernalis Forward-Looking Statement
This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products and including that of FrovaŽ for menstrual migraine, the Company's ability to find partners for the development and commercialisation of its products, the benefits of re-acquiring FrovaŽ in North America and the partnership with Endo on the Company's liquidity and results of operations, as well as the Company's future capital raising activities. 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, including with respect to FrovaŽ and the Company's other products, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of FrovaŽ and other products, as well as the achievement of expected synergies from such transactions, the acceptance of FrovaŽ and other products by consumers and medical professionals, 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.
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