12th Apr 2005 13:30
Vernalis PLC12 April 2005 Date 12 April 2005 Vernalis' US licensing partner, Endo Pharmaceuticals Inc. Launches "RALLY for Menstrual Migraine" with Serena Williams Vernalis plc (LSE: VER, NASDAQ: VNLS) today announced that its US partner, EndoPharmaceuticals Inc., a leader in pain management, has launched an educationalcampaign with tennis champion Serena Williams, "RALLY for Menstrual Migraine,"which aims to build awareness of menstrually-related migraine. See Endo pressrelease below. Ann Turner, Director of the Migraine Action Association, said: "Around 4 millionwomen in the UK suffer from migraine and many report that they are moresusceptible to an attack around the time of their menstrual period. Attacks canbe severely debilitating and have a considerable impact on the quality of lifeof sufferers, their family and their work life. Serena's campaign will increaseawareness of menstrually-related migraine, a condition which, despite itsprevalence, is under-diagnosed and often inappropriately treated." ----ends---- Enquiries: Vernalis plc +44 (0) 118 977 3133 Simon Sturge, Chief Executive Tony Weir, Chief Financial Officer Julia Wilson, Head of Corporate Communications Brunswick Group +44 (0) 20 7404 5959 Jon Coles Wendel Verbeek Laure Korenian-Chabert For further information about migraine and the work of the Migraine ActionAssociation visit their website on: http://www.migraine.org.uk 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. SERENA WILLIAMS LAUNCHES "RALLY FOR MENSTRUAL MIGRAINE" CAMPAIGN WITH ENDO PHARMACEUTICALS - First Menstrual Migraine Website Announced - www.menstrualmigraine.org - CHADDS FORD, PA, April 12, 2005 - Tennis great Serena Williams and EndoPharmaceuticals Inc., a market leader in pain management, today announced thelaunch of a new program for female migraine patients. "RALLY for MenstrualMigraine" was announced today at the American Academy of Neurology meeting inMiami, Fla. The "RALLY" (which stands for Raise Awareness LocalLY) campaign ispart of a national educational effort to encourage women who may suffer frommenstrual migraines to talk to their doctors about their condition andappropriate treatment. Separately, Endo is also supporting the formation of theNational Menstrual Migraine Coalition, led by the National Headache Foundationand a group of leading headache specialists. Serena Williams suffers from menstrual migraines along with nearly 13 millionAmerican women and has decided to tell her story so that women will know help isavailable. "I suffered with menstrual migraines for years before my doctor found atreatment appropriate for me," says Williams, one of the most dominant women intennis whose game has sometimes been severely affected by her migraines. "Now,I've joined the RALLY for Menstrual Migraine campaign to tell women my story,let them know that there is hope and that they should seek help." Last year, the 23-year-old Williams began using Frova(R) (frovatriptan), Endo'smigraine medication, to successfully treat her menstrual migraines, which hadplagued her since she was 18. Prior to Frova, she had tried a number oftreatments without success. "I really struggled with menstrual migraine, but using Frova has truly helpedme," said Williams. "It helps relieve the pain." The "Rally for Menstrual Migraine" campaign includes the first website dedicatedto menstrual migraines, www.menstrualmigraine.org, and is designed to raise theprofile of menstrual migraine as a severe, long-duration migraine. The campaignwill encourage women to talk to their physicians about available treatments formenstrual migraine. 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 pain isfrequently linked to their menstrual cycle. Up to 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. Endo also is supporting the formation of the National Menstrual MigraineCoalition, led by the National Headache Foundation and a group of leadingheadache specialists. The coalition will help educate both patients andphysicians about the prevalence, diagnosis and treatment of menstrual migraines. Information on the coalition and menstrual migraine is available atwww.menstrualmigraine.org. "As a market leader in pain management, Endo is committed to helping women whosuffer from menstrual migraines find appropriate treatment, and we are honoredto be allied with Serena Williams, the National Headache Foundation and leadingheadache specialists in educating women and their physicians about the conditionand the availability of effective treatments," said Peter A. Lankau, presidentand chief operating officer of Endo. "We believe that this is an importantwomen's health issue that has a substantial impact on women's quality of life,ability to function and productivity. By consulting with their physicians, womencan identify therapies like Frova that can help them treat these monthlydebilitating migraines." About Frova Frova (frovatriptan), which belongs to the class of drugs called triptans, caneffectively treat menstrual migraines and other long-duration migraines. Ameta-analysis of five randomized, double-blind, placebo-controlled trials foundthat 83% of patients experiencing migraine with or without aura who took Frovadid not experience recurrence of their migraine. These data suggest that Frovahas the lowest average migraine recurrence rate of any triptan. Frova is notintended for the prophylactic therapy of migraine or for use in the managementof hemiplegic or basilar migraine. The safety and effectiveness of Frova havenot been established for cluster headache, which is present in an older,predominately male, population. Frova is generally well tolerated, with a safety profile consistent with thetriptan class of medications. As with other triptans, Frova should not be usedin patients who have uncontrolled high blood pressure, have heart disease or ahistory of heart disease, have hemiplegic or basilar migraine, have had astroke, have blood flow problems, have taken a triptan or ergotamine typemedicine in the last 24 hours or have any allergic reaction to the tablet. Invery rare cases, patients taking triptans experience serious heart problems,stroke or increased blood pressure. In clinical studies, the most common sideeffects were dizziness, fatigue, paresthesia (tingling), flushing, headache, drymouth, hot or cold sensation, and chest pain. The FDA-approved dosing for Frovais one 2.5 mg tablet up to three times within a 24-hour period. Frova(R) is a registered trademark of Vernalis Development Limited, and licensedto Endo. About Endo A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP),Endo Pharmaceuticals Inc. is a fully integrated specialty pharmaceutical companywith market leadership in pain management products. The company researches,develops, produces and markets a broad product offering of branded and genericpharmaceuticals, meeting the needs of healthcare professionals and consumersalike. More information, including this and past press releases of EndoPharmaceuticals Holdings Inc., is available online at www.endo.com. Forward-Looking Statement This press release contains forward-looking statements, within the meaning ofSection 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934, as amended, that are based on management's beliefs andassumptions, current expectations, estimates and projections. Statements thatare not historical facts, including statements which are preceded by, followedby, or that include, the words "believes," "anticipates," "plans," "expects" orsimilar expressions and statements are forward-looking statements. Endo'sestimated or anticipated future results, product performance or othernon-historical facts are forward-looking and reflect Endo's current perspectiveon existing trends and information. Many of the factors that will determine theCompany's future results are beyond the ability of the Company to control orpredict. These statements are subject to risks and uncertainties and, therefore,actual results may differ materially from those expressed or implied by theseforward-looking statements. The reader should not rely on any forward-lookingstatement. The Company undertakes no obligation to update any forward-lookingstatements whether as a result of new information, future events or otherwise.Several important factors, in addition to the specific factors discussed inconnection with these forward-looking statements individually, could affect thefuture results of Endo and could cause those results to differ materially fromthose expressed in the forward-looking statements contained in this pressrelease. Important factors that may affect future results include, but are notlimited to: market acceptance of the Company's products and the impact ofcompetitive products and pricing; dependence on sole source suppliers; thesuccess of the Company's product development activities and the timeliness withwhich regulatory authorizations and product launches may be achieved; successfulcompliance with extensive, costly, complex and evolving governmental regulationsand restrictions; the availability on commercially reasonable terms of rawmaterials and other third party manufactured products; exposure to productliability and other lawsuits and contingencies; dependence on third partysuppliers, distributors and collaboration partners; the ability to timely andcost effectively integrate acquisitions; uncertainty associated withpre-clinical studies and clinical trials and regulatory approval; uncertainty ofmarket acceptance of new products; the difficulty of predicting FDA approvals;risks with respect to technology and product development; the effect ofcompeting products and prices; uncertainties regarding intellectual propertyprotection; uncertainties as to the outcome of litigation; changes in operatingresults; 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 andprivate health insurers and others; and other risks and uncertainties detailedin Endo's filings with the Securities and Exchange Commission, including itsRegistration Statement on Form S-3 filed with the SEC on April 30, 2004, asamended. Readers should evaluate any statement in light of these importantfactors. CONTACTS: Bill NewbouldEndo Pharmaceuticals(610) 558-9800 Kelly CacioppoGCI Group(212) 537-8032 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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