Vernalis PLC Regulatory News (VER)

11 Jun 2007 07:02

Vernalis PLC11 June 2007 11 June 2007 VERNALIS PLC ANNOUNCES PHASE III STUDY DATA THAT DEMONSTRATES SHORT TERM PREVENTION TREATMENT WITH FROVA(R) REDUCES FREQUENCY AND SEVERITY OF MENSTRUAL MIGRAINE WINNERSH, U.K., 11 June, 2007 -- Vernalis plc (LSE: VER) is pleased to reproducebelow the announcement made by Endo Pharmaceuticals Inc; in respect of thepresentation of data on Frova(R) at the American Headache Society. -- ends -- Enquiries:Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial Officer Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroy Lazar Partners LtdGregory Gin 212-867-1762 FROVA (R) Phase III Study Data Demonstrates That Short-Term Prevention TreatmentReduces Frequency and Severity of Menstrual Migraine CHICAGO, IL, Jun 09, 2007 (MARKET WIRE via COMTEX News Network) -- EndoPharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals HoldingsInc. (NASDAQ: ENDP), has presented results from a Phase III randomized,double-blind, placebo-controlled clinical trial evaluating FROVA (frovatriptansuccinate) 2.5 mg tablets as a six-day preventative treatment in women withdifficult-to-treat menstrual migraine (MM). The data demonstrated that FROVAsignificantly reduced the frequency and severity of MM as well as thedisabilities related to them. The results, which were presented here today atthe annual meeting of the American Headache Society (AHS), were from the secondof the two successful Phase III placebo-controlled clinical trials evaluatingthe efficacy and safety of FROVA in MM prophylaxis. Women receiving FROVA started the six-day regimen two days prior to the onset oftheir anticipated headache. Starting treatment two days before the expectedheadache ensures that patients have adequate blood levels at the time theyusually start to experience MM, and continuing treatment for six days ensuresthat they are covered during the whole period when they are likely to experiencethose headaches. Women in the study had responded poorly to previous acutetriptan treatment for MM. "In this study, appropriately timed short-term treatment with FROVA prevented orsignificantly reduced the pain of difficult-to-treat but often predictablemigraines associated with the menstrual period," said the lead investigator inthe trial, Jan Lewis Brandes, M.D., of the Nashville Neuroscience Group andassistant clinical professor of the Department of Neurology at VanderbiltUniversity School of Medicine. "This is exciting news for women and theirphysicians who need to realize that the debilitating pain of menstrual migraineis not inevitable and is not a normal part of their menstrual cycle." "In patients with menstrual migraine and predictable menses, I am intrigued bythe potential for a short-term prevention treatment to prevent or minimize MMsymptoms without continuously exposing patients to a drug," said StephenSilberstein, M.D., professor of neurology at the Jefferson Medical College ofThomas Jefferson University, director of the Jefferson Headache Center and leadinvestigator of the initial efficacy study of FROVA for the short-termprevention of menstrual migraine. Study Results In the trial, the MM status of study participants was confirmed during aplacebo-controlled, single-blind, run-in phase. Women were randomized in thedouble-blind study to receive FROVA 2.5 mg once a day, FROVA 2.5 mg twice a day,or placebo (ratio 3:2:3). FROVA once or twice daily significantly improved the number of headache-freeperimenstrual periods (PMPs) compared to women who received placebo. FROVA alsosignificantly reduced the incidence of severe migraines and therefore tended toimprove the ratio of severe to mild headache compared to women who receivedplacebo. Efficacy data were collected from 410 women in North America andEurope, 85 percent of whom participated in the study over three PMPs. Efficacydata were collected from 410 women in North America and Europe, 85 percent ofwhom participated in the study over three PMPs. The study's primary endpoint was the number of completely headache-free PMPs.FROVA therapy significantly improved the number of headache-free PMPs perpatient (0.92 (twice daily), p < 0.0001; 0.69 (once daily), p=0.009) versus 0.42(placebo). The incidence of severe headache was significantly less with FROVAonce daily (44 percent; p=0.007) and twice daily (40 percent; p=0.0003) comparedwith placebo (58 percent), lowering the ratio of severe to mild migraine from11:1 with placebo to 4:1 (once daily) and 2:1 (twice daily) with FROVA. Reductions in migraine symptoms were significant for nausea (twice daily only),photophobia, and phonophobia (p < 0.008; BID and QD vs. placebo), and patientsexperienced significantly less functional impairment during treatment with FROVA(p < 0.0001; QD and BID vs. placebo). Both FROVA regimens were equally well tolerated with a low rate of adverseevents. The most commonly reported adverse events were upper respiratory tractinfection (37 patients), nausea (36 patients), and dizziness (31 patients). Mostadverse events were rated mild or moderate in severity and did not increase inseverity with increasing doses of FROVA; the percentage rated severe was 19percent in the placebo group and 22 percent (once daily) and 14 percent (twicedaily) in the FROVA groups. Endo has submitted a supplemental New Drug Application (sNDA) for FROVA 2.5 mgtablets for the short-term (six days per month) prevention of MM to the U.S.Food and Drug Administration (FDA). About Menstrual Migraine Menstrual migraine, distinct from other types of migraines, is largely anunder-recognized condition. Of the approximately 21 million women in the U.S.who experience migraines, up to 60 percent suffer from MM and its debilitatingeffects. More than half of these women, however, may not be correctly diagnosed,and therefore may not be receiving adequate treatment. MM has been reported tobe more severe and last longer than other migraines, and women who suffer fromMM may experience significant restrictions in their daily activities. For manywomen with MM, currently available treatment options may not adequately reducethe debilitating symptoms, such as pain, nausea and vomiting, nor the migraine'sduration. For more information about MM, visit www.menstrualmigraine.org. Important Information about FROVA FROVA is indicated for the acute treatment of migraine attacks with or withoutaura in adults. FROVA is not intended for the prophylactic therapy of migraineor for use in the management of hemiplegic or basilar migraine. The safety andeffectiveness of FROVA have not been established for cluster headache, which ispresent in an older, predominantly male population. FROVA should only be used when a clear diagnosis of migraine has beenestablished. As with other drugs in this class, FROVA should not be given to patients withischemic heart disease (e.g., angina pectoris, history of myocardial infarction,or documented silent ischemia), or to patients who have symptoms or findingsconsistent with ischemic heart disease, coronary artery vasospasm, includingPrinzmetal's variant angina or other significant underlying cardiovasculardisease. FROVA should not be given to patients with cerebrovascular syndromes including(but not limited to) strokes of any type, as well as transient ischemic attacks. FROVA should not be given to patients with peripheral vascular disease including(but not limited to) ischemic bowel disease. FROVA should not be given to patients with uncontrolled hypertension. It is strongly recommended that FROVA not be given to patients in whomunrecognized coronary artery disease (CAD) is predicted by the presence of riskfactors unless a cardiovascular evaluation provides satisfactory clinicalevidence that the patient is reasonably free of coronary artery and ischemicmyocardial disease or other significant underlying cardiovascular disease. It is strongly recommended that patients who are intermittent long-term users of5-HT1 agonists, including FROVA, and who have or acquire risk factors predictiveof CAD, undergo periodic cardiovascular evaluation as they continue to useFROVA. The development of a potentially life-threatening serotonin syndrome may occurwith triptans, including FROVA treatment, particularly during combined use withselective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrinereuptake inhibitors (SNRIs). If concomitant treatment with FROVA and an SSRI(e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram,escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted,careful observation of the patient is advised, particularly during treatmentinitiation and dose increases. The most common side effects associated with the use of FROVA are dizziness,fatigue, paresthesia, flushing, headache, dry mouth, hot or cold sensation,skeletal pain, chest pain, and dyspepsia. About Endo A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., EndoPharmaceuticals is a fully integrated specialty pharmaceutical company withmarket 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 Statements This press release contains forward-lookingstatements, within the meaning of Section 27A of the Securities Act of 1933 andSection 21E of the Securities Exchange Act of 1934, as amended, that are basedon management's beliefs and assumptions, current expectations, estimates andprojections. Statements that are not historical facts, including statementswhich are preceded by, followed by, or that include, the words "believes,""anticipates," "plans," "expects" or similar expressions and statements areforward-looking statements. Endo's estimated or anticipated future results,product performance or other non-historical facts are forward-looking andreflect Endo's current perspective on existing trends and information. Many ofthe factors that will determine the Company's future results are beyond theability of the Company to control or predict. These statements are subject torisks and uncertainties and, therefore, actual results may differ materiallyfrom those expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The Company undertakes noobligation to update any forward-looking statements whether as a result of newinformation, future events or otherwise. Several important factors, in additionto the specific factors discussed in connection with these forward-lookingstatements individually, could affect the future results of Endo and could causethose results to differ materially from those expressed in the forward-lookingstatements contained in this press release. Important factors that may affectfuture results include, but are not limited to: market acceptance of theCompany's products and the impact of competitive products and pricing;dependence on sole source suppliers; the success of the Company's productdevelopment activities and the timeliness with which regulatory authorizationsand product launches may be achieved; successful compliance with extensive,costly, complex and evolving governmental regulations and restrictions; theavailability on commercially reasonable terms of raw materials and other thirdparty manufactured products; exposure to product liability and other lawsuitsand contingencies; dependence on third party suppliers, distributors andcollaboration partners; the ability to timely and cost effectively integrateacquisitions; uncertainty associated with pre-clinical studies and clinicaltrials and regulatory approval; uncertainty of market acceptance of newproducts; the difficulty of predicting FDA approvals; risks with respect totechnology and product development; the effect of competing products and prices;uncertainties regarding intellectual property protection; uncertainties as tothe outcome of litigation; changes in operating results; impact of competitiveproducts and pricing; product development; changes in laws and regulations;customer demand; possible future litigation; availability of future financingand reimbursement policies of government and private health insurers and others;and other risks and uncertainties detailed in Endo's filings with the Securitiesand Exchange Commission, including its Registration Statement on Form 10-K filedwith the SEC on March 1, 2007. Readers should evaluate any statement in light ofthese important factors. Notes to Editors Important Information 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) isnot intended for the prophylactic therapy of migraine or for use in themanagement of hemiplegic or basilar migraine. The safety and effectiveness ofFrova(R) have not been established for cluster headache, which is present in anolder, 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 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) is not currently 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. About Menstrual Migraine Menstrual Migraine (MM) can have a serious impact on women's lives because theylast longer than non-menstrual migraines, tend to be associated with severe painand often recurr. Patients with MM may suffer from migraines at any time,although their migraine is frequently linked to their menstrual cycle. Over 60percent of migraines in women are associated with menstruation. About Vernalis Vernalis is a speciality bio-pharmaceutical company focused on products marketedto specialist neurologists. The company has two marketed products, Frova(R) andApokyn(R), and a development pipeline focused on central nervous systemdisorders. The company has eight products in registration/clinical developmentand collaborations with leading, global pharmaceutical companies includingNovartis, Biogen Idec and Serono. Vernalis has established a US commercialoperation to promote Apokyn(R) and co-promote Frova(R) alongside its NorthAmerican licensing partner, Endo Pharmaceuticals, progressing the companytowards its goal of becoming a sustainable, self-funding, R&D-driven, specialitybio-pharmaceutical company. For further information about Vernalis, pleasevisit: www.vernalis.com +-------+-----------+-----+-----+-----+------------+------+------------+|Product|Indication |Phase|Phase|Phase| | |Marketing || | | | | | | |Rights || | | I | II | III |Registration|Market| || | | | | | | | || | | | | | | | |+-------+-----------+-----+-----+-----+------------+------+------------+|Apokyn |Parkinson's| | | | | x |North ||(R) |Disease | | | | | |America || | | | | | | | |+-------+-----------+-----+-----+-----+------------+------+------------+|Frova |Migraine | | | | | x |US ||(R) | | | | | | |milestones &|| | | | | | | |royalties - || | | | | | | |Endo || | | | | | | |(EU - || | | | | | | |royalties) |+-------+-----------+-----+-----+-----+------------+------+------------+|Frova |Menstrual | | | | x | |US ||(R) |Migraine | | | | | |milestones &|| |Prevention | | | | | |royalties - || | | | | | | |Endo || | | | | | | |(EU - || | | | | | | |royalties) |+-------+-----------+-----+-----+-----+------------+------+------------+|V1512 |Parkinson's| | x | | | |Worldwide || |Disease | | | | | |(excl. Italy|| | | | | | | |) |+-------+-----------+-----+-----+-----+------------+------+------------+|V10153 |Ischaemic | | x | | | |Worldwide || |stroke | | | | | | |+-------+-----------+-----+-----+-----+------------+------+------------+|V1003 |Acute Pain | | x | | | |US Profit || | | | | | | |share Option|| | | | | | | |Reckitt || | | | | | | |Benckiser |+-------+-----------+-----+-----+-----+------------+------+------------+|V3381 |Neuropathic| | x | | | |Worldwide || |Pain | | | | | | |+-------+-----------+-----+-----+-----+------------+------+------------+|V2006 |Parkinson's| x | | | | |US || |Disease | | | | | |Co-promotion|| | | | | | | |Biogen Idec |+-------+-----------+-----+-----+-----+------------+------+------------+|MMPI |Multiple | x | | | | |Royalties - || |Sclerosis | | | | | |Serono |+-------+-----------+-----+-----+-----+------------+------+------------+|V24343 |Obesity | x | | | | |Worldwide |+-------+-----------+-----+-----+-----+------------+------+------------+ Vernalis Forward-Looking Statement This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events including the clinicaldevelopment and regulatory approval of the Company's products, the Company'sability to find partners for the development and commercialisation of itsproducts, as well as the Company's future capital raising activities.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 ability of theCompany to identify and agree beneficial terms with suitable partners for thecommercialisation and/or development of its products, as well as the achievementof expected synergies from such transactions, the acceptance of Frova(R) andApokyn(R) and other products by consumers and medical professionals, thesuccessful integration of completed mergers and acquisitions and achievement ofexpected synergies from such transactions, and the ability of the Company toidentify and consummate suitable strategic and business combinationtransactions. This information is provided by RNS The company news service from the London Stock Exchange