Vernalis PLC Regulatory News (VER)

1 Oct 2007 07:00

Vernalis PLC30 September 2007 For Immediate Release ENDO PHARMACEUTICALS AND VERNALIS RECEIVE ACTION LETTER FROM FDA ON FROVA(R) SUPPLEMENTAL NEW DRUG APPLICATION CHADDS FORD, Pa., and WINNERSH, U.K., Sept. 30, 2007 -- Endo PharmaceuticalsInc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq:ENDP), and Vernalis plc (LSE: VER) today announced that the U.S. Food and DrugAdministration (FDA) has identified deficiencies and asked for additionalinformation pertaining to Endo's supplemental New Drug Application (sNDA) forFROVA(R) (frovatriptan succinate) 2.5 mg tablets in a "not approvable" letter.The sNDA is for the additional indication of FROVA for the short-term (six daysper month) prevention of menstrual migraine. FROVA is already approved andmarketed for the acute treatment of migraine with or without aura in adultswhere a clear diagnosis of migraine has been established. While the FDA acknowledged that both pivotal efficacy trials that had beensubmitted as part of this sNDA met their primary endpoints in significantlyimproving the number of headache-free perimenstrual periods (PMPs), itquestioned whether the benefit demonstrated was clinically meaningful. The FDAalso noted that even though serious vascular adverse events were not observed inthis drug development program, an increased risk (compared to the approved acuteuse) could not be ruled out. "We believe that the data submitted to the FDA was sufficiently compelling towarrant approval of FROVA for the short-term prevention of menstrual migrainebased on multiple studies that demonstrated the safety and effectiveness of thenew treatment regimen," said Peter A. Lankau, Endo President and Chief ExecutiveOfficer. "Despite this, the FDA raised a number of issues that will need to befully analyzed and then discussed with the FDA. Following this discussion withthe FDA, Endo and Vernalis will decide upon the appropriate course of action." Lankau also noted that Endo is reviewing the impact of the FDA's decision onEndo's financial results for 2007 and that Endo anticipates providing furtherguidance with its third quarter results. "We are surprised and disappointed by the FDA's response, as they had notengaged the companies in any dialogue during the extended review cycle as toFDA's interpretation of the data in the application," stated Simon Sturge, ChiefExecutive Officer of Vernalis plc. "It is important to note that this actiondoes not affect the current approved acute use of Frovatriptan and that, inaddition to Frovatriptan, Vernalis has another product on the market and afurther seven product candidates in clinical development. We have already beenevaluating a number of options for our overall operations which we shall nowreview in the light of the FDA decision. Vernalis will provide more details ofthe actions to be taken by the Company in due course." This announcement is being made in compliance with UK law, which requirespublicly traded companies to disclose material information without delay. 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. Endo Forward-Looking Statements 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 other non-historical facts are forward-looking and reflect Endo's current perspective onexisting 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 with pre-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; a determination by aregulatory agency that we are engaging in inappropriate sales or marketingactivities, including promoting the "off-label" use of our products; changes inoperating results; impact of competitive products and pricing; productdevelopment; changes in laws and regulations; customer demand; possible futurelitigation; availability of future financing and reimbursement policies ofgovernment and private health insurers and others; and other risks anduncertainties detailed in Endo's filings with the Securities and ExchangeCommission, including its Annual Report on Form 10-K filed with the SEC on March1, 2007. Readers should evaluate any statement in light of these importantfactors. 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, Servier, Chiesi and Serono. Vernalis has established aU.S. commercial operation to promote Apokyn(R) and co-promote FROVA(R) alongsideits North American licensing partner, Endo Pharmaceuticals, progressing thecompany 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 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 clearance of the Company's products and includingthat of FROVA(R) for menstrual migraine, the Company's ability to find partnersfor the development and commercialisation of its products, the benefits ofre-acquiring FROVA(R) in North America and the partnership with Endo on theCompany's liquidity and results of operations, as well as the Company's futurecapital raising activities.. Forward-looking statements involve risks anduncertainties. Actual events could differ materially from those projected hereinand depend on a number of factors including the success of the Company'sresearch strategies, the applicability of the discoveries made therein, thesuccessful and timely completion of clinical studies, including with respect toFROVA(R) and the Company's other products, the uncertainties related to theregulatory process, the ability of the Company to identify and agree beneficialterms with suitable partners for the commercialisation and/or development ofFROVA(R) and other products, as well as the achievement of expected synergiesfrom such transactions, the acceptance of FROVA(R) and other products byconsumers and medical professionals, the successful integration of completedmergers and acquisitions and achievement of expected synergies from suchtransactions, and the ability of the Company to identify and consummate suitablestrategic and business combination transactions. Endo Pharmaceuticals Inc. +1-610-558-9800Bill Newbould, Vice President,Corporate Communications GCI Group +1-404-260-3556Valerie Lind Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial Officer Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroyAlex Tweed This information is provided by RNS The company news service from the London Stock Exchange