12th Mar 2007 07:03
Vernalis PLC12 March 2007 12 March 2007 Vernalis plc Announces Pricing and Reimbursement for Frova(R) in France WINNERSH, U.K., 12 March, 2007 -- Vernalis plc (LSE: VER, Nasdaq: VNLS) todayannounces that its partner, Menarini, has received pricing and reimbursement forFrova(R) in France. Following launch in France planned for later this month,Menarini will market Frova(R) in all of the major European pharmaceuticalmarkets. Frova(R) (frovatriptan succinate tablets) is a selective 5-HT1B/1D receptoragonist approved as an acute oral treatment for migraine headache and itsassociated symptoms. Frova(R) belongs to the triptan class of drugs and isdistinguished from other triptans by its long half-life. As a result of thisdistinguishing feature, Frova(R) is also being developed for the short-termprevention of menstrual migraine (MM), a form of migraine that affects 12million women in the U.S. alone. Simon Sturge, CEO of Vernalis, commented: "We are delighted that our partner Menarini has achieved pricing andreimbursement for Frova(R) in France, one of the major pharmaceutical markets.We are also looking forward to further potential opportunities to expand thelabel for the product to include prevention of menstrual migraine, both inEurope, where Menarini plans to file an application later in the year, and inthe U.S., where we expect a decision about our Supplemental New Drug Application(sNDA) from the FDA in May." Frova in U.S. and Europe Vernalis co-promotes Frova(R) in the U.S. with its partner Endo PharmaceuticalsInc. In Europe, frovatriptan is currently marketed in 13 countries by Menariniwith a new launch expected in France in 1Q 2007. The drug was approvedthroughout the then 15 member states of the European Union via the mutualrecognition procedure (MRP) in January 2002. In 2006, Menarini launchedfrovatriptan in Slovakia, Finland, Czech Republic, Slovenia, Portugal,Switzerland and all seven Central American countries. They received approval forthe drug in Turkey, with a launch planned in 1Q 2007, and also applied formarketing authorisation in Russia, with approval expected 1H 2007. Frova for intermittent, short-term prevention of Menstrual Migraine (MM) Vernalis has completed a series of studies aimed at obtaining approval for Frova(R) for the intermittent, short-term prevention of MM and Vernalis' partner,Endo, filed a sNDA in the US with the FDA in July 2006. The FDA has acceptedthis submission and has informed the companies that it will provide its responseby 19 May 2007 (the PDUFA date) which is ten months after the sNDA submissiondate. If this application is successful, a $40 million milestone is due toVernalis from Endo, though Endo reserves the right to pay $20 million in cashand retain the remaining $20 million as partial payment due on its outstandingloan to Vernalis. In 2H 2007 Menarini plans to submit an application to extendthe current indication to include prevention of menstrual migraine throughoutEurope under the mutual recognition procedure with France acting as thereference member state. If successful, it would lead to an extension of theexisting indication for acute treatment in 25 EU countries. Frova(R) is approved for the treatment of migraines in adults. The most commonadverse events include dizziness, fatigue, paresthesia, flushing, and headache. -- ends -- Enquiries:Vernalis plc +44 (0) 118 977 3133Simon Sturge, Chief Executive OfficerTony Weir, Chief Financial OfficerJulia Wilson, Head of Corporate Communications Brunswick Group +44 (0) 20 7404 5959Jon ColesJustine McIlroy Lazar Partners LtdGregory Gin 212-867-1762 Notes to Editors 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 ExchangeRelated Shares:
Vernalis PLC