MediGene Signs Agreement with Solvay for the Commercialization of
Veregen® in Germany, Austria, and
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Solvay acquires marketing rights to Veregen® in Germany, Austria and Switzerland* MediGene to receive milestone payments totalling up to 3.65 million euros* MediGene to receive royalties on future salesMartinsried/Munich, September 29, 2009. The biotech company MediGeneAG (Frankfurt, Prime Standard, TecDAX) has signed a license andsupply agreement with Solvay Arzneimittel GmbH, the German affiliateof Solvay Pharmaceuticals (Solvay) for the supply andcommercialization of Veregen® (formerly Polyphenon E® ointment) inGermany, Austria, and Switzerland. Solvay's subsidiaries will promoteand distribute the drug for the treatment of genital warts in theabove-mentioned countries. In Switzerland Solvay will also takecharge of the Veregen® regulatory procedures. Upon the achievement ofspecified milestones and sales targets, MediGene is entitled tosuccessive payments totalling up to 3.65 million euros. MediGene willsupply Solvay with the finished product, and will receive royaltieson net sales.In July 2009, MediGene's marketing authorization application forVeregen® was assessed positively by the national regulatoryauthorities of Germany, Austria, and Spain in a decentralizedapproval procedure. The recent grant of formal marketingauthorization in Germany was the first such authorisation implementedby a European national regulatory authority. Marketing authorizationof Veregen® in Germany (the reference state in this decentralizedprocess) will provide a basis for additional marketing authorizationapplications to be submitted in additional European countries. Theissue of formal marketing authorizations in Austria and Spain isexpected within the next few months. German market launch is plannedfor the first half of 2010, and MediGene intends to concludeadditional marketing agreements in other countries both within andoutside Europe.Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented:"Following Spain and Portugal, we believe we have found the perfectpartner for the commercialization of Veregen® in Germany, Austria,and Switzerland. We have received multiple requests from physicians,pharmacists and patients in the German-speaking countries who we knoware all eagerly awaiting market launch of Veregen®. In cooperationwith Solvay we are keen to provide this as soon as possible."Dr. Wolfgang Dankert, General Manager of Solvay Arzneimittel,commented: "We are delighted to add Veregen® to our product portfolioand are convinced that it will provide an innovative option for thetreatment of genital warts. Solvay is very well positioned for thecommercialization of the product in the respective target groups, andwe will make full use of our resources and expertise in order to makethis drug available to the patients as quickly as possible."Veregen®: Veregen® for the treatment of genital warts contains aconcentrate of catechins with a defined composition extracted fromgreen tea leaves. MediGene acquired the basic rights to the activesubstance in Veregen® from the Canadian company EpitomePharmaceuticals, Inc. in 1999, and was solely responsible for thedrug's preclinical and clinical development, as well as for theapproval process. Moreover the patent protection was further upgradedby a number of proprietary inventions. The catechin concentrate ismanufactured by the Japanese company Mitsui Norin Co., Ltd. Thedrug's name during development was Polyphenon E® ointment, and itstrade name is Veregen®. The drug was approved by the US regulatoryauthority FDA in November 2006, and has been available on the USmarket since February 2009. MediGene's marketing partner for the USAis Nycomed. The results on which the approval was based were obtainedin an international phase III development program in which more than1,000 patients in 15 countries were treated with the ointment. InEurope the marketing authorization application for Veregen® wasassessed positively by the national regulatory authorities of anumber of selected countries. Marketing authorization for Germany wasgranted by the Federal Institute for Drugs and Medical Devices(Bundesinstitut für Arzneimittel und Medizinprodukte = BfArM) earlyin September 2009.Solvay Arzneimittel GmbH is the German affiliate of SolvayPharmaceuticals. For more information, visitwww.solvay-arzneimittel.de.Solvay Pharmaceuticals is a research driven group of companies thatconstitutes the global pharmaceutical business of the Solvay Group.These companies seek to fulfill carefully selected, unmet medicalneeds in the therapeutic areas of neuroscience, cardiometabolic,influenza vaccines, gastroenterology and men's and women's health.Its 2008 sales were EUR 2.7 billion, and it employs more than 9,000people worldwide. For more information, visitwww.solvaypharmaceuticals.com.SOLVAY is an international chemical and pharmaceutical Group withheadquarters in Brussels. It employs more than 29,000 people in 50countries. In 2008, its consolidated sales amounted to EUR 9.5billion, generated by its three sectors of activity: Chemicals,Plastics and Pharmaceuticals. Solvay is listed on the NYSE Euronextstock exchange in Brussels (NYSE Euronext: SOLB.BE - Bloomberg:SOLB.BB - Reuters: SOLBt.BR). Details are available atwww.solvay.com.This press release contains forward-looking statements representingthe opinion of MediGene as of the date of this release. The actualresults achieved by MediGene may differ significantly from thestatements made herein. MediGene is not bound to update any of theseforward-looking statements. MediGene® and Veregen® are registeredtrademarks of MediGene AG. Polyphenon E® is a registered trademark ofMitsui Norin Co., Ltd. These trademarks may be owned or licensed inselect locations only. - ends -MediGene AG is a publicly listed (Frankfurt, Prime Standard: MDG,TecDax) biotechnology company located in Martinsried/Munich, Germany,with subsidiaries in Oxford, UK and San Diego, USA. MediGene is thefirst German biotech company to have drugs on the market, which arebeing distributed by partner companies and has several drugcandidates in clinical development, two of which provide significantsales potential. In addition, the company has numerous projects inresearch and pre-clinical development and possesses innovativeplatform technologies. MediGene focuses on the research anddevelopment of novel drugs for the treatment of cancer and autoimmunediseases.Contact MediGene AGE-mail: investor(at)medigene.comFax: +49 - 89 - 85 65 - 2920Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: +49 - 89 - 8565 - 3324Dr. Georg Dönges, Investor Relations, Tel.: +49 - 89 - 85 65 - 2946 --- End of Message ---MediGene AGLochhamer Strasse 11 Martinsried / München GermanyWKN: 502090; ISIN: DE0005020903 ; Listed: Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in Bayerische Börse München, Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart, Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover, Regulierter Markt in Frankfurter Wertpapierbörse;
Datum: 29.09.2009 - 08:30 Uhr
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