MediGene receives Positive Assessment on Market Authorisation for
Veregen® in First European Countri
MediGene receives Positive Assessment on Market Authorisation for Veregen® in First European Countries
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Martinsried/Munich, July 10, 2009. MediGene AG (Frankfurt: MDG, PrimeStandard, TecDAX) today announces that its Marketing AuthorisationApplication for the medicinal product Veregen® (formerly PolyphenonE® Ointment) for the treatment of genital warts has been assessedpositively by the national regulatory authorities of Germany,Austria, and Spain. This binding decision guarantees that nationalMarketing Authorisations in these countries will be formally grantedby the authorities within the next few months. The MarketingAuthorisation of Veregen® in Germany, the Reference Member State inthis Decentralized Procedure, shall provide the basis for additionalMarketing Authorisations in other European countries via the MutualRecognition Procedure.MediGene is planning commercialization of Veregen® in Germany andother European countries via distribution partners. In the USA,Veregen® is already marketed by MediGene's licensee Nycomed US, Inc.MediGene has recently announced the conclusion of an agreement withthe Spanish company Juste S.A.Q.F. for the distribution of Veregen®in Spain and Portugal.Dr. Axel Mescheder, Chief Scientific Officer & Chief DevelopmentOfficer of MediGene AG commented: "We are very pleased with thisdecision by the regulatory authorities. Veregen® is the firstproprietary development compound of MediGene AG, and therefore thispositive assessment of the first Marketing Authorisation Applicationsin Europe is an important milestone for our company. Followingapproval and launch of Veregen® in the USA, we are keen to make theproduct accessible to patients in Europe as soon as possible."Veregen®: Veregen® for the treatment of genital warts contains adefined extract from green tea leaves. MediGene acquired the basicrights to the active substance in Veregen® from the Canadian companyEpitome Pharmaceuticals, Inc., in 1999, and was solely responsiblefor the drug's preclinical and clinical development, as well as forthe approval process. Moreover the patent protection was furtherupgraded by a number of proprietary inventions. The extract fromgreen tea leaves is manufactured by the Japanese company Mitsui NorinCo., Ltd. The drug's name during development was Polyphenon E®Ointment. The US market approval was made out to Veregen®, and theproduct is distributed in the USA via MediGene's licensee Nycomed US(PharmaDerm) under this name. In Europe, Marketing AuthorisationApplications under the Decentralised Procedure have been submitted inGermany, Austria, and Spain and has been assessed positively by thenational authorities.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;
Bereitgestellt von Benutzer: hugin
" alt="Outotec entered into joint venture with Eesti Energia>">
Datum: 10.07.2009 - 13:00 Uhr
Sprache: Deutsch
News-ID 3441
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 342 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"MediGene receives Positive Assessment on Market Authorisation for
Veregen® in First European Countri"
steht unter der journalistisch-redaktionellen Verantwortung von
MediGene AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
