MediGene AG presents future business plan at annual analyst
conference
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Martinsried/München, December 15, 2009. MediGene AG (Frankfurt: MDG,Prime Standard, TecDAX) presented the company's future strategicplans through 2015 at its annual analyst conference in Frankfurt. Aspart of the presentations, the company announced that it willcontinue to sharpen its business focus and outlined the futuredevelopment plans for the drug candidates EndoTAG(TM)-1 andRhuDex(TM) in detail. Sustained profitability of the company isexpected to be secured by product revenues with the launch ofEndoTAG(TM)-1 from 2015.Dr. Frank Mathias, Chief Executive Officer of MediGene AG commented:"Over the last several months the new management team has analyzedthe current status of the company, evaluated both benefit and risk,and based on that analysis, has defined a number of new strategicgoals and measures. With this five-year plan, we will seek tominimize the development risks of our pipeline, optimize the value ofour most important drug projects, improve the company structure andlead MediGene to a financially independent future."The most important strategic and operational steps for 2010-2015 willbe a step-wise focus on the field of oncology, the closing of apartnership for the cancer drug EndoTAG(TM)-1 during 2010, thefinalization of the ongoing phase II study with EndoTAG(TM)-1 for thetreatment of breast cancer in the first half of 2010 and the start ofa phase III study with EndoTAG(TM)-1 for the treatment of pancreaticcancer (together with a partner) in the first half of 2011. In thecontext of greater focus, RhuDex(TM) for the treatment of rheumatoidarthritis will be prepared for out-licensing and all othertechnologies that are deemed non-core shall be spun off or sold.To improve the value of the development project EndoTAG(TM)-1, thefreeze drying manufacturing process that is currently in place willbe converted to a spray drying process before the start of the phaseIII study, which is planned to start in the first half of 2011. Thiswill significantly improve the future EndoTAG(TM)-1 cost of goods.Moreover, the results of the phase II breast cancer study, which areexpected for the first half of 2010, will deliver a second proof ofconcept for the drug candidate. Dr. Mathias indicated that nodecision has yet been made on whether the intended partnership willbe closed before or after the presentation of the phase II breastcancer data, which could significantly increase the value of theproduct.For the drug candidate RhuDex(TM), the new development plan providesfor further preclinical studies during 2010 in order to moreaccurately specify the therapeutic window and thus optimizing theclinical development program. Clinical development is expected to beresumed in the fourth quarter of 2010 or in the first quarter of 2011and MediGene intends to out-license the immunological drug candidateonce clinical proof of concept has been achieved, if not before.Besides RhuDex(TM), MediGene will aim at out licensing or spinningoff the oHSV and AAVLP technologies to realize the desired focus ononcology and clinical development. Similar to the spin out of themTCR technology which has already taken place, MediGene will seek toretain future access to promising drug candidates in any transaction.In order to extend its pipeline, MediGene AG is planning to developnew candidates from its EndoTAG(TM) technology platform and hence toconcentrate on liposome technology, its core competence withinoncology. At a later point in time, it may be possible thatin-licensing of oncology products will extend the portfolio, andMediGene intends to bring two further products into the clinicaldevelopment pipeline by 2015.By 2015 MediGene plans to have three products on the market,including EndoTAG(TM)-1 for pancreatic cancer, which the company willseek to co-market with a partner. In addition, MediGene expects tohave one new drug candidate in development stemming from theEndoTAG(TM) technology as well as any in-licensed products. Themarket launch of EndoTAG(TM)-1 in 2015 will take MediGene intosustained profitability for the first time, but until that timeproduct revenues, payments from partnerships and tight costmanagement will contribute to the company's financial stability.At the analyst conference, MediGene confirmed its revenue forecastfor the business year 2009 of approximately 40 million euro andfurther specified the forecast on an EBITDA basis to be a loss ofapproximately 20 million euro (last forecast: -20 to -23 millioneuro). In the full year 2008, MediGene realized total revenues of39.6 million euro and an EBITDA loss of -24.6 million euro.The presentation of the analyst conference can be found in theinternet at www.medigene.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 EndoTAG(TM) are registeredtrademarks of MediGene AG. RhuDex(TM) is a registered trademark ofMediGene Ltd. These trademarks may be owned or licensed in selectlocations only. - ends -MediGene AG is a publicly listed (Frankfurt: MDG, Prime Standard,TecDax) biotechnology company located in Martinsried/Munich, Germany,Oxford, UK, and San Diego, USA. MediGene is the first German biotechcompany to have drugs on the market, which are distributed by partnercompanies. MediGene has several drug candidates in clinicaldevelopment, two of which provide significant sales potential. Inaddition, the company pursues several development projects andpossesses innovative platform technologies for drug development.MediGene focuses on clinical research and development of novel drugsfor the treatment of cancer and autoimmune diseases.Contact MediGene AGE-mail: investor(at)medigene.comFax:++49 - 89 - 85 65 - 2920Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 - 89 -85 65 - 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: 15.12.2009 - 14:51 Uhr
Sprache: Deutsch
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