MediGene: Veregen® Receives Positive Decision on Marketing Approval for 17 Additional European Countries
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MediGene AG /
MediGene: Veregen® Receives Positive Decision on Marketing Approval for 17
Additional European Countries
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Martinsried/Munich, March 8, 2012.MediGene AG (MDG, Frankfurt, Prime Standard)
announces that the Veregen(®) ointment marketing authorization applications were
positively assessed by the regulatory authorities of seventeen additional
European countries within the mutual recognition procedure. This binding
decision guarantees that national marketing authorizations will be formally
granted by the respective regulatory authorities within the next months in
Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Greece,
Hungary, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia,
Slovenia, and Sweden. The successive launch of Veregen(®) ointment for the
treatment of genital warts in these new territories is anticipated to start end
of 2012.
Veregen(®) is currently available in the United States, German, and Austrian
markets. In Spain, the drug has already been granted marketing approval and
market launch is expected in the first six months of 2012. MediGene has entered
into several marketing partnerships for Veregen(®), including Fougera (formerly
Nycomed) for the United States; Abbott for Germany, Austria, and Switzerland;
Laboratoires Expanscience for France; and a number of other partners across
Europe, America, and Asia. MediGene is planning to continue this global
licensing strategy.
Veregen(®): Veregen(®) (previously Polyphenon E(®) ointment), a topical
treatment for external genital warts, contains a concentrate of catechins with a
complex defined composition extracted from green tea leaves. MediGene acquired
the basic rights to the active ingredient in Veregen(®) from Epitome
Pharmaceuticals, Inc. in 1999, and was solely responsible for the drug's
successful preclinical and clinical development, as well as the approval
process. Sinecatechins 15% ointment (Veregen(®)) is recommended in the US
Department of Health and Human Services Center for Disease Control and
Prevention's Sexually Transmitted Diseases Treatment Guidelines 2010 as a
possible option for treating genital warts.
This press release contains forward-looking statements representing the opinion
of MediGene as of the date of this release. The actual results achieved by
MediGene may differ significantly from the forward-looking statements made
herein. MediGene is not bound to update any of these forward-looking statements.
MediGene(®) and Veregen(®) are registered trademarks of MediGene AG. Polyphenon
E(®) is a trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or
licensed in select locations only.
- ends -
MediGene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology
company headquartered in Martinsried/Munich, Germany. MediGene is the first
German biotech company to have revenues from marketed products. It has various
drug candidates in clinical development and possesses innovative platform
technologies. MediGene focuses on clinical research and development of novel
drugs against cancer and autoimmune diseases.
Contact MediGene AG
Julia Hofmann, Kerstin Langlotz
Tel.: +49 - 89 - 85 65 - 33 01
Fax: +49 - 89 - 85 65 - 29 20
Email: investor(at)medigene.com
Press release as pdf:
http://hugin.info/132073/R/1592546/500863.pdf
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Source: MediGene AG via Thomson Reuters ONE
[HUG#1592546]
Unternehmensinformation / Kurzprofil:
Datum: 08.03.2012 - 15:22 Uhr
Sprache: Deutsch
News-ID 123241
Anzahl Zeichen: 4578
contact information:
Town:
Martinsried / München
Kategorie:
Business News
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