MediGene: VeregenÂ® Marketing Approval Process Initiated for 17 Additional European Countries
MediGene AG /
MediGene: VeregenÂ® Marketing Approval Process Initiated for 17 Additional
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Decision on Marketing Approvals Expected End of Q1 2012
Martinsried/Munich, December 12, 2011.MediGene AG (Frankfurt, Prime Standard)
announces that the regulatory authorities of seventeen additional European
countries accepted the marketing authorization applications for Veregen(Â®)
ointment using the mutual recognition procedure. This means that the review
procedure has started. The decision for marketing approval in Belgium, Bulgaria,
Cyprus, Czech Republic, Denmark, Finland, France, Greece, Hungary, Luxembourg,
the Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, and Sweden is
expected by the end of the first quarter of 2012. Assuming a positive decision,
the individual countries will grant marketing approvals for Veregen(Â®) in the
course of the subsequent national phase of the approval procedure.
Veregen(Â®) is currently available in the United States, German, and Austrian
markets. In Spain, the drug was granted marketing approval and market launch is
expected in 2012. Veregen(Â®)'s German marketing approval serves as the basis for
the mutual recognition procedure. The Federal Institute for Drugs and Medical
Devices (Bundesinstitut fÃ¼r Arzneimittel und Medizinprodukte, BfArM) will make
its evaluation reports on Veregen(Â®)'s quality, efficacy, and safety available
to the participating countries. The Institute will also coordinate the process
between MediGene and the other countries.
MediGene has entered into several marketing partnerships for Veregen(Â®),
including Fougera (formerly Nycomed) for the United States; Abbott for Germany,
Austria, and Switzerland; Laboratoires Expanscience for France; and with a
number of other partners across Europe, America, and Asia. MediGene is planning
to continue this global licensing strategy.
Veregen(Â®): Veregen(Â®) (previously Polyphenon E(Â®) ointment), a topical
treatment of 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(Â®) 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(Â®)) is now also recommended as a
treatment option in the US Department of Health and Human Services Center for
Disease Control and Prevention's the Sexually Transmitted Diseases Treatment
Guidelines 2010 for the treatment of 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(Â®) and Veregen(Â®) are registered trademarks of MediGeneÂ AG. Polyphenon
E(Â®) is a trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or
licensed in select locations only.
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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
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