MediGene AG /
MediGene Announces Approval of Veregen® in Spain
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Martinsried/Munich, March 30, 2011. The biotech company MediGene AG (Frankfurt,
Prime Standard) today announces that Veregen(®) has obtained market approval
from the Spanish regulatory authority (Agencia Española de Medicamentos y
Productos Sanitarios, AEMPS), for the treatment of genital warts. Market launch
of Veregen(®) in Spain by MediGene's partner Juste S.A.Q.F. is scheduled to take
place in the first quarter of 2012, upon conclusion of the price fixing
procedure, which is conducted in conjunction with the Dirección General de
Farmacia y Productos Sanitarios.
Veregen(®) is currently available on the US, German, and Austrian markets. A
second wave of applications for market approval within the European mutual
recognition procedure is planned, with Germany serving as the reference member
state in this process.
MediGene has already entered into several marketing partnerships for Veregen(®),
e.g. with Nycomed for the US, with Abbott for Germany, Austria, and Switzerland,
with Laboratoires Expanscience for France, and with a number of other partners
across Europe, Latin America, and Asia. MediGene is planning to continue this
global licensing strategy.
Veregen(®): Veregen(®) (previously Polyphenon E(®) ointment) for the topical
treatment of external genital warts is 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 the Canadian company
Epitome Pharmaceuticals, Ltd. in 1999, and was solely responsible for the drug's
successful preclinical and clinical development, as well as the approval
process. Patent protection has also been further upgraded by a number of
proprietary inventions. Sinecatechins 15% ointment (Veregen(®)) is now also
recommended as a treatment option in the US Department of Health and Human
Services' Center for Disease Control and Prevention's 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(®) 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 several
drug candidates in clinical development and possesses innovative platform
technologies. MediGene focuses on clinical research and development of novel
drugs, with a focus on oncology.
Contact MediGene AG
Julia Hofmann, Kerstin Langlotz
Investor & Public Relations
Tel.: +49 - 89 - 85 65 - 33 01
Fax: +49 - 89 - 85 65 - 29 20
Email: investor@medigene.com
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MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany
WKN: 502090;ISIN: DE0005020903;
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Source: MediGene AG via Thomson Reuters ONE
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