Veregen - Biotech, Pharma and Life Science Channel

14:59 EST 19th November 2017 | BioPortfolio

Veregen® is an ointment used to treat external genital warts. In the USA, Germany, Austria, Spain, Switzerland and Serbia, Veregen® is already marketed by our partners. Sales and marketing partnerships are also in place for this drug in a large number of other countries in Europe, Asia and America. An overview of our partners can be found here. The sales generated with Veregen® are continually rising and making a valuable contribution to financing the Company.

As an innovative drug, Veregen® is based on a defined extract from green tea leaves obtained in a highly complex and specifically developed process.

Medigene in-licensed the basic rights to the active ingredient of Veregen® in 1999 and then completed the clinical development of Veregen®. Subsequently, Medigene successfully obtained a marketing authorization by the approval process of the US Food and Drug Administration (FDA). Veregen® is the first, and to date one of a very small number of innovative plant-based drug approved by the FDA. Furthermore, Medigene is the first German biotech company to have a drug on the US market.

In the European Union, market approval for Belgium, Bulgaria, Cyprus, Denmark, Finland, France, Hungary, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, and Sweden was granted in 2012. Market approval was granted for the Czech Republic early 2013 and is expected for Greece within the next few months. Outside the EU, Veregen® was approved in Switzerland, Serbia and Israel. In addition, market authorization applications were filed by partner companies in Mexico, Taiwan and Canada and are currently being evaluated by the respective regulatory authorities.

Veregen® is also listed in recognized treatment guidelines. The US Center for Disease Control and Prevention In its current treatment guidelines for sexually transmitted diseases, recommends Sinecatechins 15% ointment (Veregen®) as a possible option for treating genital warts. In addition, the “2012 European Guideline for the Management of Anogenital Warts” includes Sinecatechins 10% & 15% ointment (Veregen®) as a recommended treatment option for genital warts.


In 2013, the market launch of Veregen®, as well as the conclusion of further marketing partnerships are planned in a number of other countries. 

Veregen® is a trademark of Medigene AG.

Polyphenon E® is a trademark of Mitsui Norin Co., Ltd.


PubMed Articles [2 Associated PubMed Articles listed on BioPortfolio]

Topical Sinecatechins, 10%, Ointment for Superficial Basal Cell Carcinoma: A Randomized Clinical Trial.

European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development.

This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and appli...

News Articles [2 Associated News Articles listed on BioPortfolio]

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Clinical Trials [3 Associated Clinical Trials listed on BioPortfolio]

Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study

The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment ...

Treatment of the Recessive Nonbullous Congenital Ichthyosis by the Epigallocatechine Cutaneous

Lamellar ichthyosis (IL) is a rare autosomal recessive genodermatosis with a defect of keratinization of the skin which results in a severe generalized cutaneous xerosis with dark brown bi...

Pharmacokinetic Study of Topically Applied Veregen 15% Compared With Oral Intake of Green Tea Beverage

This open, monocentric study is designed to investigate plasma concentrations of certain catechins after topical application of Veregen 15% ointment to genital or perianal warts in compari...


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