Veregen® is an ointment used to treat external genital warts. In the USA, Germany, Austria, Spain, Switzerland, Serbia, the Netherlands and Taiwan 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.
Veregen® is currently available in Austria, Germany, Spain, Switzerland and the USA as well as Serbia (since April 2013), the Netherlands (since July 2013), Taiwan (since October 2013), Norway (since December 2013) and Sweden (since January 2014). Within the EU, Veregen® was approved during the course of 2012 and 2013 in all the countries for which Medigene applied for approval at the end of 2011 under the process of mutual recognition. Outside the EU, Veregen® has been approved in Israel and it also received approval in Canada in 2013. Additionally, market authorisation applications have been submitted by partner companies in Mexico and Turkey. These are currently being evaluated by the 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.
Medigene anticipates that Veregen® will be launched in several more countries, especially in Europe in 2014, and that more partnerships will be formed for international marketing. There are plans for approval applications in 2014 for further seven to nine European countries covered by the Mutual Recognition procedure.
Veregen® is a trademark of Medigene AG.
Polyphenon E® is a trademark of Mitsui Norin Co., Ltd.