MediGene AG Signs Agreement with Solvay SA for the Commercialization of Veregen(R) in Germany, Austria, and Switzerland
Martinsried/Munich, September 29, 2009. The biotech company MediGene AG (Frankfurt, Prime Standard, TecDAX) has signed a license and supply agreement with Solvay Arzneimittel GmbH, the German affiliate of Solvay Pharmaceuticals (Solvay) for the supply and commercialization of Veregen® (formerly Polyphenon E® ointment) in Germany, Austria, and Switzerland. Solvay's subsidiaries will promote and distribute the drug for the treatment of genital warts in the above-mentioned countries. In Switzerland Solvay will also take charge of the Veregen® regulatory procedures. Upon the achievement of specified milestones and sales targets, MediGene is entitled to successive payments totalling up to 3.65 million euros. MediGene will supply Solvay with the finished product, and will receive royalties on net sales.
In July 2009, MediGene's marketing authorization application for Veregen® was assessed positively by the national regulatory authorities of Germany, Austria, and Spain in a decentralized approval procedure. The recent grant of formal marketing authorization in Germany was the first such authorisation implemented by a European national regulatory authority. Marketing authorization of Veregen® in Germany (the reference state in this decentralized process) will provide a basis for additional marketing authorization applications to be submitted in additional European countries. The issue of formal marketing authorizations in Austria and Spain is expected within the next few months. German market launch is planned for the first half of 2010, and MediGene intends to conclude additional marketing agreements in other countries both within and outside Europe.
Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented: "Following Spain and Portugal, we believe we have found the perfect partner for the commercialization of Veregen® in Germany, Austria, and Switzerland. We have received multiple requests from physicians, pharmacists and patients in the German-speaking countries who we know are all eagerly awaiting market launch of Veregen®. In cooperation with Solvay we are keen to provide this as soon as possible."
Dr. Wolfgang Dankert, General Manager of Solvay Arzneimittel, commented: "We are delighted to add Veregen® to our product portfolio and are convinced that it will provide an innovative option for the treatment of genital warts. Solvay is very well positioned for the commercialization of the product in the respective target groups, and we will make full use of our resources and expertise in order to make this drug available to the patients as quickly as possible."
Veregen®: Veregen® for the treatment of genital warts contains a concentrate of catechins with a defined composition extracted from green tea leaves. MediGene acquired the basic rights to the active substance in Veregen® from the Canadian company Epitome Pharmaceuticals, Inc. in 1999, and was solely responsible for the drug's preclinical and clinical development, as well as for the approval process. Moreover the patent protection was further upgraded by a number of proprietary inventions. The catechin concentrate is manufactured by the Japanese company Mitsui Norin Co., Ltd. The drug's name during development was Polyphenon E® ointment, and its trade name is Veregen®. The drug was approved by the US regulatory authority FDA in November 2006, and has been available on the US market since February 2009. MediGene's marketing partner for the USA is Nycomed. The results on which the approval was based were obtained in an international phase III development program in which more than 1,000 patients in 15 countries were treated with the ointment. In Europe the marketing authorization application for Veregen® was assessed positively by the national regulatory authorities of a number of selected countries. Marketing authorization for Germany was granted by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte = BfArM) early in September 2009
Solvay Arzneimittel GmbH is the German affiliate of Solvay Pharmaceuticals. For more information, visit www.solvay-arzneimittel.de.
Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. These companies seek to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men's and women's health. Its 2008 sales were EUR 2.7 billion, and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 29,000 people in 50 countries. In 2008, its consolidated sales amounted to EUR 9.5 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay is listed on the NYSE Euronext stock exchange in Brussels (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR). Details are available at www.solvay.com.
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 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 registered trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in select locations only.
In July 2009, MediGene's marketing authorization application for Veregen® was assessed positively by the national regulatory authorities of Germany, Austria, and Spain in a decentralized approval procedure. The recent grant of formal marketing authorization in Germany was the first such authorisation implemented by a European national regulatory authority. Marketing authorization of Veregen® in Germany (the reference state in this decentralized process) will provide a basis for additional marketing authorization applications to be submitted in additional European countries. The issue of formal marketing authorizations in Austria and Spain is expected within the next few months. German market launch is planned for the first half of 2010, and MediGene intends to conclude additional marketing agreements in other countries both within and outside Europe.
Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented: "Following Spain and Portugal, we believe we have found the perfect partner for the commercialization of Veregen® in Germany, Austria, and Switzerland. We have received multiple requests from physicians, pharmacists and patients in the German-speaking countries who we know are all eagerly awaiting market launch of Veregen®. In cooperation with Solvay we are keen to provide this as soon as possible."
Dr. Wolfgang Dankert, General Manager of Solvay Arzneimittel, commented: "We are delighted to add Veregen® to our product portfolio and are convinced that it will provide an innovative option for the treatment of genital warts. Solvay is very well positioned for the commercialization of the product in the respective target groups, and we will make full use of our resources and expertise in order to make this drug available to the patients as quickly as possible."
Veregen®: Veregen® for the treatment of genital warts contains a concentrate of catechins with a defined composition extracted from green tea leaves. MediGene acquired the basic rights to the active substance in Veregen® from the Canadian company Epitome Pharmaceuticals, Inc. in 1999, and was solely responsible for the drug's preclinical and clinical development, as well as for the approval process. Moreover the patent protection was further upgraded by a number of proprietary inventions. The catechin concentrate is manufactured by the Japanese company Mitsui Norin Co., Ltd. The drug's name during development was Polyphenon E® ointment, and its trade name is Veregen®. The drug was approved by the US regulatory authority FDA in November 2006, and has been available on the US market since February 2009. MediGene's marketing partner for the USA is Nycomed. The results on which the approval was based were obtained in an international phase III development program in which more than 1,000 patients in 15 countries were treated with the ointment. In Europe the marketing authorization application for Veregen® was assessed positively by the national regulatory authorities of a number of selected countries. Marketing authorization for Germany was granted by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte = BfArM) early in September 2009
Solvay Arzneimittel GmbH is the German affiliate of Solvay Pharmaceuticals. For more information, visit www.solvay-arzneimittel.de.
Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. These companies seek to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men's and women's health. Its 2008 sales were EUR 2.7 billion, and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs more than 29,000 people in 50 countries. In 2008, its consolidated sales amounted to EUR 9.5 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay is listed on the NYSE Euronext stock exchange in Brussels (NYSE Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR). Details are available at www.solvay.com.
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 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 registered trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in select locations only.