Martinsried/Munich, June 23, 2009. MediGene AG (Frankfurt, Prime Standard, TecDAX) has entered into a marketing partnership with the Spanish company Juste S.A.Q.F. for the commercialization of Veregen® ointment (formerly Polyphenon E®) in Spain and Portugal. Juste, a family-owned specialty pharma company, will promote and distribute the drug for the treatment of genital warts. Depending on specified milestones and sales targets achieved, MediGene is entitled to successive payments totalling up to 2,550,000 euro. MediGene will supply Juste with the finished product, and will receive royalties on the sales revenue for Veregen®.
Veregen® is currently undergoing a decentralized procedure in Germany, Austria, and Spain, and conclusion of this process is expected soon. Thereafter, MediGene is planning to apply for approval in further European countries. MediGene intends to conclude additional marketing agreements for countries in and outside Europe.
Dr. Frank Mathias, Chief Executive Officer of MediGene, commented: “Juste is the perfect partner for us to tap the full potential of Veregen® in Spain and Portugal. We are very glad that this first move towards commercialization of Veregen® in Europe has been made. Veregen® has been approved by the FDA and has been available for sale in the US market, and we are keen to have this drug available to patients in Europe as soon as possible.”
Javier Hidalgo, General Manager of Juste: “Veregen® perfectly suits our portfolio, and will allow us to capture new markets. We will position it as one of our core products, and use our full suite of resources and expertise to capture significant market share for this competitive product.”
About Veregen®: Veregen®, for the treatment of genital warts, contains a concentrate of catechins with a defined composition that have been extracted from green tea leaves. MediGene acquired the basic rights to the active substance from the Canadian company Epitome Pharmaceuticals, Ltd., in 1999, and was solely responsible for the drug’s preclinical and clinical development, as well as for the approval process. The US regulatory authority FDA granted approval for Veregen® in November 2006, driven by the results of an international phase III development program in which more than 1,000 patients in 15 countries were treated. The decentralized procedure in selected European countries is currently ongoing. The conclusion of the procedure is expected soon. Patent protection has been augmented by a number of proprietary inventions. The catechin extract is manufactured by the Japanese company Mitsui Norin Co., Ltd. The drug’s name during development was Polyphenon E® Ointment, its trade name is Veregen®.
About Juste: JUSTE, S.A.Q.F. is a Spanish chemical-pharmaceutical company located in Madrid, with more than 80 years of experience devoted to the research, development and distribution of pharmaceutical products. Its main business areas are Central Nervous System, Primary Care and Women Health, Hospitals as well as Biotechnology and it has an important industrial activity in the manufacturing of soft gelatine capsules. JUSTE, through its affiliate Justesa Imagen SA, has presence in Central America, Argentina, Mexico and Brazil.
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.
