CollaGenex Pharmaceuticals Signs License and Supply Agreement with MediGene for Marketing Rights to Oracea in EU and Certain Other Countries
Wednesday December 20, 2:30 am ET
NEWTOWN, Pa.--(BUSINESS WIRE)--CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI - News) today announced that it has signed a License and Supply Agreement with MediGene AG for marketing rights to Oracea(TM), CollaGenex's flagship dermatology product for the systemic treatment of rosacea, in the European Union, certain contiguous countries and Russia. MediGene is a German biopharmaceutical company that is developing novel pharmaceuticals for the treatment of dermatology, cancer and certain autoimmune conditions.
Under the License and Supply Agreement, MediGene receives the right to manufacture, register, market and sell Oracea in the European Union, certain contiguous countries and Russia. CollaGenex is entitled to an upfront fee of $5 million upon signing of the agreement as well as an additional $7.5 million in milestone payments upon the achievement of certain annual sales thresholds. In addition, CollaGenex will receive a royalty of 12% of annual net sales up to $10 million and 15% of annual net sales in excess of $10 million.
Colin Stewart, president and chief executive officer of CollaGenex, stated, "This partnership, with a company that shares many of our attributes, will allow us to access the market for prescription rosacea products in the EU and other specified countries. We believe that the total size of this market in these countries is approximately $100 million, and that MediGene is well-positioned to develop Oracea into a significant product within the total market. This agreement also further strengthens our balance sheet as we continue to focus on the development of our product portfolio within the dermatology market."
Dr. Peter Heinrich, chief executive officer of MediGene, commented, "We have been very impressed with the clinical results of Oracea and the results of the commercial launch in the U.S. Following regulatory approval, Polyphenon® E-Ointment, our topical prescription drug for the treatment of HPV-related genital warts, and Oracea will form the cornerstone for the development of our commercial dermatology business in Europe."
About Oracea
Oracea was developed by CollaGenex and is the only systemic drug in the U.S. approved by the FDA to treat rosacea. Oracea was launched to the U.S. dermatology community in July 2006 and addresses a $500 million prescription drug market. CollaGenex filed a Marketing Authorization Application (MAA) for Oracea with the United Kingdom's Medicines & Healthcare Products Regulatory Agency (MHRA) on February 24, 2006 and anticipates that it will receive approval during 2007. The U.K. will act as reference member state in this decentralized procedure. In June 2006, the European Patent Office issued Patent 02731267.7, which has a priority date of April 5, 2002 and covers the use of sub anti-microbial doxycycline in the treatment of acne and rosacea, including Oracea(TM).
About MediGene
MediGene AG is a publicly quoted (Frankfurt: Prime Standard: MDG) biotechnology company located in Martinsried/Munich, Germany, with subsidiaries in Oxford, UK and San Diego, USA. MediGene is the first German biotech company with a drug on the market. A second drug, Polyphenon® E Ointment, has been approved by the FDA and is pending approval in the EU for the treatment of HPV-related genital warts. In addition, several drug candidates are currently in clinical development. MediGene also possesses innovative platform technologies. MediGene focuses on indications of high medical need and great economic opportunities. |
