MediGene and Bradley Pharmaceuticals Enter Marketing and Development Partnership for Polyphenon® E* Ointment
· Bradley acquires US commercialization rights for genital warts and other dermatological diseases. MediGene retains full rest of world commercialization rights.
· Maximum milestone payments of up to $69 MM, including initial payment of
· Royalties on product sales
· Bradley Pharmaceuticals to support development costs for further indications.
Martinsried/Munich – San Diego, January 31, 2006. The German-American biotechnology company MediGene AG (Frankfurt, TecDAX) has entered into a partnership agreement with Bradley Pharmaceuticals to commercialize Polyphenon® E* Ointment in the US. Bradley Pharmaceuticals, a US specialty pharmaceutical company that markets to niche physician specialties, will take on US promotion and commercialization of the drug for the treatment of genital warts. MediGene and Bradley also agreed upon a development partnership to examine the application of Polyphenon® E* Ointment for the treatment of other skin diseases.
Under the terms of the agreement, MediGene could receive successive milestone payments up to $69 MM, including a payment of $5 MM due upon signing of the contract. In addition, MediGene will receive royalties on sales of Polyphenon® E* Ointment in the US. Milestone payments are dependent upon specific achievements in development, approval, and commercialization of the Polyphenon® E* Ointment in the genital warts and actinic keratosis indications, and are linked to specific sales targets reached in any indication.
Bradley Pharmaceuticals will take over the majority of the development costs for Polyphenon® E* Ointment if it is developed in dermatological indications other than genital warts. MediGene holds the right to commercialize all of these developments outside the US, whereas Bradley holds the right to market Polyphenon® E* Ointment in all dermatological indications within the US.
In November 2005, the US regulatory authority Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for Polyphenon® E* Ointment for the treatment of genital warts for filing. Provided that the approval procedure is successful and marketing authorization is granted, US market launch of the Polyphenon® E* Ointment is scheduled for 2007.
“We believe that Bradley is ideally qualified to tap the full potential of Polyphenon E* in the US market,” commented Dr. Peter Heinrich, MediGene’s Chief Executive Officer. It was our objective to win a partner with a powerful sales force active in the appropriate channels. Furthermore, our product should possess high significance for this partner’s strategic company development. In the past months we screened multiple potential partners and are excited to have signed a partnership with Bradley Pharmaceuticals, one of the premier specialty pharmaceutical companies in the US. Bradley is known for its strong marketing and will promote Polyphenon® E* in the US market with more than 100 representatives"
Bradley President and CEO, Daniel Glassman, stated: “Polyphenon® E* Ointment fits perfectly into our dermatology portfolio and represents an important expansion for us into new specialty healthcare markets. We will position it as one of our core products and will utilize our full resources and expertise to capture a significant market share.”
Company profile of Bradley Pharmaceuticals: Bradley Pharmaceuticals, Inc. (NYSE: BDY) was founded in 1985 as a specialty pharmaceuticals company serving niche physician specialties in the USA and in 38 countries worldwide. The Company has 300 employees, and Net Sales of approximately 97 Million US dollars for 2004. Bradley estimates net sales for the year ended December 31, 2005 will exceed reported 2004 net sales, as 2005 net sales will include a full year’s operations of the assets acquired from Bioglan and the introduction during 2005 of several new products. Bradley’s success is based on the company’s product life cycle management strategy. This means that Bradley acquires brands and further develops them by means of line extensions and improved formulations. Bradley Pharmaceuticals is comprised of Doak Dermatologics, specializing in topical therapies in dermatology, and Kenwood Therapeutics, providing drugs for respiratory diseases, as well as for indications in gastroenterology and internal medicine.
Polyphenon® E* Ointment: The active substance in Polyphenon® E* Ointment is a green tea extract of defined catechin composition, produced by means of a patented purification process. MediGene has developed this drug for the treatment of various skin tumor diseases. The New Drug Application recently filed was based on the positive results of two phase III trials in more than 1,000 patients. In the indication genital warts alone, MediGene expects an annual sales potential of more than 100 million EUR in the USA. In parallel with the ongoing approval process in the USA, MediGene is preparing a market authorization application for European countries.
Genital warts: Genital warts are one of the most common and fastest spreading venereal diseases worldwide. Genital warts are benign, but disfiguring and contagious skin tumors in the genital and anal areas, which are usually difficult to treat. Approximately 14 million people in North America and 15 million people in Europe are infected by human papilloma viruses (HPV type 6 or 11), which cause genital warts.
This press release contains forward-looking statements that involve risks and uncertainties. The forward-looking statements contained herein represent the judgement of MediGene as of the date of this release. These forward-looking statements are no guarantees for future performance, and the forward-looking events discussed in this press release may not occur. MediGene disclaims any intent or obligation to update any of these forward-looking statements. MediGeneTM is a trademark of MediGene AG, Polyphenon® E* is a trademark of Mitsui Norin.
* Temporary name while under development
- Ends -
MediGene AG is a publicly quoted (Frankfurt: TecDAX), German-American biotechnology company located in Martinsried, Germany and San Diego, USA. MediGene is the first German biotech company with a drug on the market. The NDA for a second drug, Polyphenon® E* Ointment, has been submitted. In addition, MediGene has several oncological drug candidates undergoing clinical development, and possesses innovative platform technologies for drug development. MediGene’s core competence lies in research into and development of novel approaches for the treatment of various cancer and tumor diseases.
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