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Green tea (Camellia sinensis) has grown in popularity in the United States and around the world owing to continuing news of research suggesting positive benefits related to its well-known antioxidant properties, including reducing the risk of certain cancers. Most of the benefits of green tea is considered to be based on the chemical fraction containing catechins, a group of polyphenolic compounds.
Now, a German-American biotech company has developed an ointment containing a fraction of green tea intended to treat genital warts. The company has flied a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for this indication.
In early December Medigene AG of in Martinsried, Germany and San Diego, CA, announced the NDA for its new green tea-based PolyphenonŽ E* Ointment for the treatment of genital warts, a benign form of skin tumors caused by infections with various types of human papilloma viruses (HPV). 1
The application is based on two phase III clinical trials conducted in Europe, the United States, Argentina, Chile, Columbia, Mexico, and Peruenrolling more than 1,000 patients. The results of these studies have been presented at several scientific conferences: the 13th Congress of the European Academy of Dermatology and Venereology (November 2004, Florence, Italy), the International Herpes Papilloma Virus Symposium (May 2005, Vancouver, B.C., Canada), the Society of Investigative Dermatology Meeting (May 2005, St. Louis, MO), and the HPV and Skin Cancer Conference (September/October 2005, Berlin). The most recent conference was in October 2005 at the 14th Congress of the European Academy of Dermatology and Venereology in London. According to a company press release, MediGene plans to submit a Marketing Authorization Application in Europe in 2006. [Ref 1 and Personal communication (e-mail, J Hoffmann (Medigene) to M. Blumenthal, Dec. 21, 2005.]
Peter Heinrich, CEO of MediGene AG, says that pending approval by the FDA, the company plans to begin marketing Polyphenon EŽ Ointment in the United States, which currently represents the largest market for the target indication, and negotiations are currently underway with a potential American marketing partner. 1
The stated active substance in PolyphenonŽ E* Ointment is a green tea extract with a defined catechin composition. MediGene is developing this drug for the treatment of various skin tumors. For the indication of genital warts, MediGene estimates the sales potential of this natural drug at more than 100 million Euros annually. 1
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 area, which are 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. 1
For an extensive review of the therapeutics of green tea see the monograph on Green and Black Tea in The ABC Clinical Guide to Herbs (2003). 2 Also, a comprehensive two-part review of green tea has recently been published covering the anti-cancer and other health benefits of tea. 3,4
According to a company press release, MediGene AG is a publicly traded German-American biotechnology company located in Martinsried, Germany and San Diego, CA. The company says that it is the first German biotech company with an approved drug on the market. The NDA for a second drug, PolyphenonŽ E Ointment, has been submitted. In addition, MediGene says that it has several oncological drug candidates undergoing clinical development, and it possesses innovative platform technologies for drug development. The company literature states that its core competence lies in research into and development of novel approaches for the treatment of various cancers and tumor-related diseases.1
* PolyphenonŽ E is the name temporarily being used by the company while the ointment is in development.
---Mark Blumenthal
References
1. MediGene announces FDA Acceptance of New Drug Application for PolyphenonŽ E Ointment for the Treatment of Genital Warts [press release]. San Diego, CA: MediGene AG, Dec. 1, 2005.
2. Blumenthal M (sr. ed.), Hall T, Goldberg A, Kunz T, Dinda K, Brinckmann J, Wollschlaeger B (eds.). The ABC Clinical Guide to Herbs. Austin, TX: American Botanical Council, 2003.
3. Cooper R, Morre’ J, Morre’ DM. Medicinal Benefits of Green Tea: Part I. Review of Noncancer Health Benefits J Alt Com Med 2005;11(3): 521-528.
4. Cooper R, Morre’ J, Morre’ DM. Medicinal Benefits of Green Tea: Part II.
Review of Anticancer Properties. J Alt Com Med 2005;11(4): 639-652.
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