Yukihiko Hara

Tea Solutions, Hara Office Inc. Tokyo, Japan

Abstract Title: Attempts to make Tea Extract into Active Pharmaceutical Ingredient(API) in drugs of various medical indications

Biography:

Yukihiko Hara graduated Tokyo University, Agric Dept. in 1967 and joind Mitsui Norin Co. In the laboratory he started to separate tea catechins from green tea the first trial in the world. He earned Ph.D. from Tokyo Univ. in 1990 for his thesis: "Physiological Activities of Tea Polyphenols". He supplied Polyphenon®E/EGCg to US-NCI( National Cancer Institute) for their “Clinical Chemoprevention Program” from 1990 and shared the complete safety/toxicity data of Polyphenon®E/EGCg done by NCI.

Research Interest:

We have been extracting tea catechins out of tea(Camellia sinensis) and elucidated various health promoting actions of them. Crude Tea catechins is about 15% of dried green tea which was named Polyphenon®E, and the half of them is composed of Epigallocatechin gallate: EGCg. Making use of these tea extracts, Crude(Polyphenon®E) and Purified(EGCg), we have been attempting to put them into Active Pharfmaceutical Ingredient(API) for various medical indications. Several such attempts, successful, on- going, under planning are cited. 1) “Veregen®”: genital warts healing ointment with 10-15% Polyphenon®E as an API was successfully approved by FDA in 2006 as the first “Botanical Drug” and marketed in the US, EU as a prescribed ointment. After years in use, this ointment was defeated by insurance supported competitor and lost the market. 2) “Displasix®”: suppossitory, composed of EGCg as an API, is under Phase 2 trial for the CIN(Cervical Intraepithelial Dysplasia-Neoplasia) patients. 3) Application of EGCg ointment reduces the sexual pain(vulvodynia) and enhances sexual arousal. GTO Pharmecutical LLC is trying to promote this fact in the market asking for the collaboration of competent Pharmaceutical company.