GreenTea Extract Polyphenon
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Moving Toward the World's First Commercialization of Catechin;
Mitsui Norin's Polyphenon E as a Main Ingredient in Pharmaceutical Products.
January 5, 2005

Mitsui Norin Co., Ltd. (Headquarters: Tokyo; President: Hiroshi Kakou) maintains world leadership in the research and development of catechin extracts from tea leaves. Yearly sales revenue for catechins in FY2004 is forecast at ¥7.0 bn, double that of the previous year, due to the emphasis of beverage makers on green tea infused with catechins and the rapidly increasing use of catechins for other purposes.
At Mitsui Norin, we have been hard at work on incorporating our Polyphenon E (registered trademark) in pharmaceutical products due to the superior anti-bacterial and anti-viral properties of catechins.

Recently, the German biotech company Medi Gene AG conducted a clinical study (phase III clinical study) in the U.S. on condyloma (a dermatological condition caused by the papilloma virus) using Polyphenon E ointment and obtained clinical results showing evidence of superior safety and substantial, sustained effectiveness. The company had already achieved similar success in a clinical study in Europe in April of last year and is planning to petition the relevant authorities (FDA) in the U.S. and Europe for new drug sales approval in the spring of 2005.
Although condyloma is benign, it is a contagious condition and is therefore said to be difficult to treat. It is said to be the cause of infection by the papilloma virus for approximately 14 mn people in North America and 15 mn people in Europe. Medi Gene AG intends to sell this new product beginning in 2006 through tie-ups with major pharmaceutical companies in the U.S. and Europe and forecasts that yearly sales will exceed ¥12-13 bn. It is likely that the market size will reach ¥20-30 bn in the future, since the clinical study results indicate that Polyphenon E ointment would be effective for other skin conditions (premonitory symptoms of cancer).

As detailed above, there is an increasing likelihood that a pharmaceutical incorporating Polyphenon E, a component of tea (catechin), as the primary ingredient will be approved and commercialized during 2006. This is of epochal significance, since this means that not only a tea extract but a natural botanical extract will be approved and commercialized as an active ingredient for the first time worldwide, under U.S. FDA standards.

In response to this, Mitsui Norin has embarked on a series of investments to put in place infrastructure for the supply of active ingredients, ranging from raw materials procurement to production of active ingredients. Specifically, we have secured a base for both the raw material of tea and intermediate active ingredients in China. Mitsui Norin has also leased production facilities for the commercial manufacture of Polyphenon E from the pharmaceutical manufacturer Alps Pharmaceutical Ind. Co., Ltd. (in Gifu Prefecture); with an investment of approximately ¥400-500 mn, we are in the process of establishing production facilities. We are, furthermore, working to strengthen our company infrastructure and have established the Polyphenon E Active Ingredient Business Division in the Polyphenon Business General Headquarters.

Mitsui Norin is also working on the development of other uses for Polyphenon E, such as a prophylactic drug for cancer.

Since 1997, we have cooperated with prominent cancer research centers in the U.S. and have conducted clinical studies on Polyphenon E as a prophylactic drug for many different types of cancer in eight famous U.S. university research institutes and medical research facilities.
A phase II clinical study is currently underway to determine whether administration of Polyphenon E for premonitory symptoms of cancer (symptoms prior to onset) can retard progress of the illness somewhat or improve the symptoms.

In the U.S., there are high expectations for research on using natural products with few side effects as prophylactic drugs, with the aim of reducing medical expenses, which it is said will surpass ¥100 tr. The aforementioned cancer research institutes are working on the development of prophylactic drugs using many different natural botanical extracts; among these, tea extracts are being awarded serious attention, and hopes are pinned on clinical studies using Polyphenon E, with the cooperation of Mitsui Norin. If Polyphenon E produces successful results in clinical studies as a cancer prophylactic, this will provide great momentum to this trend.

As stated above, Mitsui Norin is preparing an infrastructure for sales of over ¥10 bn for pharmaceutical products incorporating Polyphenon E in five years. Furthermore, we intend to capitalize on our strengths in the research and development of high-quality catechins in the area of food products as well and to develop a substantial business from Polyphenon.

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