Kyowa Hakko Produces Tablet Version of Cholesterol-Lowering CSPHP Tablets Enable CSPHP to Be Incorporated into Dietary Supplements

TOKYO, Sept. 24 -- Kyowa Hakko Kogyo Co., Ltd., one of Japan's leading developers of pharmaceutical and biotechnology products, has produced a tablet version of CSPHP(R)(1), its novel cholesterol-lowering food ingredient. This development will allow dietary supplement makers to make CSPHP-based cholesterol-lowering tablets or capsules for consumers to incorporate into their daily diet, and follows the successful launch of a liquid version of CSPHP in July 2003.

Kyowa Hakko will be showcasing the active ingredient, CSPHP, along with tablets and the data from its latest trials at the Supply Side West show in Las Vegas from October 1?, 2003. Kyowa will also demonstrate its in-house capsuling and bottling capabilities in the USA, which enable supplement companies to quickly launch new products to the market, and will outline the consulting service it offers to help manufacturers devise effective advertising that meets regulatory requirements.

A randomized, double blind placebo controlled trial of 75 subjects, reported in the Japanese Pharmacology & Therapeutics journal (vol.31, no. 7), concluded that 3 grams per day of CSPHP in tablet form over 4 weeks or beyond had a significant effect in reducing serum cholesterol levels in mildly hypercholesterolemic subjects (serum total cholesterol: 220 ?240 mg/dl). At the same time, 1.5 g seemed to possess potential to lower cholesterol in a dose responsive manner.

"CSPHP is an increasingly popular and important cholesterol lowering agent in the growing Japanese functional food market, and we are excited to be adding the tablet version to the powder and liquid formats already being widely adopted in the industry," said Tadayasu Furukawa, President of Kyowa Hakko's Food Company. "We expect that its proven efficacy in lowering cholesterol will appeal to millions of health-conscious consumers looking for effective dietary supplements."

According to the National Heart, Lung, and Blood Institute's National Cholesterol Education Program, about 50 percent of American adults have elevated blood cholesterol levels ?one of the key risk factors for heart disease, the number one killer of both men and women in the U.S.

Cognizin(R), a branded citicholine ingredient for brain health, and amino acids will also be showcased.

(1)About CSPHP:

CSPHP is a novel cholesterol-lowering compound that combines soy protein hydrolyzate and soy phospholipids to block the absorption of cholesterol in the intestine. CSPHP also has a unique property that increases the production of healthy HDL cholesterol in hypercholesterolemic volunteers.

Controlled trials, conducted among hypercholesterolemic volunteers, have indicated that 3 grams of CSPHP taken every day for one month reduced LDL- cholesterol by 17 percent, compared to a 13 percent reduction with the same quantity of plant sterol ester. A daily intake of 25 grams of soy protein resulted in a reduction of LDL-cholesterol by only 10 percent.

As a food additive CSPHP is highly stable, retaining its properties even through high temperature food manufacturing processes. Because CSPHP can be added to proteins, lipids, starches, and minerals it can be used as an active health ingredient in a wide range of consumer-acceptable foods, drinks, and dietary supplements.

Japan's Ministry of Health, Labor, and Welfare officially recognizes CSPHP as a 'Food for Specified Health Use (FOSHU)'. For the U.S. market, CSPHP has been self-affirmed GRAS (Generally Recognized As Safe) through an independent evaluation by an expert panel.

About Kyowa Hakko:

Kyowa Hakko is an industry leading global supplier to the food, pharmaceutical and chemical industries, with net sales in the fiscal year ending March 31, 2003 of 359 billion yen. The Company was established in 1949 and is headquartered in Tokyo, Japan. Areas of expertise include the development and application of fermentation technology, and new forms of biotechnology. Kyowa Hakko's core pharmaceutical research focuses on drug discovery using antibody-based technologies and on developing therapeutic agents for cancer and allergies.

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