Vitamin K2 (menaquinone-7), developed and manufactured by J-OIL MILLS (Chuo-ku, Tokyo; capital of \10 billion; President and Representative Director: Shinji Sasaki) and exported and marketed to the supplements market in Europe and the United States by Sumitomo Corporation (Chuo-ku, Tokyo; capital of \219.3 billion; President and CEO: Susumu Kato), has been received a positive scientific opinion by the European Food Safety Authority (EFSA) as an ingredient for food products and supplements in its recent publication.

 

This is the first positive scientific opinion on a new vitamin since the EU Directive on foods for particular nutritional uses (PARNUTS)* issued in 2001. It also is a very first case for any ingredient to obtain a positive scientific opinion for both food products and supplements simultaneously, among all food groups, including vitamins. In January 2008, vitamin K2 (menaquinone-7) obtained self-affirmed Generally Regarded As Safe (GRAS) status from the US Food and Drug Administration (FDA).

 

The EFSA-opinion on vitamin K2 (menaquinone-7) in food products, will allow the product to be sold in the European and US food markets, for wide variety of applications, such as beverages, dairy products, confectionery and cereals. EFSA-opinion, following FDA's self-affirmed GRAS status, shall greatly contribute to sales also in areas other than Europe and the United States. Several global food manufacturers are already showing keen interest, and started developing applications containing vitamin K2 (menaquinone-7).

 

It should be noted that the EFSA-opinion was based on safety assessments of the ingredients, manufacturing method and the product quality of vitamin K2 (menaquinone-7) exclusively manufactured by J-OIL MILLS and does not apply to other vitamin K2 ingredients.

 

NattoPharma ASA (Lysaker, Norway; capital of NOK 2,040,000 or about \30 million; CEO: Egil Greve), who has jointly conducted marketing and distributed vitamin K2 (menaquinone-7) with J-OIL MILLS and Sumitomo Corportion, filed applications for approval in EU, based on The Distribution Agreement signed in December, 2004. In order to enhance the sales of vitamin K2 (menaquinone-7) outside of Japan, the three companies also signed a collaboration agreement, including a 10-year distribution agreement covering not only the European and US markets, but as well as the other countries and areas on December 12, 2007.

 

The three companies will jointly promote the sale of vitamin K2 (menaquinone-7) as an ingredient for supplements and functional foods for osteoporosis and cardiovascular diseases globally mainly in areas where the consumption of natto (fermented soybeans) is not common and the demand is high for vitamin K2 (menaquinone-7). In Japan, J-OIL MILLS and Sumitomo Corporation will collaborate and promote its application in dairy products, beverages and confectionery products.

 

Several different types of Vitamin K exist: K1, which is synthesized by plants, and K2 by bacteria. Different vitamin K2 exists according to the different length of side chains from menaquinone-4 to menaquinon-13. While only traceable amounts of vitamin K2 is found in fermented food products, natto contains a substantial amount of menaquinone-7, produced by natto bacillus.

 

Vitamin K inhibits artery calcification (the hardening of blood vessels) and helps calcification of the bones. J-OIL MILLS has verified that natto-derived vitamin K2 (menaquinone-7) manufactured and sold by the company has longer half life in blood compared with other types of the vitamin K, and reaches the vital areas such as bones and arteries easier than other existing vitamin K. Because osteoporosis,and cardiovascular disease are considered serious problems in Europe and the United States, vitamin K2 (menaquinone-7) is expected to play an important role in reducing the risk of these diseases. Therefore, the potential market size for vitamin K2 (menaquinone-7) is considered to be extremely large**.

 
Glossary
*Directives, laws and regulations for food ingredients and additives in Europe
(1) Food Supplement Directive (2002/46/EC): 
(2) Fortified Food Regulation (EC No 1925/2006):
(3) Novel Foods Regulation (258/97/EC): While natto is regarded as food, natto-derived

     vitamin K2 is required to be approved under this regulation.
(4) PARNUTS products (foods added for a specific nutritional purpose) (Directive 2001/15/EC):

 

**Market size for osteoporosis and arteriosclerosis
(1) Estimated number of worldwide patients with osteoporosis (WHO Report): 200 million
(2) Treatment cost for osteoporosis (International Osteoporosis Foundation): USD 18 billion

     (about \2 trillion) in the United States; EUR 32 billion (about \5 trillion) in Europe
(3) Worldwide annual fatalities caused by arterial disease (WHO Report): 17.5 million 

     worldwide in 2005 (Deaths caused by arterial disease account for about 30% of all

     deaths.) It is estimated that the number will increase to 20 million by 2015.
(4) Treatment cost for arterial disease (Maastricht University Survey): USD 432 billion

     (approximately \43 trillion) in 2007 in the United States; EUR 169 billion (approximately

      \21 trillion) in Europe (In Europe, deaths caused by arterial disease account for about

      50% of all deaths.)
(5) World market for supplements (survey conducted by NattoPharma): \6.7 trillion in 2006
(6) World market for functional foods (survey conducted by NattoPharma):  \8.4 trillion in 2006

 

Brief outline of NattoPharma ASA
NattoPharma ASA was founded in 2004 to conduct research and marketing of natural vitamin K2 (menaquinone-7). The company's headquarters are located in Lysaker, near Oslo in Norway. In January 2008, NattoPharma listed in the Oslo Stock Exchange, Oslo Axess. Sales for year ending December 31, 2007 were NOK 22 million (approximately \300 million) and those for the first half of fiscal 2008 were NOK 14 million (approximately \200 million).
NattoPharma ASA holds three important patents related to vitamin K and is currently in the process of filing another patent application. The company has signed a research and development agreement with Maastricht University in the Netherlands, the leading institute specializing in research of vitamin K. Under the agreement, research, including clinical studies, on vitamin K and vitamin K-dependent proteins is conducted.

NattoPharma ASA has signed a Collaboration Agreement with J-OIL MILLS and Sumitomo Corporation whereby an exclusive distributorship of vitamin K2 (menaquinone-7) has been awarded in regions excluding the Asian. The company sells natural vitamin K2 under the brand name of "MenaQ7" mainly in the European, US and South African markets.

 

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