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Spherix : FDA sieht keine Schwierigkeiten für Zuckerersatz Tagatose! - 500 Beiträge pro Seite



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Spherix`s New Sweetener Gets `No Questions` Go-Ahead From FDA; Plans for Production Reported

BELTSVILLE, Md., Oct. 26 /PRNewswire/ -- Spherix Incorporated (formerly Biospherics Incorporated) (Nasdaq: SPEX), a technology innovations firm in Beltsville, Maryland, reported today that it received a copy of a letter sent to its Danish licensee (MD Foods, now part of Arla Foods) by the FDA saying that the Agency has no questions regarding the GRAS status declared for tagatose. Furthermore, the FDA took no exception to the amounts of tagatose proposed for any of the wide variety of products that had been submitted for review. This action by the FDA follows its months`-long review of all the scientific data regarding the safety of tagatose developed over some 10 years of research.

Expressing pleasure at this event, Spherix officials also called attention to recent articles announcing the impending commercialization of the new low- calorie sweetener. On October 17, the Danish newspaper, Berlingske Tidende, reported on its website, http://www.beringske.dk , that Spherix`s Danish licensee had completed its miniature-scale testing, following which the Arla board of directors committed to the product by approving a resolution for its production. The paper says the initial goal for annual sales of the low- calorie sugar is greater than $60 million. The Spherix license permits the Danish firm to make and sell tagatose for use in regular and "healthy" foods, including foods safe for diabetics. On October 18, the newspaper printed a follow-up story in which it said that a trial production of 50 to 100 tons of tagatose will be undertaken within the next couple of months. Andreas Lundby, Arla board director, was quoted as saying that full-scale production would take at least a year. The articles were apparently triggered by Arla`s presentation of tagatose at the International Food Ingredients Fair held at Cologne, Germany last week. Mr. Lundby is reported as saying that the food industry showed quite an interest for the new sweetener. Stating that he is looking for a partner for the new venture, Mr. Lundby would not confirm earlier press reports that the huge Danish sweetener producer, Danisco, is a possibility. In its newsletter for October 15 - 20, Danisco reported on the same developments, but was silent on its possible participation. Dr. Gilbert V. Levin, Spherix CEO, said that although he is pleased at these signs of progress in the commercialization of tagatose, he has told Spherix`s licensee that they should move faster. He urges immediate construction of the 10- to 20-million pounds-per-year plant that was the basis of the market entry plan they had submitted to Spherix. Many such plants would be required to meet the demand forecast in a major market study commissioned by the Danish firm. Levin has repeatedly asked the firm to accelerate its pace with tagatose. "I`m sure they think they are merely being conservative, but unneeded delay is not conservative. Quite the opposite, it is wasteful of revenues that can never be made up. With GRAS approvals long behind them, they should be selling the product now." Spherix officials said that they are waiting for an overdue update from Denmark that will provide news of additional progress. Spherix will then determine whether its licensee is falling short on its commitment.


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