COLUMBIA, Md., May 17 /PRNewswire-FirstCall/ -- Martek Biosciences Corporation commented today on the FDA’s recent response to the generally recognized as safe (GRAS) notification GRN No. 94 (the “Notification”) filed by the Ross Products Division of Abbott Laboratories in January 2002. The FDA notified Ross Products that it has no questions at this time regarding Ross’ conclusion that docosahexaenoic acid (DHA)-rich oil from tuna and arachidonic acid (ARA)-rich oil, produced by Suntory Ltd. from Mortierella alpina, are safe as sources of DHA (at 0.15% of total fatty acids by weight) and ARA (at 0.40% of total fatty acids by weight) in term and post-discharge preterm infant formulas.
Martek’s comments are as follows: * The levels of DHA and ARA specified in the Notification are significantly lower than the levels used in the majority of all term and pre-term infant formula sold in the U.S. In addition, the levels of DHA specified in the Notification are significantly lower than the levels recommended by a Joint Expert Committee of the Food and Agricultural Organization of the United Nations and the World Health Organization, as well as other bodies. * Studies showing a positive benefit of DHA and ARA supplemented formula for term infants used DHA and ARA at levels significantly higher than those specified in the Notification and the Notification does not apply to those higher levels. * The FDA’s acceptance of a GRAS Notification does not speak to the degree of efficacy of a product. * Martek is not aware of any customer with plans to switch to DHA derived from tuna oil or any other fish oil sources for use in infant formula to be sold in the U.S. * Based on its relevant U.S. patents and related license agreements and the foregoing factors, it is expected that the impact to Martek of the FDA’s acceptance of the Notification, if any, will be immaterial.
Martek Biosciences Corporation is a leader in the innovation and development of omega-3 DHA products that promote health and wellness through every stage of life. The Company produces Martek DHA(TM), a vegetarian source of the omega-3 fatty acid DHA (docosahexaenoic acid), for use in foods, infant formula, and supplements, and ARA (arachidonic acid), an omega-6 fatty acid, for use in infant formula. For more information on Martek Biosciences, visit http://www.martek.com.
Sections of this release contain forward-looking statements concerning, among other things, expectations regarding customer agreements and plans, patents and the economic impact to Martek of the FDA’s acceptance of the Notification. These statements are based upon numerous assumptions which Martek cannot control and involve risks and uncertainties that could cause actual results to differ. For instance, Martek cannot predict with certainty what its customers’ future actions will be or whether the effect of the FDA acceptance of the Notification would impact Martek’s long-term competitive position. These statements should be understood in light of the risk factors set forth in the Company’s filings with the Securities and Exchange Commission, including, but not limited to, Part II, Item 1A of the Company’s Form 10-Q for the fiscal quarter ended January 31, 2006 and other filed reports on Form 10-K, Form 10-Q and Form 8-K.
CONTACT: Kyle Stults, Investor Relations of Martek Biosciences Corporation, +1-410-740-0081
Martek Biosciences Corporation
CONTACT: Kyle Stults, Investor Relations of Martek BiosciencesCorporation, +1-410-740-0081
Web site: http://www.martekbio.com/
