Biotech Values

[DewDiligence]

MATK was off 9% on potential competition
from fish, which has always been the bugaboo
in their business model, IMO. (DHA and AHA
additives for infant formula is MATK’s core
business.)

http://biz.yahoo.com/prnews/060517/dcw076.html?.v=28

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Martek Comments on FDA Response to GRAS Notice GRN No. 94

Wednesday May 17, 2:07 pm ET

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. [not yet].

* 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. [The market seems to disagree.]

Martek Biosciences Corporation (Nasdaq: MATK ) 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.
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