NEWARK, N.J., June 30 -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI; BDSIW) announced today that its subsidiary, Bioral Nutrient Delivery, LLC ("BND"), has utilized its licensed and patented technology, BioralTM Delivery, to formulate an Omega-3 fatty acid oil as a stable, dry powder known as Bioral(TM) Omega-3. To the best of the Company's knowledge, BioralTM Omega-3 has demonstrated, for the first time, unprecedented shelf stability and an effective means for the addition of Omega-3 fatty acids for potential use in goods that are then baked or cooked, such as cakes, muffins, pasta noodles, soups and cookies. Other potential applications may include the use of Bioral(TM) Omega-3 by manufacturers of cereals, chips, and candy bars. In addition, the Company has added the Bioral(TM) Omega-3 formulation to beverages such as soy milk, milk, liquid yogurt, grapefruit and orange juice, smoothies, sports drinks, soft drinks, coffee, iced coffees, and other beverages, in each case without altering taste or odor. All the testing to date has been performed on a small scale and there can be no assurances that Bioral(TM) Omega-3 will scale and perform as well in a larger production setting.
The development of Bioral(TM) Omega-3 is part of a larger effort by BND to utilize the Company's licensed encochleation technology platform to enable BND to encapsulate or "wrap" a selected nutrients into a crystalline structure, termed a "cochleate" cylinder, for use in processed foods and beverages. BND was formed on January 8, 2003 for the purpose of exploiting this application of the Company's licensed technology. Effective April 1, 2003, the Company sub-licensed its encochleation technology to BND for this purpose. BND intends to identify food and beverage manufacturers as potential licensees of its sub-licensed technology who will apply the encochleating technology to their products.
Omega-3 fatty acids, such as DHA and EPA, are widely recognized as health-promoting, polyunsaturated fatty acids. These fatty acids appear to promote good cardiovascular health, to suppress inflammation and to fight depression. In December, 2002, the FDA proposed to allow manufacturers to display health-promoting claims, such as those used in the supplement industry, in foods containing certain micronutrients such as omega-3 fatty acids. Natural sources of Omega-3 fatty acids include cold water fish. Typically, Omega-3 fatty acids such as DHA and EPA acquire an unpleasant fishy odor and taste upon storage and especially upon exposure to heat. The Bioral(TM) Omega-3 formulation looks and feels like flour, but has no fishy odor or fishy taste. The Bioral(TM) Omega-3 powder has been tested in food products subjected to baking and to stove-top heating and it has demonstrated an ability to protect the Omega-3 fatty acids from degradation due to heat.
The Bioral(TM) delivery system is made from all natural ingredients: calcium and phosphatidylserine, a naturally occurring soy lipid that may reduce the risk of senile dementia or age-related cognitive decline (see the FDA's website at http://www.cfsan.fda.gov/~dms/ds-ltr33.html for more information).
BioDelivery Sciences International, Inc. is a biotechnology company that is developing and seeking to commercialize a patented delivery technology designed for a potentially broad base of pharmaceuticals, vaccines, over-the-counter drugs, and nutraceuticals and, through its subsidiary, Bioral Nutrient Delivery, LLC, micronutrients in processed foods and beverages.
Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause the Company's results to differ. Factors that may cause such differences include, but are not limited to, the Company's ability to accurately forecast the demand for each of its licensed technology and products associated therewith, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, the Company's ability to obtain raw materials from its contract manufacturers on a timely basis if at all, the Company's need for additional funding, uncertainties regarding the Company's intellectual property and other research, development, marketing and regulatory risks and certain other factors that may affect future operating results and are detailed in the company's filings with the Securities and Exchange Commission.
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