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BDS INTERNATIONAL Diagnostics GmbH To Establish Israeli Subsidiary To Develop Oral Enzyme Replacement For Gauchers Disease



10/19/2005 5:09:15 PM

NEWARK, N.J., Nov. 24 /PRNewswire-FirstCall/ -- BioDelivery Sciences International, Inc. announced today that it has entered into an memorandum of understanding to establish an Israeli subsidiary, tentatively named Biorazyme Ltd., for the purpose of developing oral formulations of lysosomal storage enzymes, such as glucocerebrosidase for the treatment of Gauchers Disease.

The new company will initially be majority-owned by BDSI, with the remainder being owned by BDSI's Israeli joint venture partners who will be developing the new oral formulations in conjunction with BDSI. BDSI intends to sub-license its licensed and patented Bioral(TM) technology to assist in the creation of the new formulations. BDSI will also have the right to appoint a majority of the new company's board of directors and will provide certain support services when requested.

According to publicly available information, worldwide sales of enzyme replacement for Gauchers are estimated to be over $600,000,000. In addition, lysosomal storage enzyme replacement therapy is currently available only by intravenous infusion at bi-weekly intervals and at an annual cost of approximately $200,000 per patient. Accordingly, only the most severe cases in the most affluent countries can access the enzyme replacement therapy. BDSI believes that its patented and licensed Bioral(TM) nanotechnology may be able to provide an effective oral enzyme replacement therapy. Such an oral formulation could have many advantages, including reduced cost, daily dosing, greater patient acceptance and expanded market opportunities. In order to validate these potential benefits, it is anticipated that Biorazyme will conduct a multi-stage study plan aimed at evaluating the new formulations for, among other items, feasibility based on in vitro studies, the optimal formulation, stability, release profile and potency.

Lysosomal storage disorders represent a group of more than 40 different inherited diseases, each caused by a specific lysosomal enzyme deficiency. Although considered rare, some are more common in specific ethnic groups. Enzyme replacement therapy is currently approved for three such diseases (Gauchers disease, Fabry disease and Mucopolysaccharidosis I) and is being investigated for others. The major consequences of these diseases currently are the life long dependency on intravenous infusions and the high cost.

The Bioral(TM) delivery technology consists of nanocochleates which are nanocrystalline delivery vehicles made from all-natural components: soy-derived phospholipid and calcium. These nanocochleates wrap around the cargo pharmaceutical like a shell and allow the drug (or enzyme, in this case) to be delivered into the body safely and effectively. The Bioral(TM) delivery technology is simple, inexpensive and commercially scalable. When used in this context, BDSI's technology will be referred to as Biorazyme(TM).

Dr. Raphael Mannino, Executive Vice-President and Chief Scientific Officer of BDSI, said, "We are hopeful that our Bioral(TM) delivery system will be able to effectively deliver the missing enzyme in these diseases. In the case of Gauchers, for example, the ability to selectively target delivery to monocytes and macrophages is a potential advantage of our technology. Moreover, previous studies elsewhere have suggested that phosphatidylserine, the major phospholipid component of our Bioral(TM) delivery technology, stimulates the glucocerebrosidase enzyme activity in Gauchers, thus potentially enhancing the efficacy of the replaced enzyme"

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 and personal care products.

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.

L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies,

capital stock in the Company, warrants or options to purchase capital in the

Company.

BioDelivery Sciences International, Inc.

CONTACT: Francis E. O'Donnell, Jr., M.D., President and CEO ofBioDelivery Sciences International, Inc., +1-973-972-0015; or Leonardo Zanganiof L.G. Zangani, LLC, +1-908-788-9660, for BioDelivery Sciences International,Inc.


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