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|--| | | | | | | |--| |---| | | | | | | | - | | 2 | | - | | | |---| Lilly and Generex Sign Agreement To Develop Buccal Form of Insulin Eli Lilly and Company (NYSE: LLY) and Generex Biotechnology Corporation (NASDAQ: GNBT) today announced that they have signed an agreement to develop a buccal formulation of insulin that is administered as a fine spray into the oral cavity using Generex proprietary technology. Under the terms of the agreement, Generex will receive certain initial fees and milestone payments. Generex will also receive royalty payments based on product sales. In exchange, Lilly will receive exclusive worldwide rights to products resulting from the collaboration. Lilly will be responsible for conducting clinical trials, securing regulatory approvals and marketing on a worldwide basis. Clinical trials of the first product candidate are under way in North America and Europe. Lilly will also have the option to develop a number of additional products depending on the success of the initial product. "We look forward to working with Generex, whose buccal spray delivery technology potentially represents a novel approach to drug delivery," said James A. Harper, president, diabetes and growth disorders products for Lilly. "A buccal spray formulation of insulin could provide an attractive alternative for people with diabetes." "The opportunity to partner with Lilly, the global leader in insulins, to develop the world's first marketed buccal insulin spray represents very good news for millions of patients with diabetes throughout the world," said Anna Gluskin, chief executive officer of Generex. "We are pleased that Lilly has recognized the potential of buccal delivery of insulin and Generex's RapidMist? technology for systemic delivery of proteins, peptides and other large molecule drugs." Today, worldwide costs for treating diabetes and its complications are estimated to exceed $200 billion annually. It is also estimated that, over the next decade, the number of people with this disease will more than double. Lilly has been a leader in diabetes care for more than 75 years. The company continues to aggressively pursue the goal of being a complete diabetes care company and intends to provide innovative products to treat all types and stages of diabetes. Generex is engaged in the research and development of drug delivery systems and technologies. To date, it has focused on developing a platform technology for the buccal delivery (absorption through the inner cheek walls) of large molecule drugs which, historically, have been administered only by injection. Additional information about Generex can be found at www.generex.com. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers ? through medicines and information ? for some of the world's most urgent medical needs. Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although Generex and Lilly believe that such statements are based on reasonable assumptions within the bounds of their knowledge of their business and operations, there can be no assurance that: (i) Lilly or Generex will not terminate the collaboration, (ii) that any products will be developed, manufactured or commercialized successfully, or (iii) that significant funding will be received by Generex as a result of this collaboration. Each company's business is subject to significant risks and there can be no assurance that actual results of the companies' development activities and results of their operations will not differ materially from expectations. For information with respect to other factors, which could cause actual results to differ from expectations, reference is made to the 10-K and 10-Q reports filed by Generex and Lilly, respectively, with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. # # #
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