Generex Biotechnology Receives Indian Purchase Order for Generex Oral-Lyn; Commercial Order for 210,000 Canisters Received for Indian Product Launch
WORCESTER, Mass., March 25, 2008 (PRIME NEWSWIRE) — Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has received a Purchase Order for 210,000 canisters of Generex Oral-lyn(tm), the Company’s proprietary oral insulin spray product, from Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in), the Company’s distributor in India. This is the first Indian commercial order for the Company’s flagship product. Generex Oral-lyn was approved for sale in India in late 2007 and is the first non-injectable buccal insulin to receive Indian approval. Generex Oral-lyn is delivered into the mouth via the Company’s proprietary RapidMist(tm) device. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn does not enter the lungs.
This order signifies Shreya Life Sciences’ commitment to a successful commercial launch of the product in the Indian market.
In August, 2007 Generex entered into a Master Product Licensing & Distribution Agreement with Shreya Life Sciences, a leading Indian-based pharmaceutical company. Shreya is the fourth largest distributor of insulin in the Indian market and has interests in both pharmaceutical and biopharmaceutical products in key therapeutic segments including cardiology, neuropathy, and diabetes.
India has a significant and growing number of people with diabetes. According to the Diabetes Atlas 2007, there are approximately 40.8 million diagnosed patients with diabetes in India. There are also an estimated 35.9 million people who have pre-diabetic conditions which, if not properly treated and managed, could lead to full-blown diabetes. Generex believes that early intervention with insulin therapy could delay the onset and progression of diabetes and its numerous complications. Generex Oral-lyn, as a convenient and pain-free alternative to insulin injections, could encourage prandial insulin therapy among those patients who presently avoid injections.
“We are pleased to anticipate the commercialization of our flagship product in a major market like India and the attendant revenue,” said Anna Gluskin, Generex’s President & Chief Executive Officer. “We are optimistic about the establishment of a new treatment paradigm for diabetes and pre-diabetic conditions in India and other countries where we are now pursuing approvals. We look forward to working with Shreya to expand the market in India in order to capture a wider patient population.”
Generex Oral-lyn is presently in Phase III clinical trials at several sites around the world.
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company’s proprietary RapidMist(tm) device. The Company’s flagship product, oral insulin (Generex Oral-lyn(tm)), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in various stages of clinical development around the world. For more information, visit the Generex website at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,”"plans,”"intends,”"believes,”"will,”"estimates,”"forecasts,”"projects” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any “phase” of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
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CONTACT: American Capital Ventures, Inc. For Generex: Howard Gostfrand 305-918-7000 CEOcast, Inc. Gary Nash 212-732-4300