WORCESTER, Mass., Jan. 17, 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 Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in), the Company's marketing and distribution licensee in India, is rolling out its marketing launch activities for Generex Oral-lyn in the Indian market. The Company previously announced on November 1, 2007 that it had received regulatory approval to sell Generex Oral-lyn in India by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India.
The first effort in this marketing launch campaign involves presentations about Generex Oral-lyn to Indian key opinion leaders and endocrinologists in India at closed-door meetings in Mumbai, India.
The presentations involve Generex's medical and marketing teams including: Dr. Jaime Davidson, the Company's Medical Director; Dr. Gerald Bernstein, the Company's Vice President of Medical Affairs; and, Mr. Bill Abajian, the Company's Vice President-Global Business Development. The presentations focus on all drug handling matters concerning Generex Oral-lyn for Type 1, Type 2, and IGT (Impaired Glucose Tolerance) populations. Generex Oral-lyn is a prandial (mealtime) insulin and provides safe and effective glucose control for up to 2 hours after each meal. Generex Oral-lyn is a convenient and pain-free alternative to insulin injections and could encourage prandial insulin therapy among those patients who presently avoid injections. Missed injections for patients with Type 1 diabetes mellitus can eventually lead to health complications including heart condition, stroke, blindness, amputation, and kidney failure, to name a few.
Generex Oral-lyn is a prandial insulin which allows for easy self-administration, precise dosage control, and easy titration which allows for finer individual control. As such, Generex Oral-lyn also makes an ideal supplement at meal times for patients with Type 2 diabetes mellitus in addition to basal or combination therapies based on blood glucose measurements.
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.
"We are very excited about the marketing launch activities taking place in India by Shreya," said Anna Gluskin, Generex's President and Chief Executive Officer. "This demonstrates Shreya's commitment to entering this major jurisdiction with the proper educational tools for its marketing purposes and for training amongst physicians who will be the front runners in educating patients living with diabetes. We look forward to having both teams work closely to facilitate a successful product launch in India and to follow up with continuous educational programs throughout the course of the year."
About Shreya
Shreya Life Sciences Pvt. Ltd. is a leading Indian-based pharmaceutical company. Shreya is the fifth largest distributor of insulin in the Indian insulin market and ranked 38th in Indian Pharma Market (as per CMARC market research). Shreya has interests in both pharmaceutical and biopharmaceutical products in key therapeutic segments including cardiology, neuropathy, and diabetes. The company has business operations in India, Russia, the Commonwealth of Independent States, and African countries.
About Generex
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 device. The Company's flagship product, oral insulin (Generex Oral-lyn), 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.