WORCESTER, Mass., March 11, 2009 (GLOBE NEWSWIRE) -- On the heels of yesterday's announcement of positive study data from its Phase III protocol for its flagship product Generex Oral-lyn(tm), Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today provided an update on Generex Oral-lyn(tm) sales in India, where the product is marketed and sold by Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in).
Generex Oral-lyn(tm) was approved in India for importation, commercial marketing and sale for the treatment of Type 1 and Type 2 diabetes and has been marketed under the brand name Oral Recosulin(tm) since January 27, 2009 in Mumbai and in the cities of Bangalore, Delhi, Kolkata, Chennai and Cochin since February 3, 2009. Sales managers at Shreya Life Sciences, along with key Shreya marketing and medical personnel, have been actively involved in promoting the product to key opinion leaders and physicians in the region.
Following the initial marketing campaign, Shreya Life Sciences has to date procured Oral Recosulin(tm) orders from more than 60 doctors for over 100 patients.
"We believe that the rapid progress that our licensee has made in India reflects the demand for a pain-free insulin product," said Anna Gluskin, Generex's President and Chief Executive Officer. "Since the educational introduction of Generex Oral-lyn(tm) in India last November, Shreya has designed and implemented a strategy to identify target markets in India and establish an initial customer base from which we expect sales to continue to grow."
Generex Oral-lyn(tm) is designed to offer a simple, convenient, fast, effective, flexible, familiar and pain-free alternative to prandial injections of insulin. Generex Oral-lyn(tm) is a proprietary oral insulin spray product, the first non-injectable buccal insulin approved in India. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn(tm) does not have pulmonary side effects, and is safely and efficiently delivered without pain via Generex's proprietary RapidMist(tm) device, which looks like a simple asthma inhaler, but provides complete absorption through the buccal mucosa (lining of the mouth) with no deposit in the lungs.
About Generex Biotechnology Corporation
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 India and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, is in Phase III clinical trials at several sites around the world. For more information, visit the Generex website at http://www.generex.com.
The Generex Biotechnology Corp. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3831
About Shreya Life Sciences Pvt. Ltd.
Shreya is a leading Indian-based pharmaceutical company ranked 38th as per C-MARC and 41st as per ORG September 08. Shreya is the fourth largest marketer of insulin in terms of growth with a compound annual growth rate of 33% as per C MARC market research August 08. 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. For more information, visit the Shreya website at http://www.shreya.co.in.
Safe Harbor Statement
This release and oral statements made from time to time by Generex representatives in respect of 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.