Healthcare Industry News:  metabolic disease 

Biopharmaceuticals Drug Delivery Endocrinology Regulatory

 News Release - November 1, 2007

Generex Biotechnology Receives Regulatory Approval to Sell Generex Oral-lyn in India

Generex Oral-lyn Becomes First Non-Injectable Buccal Insulin Approved in India; Generex Enters Into Product Licensing & Distribution Agreement With Indian Pharmaceutical Company Shreya Life Sciences Pvt. Ltd.

Company to Hold Conference Call at 11 a.m. Eastern Today


WORCESTER, Mass., Nov. 1, 2007 (Healthcare Sales & Marketing Network) -- Generex Biotechnology Corporation (NasdaqCM:GNBT ), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that Generex Oral-lyn, its proprietary oral insulin spray product, has been approved for importation and commercial marketing and sale in India for the treatment of diabetes by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India. CDSCO is responsible for authorizing marketing approval of all new pharmaceutical products in India.

Generex Oral-lyn becomes the first non-injectable buccalinsulin approved in India. Generex Oral-lyn is delivered via the Company's proprietary RapidMist(tm) device into the mouth. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn does not reach the lungs.

In connection with the approval, Generex has entered into a Product Licensing and Distribution Agreement with Shreya Life Sciences Pvt. Ltd. (http://www.shreya.co.in), a leading Indian-based pharmaceutical company. Shreya is the fourth largest distributor of insulin in the Indian insulin product market with a compound annual growth rate of 38% (per C MARC 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. The parties are making arrangements for the expansion of extant production facilities to meet the anticipated demand for the product in India and other jurisdictions where governmental approvals are pending.

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.

``This approval in a market with one of the largest numbers of patients with diabetes comes after the Indian health regulatory agency conducted a rigorous review of clinical data demonstrating the safety and efficacy of Generex Oral-lyn,'' said Anna Gluskin, Generex's President & Chief Executive Officer. ``This represents the first major jurisdiction to provide approval and offers the prospect of a new treatment paradigm for diabetes and pre-diabetic conditions. We look forward to working with Shreya to offer a safe, simple, fast, flexible, familiar, convenient, and pain-free alternative to prandial insulin injections.''

Generex's in-house regulatory department along with Nectid Clinical Services, a Princeton, NJ based contract research company that provides clinical and regulatory consultation services in respect of the Indian market, spearheaded the regulatory effort. Indian approval was granted after a long and intensive review of the Generex Oral-lyn dossier by the Drugs Controller General (India) office. Indian government approved Generex Oral-lyn only after Generex submitted satisfactory responses to a series of regulatory interrogatories. As a result of this approval, Generex and Shreya are making preparations for the commercial launch of Generex Oral-lyn in the country in early 2008. Preparations include manufacturing scale-up, marketing plans, and post-approval clinical studies.

Conference Call:

The Company will hold a conference call and webcast to discuss additional details on the Indian approval. The conference call will take place at 11 a.m. Eastern time today. Interested participants should call 1888 935 4577 within the United States or 718 354 1388 internationally. Please use passcode 1673847. A playback of the conference will be available two hours after the completion of the call. To listen to the playback, please call 1866 883 4489 within the United States or 718 354 1112 internationally. Please use passcode 9286485#. The call will also be webcast and will be available on the Company's web site at http://www.generex.com.

About Generex

Generex is engaged in the research and development 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, is in various stages of clinical trials around the world. In June, 2007 the Company announced the commencement of a global Phase III clinical trial of Generex Oral-lyn(tm) in the third quarter of 2007 with patient dosing to commence before yearend. For more information, visit the Generex website at http://www.generex.com.

About Nectid

Nectid Clinical Services is a Princeton located contract research company that provides India-related regulatory and clinical consulting services through its subsidiary in India. The services Nectid provides include pharmaceutical product development, methods development, clinical research, and regulatory affairs.

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.


Source: Generex Biotechnology

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