WORCESTER, Mass., March 4, 2010 (GLOBE NEWSWIRE) -- In September of 2009, Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced that the United States Food and Drug Administration (FDA) had approved the treatment use of Generex Oral-lyn® under the FDA's Expanded Access Treatment Investigational New Drug (IND) Program. Generex Oral-lyn® is the Company's proprietary buccal insulin spray product for the treatment of patients with Type 1 or Type 2 diabetes mellitus, impaired glucose tolerance (IGT), or pre-diabetes. The product is presently in a global Phase III pivotal clinical trial in patients with Type 1 diabetes mellitus.
Today, Generex announced that it has established key strategic relationships for the development of a distribution network as part the implementation of the Program.
Generex considers the Program to be an opportunity to introduce the North American marketplace to Generex Oral-lyn® and the new paradigm for the treatment of diabetes that it represents. As a safe, simple, effective, and pain-free alternative to prandial injections of insulin, Generex Oral-lyn® is designed to improve patient compliance with diabetes treatment regimens, and to encourage an earlier application of insulin therapy into standard treatment models, thereby delaying the progression of the disease and the onset of the myriad complications associated with it.
As Generex begins to realize revenues from Generex Oral-lyn® sales under the Program and is successful in establishing the viability of new and expanded patient populations for the product, the Company's efforts to achieve suitable strategic relationships in the pharmaceuticals industry will be enhanced.
Pursuant to a Consulting Agreement, Health Management Resources, Inc. will design and implement education programs to introduce Generex Oral-lyn® to healthcare providers and to provide training and solicit feedback in respect of product utilization by patients.
In collaboration with Generex, TS BioPharma, Inc. will source, evaluate, and assist in the engagement of suitable clinical sites for the Program and mount a recruitment campaign for the participation in the Program of physicians, nurse practitioners, and patients. TS BioPharma a multi-tiered pharmaceutical development services organization and an innovator in the methods and processes used to minimize time and expense in each level of clinical development.
Pursuant to a Pharmacy Services Agreement, Assured Pharmacy, Inc., a growing chain of specialty pharmacies that provide advanced prescription services to a diverse array of medical professionals and their patients, will undertake the enrollment of family physicians and endocrinologists as well as provide Generex Oral-lyn® dispensary services to physicians and patients participating in the Program. This will include product storage, physician/patient-specific product labeling, and product delivery. Assured Pharmacy will also assist Generex with the establishment, implementation, and operation of product reimbursement programs for patients through both governmental and private insurance reimbursement mechanisms.
"We have established these initial key strategic relationships with a view to maximizing the exposure of, and the physician/nurse practitioner/patient experience with, Generex Oral-lyn® under the FDA's Expanded Access Treatment IND Program," said Anna Gluskin, the Company's President & Chief Executive Officer. "We consider the Program to be an important milestone in the introduction of Generex Oral-lyn® into the North American marketplace and we anticipate these are the first of a number of relationships we intend to establish in order to build a solid distribution network for Generex Oral-lyn® in the United States."
The FDA's Expanded Access Treatment IND Program allows companies to provide early access to investigational drugs for patients with serious or life-threatening conditions for which there is no satisfactory alternative treatment. Generex Oral-lyn® qualified for the Program following clinical demonstrations of safety and efficacy.
Under a structured Expanded Access Treatment IND protocol, Generex Oral-lyn® is available to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available, and who are not eligible to participate in the Phase III trial.
In order to learn more about the availability of Generex Oral-lyn® under the Program, as per FDA requirements, the Company will be providing information within the www.ClinicalTrials.gov website. Details will include study design and participating sites and/or physicians. Please note that the drug will be available only through physicians who are registered in the Program.
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™ device. The Company's flagship product, oral insulin (Generex Oral-lyn™), which has been launched in India, Lebanon, Algeria, 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. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
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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.