Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that it has established an action plan for obtaining cost reimbursement coverage for Generex Oal-lyn™, including the development of an insurance product that covers the costs of Generex Oral-lyn™ and any additional and/or comparable diabetes products.
Some of the objectives in the action plan will include: the creation of a prospectus for use with Insurance Underwriters; the development of cost and risk assessment profile; identifying potential underwriters; and the creation of supporting actuarial and marketing materials.
In order to implement this program, the Company has engaged the consulting services of David Brusegard, Ph.D., an individual with extensive experience in designing and marketing health related insurance and financial products. Most recently, Dr. Brusegard served as the CEO of the Pentius Group, a 5-company group involved in designing and marketing health and travel insurance and financial products in North America. Pentius was a consolidated health Managing General Agent (MGA) and Managing Underwriter (MGU) and provided a full service Third Party Administration (TPA) capability to the insurance and health oriented financial industries. As such, Pentius employed nurses and doctors for health insurance based managed care. Dr. Brusegard was responsible for all aspects of database development and analysis at Pentius as well as operational and strategic management. As CEO, he grew the company rapidly and culminated its growth with a sale to a large insurance conglomerate.
The Generex Oral-lyn™ cost reimbursement plan will apply to existing and future regulatory approvals for Generex, as well as the Company's United States Food and Drug Administration (FDA) Expanded Access Treatment IND program.
The FDA's 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. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing.
Under the Expanded Access Treatment IND program, Generex Oral-lyn™ will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the Company's ongoing global Phase III pivotal clinical trial of the product.
This Treatment IND is open to eligible patients that comply with the inclusion/exclusion criteria of the treatment protocol, including those who are taking currently approved anti-diabetic medications. There are no oral or injectable medications contraindicated for this IND program.
The Company continues to work with its key strategic relationships under the Treatment IND Program in the US for Generex Oral-lyn™ including Assured Pharmacy, which will provide Generex Oral-lyn™ dispensary services to health practitioners and patients in the program. Assured Pharmacy will also undertake the enrollment of family physicians, endocrinologists, and nurse practitioners in the program. TS Biopharma, a multi-tiered pharmaceutical development services organization, will continue to assist in mounting a recruitment campaign for the participation in the program consisting of physicians, nurse practitioners and patients. Health Management Resources is also participating in the program recruitment activities.
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