Generex Biotechnology Corporation, a company engaged in the research, development, and commercialization of drug delivery systems and technologies, has entered into a Memorandum of Understanding with NHTherapeutics, Inc. (NHT) pursuant to which the companies will co-develop a formulation for the delivery of Leuprolide into the human body via the buccal mucosa using the Generex proprietary RapidMist buccal drug delivery system.

The Generex proprietary RapidMist drug delivery platform technology administers active pharmaceutical ingredient via aerosolized metered dose spray into the mouth for rapid absorption by the buccal mucosa.  The company's most advanced product in development using RapidMist is Generex Oral-lyn, an insulin spray product for the treatment of diabetes mellitus.

NHTherapeutics holds intellectual property in respect to the dosing regimen and route of administration of Leuprolide and other GnRH agonists for the treatment of hypogonadism and other endocrine disorders.

Pursuant to a fee-for-service arrangement, Generex will develop a RapidMist formulation of Leuprolide designed to achieve the safe, simple, rapid, dose-specific, and effective administration of the active pharmaceutical ingredient into the human body via the buccal mucosa.  Thereafter, Generex will undertake local irritation and stability testing of the formulation.

It is contemplated that, pending the outcome of the RapidMist Leuprolide formuation data, Generex will grant to NHT a license for the global commercial exploitation of the product in the field of endocrine disorders in exchange for royalties.

Leuprolide belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists.  Traditionally, GnRH agonists are used at a high dose to chronically decrease hormonal release.  Leuprolide is given by injection and is marketed to treat the symptoms associated with advanced prostate cancer, central precocious puberty (CPP), endometriosis, and anemia.  Conversely, NHT intends to administer low dose Leuprolide and other GnRH agonists through an easy to use buccal spray to chronically increase hormonal levels.  Proof of concept data already exists.  "NHT recognizes that the Generex RapidMist drug delivery platform and attendant product development experience, together with NHT's expertise in the field of endocrine disorders, creates a unique opportunity to formulate Leuprolide for rapid and effective administration through the buccal mucosa," commented Dr. David Brusegard, Ph.D., the company's chief operating officer. "Generex is pleased with this new opportunity to expand our RapidMist platform technology."

Dr Aldemar Degroot, M.S., Ph.D., the president & chief executive officer of NHT, stated:  "There is a real market need for a compound that can chronically increase hormonal levels, that is safe, can be easily administered, and that does not affect fertility.  Unlike existing products that increase hormonal release, NHT's lead product (NH901) is non-scheduled and will not induce supratherapeutic hormonal levels, which can result in severe adverse effects.  We look forward to working with Generex to make this product a reality.  Its extensive experience with the buccal delivery of peptide drugs along with its RapidMist technology combined with our own experience in endocrine disorders and our intellectual property are bound to lead to success."

NHTherapeutics is a clinical stage pharmaceutical company that focuses on GnRH agonism to treat conditions associated with decreased hormonal levels (hypogonadism) due to aging or disease and other endocrine disorders.