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Generex to co-develop buccal aerosol formulation of leuprolide for NHTherapeutics

Generex Biotechnology has announced an agreement with NHTherapeutics to co-develop a formulation of leuprolide for delivery by Generex’s RapidMist buccal aerosol technology. Leuprolide is a gonadotropin-releasing hormone (GnRH) analog which is currently approved at higher dosage levels for the treatment of conditions such as prostate cancer and endometriosis; NHT is developing a lower dose formulation for the treatment of hypogonadism.

The RapidMist platform uses a metered dose device to deliver aerosolized drug to the buccal mucosa. into the mouth for rapid absorption by the buccal mucosa. Generex’s lead RapidMist product is Oral-lyn insulin spray product for the treatment of diabetes.

NHT President and CEO Aldemar Degroot commented, “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.”

Generex COO David Brusegard said, “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. Generex is pleased with this new opportunity to expand our RapidMist platform technology.”

Read the Generex press release.

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published on May 26, 2015

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