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Generex collaborates with NHTherapeutics to utilize RapidMist buccal delivery technology for Leuprolide
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Worcester, Massachusetts
May 29 , 2015
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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.
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