Contact Information: Contact: Ralph Barry Chief Business Officer Aegis Therapeutics LLC 1-858-618-1400 Ext. 102 Email:
Aegis Therapeutics Awarded Patent for Its ProTek(R) Room Temperature Stable Human Growth Hormone Formulations Suitable for Metered Nasal Spray Delivery
| Source: Aegis Therapeutics LLC
SAN DIEGO, CA--(Marketwire - September 16, 2008) - Aegis Therapeutics LLC announced today that
it has been awarded U.S. Patent 7,425,542, titled "Stabilizing
alkylglycoside compositions and methods thereof." The patent provides
broad protection for stabilized human growth hormone (hGH) formulations.
Human growth hormone is a recombinant protein drug used in the treatment of
pediatric and adult patients who have inadequate secretion of normal
endogenous growth hormone. hGH is one of the first biopharmaceuticals to
be developed and has achieved worldwide sales in excess of $ 2 billion
annually.
Like other protein therapeutics including insulin, erythropoietin, and
interferon, among others, hGH is sensitive to heat and agitation and
subject to aggregation -- a phenomenon that reduces the potency of protein
drugs and increases unwanted and sometimes dangerous immunogenicity. As a
result, protein therapeutics must be stored and shipped from manufacturer,
to the pharmacy, and ultimately to the patient under an uninterrupted chain
of refrigerated conditions, referred to as the "cold chain." Failure to
maintain the "cold chain" during shipment can compromise the effectiveness
of protein drugs. The Aegis ProTek® technology has been employed to
create stabilized formulations of hGH, insulin, antibodies, and other
protein drugs that remain unchanged even after continuous agitation for
many weeks or months at elevated temperatures. The patented formulations
are suitable for intranasal delivery via a simple metered nasal spray as
well as by standard injection or external drug infusion pump.
Human growth hormone products are sold by a number of the world's leading
pharmaceutical companies including Genentech, Sandoz, Sanofi, Novo Nordisk
and Eli Lilly. Generic or so-called bioequivalent versions of human growth
hormone are in development as the original growth hormone patent approaches
expiration. Aegis ProTek® technology is expected to provide patients
with safer, more convenient, non-injectable delivery options while
extending the effective patent life of hGH and other protein drugs.
About Aegis Therapeutics
Aegis Therapeutics LLC is a drug delivery technology company
commercializing its patented or proprietary drug delivery and drug
formulation technologies through product-specific licenses. Our
Intravail® drug delivery technology enables the non-invasive delivery of
a broad range of protein, peptide and non-peptide macromolecular
therapeutics that can currently only be administered by injection. Aegis'
Intravail® absorption enhancement agents provide exceptionally high and
unmatched bioavailability performance, comparable in efficiency to
subcutaneous injection, via the intranasal administration route.
Intravail® has also been successfully applied to buccal, oral, and rectal
administration of both small molecule and peptidic drugs. Our ProTek®
technology allows creation of proprietary, easily manufacturable, and
stable aqueous or lyophilized dosage forms that maintain the integrity and
physiological activity of many protein and peptide therapeutics. ProTek®
technology is applicable to injectable, intranasal, and other dosage forms
of peptide or protein therapeutics.
For more information about Aegis, please visit the Aegis website
at: http://www.aegisthera.com.