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(R) 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(R) 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(R) 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(R) absorption enhancement agents provide exceptionally high and unmatched bioavailability performance, comparable in efficiency to subcutaneous injection, via the intranasal administration route. Intravail(R) has also been successfully applied to buccal, oral, and rectal administration of both small molecule and peptidic drugs. Our ProTek(R) 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(R) 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.
Contact: Ralph Barry Chief Business Officer Aegis Therapeutics LLC 1-858-618-1400 Ext. 102 Email: Email Contact
SOURCE: Aegis Therapeutics LLC
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