SAN DIEGO, CA Aug 27, 2015/MarketWire — Aegis Therapeutics LLC announced today that it has been awarded US Patent No. 9,114,069 titled “Antibacterial Compositions for Drug Administration” providing non-toxic formulations of parathyroid hormone and related analogs, including teriparatide (PTH 1-34), suitable for injectable or metered nasal spray administration having intrinsic antimicrobial activity. The patent formulations meet the FDA’s antimicrobial effectiveness test criteria set forth in USP <51> without the need for metacresol, an antimicrobial agent currently used in commercial formulations of teriparatide as well as certain insulins. Metacresol is irritating and/or a sensitizer to skin, eyes and mucous membranes and is classified as a possible carcinogen.
Human clinical studies have shown that formulations of teriparatide based upon Aegis’ Intravail®/ProTek® technology show excellent nasal bioavailability offering the prospect of a “first in class” non-injectable PTH drug for treatment of osteoporosis. Non-injectable dosage forms of previously injectable-only drugs provide greater patient convenience and acceptance, improved compliance, and avoidance of needle-stick injury and disposal problems associated with the use of needles.
Aegis now has twenty-five issued patents related to non-invasive delivery of peptide, protein, nucleotide, and small molecule drugs, as well as stabilization and immunogenicity reduction for monoclonal antibody and other protein biotherapeutics, with more than 50 additional patent applications currently pending worldwide.
About Aegis Therapeutics
Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses. Our Intravail® drug delivery technology enables the non-invasive systemic delivery of a broad range of protein, peptide and non-peptide drugs that can currently only be administered by injection, via the oral, buccal, and intranasal administration routes, and with high bioavailability. Our ProTek® excipients stabilize, prevent aggregation, and reduce unwanted immunogenicity of monoclonal antibodies and other protein and peptide therapeutics while avoiding the oxidative damage and resulting unwanted immunogenicity caused by polysorbate surfactants currently found in most protein injectable drugs.
For more information about Aegis, please visit: http://aegisthera.com/.