Aegis Therapeutics has filed its first Drug Master File (DMF) for Intravail with the US FDA as part of its goal of broadly enabling intranasal delivery of peptide and protein drugs across a wide spectrum of disease categories for the world’s current and future leading pharmaceutical and biopharmaceutical companies.
Aegis' Intravail absorption enhancement agents are mild and non-irritating to mucosal membranes, providing exceptionally high and unmatched bioavailability performance, comparable in efficiency to subcutaneous injection via the intranasal, ocular and other mucosal membrane administration routes. These agents help deliver potent peptide, protein, and other small and large molecule drugs that currently can be delivered only by injection.
To date, Aegis has licensed Intravailfor beta-interferon, low molecular weight heparin, and for three undisclosed paediatric drugs. Several feasibility studies for additional drugs have been recently completed or are underway, according to a company release.
Aegis’ CEO, Dr. Edward T. Maggio, said, “DMFs provide a strategic advantage by allowing the FDA to access Aegis’ confidential regulatory and scientific material without disclosing that information privately or publicly to other parties. Pharmaceutical company licensees of Intravail will receive reference authorization to our DMFs in support of their submissions to the FDA.”