Aegis Therapeutics Files First Drug Master File with the FDA.SAN DIEGO -- Aegis Therapeutics LLC today announced that it has filed its first Drug Master File Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA). There is no requirement by law or FDA regulation to present a DMF. (DMF (Distribution Media Format) A floppy disk format from Microsoft that was used to distribute its software. DMF floppies compressed more data (1.7MB) onto the 3.5" diskette, and the files could not be copied with normal DOS and Windows commands. A DMF utility had to be used. ) for Intravail(TM) with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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(TM) 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 Intravail(TM) for beta-interferon, low molecular weight heparin In medicine, low molecular weight heparin (LMWH) is a class of medication used as an anticoagulant in diseases that feature thrombosis, as well as for prophylaxis in situations that lead to a high risk of thrombosis. , and for three undisclosed pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. drugs. Several feasibility studies for additional drugs have been recently completed or are underway. A DMF provides key confidential, detailed regulatory and scientific information about the facilities, processes, and entities used in the proprietary manufacturing, processing, packaging and storage of Aegis' patented Intravail(TM) absorption enhancement agents intended for use in humans. The information contained in the DMF will be used to support future Investigational New Drug Applications (INDs) or a New Drug Applications (NDAs), an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA), another DMF, an Export Application, or amendments to any of these. The contents of a DMF are reviewed in connection with the review of an application to the FDA such as an IND or NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any . According to Aegis' CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Dr. Edward T. Maggio, "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(TM) will receive reference authorization to our DMFs in support of their submissions to the FDA." About Aegis Therapeutics Aegis Therapeutics LLC is a specialty pharmaceutical company commercializing its patented Intravail(TM) drug delivery technology that 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(TM) absorption enhancement agents are mild and non-irritating to mucosal membranes. They provide exceptionally high and unmatched bioavailability performance, comparable in efficiency to subcutaneous injection, via the intranasal and other mucosal membrane administration routes. Intravail(TM) also provides for rapid drug absorption and onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. , controlled transient permeation of the nasal mucosal barrier, avoidance of gastric hydrolysis and "first pass effect" elimination by the liver, greater patient convenience and compliance, elimination of needle-stick injuries and associated transmission of blood borne pathogens, compatibility with current nasal delivery devices, and ease of formulation, scale-up, and production. For more information about Aegis, please visit the Aegis website at: http://www.aegisthera.com. |
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