NEW YORK--(BUSINESS WIRE)-- Fera Pharmaceuticals announces the acquisition of an investigational new drug to treat fungal otitis externa (FOE).
In a Phase 2 pilot study, Itraconazole topical suspension was shown to be effective in the treatment of FOE with no adverse events reported. In addition, the drug has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA).
“This acquisition fulfills a key strategic imperative for Fera—product development and commercialization in specialty and underserved therapeutic categories” says Frank J. DellaFera, President of Fera.
The company is working to complete clinical development required to obtain FDA approval.
About Orphan Drug Designation
Orphan Drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
About Fungal Otitis Externa
Fungal otitis externa (FOE), also known as Otomycosis, has incidence rates in the US noted from less than 1 % to approximately 10%.
About Fera Pharmaceuticals, LLC
Fera Pharmaceuticals is a privately held company. The company goal is to realize opportunities via acquisitions, in-licensing, developing and marketing abbreviated new drug applications (ANDAs), new drug applications (NDAs) and 505(b)(2) NDA products. Areas of interest include products that could benefit from lifecycle management with a special focus on niche markets. For more information visit www.ferapharma.com.
Fera Pharmaceuticals, LLC
Louis B. DellaFera, 516-277-1450
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INDUSTRY KEYWORDS: Health Hospitals Optical Pharmaceutical FDA Veterinary Managed Care