Massachusetts respiratory pharmaceutical company Acton Pharmaceuticals has entered into a licensing agreement with Sanofi US that gives Acton exclusive US rights to develop and market prescription Nasacort HFA triamcinolone acetonide nasal aerosol for the treatment of nasal allergy symptoms due to seasonal or perennial rhinitis in adults and children 6 years old and older. Sanofi will retain all rights to Nasacort AQ nasal spray, an aqueous formulation. Nasacort HFA is a dry mist formulation delivered using a pressurized metered dose device.
Acton Pharmaceuticals President and COO Daniel Kreisler commented, “Acton’s research and development strategy is to apply our extensive chemistry experience to resolve manufacturing issues that often plague aerosol products during the FDA approval process. The Nasacort HFA’s New Drug Application (NDA) was a FDA-approved aerosol product but was not commercially launched due to technical reasons related to manufacturing scale up. We believe that we can launch this important product into market. Nasacort HFA is another example of a commercial opportunity that targets a multi-billion dollar respiratory market.”
Acton recently reported positive Phase 3 data for its Aerospan flunisolide HFA inhalation aerosol, the first MDI to include a built-in spacer. The FDA approved the Aersopan NDA in 2006; Acton licensed the product from Forest Laboratories in 2009 and plans to commercialize the inhaler “upon completion of certain manufacturing requirements.”
“The therapeutic indications of Nasacort HFA and Aerospan are complementary and will enable us to provide a highly targeted commercial effort directed toward respiratory and pediatric physicians,” noted Acton CEO John Simon; “The size and scale of these markets combined with the peak sales potential of these products will enable us to further expand our reach among primary care physicians with a larger commercial partner.”
Read the Acton press release.
