Expertise in aerosol product manufacturing has won startup Acton Pharmaceuticals ($ACTOP) a development and marketing contract from Sanofi U.S. ($SNY) that could finally bring to market a drug approved in 2004. Technical problems during scale-up of Nasacort HFA have prevented the commercial debut of the steroid, a treatment for nasal allergy symptoms.
Nasacort HFA is formulated with a hydrofluoroalkane (HFA) propellant and is delivered as a fine, dry mist in a small-volume pressurized metered dose. Aqueous, or water-based, liquid spray formulations are currently the only type of nasal steroids available in the U.S., the company said in an announcement.
Acton has a focus on inhalation products and specializes in allergy and pulmonary treatments, President Daniel Kreisler said via telephone. "There are a lot of formulation issues with aerosols. Many get approved but don't get marketed."
He said Acton approached Sanofi about bringing the drug to market, leading to the development and marketing deal. Some regulatory matters lie ahead, he added, primarily concerning facility and equipment, to activate the NDA. Kreisler projects a market launch in latter 2013.
Acton used the same approach in 2009--one year after it was formed--with Forest Labs ($FRX) to win a licensing deal for asthma treatment Aerospan. The NDA for this HFA-propelled aerosol inhaled corticosteroid was approved by the FDA in 2006. Kreisler anticipates the Aerospan launch in 2012.
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Editor's Note: Nasacort HFA is a treatment for allergies, not asthma, as the headline originally stated.