Acton Pharmaceuticals Announces License Agreement for Nasal Aerosol

Acton Pharmaceuticals, Inc. recently announced it has completed a licensing agreement with Sanofi US for prescription NASACORT HFA (triamcinolone acetonide) Nasal Aerosol for the treatment of nasal allergy symptoms. Under the agreement, Acton assumes the exclusive US rights to develop and market NASACORT HFA in the $2-billion prescription nasal steroid market.

NASACORT HFA is an intranasal steroid formulated with a hydrofluoroalkane (HFA) propellant and delivered as a fine, dry mist in a small volume pressurized metered dose. Currently, only aqueous (AQ) or water-based liquid spray formulations of nasal steroids are available in the US. Under the agreement, Sanofi retains all rights to NASACORT AQ.

“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,” said Daniel Kreisler of Acton Pharmaceuticals. “The NASACORT HFA’s NDA was an FDA-approved aerosol product but was not commercially launched due to technical reasons related to manufacturing scale up. We believe 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.”

NASACORT HFA is in development as a once-a-day treatment for nasal symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children 6 years of age and older. To date, Sanofi has conducted two Phase III studies of NASACORT HFA in clinical trials involving more than 1,100 patients. The most common adverse events reported in clinical studies (>3%) were sneezing, headache, nasal irritation, and rhinitis.

In addition to NASACORT HFA, Acton is currently developing AEROSPAN (flunisolide HFA) Inhalation Aerosol. AEROSPAN is an HFA-propelled aerosol inhaled corticosteroid (ICS) for the treatment of asthma. AEROSPAN is the first HFA inhaled steroid to incorporate a built-in spacer device, designed to assist patients in delivering their medication to the lungs. The NDA for AEROSPAN was FDA approved in 2006, and Acton licensed AEROSPAN from Forest Laboratories, Inc. in 2009 and plans to commercialize AEROSPAN 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,” stated John Simon of Acton Pharmaceuticals. “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.”

In clinical trials, AEROSPAN was generally well tolerated. In AEROSPAN’s clinical trials, the most common adverse events (>3%) were headache, fever, allergic reaction, bacterial infection, pain and back pain, vomiting, dyspepsia, pharyngitis, rhinitis, cough, sinusitis, epistaxis, rash, and urinary tract infection. Combined, the inhaled and nasal steroid markets are valued at approximately $9 billion in the US.

The clinical program of NASACORT HFA Nasal Aerosol included two Phase III studies conducted in the US that involved 1,176 patients 12 to 83 years of age with allergic rhinitis, of which 729 patients were treated with NASACORT HFA Nasal Aerosol. One study was a 2-week, double-blind, parallel-group, placebo-controlled trial comparing NASACORT HFA Nasal Aerosol to NASACORT Nasal Inhaler (triamcinolone acetonide CFC formulation) in 780 patients 18 years of age and older with seasonal allergic rhinitis.

In the 2-week, double-blind study, NASACORT HFA Nasal Aerosol and NASACORT Nasal Inhaler (triamcinolone acetonide CFC formulation) were comparable, and both formulations showed a statistically significant reduction in symptoms of allergic rhinitis. There were no significant differences in the effectiveness of NASACORT HFA Nasal Aerosol across subgroups of patients defined by gender, age, or race.

The second study was a 12-month open-label safety in 396 patients with perennial allergic rhinitis. Adverse events occurring with an incidence of 3% or greater and more commonly with NASACORT HFA Nasal Aerosol arms compared to placebo irrespective of drug relationship include sneezing, headache, nasal irritation, and rhinitis.

Acton is a specialty respiratory pharmaceutical company dedicated to developing prescription drugs to improve the well-being of patients. Acton‘s corporate headquarters are located in Marlborough, MA.