Acton, Sanofi sign license agreement for allergy aerosol

MARLBOROUGH, Mass.—Acton Pharmaceuticals, Inc. and SanofiU.S. announced the completion of a licensing agreement between their companiesthis week, one focused on prescription NASACORT HFA (triamcinolone acetonide)Nasal Aerosol, which is in tended for the treatment of nasal allergy symptoms,including hay fever. Under the terms of the licensing agreement, Acton willassume the exclusive U.S. rights for the development and marketing of NASACORTHFA. Sanofi will retain all rights to NASACORT AQ.

"Acton's research and development strategy is to apply ourextensive chemistry experience to resolve manufacturing issues that oftenplague aerosol products during the FDA approval process," Daniel Kreisler,President and Chief Opertaing Officer of Acton, said in a press release. "TheNasacort HFA's New Drug Application (NDA) was an FDA-approved aerosol productbut was not commercially launched due to technical reasons related tomanufacturing scale up. We believe that we can launch this important productinto market. Nasacort HFA is another example of a commercial opportunity thattargets a multi-billion dollar respiratory market."

The current prescription nasal steroid market is valued at$2 billion, while the inhaled and nasal steroid markets combined boast a valueof approximately $9 billion in the United States.

Nasacort HFA is an intranasal steroid formulated with ahydrofluoroalkane (HFA) propellant and comes in the form of a nasal spray,dispensed in a dry mist as a small volume pressurized metered dose. As itstands now, only aqueous (AQ) or water-based liquid spray forms of nasalsteroids are available in the United States.

The product is currently under development as a once-a-daytreatment for nasal symptoms associated with season allergic rhinitis (SAR) andperennial allergic rhinitis (PAR) in patients ages 6 and older. Two Phase IIIstudies of Nasacort HFA have been conducted so far with more than 1,100patients, and the most common adverse events—occurring with an incidence of 3percent or greater—in those taking Nasacort HFA Nasal Aerosol were nasalirritation, sneezing, headache and rhinitis.

Acton has other related treatments lined up inaddition to Nasacort, such as AEROSPAN (flunisolide HFA) Inhalation Aerosol,another HFA-propelled aerosol. Aerospan is an inhaled corticosteroid (ICS)intended for the treatment of asthma, and is also the first HFA-inhaled steroidto incorporate a built-in spacer device, which is intended to help patients indelivering the asthma medication to their lungs. The treatment was generallywell tolerated in clinical trials, with the most common adverse eventsconsisting of allergic reaction, vomiting, headache, rhinitis, fever, bacterialinfection, sinusitis, cough, dyspepsia, pain and back pain, pharyngitis, rash,epistaxis and urinary tract infection. Aerospan's NDA received approval fromthe U.S. Food and Drug Administration in 2006, and in 2009, Acton licensedAerospan from Forest Laboratories, Inc. Acton intends to commercialize Aerospanonce certain manufacturing requirements have been completed.

"The therapeutic indications of Nasacort HFA and Aerospanare complementary and will enable us to provide a highly targeted commercialeffort directed toward respiratory and pediatric physicians," John Simon, ChiefExecutive Officer of Acton, noted in a press release. "The size and scale ofthese markets combined with the peak sales potential of these products willenable us to further expand our reach among primary care physicians with alarger commercial partner."

SOURCE: Acton press release