Acton Pharmaceuticals, Meda deal

Meda will acquire Acton for $135 million in cash plus a $10 million near-term undisclosed development milestone. Acton is also eligible for sales-based milestones, which the company said may bring the total deal value up to $200 million. The deal is slated to close next quarter. Meda will gain Acton's Aerospan flunisolide, which is approved in the U.S. as maintenance treatment for asthma in patients at least six years of age. Meda said it plans to launch the hydrofluoroalkane (HFA)-propelled inhaled formulation of flunisolide in the U.S. early next year. Meda said the acquisition is within its respiratory primary focus area. The company markets Dymista azelastine/fluticasone in the U.S. to treat seasonal allergic rhinitis and in Europe to treat seasonal and perennial allergic rhinitis. Dymista is a combination of azelastine and fluticasone propionate in a single nasal spray delivery device. Meda has full rights from Cipla Ltd. (Mumbai, India) to Dymista in Latin, South and North America, the Middle East, Africa, Asia, Europe, Japan, Brazil, South Korea and Australia. Barclays is Acton's financial advisor, and Bingham McCutchen LLP is the company's legal advisor (see BioCentury, June 10).

FDA originally approved an NDA from Forest Laboratories Inc. (NYSE:FRX, New York, N.Y.) for Aerospan in 2006, but the product was never launched. Acton, which acquired rights to Aerospan from Forest in 2009, said Forest could not meet FDA's specifications for impurities levels formed by the formulation reacting with the lining of the aluminum aerosol can. Acton subsequently corrected the issue and submitted an sNDA to FDA in November 2010. ...