Company to develop combination treatment based on inhaled long-acting beta2 agonist.
Forest Laboratories is paying Almirall $75 million up front as part of a U.S. development, marketing, and distribution agreement for the latter’s once-daily, long-acting beta2 agonist, LAS10097. The deal covers development of LAS100977 in combination with an undisclosed corticosteroid for the treatment of both asthma and chronic obstructive pulmonary disease (COPD), using Almirall’s Genuair® inhaler. LAS10097 has already completed Phase IIa trials in asthma patients.
Under terms of the deal, Forest will be responsible for U.S. regulatory approval and commercialization of the LAS100977-based therapy. Almirall will receive milestone payments and sales-based royalties on top of the up-front fee.
The deal represents the second major respiratory therapies collaboration between the companies. In April 2006 Almirall and Forest signed a $60 million up front deal to develop, market, and distribute Almirall’s inhaled, long-acting muscarinic antagonist, aclidinium bromide, in the U.S. The drug is an anticholinergic bronchodilator, selective M3 muscarinic antagonist for the treatment of COPD.
The companies had originally anticipated filing an NDA in the fourth quarter of 2009 or the first quarter of 2010. However, in March 2009 the companies announced that after consultation with FDA, additional clinical studies with aclidinium bromide will need to be conducted to provide further support for the selected regimens, including higher and/or more frequent doses. EU filing of aclidinium bromide by Almirall is currently projected for 2011.
Commenting on the deal, Howard Solomon, chairman and CEO at Forest, said, “with the addition of LAS100977, Forest rounds out a broad COPD pipeline that was recently augmented with Daxas® (roflumilast) and will also gain access to the larger asthma market with a once-daily inhaled corticosteroid/LABA combination.”