Actavis plc, of Dublin, and Astrazeneca plc, of London, said they entered an agreement under which Astrazeneca will acquire the rights to Actavis' branded respiratory business in the U.S. and Canada for an initial consideration of $600 million on completion and low single-digit royalties above a certain revenue threshold. Upon completion of the transaction, Astrazeneca will gain rights to Tudorza Pressair (aclidinium bromide inhalation powder), a twice-daily long-acting muscarinic antagonist for chronic obstructive pulmonary disease (COPD), and Daliresp (roflumilast), a once-daily oral PDE4 inhibitor currently on the market for COPD. The two products had combined annual sales in the U.S. of about $230 million in 2014. Astrazeneca will also own development rights in the U.S. and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long-acting beta agonist in a dry powder inhaler, which is approved in the EU under the brand name Duaklir Genuair. Astrazeneca will pay Actavis an additional $100 million, and Actavis has agreed to a number of contractual consents and approvals, including certain amendments to the ongoing collaboration agreements between Astrazeneca and Actavis. The transaction is set to complete this quarter.

Pfizer Inc., of New York, said the FDA accepted for review the supplemental new drug application for Xeljanz (tofacitinib), a JAK inhibitor, for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The PDUFA date is in October 2015. Xeljanz previously gained approval in rheumatoid arthritis. (See BioWorld Today, Nov. 8, 2012.)