Pulmatrix, a clinical-stage biopharmaceutical company developing innovative inhaled therapies for serious pulmonary diseases, has entered into an ex-US development agreement with Mylan N.V. for PUR0200, a clinical-stage bronchodilator therapy being studied for chronic obstructive pulmonary disease (COPD) and a small-molecule formulation from the company’s inhaled dry-powder technology. PUR0200 is under development as a once-daily therapy in a capsule-based dry powder inhaler (DPI). Continued development work under the agreement will initiate in 2015.

Under the agreement, Pulmatrix will lead the development work and pharmacokinetic clinical study with collaborative support from Mylan. Mylan has retained an option for PUR0200 ex-US based on successful completion of the clinical study. Financial terms of the agreement are confidential. Continued development work under the agreement will initiate in 2015.

PUR0200 contains a long-acting muscarinic agent (LAMA) being studied for the treatment of COPD, and current clinical development is focused on pharmacokinetic bioequivalence in Europe. According to IMS Health, global sales of LAMA monotherapies for COPD are approximately $5 billion for the 12 months ending Dec. 31, 2014 with $1.5 billion in sales outside the US, and as reported by Mylan.

Pulmatrix is a clinical-stage biopharmaceutical company developing inhaled therapies to address serious pulmonary disease using its prorietary iSPERSE technology, an inhaled dry-powder technology. The company’s proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF) as well as PUR1500, an inhaled product for the treatment of idiopathic pulmonary fibrosis. and PUR0200, a branded generic in clinical development for COPD.

Source: Mylan