Pulmatrix and Mylan Enter Into ex-U.S. Development Agreement for PUR0200
LEXINGTON, Mass. and HERTFORDSHIRE, England and PITTSBURGH, June 16, 2015 /PRNewswire/ -- Pulmatrix (Nasdaq: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies for serious pulmonary diseases, today announced that it has entered into an ex-U.S. development agreement with Mylan N.V. (Nasdaq: MYL), one of the world's leading global pharmaceutical companies. The agreement is for PUR0200, a clinical stage bronchodilator therapy being studied for chronic obstructive pulmonary disease (COPD) and the first small molecule formulation from the company's novel iSPERSE™ inhaled dry powder technology. PUR0200 is under development as a once-daily therapy in a capsule-based dry powder inhaler (DPI).
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 U.S. Continued development work under the agreement will initiate in 2015.
Robert Clarke, CEO of Pulmatrix, said: "Our agreement with Mylan for the development of PUR0200 is a major step for Pulmatrix and the continued development of our iSPERSE technology. At the current stage of development of PUR0200 and goals of the program, Mylan is the ideal partner to bring this product forward for COPD patients."
Mylan President Rajiv Malik said: "Mylan is excited to partner with Pulmatrix on this potential generic LAMA DPI opportunity. This collaboration demonstrates our continued commitment to building our global respiratory pipeline, a key strategic growth driver for the company."
Under the terms of 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-U.S. based on successful completion of the clinical study. Financial terms of the agreement are confidential.
Pulmatrix Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements," including with regard to sales of products; product development, studies and potential; product markets; and the company's strategy, future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impacts of competition; changes in economic and financial conditions of the company's business; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in product development and legal and regulatory processes; risks associated with international operations; changes in third party relationships; uncertainties and matters beyond the control of management; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
SOURCE Mylan N.V.; Pulmatrix
For further information: Mylan Contacts: Nina Devlin (Media), 724.514.1968; Kris King (Investors), 724.514.1813; Pulmatrix Contacts: Kathryn Morris (Media), The Yates Network, 845.635.9828; Tom Baker (Investors), 617-532-0624, firstname.lastname@example.org