LEXINGTON, Mass. and
HERTFORDSHIRE, England and
PITTSBURGH, June 16, 2015 /PRNewswire/ -- Pulmatrix, 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.
About Pulmatrix
Pulmatrix is a clinical stage
biopharmaceutical company developing innovative inhaled therapies
to address serious pulmonary disease using its patented iSPERSE
technology. The Company's proprietary product pipeline is focused
on advancing treatments for rare diseases, including PUR1900, a,
inhaled anti-fungal for patients with cystic fibrosis (CF) as well
as PUR1500, an inhaled product for the treatment of idiopathic
pulmonary fibrosis. In addition, Pulmatrix is pursuing
opportunities in major pulmonary diseases through collaboration
with partners. This includes PUR0200, a branded generic in clinical
development for chronic obstructive pulmonary disease (COPD), and
other potential first-in-class treatments. Pulmatrix's
product candidates are based on iSPERSE, its proprietary dry powder
delivery platform, which seeks to improve therapeutic delivery to
the lungs by maximizing local concentrations and reducing systemic
side effects to improve patient outcomes.
Pulmatrix Forward-Looking Statements
Certain
statements in this press release that are forward-looking and not
statements of historical fact are forward-looking statements within
the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Pulmatrix cautions that such
statements involve risks and uncertainties that may materially
affect Pulmatrix's results of operations. Such forward-looking
statements are based on the beliefs of management as well as
assumptions made by and information currently available to
management. Actual results could differ materially from those
contemplated by the forward-looking statements as a result of
certain factors, including but not limited to the ability to
establish that potential products are efficacious or safe in
preclinical or clinical trials; the ability to obtain appropriate
or necessary governmental approvals to market potential products;
the ability to obtain future funding for developmental products and
working capital; and the ability to secure and enforce legal rights
related to the companies' products, including patent protection. A
discussion of these and other factors, including risks and
uncertainties with respect to Pulmatrix, is set forth in the
registration statement on Form S-4 filed by Pulmatrix on
April 15, 2015, as amended. Pulmatrix
disclaims any intention or obligation to revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in healthcare. Working together
around the world to provide 7 billion people access to high quality
medicine, we innovate to satisfy unmet needs; make reliability and
service excellence a habit; do what's right, not what's easy; and
impact the future through passionate global leadership. We offer a
growing portfolio of around 1,400 generic pharmaceuticals and
several brand medications. In addition, we offer a wide range of
antiretroviral therapies, upon which approximately 40% of HIV/AIDS
patients in developing countries depend. We also operate one of the
largest active pharmaceutical ingredient manufacturers and
currently market products in about 145 countries and territories.
Our workforce of approximately 30,000 people is dedicated to
creating better health for a better world, one person at a time.
Learn more at mylan.com
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.
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SOURCE Mylan N.V.; Pulmatrix