LEXINGTON, Mass., Jan. 17, 2017 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage
biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that its
drug candidate for treating fungal infections in the lungs of CF patients, PUR1900, has been designated as a "Qualified
Infectious Disease Product" (QIDP) by the U.S. Food & Drug Administration.
Under the QIDP
program, which is designed to speed the development of novel drugs against important pathogens, Pulmatrix will receive five
years of additional market exclusivity for PUR1900.
In its letter to Pulmatrix, the FDA wrote: "We have reviewed your request and conclude that it meets the criteria for QIDP.
Therefore we are designating your Itraconazole Inhalation Powder (PUR1900) product for inhalation use as a QIDP for….treatment of
pulmonary Aspergillus infections in patients with cystic fibrosis."
"The new QIDP designation is a significant boost to our efforts to make this drug available as quickly as possible to cystic
fibrosis (CF) patients suffering from fungal lung infections," said Pulmatrix CEO Robert Clarke, PhD. "It will give us the
benefit of an expedited regulatory review. Added to our existing FDA Orphan drug designation for PUR1900, it will give us a full 12 years of market
exclusivity."
Currently, many CF patients experience allergic reactions when their lungs become infected with a fungus called
Aspergillus. Doctors now try to treat those infections with oral drugs such as itraconazole. Oral antifungals require very
high doses to get enough of the drug to the lungs through the bloodstream to fight the fungus, causing severe side effects, and
oral antifungals are not always effective.
Pulmatrix's goal is to solve this problem by combining itraconazole with its innovative dry powder iSPERSE™ technology. The
combination of iSPERSE™ and itraconazole makes it possible for patients to inhale the drug into their lungs, to the
site of infection, where it's needed.
"By delivering the
drug directly to the lungs, we should be able to fight the infection far more effectively than the oral drug can, with far
fewer side effects," explained Pulmatrix's Chief Scientific Officer, David L. Hava, PhD. "That
should bring great benefits to patients."
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 lung diseases, including
opportunities in major pulmonary diseases through collaborations, like PUR0200, a branded generic in clinical development for
chronic obstructive pulmonary disease (COPD) and PUR1900, an inhaled antifungal that could benefit severe asthmatics and patients
with rare disease like cystic fibrosis. 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.
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. The Company
cautions that such statements involve risks and uncertainties that may materially affect the Company'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 establish or maintain collaborations on the development of therapeutic
candidates; 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 to obtain such funding on commercially reasonable terms;
the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in
the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce
legal rights related to the Company's products, including patent protection. A discussion of these and other factors, including
risks and uncertainties with respect to the Company, is set forth in the Company's annual report on Form 10-K filed by the
Company with the Securities and Exchange Commission on March 10, 2016. The Company 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.
Investor
Contact
Robert Clarke,
CEO
(781)
357-2333
rclarke@pulmatrix.com
William Duke, CFO
(781) 357-2333
wduke@pulmatrix.com
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SOURCE Pulmatrix, Inc.