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.