The patent gives Pulmatrix intellectual property protection for the drug until 2033
LEXINGTON, Mass., May 9, 2017 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that it has received a key patent in the United States for its lead drug candidate, PUR0200, which is intended to treat chronic obstructive pulmonary diseases (COPD).
"This patent ensures that the product is protected by intellectual property until 2033," said Robert W. Clarke, Ph.D., Chief Executive Officer for Pulmatrix. "It also is further recognition of the potential medical advances offered by our innovative iSPERSE™ technology for delivering drugs to the lungs more efficiently."
The new patent, US 9642798, follows both an earlier patent granted in Japan in 2016 (JP 5877204) for the composition of PUR0200 and several broader patents (such as US 9061352, 9119778, 9233158, 9238005 and 9433576) that provide protection for Pulmatrix's technology platform and its use to treat a wide variety of diseases.
The new patent covers PUR0200, an inhaled drug made by combining Pulmatrix's technology platform with tiotropium bromide. Tiotropium bromide is the active ingredient in Spiriva, a blockbuster inhaled drug with annual global sales of approximately €3 billion in 2016.
The limitation with current inhaled products is that a significant amount of the drugs get stuck in the mouth or throat, causing side effects and poor delivery efficiency to the intended site of action in the lungs. Pulmatrix has tackled this problem by creating a dry powder that 'flies' more easily into the lungs. Drugs like tiotropium bromide that are incorporated into the iSPERSE powder thus are far more likely to reach their intended target, offering a major medical benefit.
In fact, clinical trials of PUR0200 have shown that the product is up to five times more efficient at delivering the drug to the lungs than are the currently marketed alternatives.
Pulmatrix is now developing PUR0200 in both Europe and the United States, following regulatory pathways that offer quicker approvals and lower costs.
"This new patent is another step forward to bringing PUR0200 to market—and to be able to offer new benefits to patients suffering from COPD," added Dr. Clarke.
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 diseases 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.
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. Such forward-looking statements include, but are not limited to, statements concerning the amount and use of proceeds the Company expects to receive from the sale of the shares of common stock in the registered direct offering, the closing of the transaction described in this press release, which is subject to customary conditions, and other statements that are not statements of historical fact, and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. 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, market and other conditions, the satisfaction of customary closing conditions related to the registered direct offering of common stock, 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 filings with the Securities and Exchange Commission, including its annual report on Form 10-K filed with the Securities and Exchange Commission on March 10, 2017, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q. 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.
Robert Clarke, CEO
William Duke, CFO
SOURCE Pulmatrix, Inc.