MONMOUTH JUNCTION, NJ-- September 11, 2013 - Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, announces two important patent allowances in the U.S. and Europe that strengthen the Company's global patent portfolio. Insmed is focused on the development and commercialization of ARIKACE® (liposomal amikacin for inhalation) for at least two identified orphan patient populations: cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections and patients with non-tuberculous mycobacteria (NTM) lung infections.
The U.S. Patent and Technology Office (USPTO) intends to grant U.S. Patent Application No. 13/666,420 for ARIKACE in a patent titled, "Lipid-based compositions of anti-infectives for treating pulmonary infections and methods of use thereof." Once granted, it will provide exclusivity at least through December 5, 2026. The new U.S. patent will cover an aerosolized composition of Insmed's novel, once-daily inhalation formulation comprising amikacin and liposomal delivery technology for the treatment of pulmonary infections, including Pseudomonas aeruginosa and mycobacterial infections, among others.
In May 2010 and July 2012, the USPTO issued composition-of-matter patents covering the Company's liposomal amikacin for inhalation, with exclusivity extending until at least June 2025 and August 2028, respectively.
The European Patent Office intends to grant EU Patent Application No. 03816990 for ARIKACE in a patent titled, "Sustained release of anti-infectives." Once granted, it will provide exclusivity at least through October 29, 2023 in any European Patent Office member state where Insmed chooses to validate the patent. This patent will provide protection for the use of ARIKACE's formulation comprising amikacin and liposomal delivery technology for the treatment of pulmonary infections in CF patients. Specifically, the allowed patent application includes claims relating to the use of the aforementioned formulation for treating Pseudomonas aeruginosa pulmonary infections, as well as certain mycobacterial infections among others.
This patent allowance is in addition to the recent European Patent Office's issuance of EU patent No. 1909759 for ARIKACE that will provide exclusivity through at least July 19, 2026.
"These patent allowances provide a firm foundation for our ARIKACE intellectual property estate, which now includes four granted and allowed U.S. patents and 27 granted and allowed patents in Europe and other countries including Japan, Australia, China and Korea," commented Walter Perkins, Ph.D., Chief Technology Officer of Insmed.
Will Lewis, President and Chief Executive Officer of Insmed, commented, "These new patent allowances are a credit to our technology development team and demonstrate the inventiveness and utility of our approach to treating serious and oftentimes life-threatening lung diseases. As we move toward potential marketing approval and commercialization of ARIKACE to treat Pseudomonas aeruginosa in CF patients in Europe and Canada, and continue the clinical development of our liposomal amikacin for inhalation to treat NTM in the U.S., these new patent allowances provide additional protection for this valuable asset. We are pursuing a broad intellectual property strategy that provides the foundation to achieve our global clinical and commercial objectives and protects shareholder value."
Insmed Incorporated is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. Insmed is focused on the development and commercialization of ARIKACE®, or liposomal amikacin for inhalation, for at least two identified orphan patient populations: cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections and patients with non-tuberculous mycobacteria (NTM) lung infections. For more information, please visit http://www.insmed.com.
This release contains forward-looking statements that are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Words, and variations of words, such as "intend," "expect," "will," "anticipate," "believe," "continue," "propose" and similar expressions are intended to identify forward-looking statements. Investors are cautioned that such statements in this release, including statements relating to the status, results and timing of results of preclinical studies and clinical trials and preclinical and clinical data and the anticipated benefits of Insmed's products, constitute forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, without limitation, failure or delay of U.S. Food and Drug Administration and other regulatory reviews and approvals, competitive developments affecting our product candidates, delays in product development or clinical trials or other studies, patent disputes and other intellectual property developments relating to our product candidates, unexpected regulatory actions, delays or requests, the failure of clinical trials or other studies or results of clinical trials or other studies that do not meet expectations, inability to successfully develop our product candidates or receive necessary regulatory approvals, inability to make product candidates commercially successful, changes in anticipated expenses, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2012. Investors are cautioned not to place undue reliance on any forward-looking statements that speak only as of the date of this news release. We undertake no obligation to update these forward-looking statements to reflect events or circumstances or changes in our expectations.
Investor Relations Contact:
Anne Marie Fields
Senior Vice President
SOURCE: Insmed Incorporated