SOURCE: Insmed Incorporated

Insmed Incorporated

May 13, 2014 08:15 ET

Insmed Announces Data Presentations for ARIKAYCE in Two Orphan Lung Diseases at the American Thoracic Society Meeting

MONMOUTH JUNCTION, NJ--(Marketwired - May 13, 2014) - Insmed Incorporated (NASDAQ: INSM) announces that multiple poster presentations reporting data on ARIKAYCE™, or liposomal amakacin for inhalation, for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis (CF) patients and for the treatment of patients with treatment-resistant nontuberculous mycobacterial (NTM) lung infections will be presented at the American Thoracic Society Annual Meeting 2014, taking place May 16-21 in San Diego, California.

Information on the three poster presentations is as follows:

Session: Late-Breaking Abstracts in Clinical Trials - Mini Symposium
Title
: Interim analysis of a long-term, open-label safety, tolerability, and efficacy study of liposomal amikacin for inhalation in cystic fibrosis patients with chronic infection due to Pseudomonas aeruginosa
Day/Date: Sunday, May 18, 2014
Session Time: 8:15 a.m. - 10:45 a.m.
Publication Page: A6571
Discussion: 10:30 a.m.
Room: Room 31 A-C (Upper Level)
Location: San Diego Convention Center

Session: Diagnosis and Treatment of Nontuberculous Mycobacteria Infections
Title:
 A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation (Arikayce) in Patients with Recalcitrant Nontuberculous Mycobacterial Lung Disease
Day/Date: Tuesday, May 20, 2014
Session Time: 8:15 a.m. - 10:45 a.m.
Poster Board: #1018
Poster Viewing: 8:15 a.m. - 9:15 a.m.
Discussion: 9:15 a.m. - 10:45 a.m.
Room: Sapphire Ballroom E-F (Level 4)
Location: Hilton San Diego Bayfront

Session: Late-Breaking Abstracts in Disease Treatment and Clinical Outcomes
Title: Clinical Benefit of Liposomal Amikacin for Inhalation as Assessed by the Cystic Fibrosis Questionnaire-Revised
Day/Date: Tuesday, May 20, 2014
Session Time: 8:15 a.m. - 10:45 a.m.
Poster Board: #421
Poster Viewing: 8:15 a.m. - 9:15 a.m.
Discussion: 9:15 a.m. - 10:45 a.m.
Room: Room 8 (Upper Level)
Location: San Diego Convention Center

About Insmed
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 ARIKAYCE, or liposomal amikacin for inhalation, for at least two identified orphan patient populations: patients with non-tuberculous mycobacteria (NTM) lung infections and cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections. For more information, please visit http://www.insmed.com.

Forward-looking statements
This release contains forward-looking statements. 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 clinical trials and clinical data, the anticipated benefits of Insmed's products, the anticipated timing of regulatory submissions, and the ability to obtain required regulatory approvals, bring products to market and successfully commercialize 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 European, Canadian, U.S. Food and Drug Administration and other regulatory reviews and approvals, competitive developments affecting the Company's product candidates, delays in product development or clinical trials or other studies, patent disputes and other intellectual property developments relating to the Company's 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, the fact that subsequent analyses of clinical trial or study data may lead to different (including less favorable) interpretations of trial or study results or may identify important implications of a trial or study that are not reflected in Company's prior disclosures, and the fact that trial or study results or subsequent analyses may be subject to differing interpretations by regulatory agencies, the inability to successfully develop the Company's product candidates or receive necessary regulatory approvals, the ability to obtain Breakthrough Therapy Designation for ARIKAYCE in the U.S., the inability to make product candidates commercially successful, changes in anticipated expenses, changes in the Company's financing requirements or ability to raise additional capital, and other risks and challenges detailed in the Company's filings with the U.S. Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2013 and its subsequent quarterly reports on Form 10-Q. Investors are cautioned not to place undue reliance on any forward-looking statements that speak only as of the date of this news release. The Company undertakes no obligation to update these forward-looking statements to reflect events or circumstances or changes in its expectations.

Contact Information

  • Investor Relations Contacts:
    LHA

    Anne Marie Fields
    Senior Vice President
    212-838-3777
    afields@lhai.com

    Bruce Voss
    Managing Director
    310-691-7100
    bvoss@lhai.com