MONMOUTH JUNCTION, NJ -- (Marketwired) -- 05/07/13 -- Insmed Incorporated (NASDAQ: INSM), ("Insmed" or the "Company"), a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, reported financial results for the three months ended March 31, 2013.
Highlights of the first quarter of 2013 and recent weeks included:
•Phase 3 update. Completed the patient treatment period of the Company's registrational Phase 3 clinical trial of ARIKACE®, the Company's Iiposomal amikacin for inhalation, to treat cystic fibrosis (CF) patients with Pseudomonas lung infections in Europe and Canada and remain on track to report top-line clinical results from the trial in mid-2013. •Orphan Drug Designation. Received orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of infections caused by non-tuberculous mycobacteria (NTM) for ARIKACE. •Cash Payment expected from Premacure. Reported that Premacure AB, recently acquired by Shire plc, elected to obtain all of the Company's rights to receive revenues for former product candidate, IGF-1, under the May 2012 Premacure License Agreement. Insmed expects to receive $11.5 million in May 2013 in exchange for any future royalties from Premacure, and Premacure will assume Insmed's royalty obligations to other parties. •Appointed Matt Pauls as Chief Commercial Officer. Mr. Pauls has more than 20 years of experience in the pharmaceutical industry, including senior-level leadership roles in global marketing, sales, reimbursement, new product launches and commercial operations at leading pharmaceutical companies. •Appointed Peter Clarke as Vice President of Manufacturing. Mr. Clarke has nearly 30 years of experience in biopharmaceutical manufacturing at both startup and established pharmaceutical companies in Europe and the United States.
"We continue to advance Insmed's transformation into a commercial entity. During the first quarter we made significant progress in executing our hiring plan, advancing our manufacturing strategy and carrying out our clinical trials and regulatory filing preparation for ARIKACE," stated Will Lewis, President and Chief Executive Officer of Insmed.
"We remain on track to report top-line clinical results from our Phase 3 trial in CF mid-year and our Phase 2 trial in NTM before the end of the year. Collectively, these data sets bring us closer to our goal to commercialize a potentially life-saving treatment for patients suffering from these orphan lung diseases."
First Quarter Financial Results
For the first quarter of 2013, Insmed posted a net loss of $13.7 million, or $0.43 per share, compared with a net loss of $6.8 million, or $0.28 per share, for the first quarter of 2012.
Research and development expense in the first quarter increased to $10.3 million from $4.7 million in the first quarter of 2012, primarily due to a $4.6 million increase in external costs for clinical trial activities associated with the Company's Phase 3 CF clinical trial and two-year extension study in Europe and Canada, and its Phase 2 NTM clinical trial in the United States.
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