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LONDON, UK / ACCESSWIRE / May 18, 2018 / If you want access to our free research report on Insmed Inc. (NASDAQ: INSM), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=INSM as the Company's latest news hit the wire. On May 16, 2018, the Company announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALIS (Amikacin Liposome Inhalation Suspension) for treatment of adult patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC). Insmed submitted the NDA for ALIS to the FDA on March 29, 2018. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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The FDA's Action Date Set in September 2018
The FDA has completed the filing review and determined that the application is sufficiently complete to permit a substantive review. The FDA granted Insmed's request for Priority Review and has set an action date of September 28, 2018, under the Prescription Drug User Fee Act (PDUFA). Priority Review applies to an application for a drug that treats a serious condition and that, if approved, would provide a significant improvement in safety or effectiveness. FDA has previously designated ALIS as an orphan drug, a breakthrough therapy and a Qualified Infectious Disease Product (QIDP).
ALIS has the Potential to be the First Approved Inhaled Therapy for Treatment of NTM Lung Infection in the US
Will Lewis, President and Chief Executive Officer of Insmed, stated that the Company is pleased that the FDA has accepted the NDA with Priority Review, which underscores the urgent need for therapies which address NTM lung disease caused by MAC.
Will added that ALIS has the potential to be the first approved inhaled therapy for the treatment of this serious and debilitating lung infection in the United States, and Insmed looks forward to working with the Agency through the review process.
Insmed Extended ALIS Intellectual Property Protection to 2035 with Issuance of 9th US Patent
On February 20, 2018, the United States Patent and Trademark Office (USPTO) issued US Patent Number 9,895,385 concerning methods for treating NTM lung infections, including NTM lung infections caused by MAC, with the Company's ALIS. The claims of the patent relate to methods for treating MAC lung infections via administration of ALIS to non-cystic fibrosis patients by nebulization once daily for a defined treatment period. The patent extended previously existing patent coverage for ALIS by 16 months, from January 2034 into May 2035.
About NTM Lung Disease
NTM lung disease is a rare and serious disorder associated with increased rates of morbidity and mortality. There is an increasing prevalence of lung disease caused by NTM. Patients with NTM lung disease may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue. Patients with NTM lung disease frequently require lengthy hospital stays to manage their condition. Current guideline-based approaches involve use of multi-drug regimens not approved for the treatment of NTM lung disease, and treatment can be as long as two years or more.
ALIS is a novel, inhaled, once-daily formulation of amikacin that is in late-stage clinical development for adult patients with treatment-refractory NTM lung disease caused by MAC. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function.
Insmed's advanced pulmonary liposome technology uses charge neutral liposomes to deliver amikacin directly to the lung where it is taken up by the lung macrophages where the NTM infection resides. This prolongs the release of amikacin in the lungs while minimizing systemic exposure thereby offering the potential for decreased systemic toxicities. ALIS's ability to deliver high levels of amikacin directly to the lung distinguishes it from intravenous amikacin.
About Insmed Incorporated
Founded in 1999 and headquartered in Bridgewater, New Jersey, Insmed is a global biopharmaceutical company focused on the needs of patients with rare diseases. Insmed is a dynamic and rapidly growing company with a strong pipeline of drug candidates.
Stock Performance Snapshot
May 17, 2018 - At Thursday's closing bell, Insmed's stock was slightly down 0.11%, ending the trading session at $18.51.
Volume traded for the day: 190.99 thousand shares.
Stock performance in the last month – up 2.21%; previous three-month period – up 10.44%; past twelve-month period – up 10.51%; and year-to-date - up 0.05%
After yesterday's close, Insmed's market cap was at $1.83 billion.
Price to Earnings (P/E) ratio was at 10.10.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.1% at the end of the session.
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