Navigation Links
Insmed Incorporated Provides Corporate Update
Date:1/20/2012

MONMOUTH JUNCTION, N.J., Jan. 20, 2012 /PRNewswire/ -- Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on ARIKACE® (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacteria (NTM) lung disease.  Insmed continues to engage in discussions with FDA regarding the clinical hold placed on ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections.

The clinical holds placed on the ARIKACE programs in NTM and CF were based on an initial review by FDA of the results reported by Insmed of a long-term rat inhalation carcinogenicity study of ARIKACE.

FDA previously requested that Insmed conduct a phase 2 clinical trial of ARIKACE in adult patients with NTM to provide proof-of-concept efficacy and safety data before proceeding with a phase 3 clinical trial.  As part of its on-going assessment of the appropriate path forward for the ARIKACE program, including the phase 2 trial of ARIKACE in NTM patients, the Company is continuing communication with FDA regarding the CF clinical hold.

Insmed also announced that it will move ahead with the 9-month dog inhalation toxicity study of ARIKACE as previously requested by FDA to determine if the findings of the rat inhalation carcinogenicity study are observed in a non-rodent model.

"We are pleased that FDA has lifted the clinical hold on the ARIKACE development program in NTM," said Timothy Whitten, President and CEO of Insmed.  "Insmed continues to work closely with regulatory authorities regarding the development program for ARIKACE.  We are initiating the work required to begin the 9-month dog study during the second quarter and are continuing our dialogue with FDA regarding the CF clinical program."

Insmed also announced that IPLEX® inventory has now been fully depleted.  At present, about 10 patients remain on drug.  Regarding potential future IPLEX initiatives, the Company is currently evaluating possible out-licensing opportunities for the drug.

About Insmed

Insmed Incorporated is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of serious lung diseases, and has a proprietary protein platform aimed at niche markets with high unmet medical need. Insmed's primary focus is on the development of inhaled antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases.  For more information, please visit http://www.insmed.com.

Forward-Looking Statements

This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to our financial position, results of operations, the status and the results of preclinical studies and clinical trials and preclinical and clinical data described herein, the timing of responses to information and data requests from FDA, the development of our products, and the business strategies, plans and objectives of management, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements.  Our results may be affected by such factors as the receipt and timing of FDA and other regulatory reviews and approvals, if at all, competitive developments affecting our product development, delays in product development or clinical trials, and patent disputes involving currently developing products.  The risks and uncertainties include, without limitation, we may experience unexpected regulatory actions, delays or requests, our future clinical trials may not be successful, we may be unsuccessful in developing our product candidates or receiving necessary regulatory approvals, we may experience delays in our product development or clinical trials, our product candidates may not prove to be commercially successful, our expenses may be higher than anticipated 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, 2010 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2011.  Investors are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release.  We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

Investor Relations Contact:
Brian Ritchie – FTI Consulting
212-850-5683
brian.ritchie@fticonsulting.com

Media Contact:
Irma Gomez-Dib – FTI Consulting
212-850-5761
irma.gomez-dib@fticonsulting.com


'/>"/>
SOURCE Insmed Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Insmed to Host 2011 Third Quarter Earnings Conference Call
2. Insmed to Present at 2011 Wedbush Securities Life Sciences Management Access Conference
3. Andrea Drucker Joins Insmed as General Counsel
4. Insmed Announces FDA Clearance of IND for Pivotal Phase 3 Trial of ARIKACE™ in Nontuberculous Mycobacteria Indication
5. Insmed Announces Fourth Quarter and Full-Year 2010 Financial Results
6. Insmed to Host Second Quarter 2009 Conference Call
7. Insmed Announces Addition to the Russell 3000(R) Index
8. Insmed Announces Results of IPLEX(TM) Phase II Trial in Myotonic Muscular Dystrophy
9. Insmed CEO Resigns Due to Health Concerns
10. Insmed Announces First Quarter 2009 Financial Results
11. Insmed Regains NASDAQ Compliance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... , ... May 26, 2016 , ... ... FireflySci cuvettes are used in leading laboratories all over the globe. Their cute ... In addition to manufacturing awesome cuvettes, FireflySci makes spectrophotometer calibration standards that never ...
(Date:5/25/2016)... ... May 25, 2016 , ... The American ... the Office of the National Coordinator for Health IT (ONC) outlining a measurement ... relevant data were available when and where it was needed. The organization of ...
(Date:5/24/2016)... Worcester, Mass. (PRWEB) , ... May 24, 2016 ... ... including heart attacks, diabetes, and traumatic injuries, will be accelerated by research at ... skin cells into engines of wound healing and tissue regeneration. , The novel ...
(Date:5/23/2016)... Willoughby, Ohio (PRWEB) , ... May 23, 2016 ... ... Six Trends That Will Drive Precision Farming in 2017 and Beyond. The paper ... and practitioners in the precision ag industry. , “We’ve witnessed a lot of ...
Breaking Biology Technology:
(Date:3/14/2016)... Allemagne, March 14, 2016 ... - --> - Renvoi : image disponible ... --> --> DERMALOG, ... fournit de nouveaux lecteurs d,empreintes digitales pour l,enregistrement ... DERMALOG sera utilisé pour produire des cartes d,identité ...
(Date:3/11/2016)... March 11, 2016 --> ... research report "Image Recognition Market by Technology (Pattern Recognition), ... Advertising), by Deployment Type (On-Premises and Cloud), by Industry ... published by MarketsandMarkets, the global market is expected to ... 29.98 Billion by 2020, at a CAGR of 19.1%. ...
(Date:3/10/2016)... 10, 2016   Unisys Corporation (NYSE: UIS ... (CBP) is testing its biometric identity solution at the ... to help identify certain non-U.S. citizens leaving the country. ... designed to help determine the efficiency and accuracy of using ... and will run until May 2016. --> ...
Breaking Biology News(10 mins):