Navigation Links
Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
Date:2/5/2008

RICHMOND, Va., Feb. 5 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM) CEO Geoffrey Allan issued the following statement today following the White House FY09 Budget and Food and Drug Administration statements on developing an approval pathway for follow-on biologics:

"Insmed is very pleased to see that the White House recognizes the importance of establishing a follow-on biologics approval pathway to deliver safe and more affordable medicines to Americans.

"We are also pleased by news of the Food and Drug Administration's preparation of a proposal to assist the Congress in moving forward with legislation to establish an approval pathway for follow-on biologics.

"We hope that the attention this important issue has received from both the White House and FDA will move Congress to adopt follow-on biologics legislation so patients can receive safe and affordable access to generic versions of these life-saving biotech drugs."

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs. Insmed has a state-of-the- art, FDA-approved biologic commercial manufacturing facility in Boulder, Colorado and a Corporate office in Richmond, Virginia. 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 planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, 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. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our entrance into the follow on biologics market may be unsuccessful, our common stock could be delisted from the Nasdaq Global Market and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2007. Readers 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 - FD

212-850-5683

brian.ritchie@fd.com

Corporate Communications Contact:

John Procter - Gibraltar Associates

202-879-5808

jprocter@gibraltar-llc.com


'/>"/>
SOURCE Insmed Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Insmed President Interviewed for Follow-On Biologics Podcast: Insmed Inc. President Steve Glover Discusses Safe and Effective Biologic Therapies and Reduced Costs with The American Magazine
2. Insmed to Appeal Delisting Notification From Nasdaq
3. Insmed Awarded $2.1 Million by Muscular Dystrophy Association
4. Insmed Appoints Dennis M. Lanfear to Board Of Directors
5. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
6. FDA Issues Approvable Letter for LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
7. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
8. CCPM Issues Statement on FDAs GIVE Initiative
9. Symmetry Medical Discloses Accounting Issues at Sheffield, UK Operating Unit and Possible Restatement
10. CalbaTech Issues Update; Beginning Training for Adult Stem Cell Collections in Atlanta
11. HHS Issues First Department-Wide Report on Personalized Health Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... ... February 09, 2016 , ... ... current winner of the Highest Overall Customer Rating Award from Circuits Assembly ... its business units across the USA, Canada, Mexico and China. , The EMS ...
(Date:2/9/2016)... , ... February 08, 2016 , ... ... testing services, announced today the launch of its revamped and improved website. In ... language service solutions, the redesigned website will better communicate how the company designs ...
(Date:2/9/2016)... ... February 09, 2016 , ... The publishing ... Open Access publishing is one of the popular publication models that has received ... journals and 3000+ International Conferences across the globe, OMICS International ...
(Date:2/9/2016)... and LONDON , February 9, ... leading bio tech replace paper and protect ... web-based electronic laboratory notebook (ELN) will be rolled out in ... paper-based research and development (R&D) and protect valuable IP. Users ... and follow a specific researcher or experiment as part of ...
Breaking Biology Technology:
(Date:1/28/2016)... SYNA ), a leading developer of human interface solutions, today ... --> --> Net revenue ... to the comparable quarter last year to $470.5 million. Net income ... $0.93 per diluted share. --> ... 2016 grew 9 percent over the prior year period to $60.3 ...
(Date:1/22/2016)... DUBLIN , Jan. 22, 2016 /PRNewswire/ ... announced the addition of the "Global ... report to their offering. --> ... of the "Global Biometrics Market in ... offering. --> Research and ...
(Date:1/18/2016)... SAN JOSE, Calif. , Jan. 18, 2016 ... storage security software that simplifies the use and ... a technology and go-to-market partnership with American Cyber.  ... "American Cyber brings extensive experience leading transformational C4ISR ... missions implementing and integrating the latest proven technology ...
Breaking Biology News(10 mins):