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:6/23/2016)... ... June 23, 2016 , ... Charm Sciences, Inc. is ... has received AOAC Research Institute approval 061601. , “This is another AOAC-RI approval ... Bob Salter, Vice President of Regulatory and Industrial Affairs. “The Peel Plate methods ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry ... Supplyframe Design Lab . Located in Pasadena, Calif., the Design Lab’s mission ... hardware projects are designed, built and brought to market. , The Design Lab ...
(Date:6/23/2016)...  Blueprint Bio, a company dedicated to identifying, protecting ... has closed its Series A funding round, according to ... "We have received a commitment from Forentis Fund that ... meet our current goals," stated Matthew Nunez . ... complete validation on the current projects in our pipeline, ...
(Date:6/23/2016)... WI (PRWEB) , ... June 23, 2016 , ... ... focused on quality, regulatory and technical consulting, provides a free webinar ... presented on July 13, 2016 at 12pm CT at no charge. , Incomplete ...
Breaking Biology Technology:
(Date:5/16/2016)... , May 16, 2016   EyeLock LLC ... today announced the opening of an IoT Center of ... strengthen and expand the development of embedded iris biometric ... unprecedented level of convenience and security with unmatched biometric ... one,s identity aside from DNA. EyeLock,s platform uses video ...
(Date:4/28/2016)... BANGALORE, India , April 28, 2016 /PRNewswire/ ... product subsidiary of Infosys (NYSE: INFY ), and ... global partnership that will provide end customers with ... banking and payment services.      (Logo: http://photos.prnewswire.com/prnh/20130122/589162 ... area for financial services, but it also plays a fundamental ...
(Date:4/19/2016)... April 20, 2016 The new ... a compact web-based "all-in-one" system solution for all door ... reader or the door interface with integration authorization management ... control systems. The minimal dimensions of the access control ... the building installations offer considerable freedom of design with ...
Breaking Biology News(10 mins):