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RICHMOND, Va., April 10, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced receipt of a letter and questionnaire from the Chairman and Ranking Member of the U.S. House of Representatives' Subcommittee on Health on the possible development of legislation to establish a Follow-On Biologics (FOBs) regulatory pathway.
Sent to approximately 30 stakeholders in the biotechnology industry, healthcare and patient communities, the letter notes that the " ... Members of the Subcommittee on Health are committed to this issue" and has requested Insmed's input "to better evaluate the merits, benefits, and costs of a biosimilars bill ... " Included in the letter for response are six pages of questions covering a range of related issues, including science, potential economic impact, incentives, and innovation.
Insmed intends to submit responses to the Subcommittee in advance of the April 22, 2008 deadline.
"We are very pleased that Insmed has been selected by the Subcommittee for input on this important issue," said Geoffrey Allan, Ph.D., CEO of Insmed. "We are pleased to be at the forefront of this critical healthcare initiative, look forward to submitting our thoughts and welcome the Member's commitment to adopt legislation so patients can readily receive affordable access to life-saving biotechnology drugs."
Insmed is currently developing a portfolio of FOBs and intends to initiate clinical trials for its first two FOBs in 2008, both of whose brand sales represent over $3 billion in current sales worldwide. Members of Insmed's skilled biologics team have worked on the development of over 50 therapeutic proteins. Their focused protein-based drug development backgrounds, coupled with the Company's FDA-approved protein manufacturing facility, and clinical and regulatory expertise, positions Insmed, upon the establishment of a regulatory pathway, to be an initial entrant into the U.S. FOBs market following the expiration of patents covering certain innovator products.
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.
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 Capital Market 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, 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.