RICHMOND, Va., July 17 Insmed Inc. (Nasdaq:INSM), a developer of follow-on biologics and biopharmaceuticals for unmetmedical needs, today announced that The Honorable Bill Thomas, Former Chairmanof the House Ways and Means Committee from 2001 to 2007, has been retained byInsmed as a strategic advisor to assist the Company's efforts to bringfollow-on biologics to U.S. customers and consumers.
Bill Thomas played a critical role developing key health legislationduring his 28 years of service in the US House of Representatives, culminatingin the passage of the Medicare Modernization Act of 2003, which createdMedicare Part D prescription drug coverage for seniors.
"During my time in Congress I helped lay the groundwork to allow biologiccompetition from follow-on biologics. I am excited to partner with Insmed tocontinue that fight," said Chairman Thomas. "Biotechnology represents thefuture of modern healthcare in America, but as is the case across allindustries in our economy, competition will foster innovation and benefits forconsumers," Thomas continued. "Insmed is walking the walk, having alreadyproduced data showing bioequivalence between one of their products and apioneer drug. Given the rising costs of healthcare, Congress needs to passlegislation creating a pathway for follow-on biologics."
The announcement follows Insmed's release of data last week demonstratingbioequivalence between INS-19 and Neupogen(R) (patented in 1996) in Phase Iclinical trials. In the coming months, Insmed will seek FDA approval to beginPhase III clinical trials for INS-19 and also initiate Phase I trials forInsmed's second follow-on biologic product, INS-20, a generic form ofNeulasta(R) (patented in 1998). The two biologics represented combined 2007worldwide sales of over $4 billion. Insmed plans to launch its follow-onbiologic versions of the innovator products when the patents on the innovatorproducts expire.
"Chairman Thomas' legislative expertise and strategic counsel will proveinvaluable in the coming months as Insmed continues in its mission to be thefirst US-based biotechnology company to develop a comprehensive portfolio offollow-on biologics products," said Dr. Geoffrey Allan, President and CEO ofInsmed. "We want to demonstrate to Washington policymakers that thecapability to produce safe, effective and more affordable biologics existstoday. All that's needed is for Congress to create an approval pathway."
Insmed Inc. is a biopharmaceutical company with unique protein processdevelopment and manufacturing experience and a proprietary protein platformaimed at niche markets with unmet medical needs. For more information, pleasevisit www.insmed.com
The Follow-on Biologics Market
According to published reports, an estimated $10 billion worth of biologicdrugs are expected to come off patent by 2010, with an additional $10 billionby 2015. FOBs would provide safe and effective therapies at a reduced costfollowing the expiration of the original product's patent. A recenteconometric study by economist Dr. Robert J. Shapiro, former Under Secretaryof Commerce in the Clinton Administration, found that "...generic versions ofthe top 12 categories of biologic treatments with patent protections that haveexpired or that are due to expire in the near future could save Americans $67billion to $108 billion over 10 years and $236 billion to $378 billion over 20years."
This release contains forward-looking statements which are made pursuantto provisions of Section 21E of the Securities Exchange Act of 1934. Investorsare cautioned that such statements in this release, including statementsrelating to planned clinical study design, regulatory and business strategies,strategic alternatives, plans and objectives of management and growthopportunities for existing or proposed