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"Insmed's Board of Directors and senior management team are dedicated toenhancing shareholder value and will be utilizing RBC's experience andexpertise to examine a number of various strategic alternatives that mayachieve this end," said Geoffrey Allan, President and CEO of Insmed. "Wefirmly believe that Insmed has one of the most advanced follow-on biologicsplatforms in the U.S. and that follow-on biologics represent a multi-billiondollar opportunity. We are confident that this process to prioritizestrategic alternatives aimed at leveraging our significant assets will lead toenhanced value for all of our stakeholders."
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Insmed's biologics facility in Boulder, CO, in combination with its highlyexperienced staff specialized in therapeutic protein development, positionsthe Company to pursue the significant opportunities expected to be availablein the emerging follow-on biologics (FOB) industry. Insmed's comprehensivecapabilities in cell line development, product characterization,manufacturing, and clinical development of follow-on biologics, positionInsmed to potentially be one of the first few initial entrants in the rapidlyevolving FOB marketplace.
Insmed's most advanced follow-on biologics, INS-19, (Granulocyte ColonyStimulating Factor or G-CSF), an FOB of Neupogen(R), and INS-20 (Peg G-CSF),an FOB of Neulasta(R), recorded combined 2007 brand sales of over $4 billionfor the treatment of neutropenia. The Company recently announced that it hasdemonstrated the bioequivalence of INS-19 compared to Neupogen(R), becomingthe first U.S. company to disclose such human bioequivalence data. Based onthis data, Insmed intends to request a meeting with the FDA to discusspotentially initiating a Phase III clinical trial program for INS-19. TheCompany also intends to initiate human bioequivalence clinical studies forINS-20 in the fourth quarter of 2008, with data expected in the first quarterof 2009. Insmed has several other FOB products which are currently at anearlier stage of cell line development and product characterisation.
About Insmed
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.
Forward-Looking Statements
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 products, constitute forward-lookingstatements which involve risks and uncertainties that could cause actualresults to differ materially from those anticipated by the forward-lookingstatements. The risks and uncertainties include, without limitation, risksthat strategic alternatives may never be consummated, product candidates mayfail in the clinic or may not be successfully marketed or manufactured, we maylack financial resources to complete development of product candidates, theFDA may interpret the results of studies differently than us, competingproducts may be more successful, demand for new pharmaceutical products maydecrease, the biopharmaceutical industry may experience negative markettrends, our entrance into the follow-on biologics market may be unsuccessful,our common stock could be delisted from The NASDAQ Capital Market and otherrisks a
