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Insmed Inc. (INSM) Shares Climb 15% on Word of Positive Bioequivalence Testing

Shares of Insmed Inc. (Nasdaq: INSM) hiked 15% to a close of 46 cents today, spurred by word the biopharmaceutical company has demonstrated the bioequivalence of INS-19, the company’s recombinant human granulocyte colony stimulating factor (G-CSF). The company compared G-CSF to FDA-approved Neupogen, used to treat neutropenia, a disorder characterized by an abnormally low number of white blood cells.

“These results are very exciting, as they represent Insmed’s ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug,” Dr. Geoffrey Allan, president and CEO of Insmed stated in the press release. “To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field.”

The human bioequivalence studies followed the FDA’s strict standards to demonstrate the equivalence between Insmed’s INS-19 and Neupogen. Results show the primary pharmacodynamic marker for G-CSF products had the same response for INS-19 and Neupogen products.

“Demonstration of bioequivalence is typically the sole clinical requirement to support FDA approval of generic drugs today. Thus, based on these data, Insmed intends to request a meeting with the FDA to discuss potentially initiating a phase III clinical trial program for INS-19,” Allan stated.

The positive results are integral to Insmed’s product pipeline. Neupogen recorded 2007 sales of approximately $1 billion, marking a huge window of opportunity for Insmed’s INS-19 as it steps toward commercialization.

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