Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company

Thursday, July 10, 2008 General News
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RICHMOND, Va., July 10, 2008 Insmed Inc.(Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals forunmet medical needs, today announced that it has demonstrated thebioequivalence of INS-19, the company's recombinant human granulocyte colonystimulating factor (G-CSF), compared to Neupogen(R), an FDA-approved G-CSFproduct for the treatment of neutropenia that recorded 2007 sales ofapproximately $1 billion.

Human bioequivalence studies utilize well-established, FDA-recognizedmethodology with rigorous standards. Results of this clinical studydemonstrated bioequivalence between INS-19 and Neupogen(R). G-CSFconcentration profiles for the two products were identical. Absoluteneutrophil count, the primary pharmacodynamic marker for G-CSF products,exhibited the same response profile to dosing with INS-19 as with Neupogen(R).These human INS-19 and Neupogen(R) data complement Insmed's extensiveanalytical testing and comparative data from pre-clinical assessments.

"These results are very exciting, as they represent Insmed's ability toreplicate a protein product, to bring that product rapidly through the clinicand to demonstrate clear bioequivalence to the innovator drug," said Dr.Geoffrey Allan, President and CEO of Insmed. "To our knowledge, we are thefirst U.S. company to report human bioequivalence data for a follow-onbiologic product, validating the idea that follow-on biologics can be ascientific reality in the U.S. and that Insmed is well positioned to be aleader in the field. Demonstration of bioequivalence is typically the soleclinical requirement to support FDA approval of generic drugs today. Thus,based on these data, Insmed intends to request a meeting with the FDA todiscuss potentially initiating a Phase III clinical trial program for INS-19."

Insmed has one of the most robust follow-on biologics pipelines in theindustry. Building upon the success of INS-19, the Company has also completedpre- clinical pharmacological and pharmacokinetic studies for its secondfollow-on biologic product, INS-20, which has demonstrated comparability toFDA-approved Neulasta(R). Based on these data, Insmed intends to initiate aPhase I bioequivalence study of INS-20 in humans in the fourth quarter of2008. Insmed intends to seek approval of both products in the U.S. and launchthe products on expiration of the relevant innovator patents.

Study Design

The study was a single-center, randomized, double-blind, two-way,crossover bioequivalence design in healthy volunteers. Thirty-two volunteersenrolled, and all completed the study as planned. Each volunteer received asingle dose of either INS-19 or Neupogen(R), underwent a wash-out period, andreturned to the clinic for a single dose of the alternate product. Bloodsamples were collected to characterize the pharmacokinetic and pharmacodynamicresponses to each dose administration. Point estimates and 90% confidenceintervals (CI) for the mean ratios of the products' maximum G-CSFconcentrations (Cmaxs) and areas under the G-CSF concentration curves (AUCs)were calculated, and bioequivalence was assessed.

Study Results

Results of this clinical study demonstrated bioequivalence between INS-19and Neupogen(R). G-CSF concentration profiles for the two products wereidentical. The Cmaxs following INS-19 and Neupogen(R) administration were44.7 +/- 2.1 and 45.5 +/- 1.9 ng/mL, respectively (mean +/- standard error).The AUCs for INS-19 and Neupogen(R) were 341 +/- 16 and 343 +/- 14 ng/mL*hr,respectively. In comparing INS-19 to Neupogen(R), the CI for the ratio ofCmaxs was 92-103% and the CI for the ratio of AUCs was 94-103%. These datademonstrate that the pharmacokinetic behaviour of the products wasstatistically indistinguishable. Absolute neutrophil count, the primarypharmacodynamic marker for G-CSF products, exhibited the same response profileto dosing with INS-19 as

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