Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.... (ld. Demonstration of bioequivalence is t...)

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

Date:7/10/2008

ld. 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."

Insmed has one of the most robust follow-on biologics pipelines in the industry. Building upon the success of INS-19, the Company has also completed pre- clinical pharmacological and pharmacokinetic studies for its second follow-on biologic product, INS-20, which has demonstrated comparability to FDA-approved Neulasta(R). Based on these data, Insmed intends to initiate a Phase I bioequivalence study of INS-20 in humans in the fourth quarter of 2008. Insmed intends to seek approval of both products in the U.S. and launch the 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 volunteers enrolled, and all completed the study as planned. Each volunteer received a single dose of either INS-19 or Neupogen(R), underwent a wash-out period, and returned to the clinic for a single dose of the alternate product. Blood samples were collected to characterize the pharmacokinetic and pharmacodynamic responses to each dose administration. Point estimates and 90% confidence intervals (CI) for the mean ratios of the products' maximum G-CSF concentrations (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-19 and Neupogen(R). G-CSF concentration profiles for the two products were identical. The Cmaxs following INS-19 and Neupogen(R) administration were 44.7 +/- 2.1 and 45.5 +/- 1.9 ng/mL, respectively (mean +/- standard error). The AUCs for INS-19 and Neupogen(R) were 341 +/- 16
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