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news.Insmed has received approval from the UK's Medicines and Healthcare products Regulatory Agency to initiate a Phase I clinical study for the company's second follow-on biologic product candidate, INS-20.
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According to the company, preclinical studies demonstrated that INS-20 and the FDA-approved Neulasta are comparable in both their pharmacological and toxicological profile. Detailed analytical characterization also demonstrated that the products have a high degree of similarity. Data from these initial evaluations have been used, in part, to support the Phase I study, which will be initiated immediately.
The Phase I study will be conducted in the UK and will compare the safety and establish the bioequivalence of INS-20 to Neulasta. Results from the trial are anticipated in 2009, and are expected to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial.
The initiation of this follow-on biologic (FOB) trial is the second of two planned for 2008 as part of Insmed’s development of a portfolio of FOBs. Previously, Insmed announced that a completed Phase I clinical trial had demonstrated the bioequivalence of INS-19, the company’s recombinant human granulocyte colony stimulating factor (G-CSF), compared to Neupogen, an FDA-approved G-CSF product for the treatment of neutropenia.
Insmed intends to seek approval of INS-19 and INS-20 in the US and launch the products on expiration of the relevant innovator patents, which is in 2013 for Neupogen and 2015 for Neulasta.
Geoffrey Allan, president and CEO of Insmed, said: “We intend to use the data to be generated from the Phase I trial, in combination with the positive preclinical results previously garnered, as the basis for discussions with the FDA in an effort to establish a Phase III development path for INS-20.”