Novo Nordisk Inhaled Insulin To Resume Phase III Studies
This article was originally published in The Pink Sheet Daily
Executive Summary
Trials for the AERx inhaled insulin system will involve both type 1 and type 2 diabetes, despite a previous safety signal in type 1 patients.
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Novo Nordisk/Aradigm's inhaled insulin therapy will resume Phase III clinical trials for the management of both type 1 and type 2 diabetes in the second quarter, Novo announced during an April 28 earnings call. The AERx insulin Diabetes Management System had shown an unexpected delay in post-meal plasma glucose suppression for type 1 diabetes in interim analysis of the Phase III study. The signal caused Novo to amend the trial protocol to 19 months instead of the planned 24 months. At the time, the firm cautioned that the indication may be limited to type 2 diabetes only (1 (Also see "Novo Nordisk/Aradigm Inhaled Insulin Study For Type 1 Diabetes Raises Efficacy Concern" - Pink Sheet, 30 Apr, 2004.)). "Clinical data to date, including the results from an interim analysis of Phase III data, show the AERx iDMS system to be comparable to injectable insulin in the overall management of type 1 and type 2 diabetes," Aradigm said in a same-day release. Under a recently restructured license agreement, Novo is responsible for funding and executing future development and commercialization, as well as function as a contract manufacturer for Aradigm's non-iDMS AERx development programs. "Upon commercialization of the AERx iDMS, Aradigm will receive a royalty on sales," Aradigm stated. The Phase III trial will enroll approximately 2,200 type 1 and type 2 diabetes patients worldwide, focusing recruitment primarily in Europe and the U.S. According to Aradigm, the clinical program will include various treatment comparisons, including long-term pulmonary safety studies and combination treatment with other anti-diabetics. The studies will take three years to complete, the firm said. Novo and Aradigm can stand to potentially benefit from establishing efficacy in both type 1 and type 2 diabetes. Pfizer's Exubera is the only FDA-approved inhaled insulin product (2 (Also see "Pfizer Breathes Easy: FDA Approves Exubera" - Pink Sheet, 27 Jan, 2006.)). The company has said it will launch the product in June for the treatment of type 1 and type 2 diabetes. Lilly/Alkermes' AIR inhaled insulin system is expected to the next to market. The companies have initiated Phase III studies in 400 type 2 diabetes patients to test the efficacy of their inhaled insulin system versus injected insulin (3 (Also see "Lilly Begins Efficacy Study For Inhaled Insulin" - Pink Sheet, 26 Apr, 2006.)). Mannkind is slated to file an inhaled insulin product in the second half of 2008. Kos' excipient-free formulation of crystalline recombinant inhaled insulin is likely two years behind Mannkind's product. Like Pfizer's Exubera, Mannkind and Lilly/Alkermes' products utilize a powdered form of insulin. All three companies noted an increase in cough in Phase II studies. Novo's liquid rapid-acting insulin formulation distinguishes it from others in the class. According to researchers, its liquid formulation allows the AERx inhaler the precision and flexibility to dose by units. Pfizer's Exubera has been critiqued for its complicated dosing scheme. Exubera's labeling provides a chart to assist patients in converting from units of insulin into 1 mg and 3 mg blister packs. Pfizer is undertaking an extensive education campaign for patients and physicians on Exubera's dosing and inhaler use as part of the product's launch. Although precise, the AERx has been criticized as cumbersome to use. -Turna Ray |