BiotechTracker - Long-Term Data Still Lacking for Inhaled Insulin Formulations
June 16, 2003, Exubera – Pfizer (NYSE: PFE), Aventis (NYSE: AVE), and Nektar’s (NASDAQ: NKTR) inhaled insulin formulation – continues to generate short-term efficacy data suggesting its approvability. However, these data continue lack the strength to resolve concerns of longer-term adversity. Exubera presentations at the American Diabetes Association (ADA) meeting again focus on reassuring short-term safety and adverse effect profiles. ADA presentations for other inhaled insulin formulations (from Novo Nordisk [NYSE: NVO] and Aradigm [NASDAQ: ARDM], in phase III trials, and from Eli Lilly [NYSE: LLY] and Alkermes [NASDAQ: ALKS], in phase II trials) also fail to address these longstanding concerns.  An Exubera NDA was originally expected in 2002, but was delayed due to concerns of recipients’ experiencing diminished lung function. Pfizer, Aventis, and Nektar have not offered guidance regarding a new filing timetable. The generalizability of experimental benefit/risk ratios to real-world clinical practice remains suboptimal.  Data presented at ADA indicate that Exubera’s proper use provides glycemic control to significantly more phase III clinical trial study subjects than GlaxoSmithKline’s (NYSE: GSK) Avandia (rosiglitazone) in type II diabetics who disease is poorly-controlled on diet and exercise. A three-month, phase III, clinical trial assessed Exubera versus Avandia, both supplementing appropriate diet and exercise, in 145 type II diabetics patients. Clinically significant Exubera advantages included:  a greater percentage of patients (82.7% to 58.2%) achieving HbA1c levels of 8.0% (clinically relevant)  a greater percentage of patients (44.0% to 17.9%) achieving HbA1c levels of 7.0% (optimal, per ADA guidelines)  a greater absolute HbA1c decrease (-2.3% to -1.4%).  Exubera’s short-term adverse effect and tolerability profiles remained reassuring. Pulmonary function data were not available beyond the three-month time horizon.
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