Pfizer Inc and Aventis are planning to complete additional long-term studies for the Exubera (inhaled insulin) development program. These trials are well under way and involve patients with Type 1 and Type 2 diabetes. The companies also are continuing their discussions with regulatory agencies regarding the timing of the submissions.
As previously reported, small non-progressive differences in pulmonary function tests (PFTs) without clinical manifestation were seen between a limited group of Exubera and control patients. "Because of the potential widespread use of Exubera among diabetes patients, additional rigorous testing and assessment of all pulmonary function measures are appropriate to deepen the medical understanding of diabetes and Exubera's role in the future management of diabetes," said Dr. Peter B. Corr, senior vice president, Science and Technology, Pfizer Inc.
"Pfizer and Aventis will further characterize Exubera's long-term pulmonary safety profile using clinical standards unprecedented in the area of diabetes," he said. "This will significantly augment the information available on background pulmonary function trends in patients with diabetes. Based on interim data from one-year controlled safety studies, we are confident that Exubera will be an important medication to treat this devastating disease."
Over 2,000 patients in clinical trials worldwide have taken Exubera, some for as long as five years. Data presented to date suggest that Exubera is as efficacious as injected insulin and superior to oral agents in lowering blood glucose in patients with diabetes.
Diabetes is fast reaching epidemic proportions, affecting roughly 17 million people in the United States alone. When left uncontrolled, diabetes can lead to kidney failure, blindness, amputations and premature death. Studies have found that improved blood glucose control benefits people with either Type 1 or Type 2 diabetes by reducing, and even preventing, diabetes-related complications.
Exubera is being developed for patients with Type 1 or Type 2 diabetes through a collaboration between Pfizer and Aventis. The two companies have entered into a global agreement to co-develop, co-promote (where permitted by local law) and co-manufacture inhaled insulin. Pfizer is also in collaboration with Inhale Therapeutic Systems, developers of the inhalation device and formulation process.
Separately, Pfizer and Aventis have reached an agreement to allow Aventis to use the companies' joint insulin manufacturing facility in Frankfurt, Germany, for a limited period of time. Further terms of the agreement were not disclosed. The facility, the largest insulin manufacturing plant in the world, was completed this year.