Inhale Reports on Phase III Exubera Inhaled Insulin Data that Show Comparable Glycemic Control to Insulin Injections and Better Glycemic Control than Oral Therapy
SAN CARLOS, Calif.--(BUSINESS WIRE)--June 17, 2002--Inhale Therapeutic Systems, Inc. (Nasdaq:INHL - News) reported today on new data released from Phase III studies conducted by Pfizer Inc. and Aventis Pharma with the Exubera® inhaled insulin product using Inhale's advanced inhaleable technology. The data show that patients with type 2 diabetes, who had failed to meet recommended blood glucose levels with combination oral therapy, achieved better glycemic control with Exubera® inhaled insulin than patients who received only oral agents. In addition, the study results show that Exubera® inhaled insulin provides glycemic control equal to insulin injections in patients with type 1 diabetes.
The data were presented at the 62nd annual scientific sessions of the American Diabetes Association, June 14-18, in San Francisco. This brings the total number of patients reported on in Phase III studies to almost 2,000.
Study of Patients with Type 2 Diabetes
This three-month, Phase III study involved 309 patients who had been diagnosed with type 2 diabetes. There are approximately 17 million people in the United States with diabetes with 90-95% of all cases accounting for type 2 diabetes. Type 2 diabetes is typically associated with older age, obesity, family history and race/ethnicity and is increasingly being diagnosed in children and adolescents. The study examined whether Exubera®, an inhaleable rapid-acting dry powder insulin, could provide better glycemic control when taken alone or in combination with oral agents, compared with patients taking only oral agents. Exubera® was administered before meals.
Patients in the study taking either Exubera® alone or Exubera® plus oral agents experienced a significant decrease in the hemoglobin (HbA1c). Patients taking oral agents alone experienced no change in HbA1c levels over the three-month period. The HbA1c levels reflect average blood glucose readings over a period of several months; a level below seven percent is the American Diabetes Association's recommended treatment goal for patients with diabetes.
"Currently many patients with type 2 diabetes fail to reach target glucose levels on oral agents, which will eventually lead to the need for insulin therapy," said Dr. Julio Rosenstock, Dallas Diabetes and Endocrine Center and Clinical Professor of Medicine at the University of Texas, Southwestern Medical Center. "This study shows that Exubera® has the potential to help patients with type 2 diabetes by providing an effective and highly acceptable treatment option."
Patients taking Exubera® showed also significantly greater decreases in both fasting plasma glucose concentrations (a measurement taken before breakfast) and two-hour post-prandial glucose levels (a measurement taken after a meal) compared to patients who took only oral agents. In addition, target HbA1c levels of less than 8% and less than 7% (recommended ADA action and goal levels, respectively) were achieved by significantly more Exubera® patients.
Patients preferred using Exubera® and reported significant improvements in overall treatment satisfaction. Patients also showed more favorable improvements in symptoms and cognitive function, according to a Diabetes Quality of Life and Treatment Satisfaction questionnaire.
The majority of adverse events in the study were mild to moderate in all treatment groups. Hypoglycemia rates (abnormally low levels of blood sugar) and weight gain, both common side effects of insulin therapy, were higher in those patients treated with Exubera®. There was an increased incidence of antibody serum binding in patients who used Exubera®, but there did not appear to be any related clinical significance. Pulmonary function remained stable in patients using Exubera® and pulmonary function tests showed no significant differences between groups.
Study of Patients with Type 1 Diabetes
In this six-month Phase III study, 328 patients with type 1 diabetes received either Exubera®, an inhaleable rapid-acting dry powder insulin taken before meals, plus two daily insulin injections, or a regimen of four insulin injections per day.
The patients who received Exubera® experienced a decrease in the glycated hemoglobin (HbA1c) that was similar to patients taking only insulin injections. The HbA1c levels reflect average blood glucose readings over a period of several months; a level below seven percent is the American Diabetes Association's recommended treatment goal for patients with diabetes.
In addition, patients who received Exubera® experienced significant reductions in both fasting plasma (blood glucose measurement before breakfast) and two-hour post prandial glucose levels (blood glucose measurement taken after meals) compared to patients who received only insulin injections.
"Research has shown that patients with type 1 diabetes who maintain tight blood sugar control will experience major, long-term benefits. However, millions of patients are still not achieving good control," said Dr. Jay Skyler, Professor and Director of the Division of Endocrinology, Diabetes and Metabolism at the University of Miami. "These results show that in patients with type 1 diabetes, Exubera® can offer comparable glucose control to meal-related insulin injections."
Patients preferred using Exubera® and reported significant improvements in overall treatment satisfaction. Patients also showed more favorable improvements in symptoms and cognitive function, according to a Diabetes Quality of Life and Treatment Satisfaction questionnaire.
The frequency and nature of adverse events reported in the study were comparable in both treatment groups. Mild to moderate cough was seen more frequently in patients taking Exubera®, but decreased in incidence and prevalence over the course of the study. Small relative decreases in one of the pulmonary function tests were seen in the Exubera® treatment group. Pfizer and Aventis are conducting additional studies to further explore whether there is any potential clinical significance to this observation. There was an increased incidence of antibody serum binding in patients who used Exubera®, but there did not appear to be any related clinical significance.
When left uncontrolled, diabetes can lead to kidney failure, blindness, amputations and premature death. In addition, people with diabetes are two to four times more likely to have a heart attach or stroke. Research studies in the United States and abroad have found that improved glycemic control benefits people with either type 1 or type 2 diabetes by reducing, and even preventing, diabetes related complications. (2002 CDC National Diabetes Fact Sheet)
Exubera® is being developed for patients with type 1 and type 2 diabetes through a collaboration between Pfizer Inc. and Aventis Pharma. 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 a collaboration with Inhale, developers of the inhalation device and formulation process.
Inhale Therapeutic Systems, Inc. provides a portfolio of breakthrough drug delivery technologies to enable improved performance of drug products. Inhale offers three leading drug delivery platforms: PEGylation for enhanced delivery performance of most major drug classes, including macromolecules and small molecules; a suite of technologies for the inhaleable delivery of macromolecules and small molecules for systemic and local lung delivery; and particle engineering with supercritical fluid technology to easily control particle shape and size for a variety of drug delivery applications. The Company is collaborating with major pharmaceutical and biotechnology companies, including Amgen, AstraZeneca, Aventis Behring, Bristol-Myers Squibb, Chiron, Enzon, GlaxoSmithKline, Johnson & Johnson, Lilly, Pfizer, Pharmacia, Roche, Schering-Plough and Serono. Additional information about Inhale is available on the Company's WEB site at www.inhale.com.
This release contains forward-looking statements that reflect the current views of Inhale management as to future products, product development, and other future events and operations. These forward-looking statements involve uncertainties and other risks that are detailed in reports and other filings with the Securities and Exchange Commission, including the Form 10-K for 2001. These documents identify important factors that could cause the Company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review, manufacturing capabilities and marketing effectiveness.
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Contact:
Inhale Therapeutic Systems, Inc.
Joyce Strand, 650/631-3138 |
