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 Recent news - Diabetes
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        New Data Show Exubera Patients With Type 1 Diabetes Reach Recommended Blood Glucose Levels Equal to Insulin Injections

        Study Shows ExuberaŽ Significantly Enhances Treatment Satisfaction, Quality of Life, and Acceptance of Insulin Therapy

        CHICAGO, IL -- May 2, 2002 -- ExuberaŽ (inhaled insulin) may provide a promising treatment option for patients with Type 1 diabetes, according to data presented today at the annual meeting of the American Association of Clinical Endocrinologists.

        The six-month, Phase III study involved 335 patients with Type 1 diabetes between the ages of 12 and 65. The study was designed to evaluate whether an insulin regimen that included ExuberaŽ, an inhalable, rapid-acting dry powder insulin, taken before meals, plus a single injection of long-acting insulin at bedtime, could provide glycemic control similar to two to three insulin injections per day.]

        In the study, the glycated hemoglobin (HbA1c), which reflects average blood glucose levels over an eight to 12 week period, decreased similarly for patients taking Exubera and one injection compared to patients who received two to three insulin injections per day. The percentage of patients achieving an HbA1c of less than seven percent or eight percent -- a recommended treatment goal for patients with diabetes -- was also similar in both groups.

        In addition, patients using ExuberaŽ showed 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 insulin injections. Patients in both the ExuberaŽ and multiple injection groups worked with their physicians during the study to adjust their insulin dose to optimize blood glucose control.

        Overall, patients in the study preferred using ExuberaŽ and experienced fewer hypoglycemic events (or abnormally low levels of blood sugar) compared to patients taking only insulin injections. Additionally, patients taking ExuberaŽ reported significant improvements in overall treatment satisfaction and quality of life and showed more favorable improvements in symptoms such as depression, well-being and cognitive function, according to a Diabetes Quality of Life and Treatment Satisfaction Questionnaire. Patients taking Exubera also experienced less weight gain.

        "The results of this study suggest that inhaled insulin in combination with one injection of long-acting insulin can be a new, effective and non-invasive form of insulin therapy in patients with type 1 diabetes," said Dr. Teresa Quattrin, lead study investigator and associate professor at the Children's Hospital of Buffalo.

        The frequency and nature of adverse events reported in the study were comparable in both groups. Mild to moderate cough was seen more frequently in patients taking ExuberaŽ, 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 ExuberaŽ treatment group. Pfizer and Aventis are conducting additional studies to further explore whether there is any potential clinical significance to this observation.

        Nearly half of the 16 million Americans with diabetes have blood sugar levels that are not controlled [NHANES III]. 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 attack or stroke [Juvenile Diabetes Research Foundation]. ExuberaŽ 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 collaboration with Inhale Therapeutic Systems, developers of the inhalation device and formulation process.

        Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best known consumer products.

        Aventis Pharmaceuticals conducts the U.S. business of Aventis. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.

        Aventis is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of euro 17.7 billion ($15.9 billion), invested approx. euro 3 billion ($2.7 billion) in research and development and employed approx. 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: <http://www.aventis.com> .

        To receive a copy of this release or any recent release, visit the Aventis Pharmaceuticals U.S. Web site at <http://www.aventispharma-us.com> or call 800/207-8049. Contact Pfizer Medical Information at 800-438-1985 or visit <http://www.pfizer.com>.

        Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.

        SOURCE: Aventis Pharmaceuticals; Pfizer Inc



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