Data Presented At European Association For The Study Of Diabetes 41st Annual Meeting Support EXUBERA Efficacy And Safety Profile In Patients with Type 1 Diabetes 1
PARIS, September 16 – Findings from a 24 week study presented at the 41st Annual Meeting of the European Association for the Study of Diabetes (EASD) show that EXUBERA® (human insulin powder) is well tolerated and as effective as subcutaneous (injectable), rapid acting insulin, in achieving improved glycemic control in patients with type 1 diabetes.
1 Dr Paul Norwood, lead study investigator and Associate Clinical Professor of Medicine at the University of California, San Francisco, and researchers investigated the efficacy and safety profile of EXUBERA compared to subcutaneous (injectable) insulin in 226 patients with type 1 diabetes aged between 25 to 65 years, over 12 weeks. A follow-up phase was then conducted with subcutaneous (injectable) insulin for another 12 weeks. In this study, EXUBERA was found to be as effective as subcutaneous (injectable) insulin and was well tolerated.1 “This study reinforces EXUBERA's efficacy and safety profile in people with type 1 diabetes," said Dr Paul Norwood, "EXUBERA is a promising new treatment option which may enable clinicians to overcome barriers relating to acceptance of insulin therapy and ultimately better manage glycemic control". Patients with baseline glycemic (A1C) control of 7.5 percent demonstrated improved control with EXUBERA or subcutaneous (injectable) insulin. At week 12, patients treated with EXUBERA further lowered their glucose level to 7.1 percent, showing that EXUBERA was able to improve tight glycemic control.1 Pulmonary safety was analysed with a comprehensive range of pulmonary function tests using highly standardized methodology. Consistent with previous studies, the observed treatment 1 group differences in pulmonary function were small, occurred within the first two weeks of treatment, were nonprogressive, and resolved within two weeks of treatment discontinuation. The most common adverse events reported in the trial were hypoglycemia and cough. Hypoglycemia occurred in nine patients receiving EXUBERA, compared to 17 patients receiving subcutaneous (injectable) insulin. Cough was reported in some patients but was generally mild, not productive, and occurred mainly within minutes of dosing.1 The cost of diabetes A further study presented by Dr Richard Bergenstal, Executive Director of the International Park Nicollet Diabetes Center, Minneapolis, US, at EASD has provided new insights into the extent of the cost of diabetes in the United States (US). The study found that in patients without known complications, hospitalizations are associated with the highest costs ($56,517$78,246 per patient per year). In patients with known complications, end-stage renal disease and macrovascular disease are associated with the highest costs ($46,585$31,970 to $135,275$121,105 per patient per year).2 Complications associated with diabetes, including heart disease, retinopathy (blindness), nephropathy (kidney damage) and neuropathy (nerve damage), are estimated to account for 2.5 percent to 15 percent of a nation’s health budget.3 Dr Bergenstal's study concludes that more aggressive adoption of strict treatment goals and effective treatment to target clinical decision making strategies must be implemented in order to help reduce the billions of dollars currently spent on diabetes worldwide. About EXUBERA The product of a joint development program between sanofi-aventis and Pfizer, EXUBERA is an inhaled rapid-acting insulin preparation that is inhaled into the lungs prior to eating, using a proprietary inhalation device developed by Nektar Therapeutics. EXUBERA has been submitted for approval in Europe and the United States for the treatment of both type 1 and type 2 diabetes in adults. On September 8 2005, a U.S. Food and Drug Administration advisory committee 2 recommended the approval of EXUBERA for the treatment of adults with type 1 and type 2 diabetes. The FDA is not obligated to follow the recommendations of the panel. Pfizer and sanofi-aventis are committed to continuing to work with the FDA to make EXUBERA available for patients in need. Regulatory proceedings with the European Medicines Evaluation Agency (EMEA) are ongoing. Pending approval, EXUBERA would represent the first non-injectable insulin treatment available in Europe and the US. About diabetes An estimated 194 million people worldwide suffer from diabetes4 and complications arising from diabetes cause 9 percent of all deaths worldwide.3 Diabetes is associated with a number of serious complications including heart disease, blindness (retinopathy), kidney failure (nephropathy) and nerve damage (neuropathy). The estimated direct healthcare costs of diabetes may be as much as $286 billion worldwide.4 Research suggests that only 7 percent of these costs relate to diabetes medications: most costs are associated with hospitalization and appointments with healthcare professionals.5 Type 2 diabetes accounts for more than 90 percent of diabetes cases globally.5 An estimated 50 percent of people with type 2 diabetes are inadequately controlled, and lack of control is associated with significant morbidity and mortality. Insulin is currently the only way of maintaining an appropriate level of glycemic control in the long term,6 yet is refused by many people with type 2 diabetes,7 increasing the risk of, and costs of treating, complications caused by diabetes.8 About Pfizer Pfizer discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best known consumer products. PFIZER DISCLOSURE NOTICE: The information contained in this release is as of 13 September 2005. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a product candidate which is under review by the United States Food and Drug Administration and the European Medicines Evaluation Agency that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, whether and when such regulatory authorities will approve the product candidate, their decisions regarding labeling and other matters that could affect its commercial potential as well as competitive developments. 3 4 A further list and description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2004 and in its reports on Form 10-Q and Form 8-K. About sanofi-aventis The sanofi-aventis Group is the world's third largest pharmaceutical company, ranking number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines. sanofi-aventis is listed in Paris and in New York. The sanofi-aventis Group conducts business in the United States through its affiliates Sanofi-Synthelabo Inc. and Aventis Pharmaceuticals Inc. Forward Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. 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The sanofi-aventis Group conducts its business in the United States through its subsidiaries Sanofi-Synthélabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc. # # # # # References 1. Norwood P, Dumas R, England RD et al. Inhaled Insulin (Exubera®) achieves tight glycemic control and is well tolerated in patients with Type 1 diabetes. Presented at the European Association for the Study of Diabetes (EASD), September 13 2005-08-05 (OP 13) 2. Bergenstal RM, Gerber RA, Bolinder B et al. Direct cost of treatment for patients with Type 1 or 2 diabetes with or without complications in the USA. Presented at the European Association for the Study of Diabetes (EASD), September 13 2005-08-05 (PS 81) 3. World Health Organization The Cost of Diabetes Fact sheet N°236 Revised September 2002 4. International Diabetes Federation. Diabetes Atlas 2nd edition. 2003 5 5. Jonsson et al. Revealing the Cost of Type 2 Diabetes in Europe. Diabetologia 2002;45:S5–S12 6. Home PD, Boulton, AJM, Jimenez J, et al on behalf of the Worldwide Initiative for Diabetes Education, Issues relating to the early or earlier use of insulin in type 2 diabetes. Pract Diab Int 2003;20:63-71 7. NOP Healthcare Omnibus Study 2003, survey of 800 GPs, 740 Specialists in Europe, North America & Japan 8. UK Prospective Diabetes Study Group, Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998; 352: 854-865 Contacts: Pfizer Inc Vanessa Aristide + 1 (212) 733-3784 sanofi-aventis Sarah Sheppard +33 (0) 153 77 4455