14th Oct 2005 06:00
Exubera(R) Receives Positive Opinion from CHMP for the Treatment of Type 1 and Type 2 Diabetes NEW YORK, Oct. 14 -- Pfizer Inc. said today that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of Exubera(R) (insulin human), an inhalable form of insulin, for the treatment of type 1 and type 2 diabetes. The proposed therapeutic indication for Exubera is for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy; and for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns. Exubera, the product of a joint-development program between sanofi-aventis and Pfizer, is an inhaled rapid-acting insulin preparation that is inhaled into the lungs prior to each meal, using a proprietary inhalation device and powdered insulin formulation developed by Nektar Therapeutics. Exubera closely mimics the normal physiological insulin response to meals by quickly being absorbed into the bloodstream to reduce meal-related spikes in glucose levels in people with diabetes. In Europe, approximately 22.5 million people suffer from diabetes. Type 2 diabetes accounts for 85 percent to 95 percent of all diagnosed cases. Although insulin is a very important treatment for diabetes, healthcare providers and patients are often reluctant to initiate or intensify insulin treatment. The reasons for this include concerns about lifestyle changes, compliance, disease progression and injection-related factors. Complications commonly associated with uncontrolled or poorly controlled diabetes include cardiovascular disease, kidney failure and blindness. A large study in eight major European countries has shown that the total direct medical costs for type 2 diabetes are estimated to be euro 29 billion each year, of which hospitalizations account for euro 15.9 billion. Pending approval of the European Commission, Exubera would represent a major advance in insulin delivery and would be the first non-injectable insulin available in Europe since the discovery of insulin in the 1920s. 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 October 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. 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. SOURCE Pfizer, Inc 10/14/2005 /CONTACT: Vanessa Aristide, +1-212-733-3784 for Pfizer, Inc/ /Company News On-Call: http://www.prnewswire.com/comp/688250.html/ /Company News On-Call: Pfizer's press releases are available through PR Newswire's Company News On-Call service on PRN's Web Site. Visit http://www.prnewswire.com/comp/688250.html/ /Photo: A free corporate logo to accompany this story is available immediately via Wieck Photo Database to any media with telephoto receiver or electronic darkroom, PC or Macintosh, that can accept overhead transmissions. To retrieve a logo, please call 972-392-0888./ /Web site: http://www.pfizer.com / ENDPFIZER INCRelated Shares:
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