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Nektar Reports That Pfizer and The Sanofi-Aventis Group Seek Approval to Market Exubera in the United States

Posted on: Wednesday, 2 March 2005, 09:00 CST

Nektar Therapeutics (Nasdaq:NKTR) today reported that Pfizer Inc and The Sanofi-Aventis Group announced that the United States Food and Drug Administration (FDA) has accepted for filing a new drug application for Exubera(R) (inhaled human insulin powder). Nektar develops and provides the inhalers and the powdered insulin for the Exubera product.

"Today marks an important milestone for Exubera and for Nektar. We believe that with the filing of Exubera with the FDA, we are a step closer to offering a breakthrough for treating patients with diabetes," said Dr. John Patton, co-founder and chief scientific officer, Nektar.

Exubera, a dry powder form of insulin that is inhaled into the lungs prior to eating using a specially designed inhalation device, has been studied in more than 3,500 patients, some for more than seven years.

Pfizer and Sanofi-Aventis seek approval to market Exubera for adult patients with type 1 and type 2 diabetes. Exubera is currently also under review by the European Medicines Evaluation Agency.

It is estimated that nearly 180 million people worldwide suffer from diabetes, and the number is expected to rise to 300 million people in the next 20 years. More than half of people with diabetes remain uncontrolled or poorly controlled and are at risk for common complications such as heart disease, stroke, kidney failure, nerve damage and blindness. Currently, diabetes and its complications account for more than $100 billion in healthcare costs annually in the United States.

Exubera is being developed for patients with type 1 and type 2 diabetes through a collaboration between Pfizer and Sanofi-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. Nektar is in collaboration with Pfizer as the developer of the inhalation device and formulation.

About Nektar Advanced Pulmonary Delivery

Nektar Advanced Pulmonary Technology uses innovative molecular formulations and novel delivery devices to improve or enable administration of medicines to and through the lungs for both lung diseases and systemic conditions. Exubera is the most advanced product using Nektar Pulmonary Technology.

About Nektar

Nektar Therapeutics enables the development of differentiated pharmaceutical products using its advanced proprietary drug delivery technologies and services. Nektar's technological, clinical and market analysis expertise allow it to identify, develop and offer to partners new product opportunities, solve their development challenges, and realize the full potential of their therapeutics from new molecular entities to life-cycle management. Additional information is available at http://www.nektar.com.

This release contains forward-looking statements that reflect the current views of Nektar's management as to future products, product and technology development, collaboration arrangements, clinical trials 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 Nektar's Annual Report on Form 10-K, as amended, for the fiscal year ended December 31, 2003 and its Quarterly Report on 10-Q for the quarter ended September 30, 2004. 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.

Source: Business Wire

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