Nektar Therapeutics (NKTR)

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Nektar Therapeutics Reports Exubera(R) Receives Positive Opinion from CHMP for the Treatment of Type 1 and Type 2 Diabetes
<PR, 10/13/05>

SAN CARLOS, Calif.--(BUSINESS WIRE)--Oct. 13, 2005--Nektar Therapeutics (Nasdaq:NKTR - News) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of Exubera® (insulin human), an inhaleable 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) EUR 29 billion each year, of which hospitalizations account for (euro) EUR 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 Nektar Advanced Pulmonary Delivery Technology

Nektar Advanced Pulmonary Technology uses a portfolio of innovative 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.

Recently Nektar announced that it is developing two inhaleable products that use its Advanced Pulmonary Delivery Technology, including: an inhaled amphotericin B product for preventing fatal pulmonary fungal infections in immunosuppressed patients to reduce the incidence, morbidity, mortality and high cost of treating these infections; and inhaled ICU antibiotics for the prevention of ventilator-associated pneumonia (VAP) in the intensive care unit (ICU). Both are in clinical trials.

In addition, Nektar is partnered with Chiron to develop Tobramycin inhalation powder (TIP), a next-generation inhaled antibiotic in Phase III trials to treat lung infection in cystic fibrosis patients.

About Nektar

Nektar Therapeutics enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.

The information contained in this release is as of 13 October 2005. Nektar 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.

This release contains forward-looking statements that reflect management's current views as to Nektar's business strategy, product and technology development plans and funding collaborative arrangements, clinical trials, developments in connection with the regulatory approval process for Exubera. These forward-looking statements involve uncertainties and other risks that are detailed in Nektar's reports and other filings with the SEC, including its Annual Report on Form 10-K, as amended, for the year ended December 2004 and its Quarterly Report on 10-Q for the quarter ended June 30, 2005. Actual results could differ materially from these forward-looking statements.

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