Nektar Reports That New Long-Term Safety and Efficacy Data on EXUBERA --Human Insulin Powder-- Presented at American Diabetes Association Scientific Sessions.

Business Editors/Health/Medical Writers

ORLANDO, Fla.--(BUSINESS WIRE)--June 7, 2004

Nektar Therapeutics (Nasdaq:NKTR) reported today that Pfizer and Aventis announced results of long-term studies showing sustained glycemic control and pulmonary function in patients with type 2 diabetes taking EXUBERA(R), an inhalable, rapid-acting dry powder insulin.(1,2) Nektar developed the inhalers and the powdered insulin formulation for the EXUBERA(R) product. These new data were presented this weekend at the 64th Annual Scientific Sessions of the American Diabetes Association.

A pooled analysis of two one-year open-label studies involving 627 patients with type 2 diabetes showed that patients who added EXUBERA(R) to their treatment regimen experienced no clinically important effect on pulmonary function compared with patients treated with oral agents alone.(1) Glycemic control was maintained in both arms.(1) An additional analysis of 209 patients, 159 of whom were treated with EXUBERA(R) for up to four years, further supported these findings in type 1 and type 2 patients treated with EXUBERA(R).(2)

Nektar pulmonary technologies integrate customized formulation and proprietary fine-powder processing and packaging technologies with a proprietary inhalation device for efficient, reproducible, and convenient deep-lung drug delivery. Beyond EXUBERA(R), Nektar envisions applying its Pulmonary Technology to address additional unmet therapeutic needs, including targeted treatment of lung disorders, a non-invasive alternative to injection for macromolecules such as peptides and proteins, and applications where faster onset of action is desired. Providing a non-invasive alternative to injection and rapid action for otherwise slow-acting oral therapies, the pulmonary delivery route offers opportunities for improved and innovative drug delivery and greater patient compliance.

"The results of these studies suggest that EXUBERA(R) may be effective and well-tolerated in this patient group," said Anthony Barnett, M.D., lead study investigator and Professor of Medicine, University of Birmingham, United Kingdom. "In addition, the results suggest that changes in pulmonary function are small, similar between treatment groups and non-progressive."

In addition, subanalyses of these studies focused on treatment satisfaction of patients failing oral agents. Among uncontrolled patients with a Hemoglobin A1c (HbA1c) of more than 9.5 percent, those who received EXUBERA(R) showed improved glycemic control from baseline and higher overall patient satisfaction compared with those patients receiving additional oral agents.(3,4) HbA1c level reflects blood glucose readings over a period of a few months.

"In these studies, patients were able to successfully incorporate EXUBERA(R) into their daily treatment regimen," said Marcia A. Testa, M.P.H., Ph.D., Senior Lecturer, Harvard School of Public Health and lead investigator for the studies. "The profile of EXUBERA(R), coupled with our new data showing patients' preference of inhaled insulin over oral agents, suggest that EXUBERA(R) may be a promising treatment option for patients with diabetes."

Insulin is the standard of care for people with type 1 diabetes. More than 30 percent of those with type 2 diabetes will eventually need insulin.(5) Treatment with insulin typically includes multiple daily injections which can affect compliance.(6) When available, inhaled insulin may assist patients to achieve glycemic control without additional injections.(7)

EXUBERA(R) is being developed for use in patients with type 1 and type 2 diabetes through a collaboration between Pfizer Inc and 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. Pfizer is also in collaboration with Nektar Therapeutics, developers of the inhalation device and formulation process. EXUBERA(R) was submitted to the European Medicine Evaluation Agency (EMEA) in early 2004.

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

Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of EUR 16.79 billion, invested EUR 2.86 billion in research and development and employed approximately 69,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.

Nektar Therapeutics, San Carlos, Calif., provides industry-leading drug delivery technologies, expertise and manufacturing to enable the development of high-value, differentiated therapeutics. Nektar's advanced drug delivery capabilities are designed to enable the company's biotechnology and pharmaceutical partners to solve drug development challenges and realize the full potential of their therapeutics, from developing new molecular entities to managing the life cycles of established products. For more information, please visit: www.nektar.com.

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, and other future events and operations. 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 fiscal year ended December 31, 2003. Actual results could differ materially from these forward-looking statements.

References

1. Barnett AH, et al. "Efficacy and One-year Pulmonary Safety of Inhaled Insulin (EXUBERA(R)) as Adjunctive Therapy with Metformin or Glibenclamide in Type 2 Diabetes Patients Poorly Controlled on Oral Agent Monotherapy." Poster presented at 64th Annual Scientific Sessions, American Diabetes Association, Orlando, FL, June 2004.

2. Skyler J, et al. "Sustained Long-term Efficacy and Safety of Inhaled Insulin During Four Years of Continuous Therapy." Poster presented at 64th Annual Scientific Sessions, American Diabetes Association, Orlando, FL, June 2004.

3. Testa MA, et al. "Quality of Life (QOL) Improvements in Type 2 Diabetes When EXUBERA(R) Is Added After Failure on Metformin Monotherapy: An International Phase 3 Trial." Poster presented at 64th Annual Scientific Sessions, American Diabetes Association, Orlando, FL, June 2004.

4. Testa MA, et al. "Satisfaction and Quality of Life with Sulfonylurea Plus Either Metformin or EXUBERA(R): An International Randomized Phase 3 Trial." Poster presented at 64th Annual Scientific Sessions, American Diabetes Association, Orlando, FL, June 2004.

5. Dunning, T, et al. "Insulin Delivery Devices." Australian Prescriber, 2002;25:136-138.

6. Owens DR, et al. "Alternative Routes of Insulin Delivery." Diabetic Medicine, 2003;20:886-898.

7. Johnson, FR, et al. "Trading Health for Convenience: Diabetes Patients' Stated Preference for Insulin Therapies." Poster presented at 64th Annual Scientific Sessions, American Diabetes Association, Orlando, FL, June 2004.

Note: In "Hemoglobin A1c," "1c" should be subscript.