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Pharma & Bio Ingredients
Nektar developed the inhalers and the powdered insulin formulation for Exubera in partnership with Pfizer. Pfizer is responsible for marketing, manufacturing and the clinical development of Exubera. Nektar provides support in the manufacturing process for Exubera insulin, and manufactures the inhalation devices. Under the agreement between Nektar and Pfizer, Nektar will receive royalties on all marketed products as well as revenue for the manufacture of the powders and the inhalation devices.
In the European Union, Exubera has been approved for the treatment of adults with type 2 diabetes (greater than 18 years of age) not adequately controlled with oral antidiabetic agents and requiring insulin therapy. Exubera is also indicated for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting injectable insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.
Exubera is pending approval in the U.S. In September 2005, the U.S. Food and Drug Administration (FDA) Advisory Committee recommended that Exubera should be approved for the treatment of adults with type 1 and type 2 diabetes.
"Today's EU approval of Exubera is an important landmark in the treatment of diabetes, a disease that is growing at epidemic proportions," said Dr. John Patton, co-founder and chief scientific officer, Nektar. "Approval of Exubera in the EU is the next step toward the realization of the dream we had when we founded Nektar and is a testament to all of our employees whose innovation and dedication resulted in this breakthrough product."
According to the World Health Organization (WHO), diabetes has reached epidemic proportions and affects approximately 48 million people in Europe alone. People with diabetes often suffer from debilitating complications due to uncontrolled blood sugar levels including heart disease, amputation, blindness and kidney failure. The direct healthcare costs associated with diabetes are estimated to be approximately $286 billion, with the majority of these costs linked to treating diabetes-related complications.
