Pfizer's Exubera inhalable insulin for diabetes approved by European Commission

By Lisa Kerner

Erie, Pa., Jan. 26 - Pfizer Inc said the European Commission has approved Exubera (inhaled human insulin) for the treatment of adults with type 1 and type 2 diabetes.

Exubera is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s and represents a major advance in diabetes treatment, according to a company news release.

Exubera is a fast-acting, dry powder formulation of human insulin that is inhaled by mouth into the lungs before meals using a simple-to-use, hand-held device, officials said. The four-ounce device does not require batteries or electricity and is about the size of an eye glasses carrying case.

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, Pfizer said. Exubera is also indicated for the treatment of adult patients with type 1 diabetes mellitus for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.

Exubera is pending approval in the United States. In September 2005, the Food and Drug Administration Advisory Committee recommended that Exubera should be approved for the treatment of adults with type 1 and type 2 diabetes.

Pfizer said the efficacy and safety profile of Exubera was studied in more than 2,500 adults with type 1 and type 2 diabetes for an average duration of 20 months. Exubera was shown to be as effective as injectable insulin in achieving glycemic control.

"Exubera is a major, first-of-its-kind, medical breakthrough that marks another critical step forward in the treatment of diabetes, a disease that has taken an enormous human and economic toll worldwide," Hank McKinnell, Pfizer chairman and chief executive officer, said in the release. "Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease."

Exubera is the result of a collaboration between Pfizer and Nektar Therapeutics, developer of the inhalers and the powdered insulin formulation.

Pfizer recently reached an agreement to acquire the sanofi-aventis worldwide rights to Exubera from Nektar. Under terms of the agreement, Pfizer is responsible for the marketing, manufacturing and clinical development of Exubera.

Nektar will provide support in the manufacturing process for Exubera insulin and will manufacture the inhalation devices. The company will receive royalties on all marketed products as well as revenue for the manufacture of the powders and the inhalation devices, officials said.

Pfizer said it has invested more than $1 billion in its diabetes development program, including investing in two state-of-the-art manufacturing facilities.

New York-based Pfizer engages in the discovery, development, manufacture and marketing of prescription medicines.

Nektar Therapeutics, based in San Carlos, Calif., provides drug delivery technologies.

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