Pfizer has reached an agreement with sanofi-aventis to acquire its worldwide rights to the potential blockbuster diabetes drug Exubera.

The two companies were previously part of an alliance to develop, promote and manufacture Exubera (inhaled powder insulin) as a treatment for Type 1 and 2 diabetes, and the device used to administer the drug. Exubera is a fast-acting dry powder formulation of human insulin.

Pfizer's $1.3 billion deal for Exubera includes the insulin production facilities in Frankfurt, Germany, which were jointly owned by Pfizer and sanofi-aventis, Pfizer said recently.

Exubera is under regulatory review in the U.S. and Europe. The FDA in late October 2005 extended its review period of Exubera to consider additional technical chemistry data submitted by the sponsors.

Exubera is a potential blockbuster drug that, if approved, would be the first inhaled insulin powder available on the U.S. market. Roughly 194 million people worldwide have diabetes, and that number is expected to more than double by 2030, Pfizer said.

The product, which is self-administered using an inhaler, is highly anticipated by diabetics, many of whom want an alternative to insulin injections, the current standard of treatment. The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 7-2 in September 2005 to recommend approval of the drug.

Pfizer said plans to make Exubera available to patients as soon as possible following regulatory approvals. "We sought the sanofi-aventis rights to Exubera based on the strong addition it would represent to our portfolio of innovative medicines," said Hank McKinnell, chairman and CEO of Pfizer. "The acquisition of these rights also underscores our ability to invest in new product opportunities that will drive our future growth."