said Monday that they remain committed to seeking regulatory approval for an inhaled form of insulin, known as Exubera, but the drugmakers did not say when an approval application would be filed with the Food and Drug Administration.
The joint statement issued today regarding Exubera doesn't add much to what was
said in December. Pfizer and Aventis are conducting long-term safety studies of the product in people with Type 1 and Type 2 diabetes. Discussions with the FDA are also still ongoing.
Exubera is being developed with drug-delivery technology from the biotech firm Inhale Therapeutics, although Pfizer and Aventis control the product's future.
At one time, Exubera was expected to reach the FDA at the end of 2001, but safety concerns focused on the drug's impact on patients' lungs has forced delays.
In December, Pfizer said long-term safety studies would be completed by the end of 2002. But Monday, the company made no such commitment, nor did it say when Exubera might be filed with the FDA.
Shares of Inhale closed Friday at $5.39, Pfizer closed at $29.97, and Aventis closed at $58.34.