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Biotech / Medical : INHL - Inhale Therapeutics - Pulmonary Insulin! -- Ignore unavailable to you. Want to Upgrade?

To: SemiBull who wrote (202)	6/18/2002 3:16:52 AM
From: michael_f_murphy	Read Replies (1) \| Respond to of 225

Exubera as effective as injected insulin in phase III, but lung function issues persist Last Updated: 2002-06-17 15:46:14 -0400 (Reuters Health) By Doug Macron NEW YORK (Reuters Health) - Pfizer Inc. said on Monday that data from a phase III study show its experimental inhaled form of insulin controls blood glucose levels in diabetes patients as well as injected insulin, but issues with the product's effect on lung function continue to linger. While earlier studies indicate that the insulin formulation, called Exubera, is as effective as injected insulin, it appears to be associated with a slight but clinically significant decline in breathing ability. This trend is believed to have led Pfizer, which licensed the global rights to Exubera with France's Aventis SA from Inhale Therapeutic Systems Inc., to delay filing a US regulatory application for the product last year while additional safety tests are conducted. In the trial, 328 patients with type I diabetes received either Exubera plus twice-daily insulin injections, or four daily insulin injections. Patients treated with Exubera experienced a decrease in HbA1c levels similar to those treated with the injectable insulin alone. An HbA1c measure is an estimate of blood glucose levels for a 90- or 120-day period. The frequency and nature of adverse events was similar in both treatment groups, said Pfizer. Mild to moderate cough was reported in Exubera-treated patients, but this decreased in incidence and prevalence over the course of the six-month study. However, Pfizer also said that "small relative decreases in one of the pulmonary function tests were seen in the Exubera treatment group." Specifically, Pfizer Senior Medical Director Dr. Michael Berelowitz told Reuters Health in a telephone interview that patients treated with Exubera experienced a slightly greater decline in diffusing capacity for carbon monoxide than patients receiving injected insulin. He added that "findings not dissimilar" were seen in a previous clinical trial, but denied that Pfizer held off on filing Exubera last year because of this issue. "We've taken the position that we want to...understand all of the safety components of the [Exubera] program before we file," he said. "People interpreted when we're going to file, and people have interpreted why we haven't, but in actual fact we're continuing studies in a completely committed way." Dr. Berelowitz stressed that there have been "absolutely no clinical manifestations" in patients related to carbon monoxide diffusion capacity decreases, and that the decreases were not experienced by patients in a separate trial reported on Monday. In that phase III trial, 309 type II diabetes patients, who had failed to control their glucose levels with combination oral therapy, responded to Exubera. Patients received either Exubera alone, Exubera plus oral agents, or oral agents alone. According to Inhale, patients in the two groups receiving Exubera experienced a significant drop in HbA1c levels after three months, versus no change in patients receiving just the oral therapy. Pulmonary function was stable in patients receiving Exubera, said Pfizer, with no differences between treatment groups. Dr. Berelowitz said that Pfizer and Aventis are exploring a number of theories as to why some Exubera-treated patients experience the diffusion decreases, but he declined to comment further. He also declined to project when Pfizer might file the product with the US Food and Drug Administration. "Until we feel confident in ourselves that we have this full picture [of Exubera's safety], we're not going to make any announcement." In late afternoon trading on the New York Stock Exchange, shares of New York City-based Pfizer climbed $0.55 up to $35.89, as shares of Aventis jumped $3.45 to $69. On the NASDAQ, shares of San Carlos, California-based Inhale rose $0.46 to $6.76.