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[IP] Re: insulin-pumpers-digest V2 #623
Tuesday November 10, 4:31 pm Eastern Time
Company Press Release
Inhale Reports Beginning of Phase III Trials for Inhaled Insulin
SAN CARLOS, Calif.--(BW HealthWire)--Nov. 10, 1998--Inhale Therapeutic
Systems, Inc. (Nasdaq:INHL - news) today reported that Pfizer
Inc.(NYSE:PFE - news) announced the beginning of Phase III clinical
trials to test the systemic delivery of insulin through the lungs
using Inhale's pulmonary delivery system.
Phase III trials were kicked off with an investigators meeting held
Nov. 7-9, and will be followed with recruitment, enrollment and dosing
of patients. The trials are projected to include Type 1 and Type 2
diabetics at 117 sites.
Inhale and Pfizer have been developing a pulmonary delivery system for
insulin to address the need for a non-invasive delivery system. Phase
II results have demonstrated that inhaled insulin is as effective as
regular injectable insulin and that addition of inhaled insulin
produces significantly better control for patients not well-controlled
on oral agents. The Phase III trials will further evaluate clinical
efficacy and safety within an expanded patient population at
geographically dispersed clinical study sites.
``We believe that pulmonary insulin could provide a major improvement
in therapy for diabetics. The initiation of the Phase III clinical
trials, combined with the recent agreements between Pfizer and
Hoechst, are important steps as we move toward commercialization,''
said Robert Chess, Co-CEO of Inhale.
Pfizer recently announced worldwide agreements with Hoechst Marion
Roussel AG to co-develop and co-promote the inhalable insulin product
based on Inhale's pulmonary delivery system. Inhale will use
recombinant insulin supplied by Hoechst Marion Roussel for producing
the dry powder insulin for Phase III trials.
Inhale's pulmonary delivery system administers fine, dry aerosol
powders to the deep lung. From the deep lung, the aerosolized insulin
is transported through the lung tissue to the bloodstream for systemic
Inhale, located in San Carlos, Calif., is developing pulmonary
delivery systems to enable a range of drugs, including peptides and
proteins, to be delivered by the pulmonary route for systemic and
local lung indications. The company has six drugs in human clinical
trials using its delivery system and has feasibility and development
partnerships with several pharmaceutical, biotechnology, and medical
technology companies, including Pfizer, Lilly, Baxter and Centeon.
This release contains forward-looking statements that reflect
management's current views as to the company's collaborative
arrangements, clinical trials, product developments, manufacturing
scale-up, and other future events and operations. These
forward-looking statements involve uncertainties and other risks that
are detailed in Inhale's reports and other filings with the SEC,
including its Form 10-K for the year ending Dec. 31, 1997. Actual
results could differ materially from these forward-looking statements.
Insulin-Pumpers website http://www.insulin-pumpers.org/