[PFE] Inhale Reports Beginning of Phase III Trials for Inhaled Insulin
Business Wire
November 10, 1998, 1:46 p.m. PT
Business Editors and Health/Medical Writers
SAN CARLOS, Calif.--(BW HealthWire)--Nov. 10, 1998--Inhale
Therapeutic Systems, Inc. (Nasdaq:INHL) today reported that Pfizer
Inc.(NYSE:PFE) 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
distribution.
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.
--30--ac/sf* lmm/sf
CONTACT: Inhale Therapeutic Systems, Inc.
Joyce Strand, 650/631-3138
KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: PHARMACEUTICAL MEDICINE PRODUCT
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