|HAYWARD, Calif., Nov. 17 /PRNewswire-FirstCall/
-- Aradigm Corporation (Nasdaq: ARDM) today announced positive results
from a pilot pharmacokinetic study in which sumatriptan delivered via its
needle-free Intraject(R) system was compared to the currently marketed
subcutaneous needle-injected sumatriptan product. Sumatriptan is indicated
for the acute treatment of migraine headache. Results from the study
showed that sumatriptan administered via the Intraject system met all
bioequivalence criteria and demonstrated statistically equivalent
pharmacokinetics to the marketed injectable product.
"This study provides the final validation of
Intraject as the system successfully delivered active drug," said Dr.
Bryan Lawlis, Aradigm's President and Chief Executive Officer. "We have
funded this program to date in order to demonstrate conclusively that
Intraject needle-free delivery is a viable replacement for conventional
subcutaneous injection, and to accelerate our path to first product
launch. In the first half of 2005, we anticipate manufacturing
registration lots and preparing for pivotal bioequivalence trials in the
second half of the year. We are encouraged that our rapid progress is
generating attractive partnering prospects for this product, as well as
for other products that are currently marketed or being developed for
The trial was a randomized, open-label,
single-dose, crossover study evaluating the pharmacokinetics of
sumatriptan at three injection sites in 18 healthy adult male and female
volunteers. Subjects were randomized to receive sumatriptan both by
Intraject and by the currently marketed subcutaneous needle-injected
sumatriptan product into the abdomen, thigh, and arm.
The comparability of Intraject to the
subcutaneous needle-injected sumatriptan product was established at all
three injection sites using standard bioequivalence criteria of peak
concentration achieved in blood plasma (Cmax), and total drug
concentration in blood plasma achieved over time (AUC). Other
pharmacokinetic measures were similar between Intraject and the
needle-injected product, and there was no significant difference in blood
levels between the two products.
"This positive data means that Intraject
has the potential to be
competitively positioned in the $2 billion triptan market," said Dr.
Stephen Farr, Senior Vice President and Chief Scientific Officer of
Aradigm. "Rapid absorption is important for achieving rapid relief in the
treatment of migraine attacks. To date, the performance of injected
sumatriptan has not been equaled by any oral triptan. We expect that
patients seeking faster pain relief will be pleased to have an effective
option that does not involve a needle."
Aradigm develops non-invasive delivery systems to enable patients to
comfortably self-administer biopharmaceuticals and small molecules that
would otherwise be given by injection. The company's advanced AERx(R)
pulmonary and Intraject(R) needle-free delivery technologies offer rapid
delivery solutions for liquid drug formulations. Current development
programs focus on neurological disorders, heart disease, respiratory
conditions and cancer. More information about Aradigm can be found at
Except for the historical information contained herein, this news release
contains forward-looking statements that involve risk and uncertainties,
including clinical results, the timely availability and acceptance of new
products, the impact of competitive products and pricing, and the
management of growth, as well as the other risks detailed from time to
time in Aradigm Corporation's Securities and Exchange Commission (SEC)
Filings, including the company's Annual Report on Form 10-K, and quarterly
reports on Form 10-Q.