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Release issued 13th October 2004
Hayward, California - October 13, 2004 Aradigm Corporation (NASDAQ: ARDM) today announced positive results from the Clinical Performance Verification (CPV) Trial of its Intraject needle-free delivery system. Results from the trial showed that the study met its primary endpoint of demonstration of successful injection performance with Intraject with an excellent reliability profile.
The trial demonstrated acceptable performance and delivery consistency of the selected configuration in 194 healthy subjects who were each given multiple injections of saline via Intraject. In total, there were 1152 injections with no occurrence of injection-related adverse events and no reliability issues such as glass breakage or malfunctions. Subjects rated their injections as causing little or no pain sensation, a result in line with numerous other studies previously conducted with Intraject. In addition, the majority of subjects responded that they preferred the use of the Intraject device to a standard needle injection.
"This trial was the final stage of technical development for Intraject and clearly demonstrates that the technological and design issues that faced the system prior to our acquisition of the Intraject technology have been fully addressed," said Dr. Bryan Lawlis, President and Chief Executive Officer of Aradigm. "The CPV data and extensive reliability testing conducted on the final Intraject configuration in parallel with this study exceed the performance requirements for Intraject. In addition, we have made excellent progress with our contract manufacturers towards process scale-up for registration and commercial manufacturing. This strong technical foundation lets us initiate the partnering of the platform to companies for use with their drugs, as well as allowing us to commence clinical trials using Intraject with a drug of our own choosing. We expect to complete and announce the selection of the drug by the end of the year with the objective of commencing pivotal trials for regulatory submissions in the second half of next year."
Please note: Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including 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) Registration Statements, including the company's Annual Report on Form 10-K as amended and its Quarterly Reports on Form 10-Q.
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® pulmonary and Intraject® needle-free delivery technologies offer rapid delivery solutions for liquid drug formulations. Current development programmes focus on neurological disorders, heart disease, respiratory conditions and cancer. More information about Aradigm can be found at aradigm.com. Investors may also request company information via e-mail by directing inquiries to investor@aradigm.com.
AERx® and Intraject® are registered trademarks of Aradigm Corporation.
If you want to find out more about the company visit Aradigm profile.
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