Aradigm Intraject Development Program Advances With Configuration Trial Results
Tuesday September 16, 7:30 am ET
Data Supports Needle-Free System's Progression Into Development Stage
HAYWARD, Calif., Sept. 16 /PRNewswire-FirstCall/ -- Aradigm Corporation (Nasdaq: ARDM - News), a leader in drug delivery, today announced results from a Configuration Trial (C-Trial) of its Intraject needle-free technology. The trial was conducted to determine the optimum design of the system by evaluating injection performance and site preference with the goal of establishing a viable in vivo system. Results showed that the three best-performing Intraject configurations all gave acceptable performance. Based on these results, Aradigm has concluded that at least one of these configurations enables a commercially viable product to be used across a wide variety of drugs.
The trial was designed to test 28 different configurations of the Intraject in 300 healthy volunteers with the goal of establishing the optimum configuration in terms of complete injections. Each volunteer received 12 injections at randomized sites to measure tolerability to, and quality of, the injection. Of the 28 configurations, all 28 passed mechanical reliability tests, including accelerated shelf life testing and ability to manage bubbles in the formulations. All configurations of the system were well tolerated, and there were no device breakages in any of the configurations throughout the trial. No adverse events related to Intraject were reported.
"Based on these data, we are confident that Intraject is a viable drug delivery option for needle-free injection," said Stephen Farr, Aradigm's Chief Scientific Officer. "This now allows us to map out the next steps in the Intraject development program taking us through the remainder of 2003. I am pleased with the progress made in integrating this acquisition and in the abilities of the Intraject team, led by Toby King, formerly of Weston Medical."
This trial was carried out earlier this year by Weston Medical as part of their work to resolve a tolerance stack-up issue, identified in Q3 2002, which resulted in unacceptably high rates of incomplete injections in some subjects. Following the recent completion of the technology transfer phase of the acquisition, Aradigm reviewed this data and reached these conclusions regarding the configuration.
"These data provide us with a much clearer picture of the parameters needed by the Intraject system to efficiently deliver a wide range of drugs," said Toby King, Aradigm's Senior Technical Director for Intraject. "We will use this information to refine and complete an in vivo/in vitro correlation, and to select and test the final commercial configuration of Intraject. This will then allow us to go forward to the final Clinical Performance Verification trial that we anticipate will occur in 2004. Successful completion of this trial will be the trigger for our licensees to commence their bioequivalence studies to demonstrate that Intraject is comparable to the subcutaneous injection delivery of their compounds."
Aradigm is working to improve the quality of life for patients through the development of its innovative needle-free drug delivery platforms. The Company's AERx® advanced pulmonary delivery platform and its Intraject® needle-free injector system provide leading pharmaceutical and biotechnology partners with effective drug delivery solutions. Aradigm's technologies both use liquid drug formulations to deliver drugs to the targeted area of either the lung, or the systemic circulation. The company is in Phase 3 clinical trials for the treatment of diabetes in a partnership with Novo Nordisk, a world leader in diabetes care. More information about Aradigm can be found at www.aradigm.com.
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 as amended, and quarterly reports on Form 10-Q.
NOTE: AERx, and Intraject are registered trademarks of Aradigm Corporation.
CONTACT: Media, Chris Keenan of Aradigm Corporation, +1-510-265-9370; or Investors, Joe Dorame of RCG Capital Markets Group, Inc., +1-480-675-0400, for Aradigm Corporation.
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