SOURCE: Aradigm

March 07, 2006 08:00 ET

Aradigm Reports Novo Nordisk to Initiate Additional Phase 3 Clinical Trials of AERx Diabetes Management System

Growing Body of Positive Clinical Data Support These Additional Trials

HAYWARD, CA -- (MARKET WIRE) -- March 7, 2006 -- Aradigm Corporation (NASDAQ: ARDM) today reported that its partner, Novo Nordisk, announced the initiation of additional Phase 3 clinical trials of the AERx® insulin Diabetes Management System (iDMS). In a press release issued this morning, Novo Nordisk stated that they will reinitiate the Phase 3 clinical program and that additional details on the corresponding clinical trials would be provided during their April 28, 2006 financial announcement.

In their press release, Novo Nordisk stated: "Novo Nordisk has now finalised the outstanding issues related to the AERx iDMS inhalable insulin project and decided to reinitiate the phase 3 programme. Aradigm Corporation, the US company from which Novo Nordisk has acquired the licensing rights to AERx iDMS, has today in a separate release informed its shareholders about the decision. Novo Nordisk will provide additional information about the phase 3 programme for AERx iDMS in connection with the release on 28 April 2006 of financial results for the first three months of 2006."

Dr. Bryan Lawlis, President and Chief Executive Officer of Aradigm commented: "We are pleased to see Novo Nordisk's ongoing commitment to the AERx iDMS product and their recognition that the growing body of positive clinical data to date support these additional trials. We firmly believe that the AERx iDMS has the potential to become a catalyst in helping millions of diabetics worldwide to better manage their conditions and improve the quality of their lives."

Clinical data to date, including the results from the interim analysis of Phase 3 data in 2004, show the AERx iDMS System to be comparable to injectable insulin in the overall management of Type 1 and Type 2 diabetes.

In January 2005, Aradigm and Novo Nordisk restructured the license agreement for the AERx iDMS where Novo Nordisk would be responsible for funding and executing future development and commercialization activities and serve as a contract manufacturer for the AERx System for Aradigm's non-iDMS clinical trials. Upon commercialization of the AERx iDMS, Aradigm will receive an average of 6% royalty on sales.

Aradigm combines its non-invasive delivery systems with novel formulations to create products that enable patients to comfortably self-administer biopharmaceuticals and small molecule drugs. The company's advanced AERx® pulmonary and Intraject® needle-free delivery technologies offer rapid delivery solutions for liquid drug formulations. Current development programs and priorities focus on the development of specific products, including partnered and self-initiated programs in the areas of respiratory conditions, neurological disorders, heart disorders, smoking cessation, and diabetes. 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, the availability of funding from partners or capital markets, 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.

Aradigm, AERx and Intraject are registered trademarks of Aradigm.

Contact Information

  • Contact:
    Christopher Keenan
    Aradigm
    (510) 265-9370