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Aradigm Announces Update by Novo Nordisk on AERx Inhaled Insulin Phase 3 Clinical Program |
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29 Apr 2006 |
HAYWARD, CA, USA | Apr 28, 2006 | Aradigm Corporation (NASDAQ: ARDM) today reported that its partner, Novo Nordisk, has provided additional details concerning the resumption of Phase 3 clinical trials of the AERx(R) insulin Diabetes Management System (iDMS).
In their quarterly financial press release issued earlier this morning, Novo Nordisk stated: "As previously communicated, Novo Nordisk is now ready to re-initiate the phase 3 development of AERx(R) iDMS inhalable insulin. The phase 3 programme is expected to include approximately 2,200 type 1 and type 2 diabetes patients and will take place worldwide with primary focus on Europe and the US. The programme, which will include a number of different treatment comparisons including long-term pulmonary safety studies and combination treatment with other antidiabetics, is expected to be initiated in the second quarter of 2006 and is estimated to take three years to complete."
Dr. Bryan Lawlis, President and Chief Executive Officer of Aradigm commented: "The initiation of these trials confirms Novo Nordisk's continued commitment to the late stage development of the AERx iDMS. We are confident that the combination of Novo Nordisk's broad development and commercialization experience in diabetes and its application of significantly increased resources to this opportunity will lead to a well designed and well executed clinical development program."
Clinical data to date, including the results from an interim analysis of Phase 3 data, 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 AERx development programs. Upon commercialization of the AERx iDMS, Aradigm will receive a 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(R) pulmonary and Intraject(R) 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:
Christopher Keenan
Aradigm
(510) 265-9370
SOURCE: Aradigm |
