Aradigm and Novo Nordisk are currently in Phase 2 clinical trials with the AERx® insulin Diabetes Management System (iDMS). Clinical results to date confirm that pulmonary drug delivery using the AERx® System is a reproducible method for delivering insulin to the bloodstream that is comparable to subcutaneous administration.
"Aradigm and Novo Nordisk are jointly developing a product that offers a precise and flexible system for non-invasive insulin delivery that we believe will become an important treatment option for people with diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "We are pleased to have the opportunity to invest in our partner Aradigm."
As part of this agreement, Novo Nordisk will retain all of the Aradigm stock held by it for at least two years from the effective date of this agreement, subject to certain conditions.
In a separate agreement, Aradigm and Novo Nordisk have decided that Novo Nordisk will assume the responsibility for providing manufacturing capacity for all requirements beyond that produced in Aradigm's recently completed Hayward, California commercial scale manufacturing facility. This agreement creates an important limit on Aradigm's requirement to invest in additional manufacturing facilities to meet higher product volumes. There were no material changes in the other financial arrangements between the companies. In addition, Novo Nordisk's rights have been expanded to include full ability to produce product using Aradigm's proprietary technology at its production facilities.
In a separate agreement, Aradigm and Novo Nordisk have decided that Novo Nordisk will assume the responsibility for providing manufacturing capacity for all requirements beyond that produced in Aradigm's recently completed Hayward, California commercial scale manufacturing facility. This agreement creates an important limit on Aradigm's requirement to invest in additional manufacturing facilities to meet higher product volumes. There were no material changes in the other financial arrangements between the companies. In addition, Novo Nordisk's rights have been expanded to include full ability to produce product using Aradigm's proprietary technology at its production facilities.
"These agreements are a further demonstration of the confidence Novo Nordisk has in our programme," stated Rick Thompson, chairman, president and CEO of Aradigm. "Our teams are very pleased with the safety and efficacy data generated to date as we prepare for the initiation of Phase 3 trials."
The agreement will not impact Novo Nordisk's expectations for the financial result for 2001.
Novo Nordisk A/S is a focused healthcare company and the world leader in diabetes care. In addition, Novo Nordisk manufactures and markets a variety of other pharmaceutical products. With headquarters in Denmark, Novo Nordisk employs approximately 15,000 people in 68 countries and markets its products in 179 countries. Its B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol "NVO". For further company information visit http://www.novonordisk.com.
Aradigm is working to improve the quality of life of patients by developing aerosol-based drug delivery alternatives to injectable therapeutics. The Company's advanced pulmonary delivery technologies provide leading pharmaceutical and biotechnology partners with effective drug delivery solutions. Aradigm's technology uses liquid drug formulations that are similar to the injectable forms and minimize the potential for safety concerns when delivered by the pulmonary route. Current development programs focus on diabetes, pain management, and the pulmonary delivery of existing and emerging biotech therapeutics.
Based in Hayward, California, Aradigm is currently developing products for diabetes management with Novo Nordisk A/S, the world leader in insulin and diabetes care, and breakthrough and acute pain management for GlaxoSmithKline, a world leader in oncology therapy and supportive care. In addition, Aradigm has four additional partner-funded programs and a gene therapy effort funded through the National Institutes of Health. More information about Aradigm can be found at www.aradigm.com. Investors may also request company information via email by directing inquiries to investor@aradigm.com.
Please note:
Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the timely development, 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 and Novo Nordisk's Corporation's Securities and Exchange Commission (SEC) Registration Statements, including the companies Annual Reports on Form 10-K (Aradigm Corporation) and Form 20-F (Novo Nordisk) as amended.
For further information please contact:
Novo Nordisk
Media:
Outside North America:
Karsten Madsen
Phone (direct): (+45) 4442 4137
Outside North America:
Karsten Madsen
Phone (direct): (+45) 4442 4137
In North America:
Susan Jackson
Phone (direct): (+1) 609 919 7776
Susan Jackson
Phone (direct): (+1) 609 919 7776
Investors:
Outside North America:
Peter Haahr
Phone (direct): (+45) 4442 1207
Outside North America:
Peter Haahr
Phone (direct): (+45) 4442 1207
Palle Holm Olesen
Phone (direct): (+45) 4442 6175
Phone (direct): (+45) 4442 6175
In North America
Rasmus Jorgensen
Phone (direct): (+1) 212 878 9607
Rasmus Jorgensen
Phone (direct): (+1) 212 878 9607
Aradigm
At Aradigm Corporation
Tracy Hudson
Investor Relations Coordinator
Phone: (+1) 510 265 9000
Media:
Claire Campbell
Ogilvy Public Relations Worldwide
Phone: (+1) 310 407 7900
Tracy Hudson
Investor Relations Coordinator
Phone: (+1) 510 265 9000
Media:
Claire Campbell
Ogilvy Public Relations Worldwide
Phone: (+1) 310 407 7900
Investors:
Kari Lampka
Feinstein Kean Healthcare
Phone: (+1) 617 577 8110
Kari Lampka
Feinstein Kean Healthcare
Phone: (+1) 617 577 8110
Stock Exchange Announcement No 18 / 2001