"This recently completed study is significant as it demonstrates that the AERx® iDMS appears to be a safe and efficacious product," said Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk. "It is our goal to improve the quality of life for people with diabetes, and we believe the AERx® iDMS will help us accomplish this by providing a convenient way to dose insulin."
The Phase 2b trial was designed to investigate the safety and efficacy of pulmonary insulin via the AERx® iDMS compared to intensified treatment with subcutaneous insulin in people with Type 2 diabetes. This type of intensified treatment with insulin, delivered at mealtimes has long been advocated by leading diabetologists for prevention of long-term complications of the disease. We believe this is the first time pulmonary insulin has been evaluated against intensified subcutaneous insulin therapy. Approximately 100 patients were included for a twelve-week period in this study.
The results of the study showed the AERx® iDMS to be at least as effective as intensified subcutaneous injections of insulin. The detailed study results will be presented at scientific conferences during 2002.
"The completion of this study represents a major milestone in our partnership with Novo Nordisk and the development of the AERx® iDMS," said Richard Thompson, president and CEO of Aradigm. "It is important to note that the safety profile raised no concerns that would prevent further clinical development."
Preparation for the initiation of Phase 3 with the AERx® iDMS project is ongoing.
Pursuant to the announced share investment agreement Aradigm Corporation has the right, but not the obligation, to sell to Novo Nordisk an additional USD 25 million of common stock, subject to certain conditions.
"This new agreement provides Aradigm with additional financial flexibility," stated Rick Thompson. "We are very pleased to have this level of support from one of our most important partners."
The agreement limits the purchase per quarter to a maximum of USD 10 million, starting in the first quarter of 2002. Each purchase will be based on the market price prevailing around the time of each transaction. Novo Nordisk will hold the shares to be purchased under the agreement for at least two years from the effective date of each purchase, subject to certain conditions. No shares are being sold to Novo Nordisk at this point in time and the agreement will not impact Novo Nordisk's expectations for its financial results for 2001.
This new investment agreement is in addition to the agreement announced October 25, 2001 in which Novo Nordisk purchased USD 20 million in Aradigm common stock.
Aradigm and Novo Nordisk have been collaborating on the development of the AERx® iDMS since 1998. The AERx® iDMS uses a liquid solution of insulin, which allows for lower cost manufacturing, and includes automatic breath control to ensure that patients are inhaling each dose of insulin correctly.
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 16,000 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 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.
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
Media:
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
Aradigm Corporation:
Tracy Hudson
Investor Relations Coordinator
(+1) 510 265 9000
Investors:
Kari Lampka
Feinstein Kean Healthcare
(+1) 617 577 8110 Media:
Claire Campbell
Ogilvy Public Relations Worldwide
(+1) 310 407 7900
Rasmus Jorgensen
Phone (direct): (+1) 212 878 9607
Aradigm Corporation:
Tracy Hudson
Investor Relations Coordinator
(+1) 510 265 9000
Investors:
Kari Lampka
Feinstein Kean Healthcare
(+1) 617 577 8110 Media:
Claire Campbell
Ogilvy Public Relations Worldwide
(+1) 310 407 7900