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ARADIGN: NEW CLINICAL RESULTS  SHOWING DOSING OF PULMONARY INSULIN IN SMOKERS AND NON-SMOKERS

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Date: 12 Dec 2007
Time: 09:34:16

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Date: 25 Jun 2001
Time: 10:53:16

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PHILADELPHIA, June 25, 2001: The first carefully controlled clinical study examining the use of pulmonary insulin in both smokers and non- smokers using the AERx(R) insulin Diabetes Management System (iDMS), has found the new insulin delivery route to be safe and effective. The study was performed in healthy volunteers. Novo Nordisk A/S (NYSE: NVO), the world's leader in diabetes research and treatment development, in collaboration with Aradigm Corporation (Nasdaq: ARDM) today reported the promising data at the 61st Annual Diabetes Association Meeting.

In line with previous studies reported in the literature pulmonary insulin is enhanced in smokers compared to non-smokers. The study found not only the absorption of insulin to be in line with this, but also that smokers and non- smokers tolerate pulmonary insulin equally well. The study also showed that the variability of insulin absorption was very low in individual smokers and similar to the non-smoking group. This low level of variability for both groups compares favorably to data from subcutaneous injected insulin data in other studies.

"Because smokers absorb more of the inhaled insulin, they may require lower doses than non smokers," said Dr. Peter Damsbo head of Clinical Drug Development for Novo Nordisk. "The AERx(R) system is designed to provide sufficient flexibility in dosing so that differences between patients can be easily accommodated". He added that, "further studies are required to understand the factors in smoking that affect pulmonary absorption of insulin, and until that information is available smokers would not be included in the longer-term clinical studies."

The study was conducted in 43 healthy volunteers, 27 smokers and 16 non- smokers, to assess the pharmacokinetics of inhaled insulin with the AERx(R) System. After receiving a single dose of inhaled insulin on two consecutive days, both smokers and non-smokers were able to absorb the insulin effectively. The effect of acute smoking was also studied and it was found that although insulin absorption is high compared to non-smokers, absorption is lowered immediately after smoking. No safety issues or major adverse events were reported.

"Pulmonary insulin could redefine what insulin therapy means to diabetes patients," said study investigator Professor Per Wolmer, University of Lund, Sweden. "At least 20 percent of patients with type 2 diabetes are also smokers. Additional work is warranted to determine if these patients can effectively incorporate pulmonary insulin into their treatment regimen."

Main points of discussion among the world's leading clinical diabetes experts have included the need to set standards for the reliability of pulmonary insulin delivery and the perceived lack of dose dependability or reproducibility with conventional inhalers. The sophisticated AERx(R) iDMS electronic system sets such standards, resulting in a high level of lung delivery efficiency and dose reproducibility. These are achieved through the use of a liquid insulin formulation that allows correct particle sizing and electronic breath control that allows insulin delivery only if the rate of breathing is correct. The system also features the ability to adjust the insulin dose in small increments and a data downloading system that allows patients to review accurate dosing, potentially leading to improved patient compliance. This contrasts sharply with conventional inhalers, which deliver widely varying doses depending upon the use of the device and the patients breathing patterns.

Studies using AERx(R) iDMS have shown that patients of all ages and educational levels are able to quickly master the new system. High dosing precision combined with ease of use, without the need for self-administered injections, makes AERx(R) iDMS an exciting new alternative for a disease now considered a worldwide epidemic.

AERx(R) is a registered trademark of Aradigm Corporation.

For further information on AERx(R) iDMS or other Novo Nordisk products please contact:

Media: Investors:

Outside North America: Outside North America:

Karsten Madsen Peter Haahr

Phone (direct): (+45) 4442 4137 Phone (direct): (+45) 4442 1207

In North America: In North America:

Susan Jackson Rasmus Jorgensen

Phone: (+1) 212 867 0123 Phone (direct): (+1) 212 878 9607

For further information on Aradigm Corporation please contact:

Investors Investors & Media

Tracy Hudson Kari Lampka

(+1) 510 265 9000 (+1) 617 577 8110

About Novo Nordisk

Novo Nordisk is a focused healthcare company and world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as coagulation disorders, growth disorders and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 14,000 people in 68 countries and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADSs are listed on the New York Stock Exchange under the symbol 'NVO'. For further company information visit www.novonordisk.com.

About Aradigm Corporation

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. Current development programs focus on diabetes, pain management, and the pulmonary delivery of existing and emerging biotech therapeutics. 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 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.

 




 

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