Novo Nordisk and Aradigm Corporation initiate Phase 3 clinical programme for NN1998

"We are pleased that the Phase 3 studies are now underway to help us make this innovative treatment available to the patients," said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk.
 
This 24-month study is a multi-centre, open-label study with patients receiving either inhaled insulin via the AERx® system or subcutaneous injections of NovoRapid® (NovoLog® in the US) three times daily before meals. Additionally, both groups are receiving basal insulin once or twice daily.
 
"With this important milestone for Aradigm, we are one step closer to bringing a significant alternative to insulin injections to patients with diabetes," said Richard Thompson, president and chief executive officer of Aradigm. "Encouraging data from our earlier studies have enabled us to design a robust Phase 3 clinical programme."
 
In addition to investigating long-term pulmonary safety, the study will also study the incidence of hypoglycaemic events, insulin antibody formation, glycaemic control (blood glucose profiles) and overall treatment satisfaction.
 
In recent meetings with regulatory authorities a plan to demonstrate safety and efficacy in people with both type 1 and type 2 diabetes was agreed. Since type 1 patients are more sensitive to minor health and life events such as illness, changes in exercise regimen, or travel, significant attention is paid to meeting the greater requirements of these people.
 
About NN1998 - AERx® iDMS
The AERx® electronic platform guides users to inhale correctly and automatically deliver the drug at the right time in the breath (Breath-Check System). Based on a proprietary liquid formulation and the AERx® iDMS Strip(TM) the system converts the liquid insulin formulation into fine aerosolised particles to be delivered locally to the deep lung and thereby to the systemic circulation.
 
In June 2002, at the Annual Meeting of the American Diabetes Association, the two companies Novo Nordisk and Aradigm announced clinical results from a Proof-of-Concept study in people with type 2 diabetes, which showed comparable glycaemic control between patients using the AERx® system and those using an intensive regimen of mealtime insulin injections. In addition, results from the 12-week study showed a favourable safety profile for the AERx® system including no difference between the two groups in FEV1, a lung function parameter. The number of hypoglycaemic events was 151 in the AERx® group compared to 211 in the comparator group.
 
Clinical safety and efficacy data on the AERx® iDMS system was presented at the 38th European Association for the Study of Diabetes (EASD) annual meeting on 2 September 2002 in Budapest, Hungary. The press release containing these data, and other press releases distributed by Novo Nordisk at the EASD, can be found at www.novonordisk.com. All abstracts presented by Novo Nordisk at the conference can also be found at www.novonordisk.com/investors under 'Conferences and Abstracts'.
 
Forward-looking statement
The above sections contain forward-looking statements as the term is defined in the US Private Securities Litigation Reform Act of 1995. Forward-looking statements provide current expectations or forecasts of events such as new product introductions, product approvals and financial performance.
 
Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Novo Nordisk's products, introduction of competing products, Novo Nordisk's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, unexpected growth in costs and expenses. 
 
Risks and uncertainties are further described in reports filed by Novo Nordisk with the US Securities and Exchange Commission (SEC) including the company's Form 20-F, which was filed on 26 April 2002. Please also refer to the section 'Financial Risk Factors' in the Annual Financial Report 2001. Novo Nordisk is under no duty to update any of the forward-looking statements or to conform such statements to actual results, unless required by law.
 
 
Novo Nordisk (NYSE:NVO) 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 17,500 people in 68 countries and markets its products in 179 countries. For further company information visit www.novonordisk.com.
 
 
Aradigm is working to improve the quality of life for patients by developing aerosol-based drug delivery alternatives to injectable therapeutics. The company's advanced pulmonary delivery technologies provide pharmaceutical and biotechnology partners with effective drug delivery solutions. Aradigm's technology uses liquid drug formulations that are similar to the injectable forms, which may minimise the potential for safety concerns when delivered by the pulmonary route. Current development programmes focus on diabetes, pain management and the pulmonary delivery of existing and emerging biotech and pharmaceutical 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 for breakthrough and acute pain management with GlaxoSmithKline, a world leader in oncology therapy and supportive care. Aradigm has three additional partner-funded programmes 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 e-mail by directing inquiries to investor@aradigm.com.
 
   
 
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