Perspective - August 1998
Growth factors in a challenging market
Cost curbing measures and economic recession are among the challenges facing Novo Nordisk in Japan.
Financial highlights
Summary of the Group.
Financial statement
For the first half of 1998.
Activelle™ - an expansion of the HRT port folio
A new HRT product from Novo Nordisk. It is the first HRT product to ever receive a unanimous approval from all EU member countries.
Novo Nordisk hit by parallel import
It should be countered by the introduction of free pricing systems. The only other option is to refrain from launching new products in low- price markets or - if it is found to be legal - to operate with differentiated prices.
Dose accuracy is of the essence
The success of any project designed to develop alternative administration forms for insulin is dependent on its ability to provide single unit precision and consistency over time.
Novo Nordisk
Dose accuracy is of the essence

The success of any project designed to develop alternative administration forms for insulin is dependent
on its ability to provide single unit precision and consistency over time.

Aradigm Corporation in Hayward, California has several years of experience in the development of systems for the inhalation of drugs. Novo Nordisk can take advantage of this experience in the two companies’ collaboration to develop a system for pulmonal (through the lungs) administration of insulin.
“Novo Nordisk has a vast experience in insulin treatment of diabetes and we applied this expertise when we evaluated various project opportunities,” explains Mads Krogsgaard Thomsen, corporate vice president in charge of Novo Nordisk’s Health Care Discovery. “We found that the technology developed by Aradigm is the best technology for pulmonary administration of insulin available at the moment.”
Mads Krogsgaard Thomsen
Mads Krogsgaard Thomsen: “Pulmonary administration using insulin in liquid form will primarily be positioned for people with Type 2 diabetes”.

Aradigm’s AERx™ Pulmonary Drug Delivery System provides a very satisfactory control of dosage as well as particle size. In contrast to other systems, Aradigm’s technology controls the breathing characteristics, preventing inhalation of insulin if the breathing is sub-optimal. This feature is not found in any other technology. In Aradigm’s technology each single-use packet (blister) with insulin has its own aerosol nozzle. This means that the nozzle is clean and unused before each dose, preventing it from being blocked after repeated use. In addition, Aradigm’s system is hand-held and portable. The convenient size of the applicator adds to the patient’s flexibility, eg in connection with travelling.
In addition, the AERx™ system delivers insulin in liquid form, which is expected to provide a more consistent drug delivery as compared to systems based on solids, which are much more sensitive, eg to changes in humidity. Furthermore, the insulin crystals in these systems are coated, which may influence the stability of the protein.
Initially the technology is being developed for use with Novo Nordisk’s range of recombinant insulins with a view to studying, among other things, the long-term effects of taking insulin via the lungs. Following clinical tests with these, trials may be initiated with Novo Nordisk’s new short-acting insulin analogue.

The market
Pulmonary insulin will primarily be positioned for people with Type 2 diabetes who experience poor glycaemic control on OHAs (oral hypoglycaemic agents).
However, for the foreseeable future, insulin injections will remain the best option for people with Type 1 diabetes due to the extended treatment period and the demand for tight glycaemic control which can hardly be achieved with pulmonary insulin. It is expected that the ease-of-use and convenience of the technology will lead to better compliance: “We target the dosing, using pulmonary administration, to be meal-related. Pulmonary administration allows the insulin to be absorbed fast and thus provides a rapid onset of action at meal times. This, hopefully, will provide better glucose control and thus better mimic insulin produced by the body,” explains Krogsgaard Thomsen.

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