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New Insulin Analog Formulation With Disposable Prefilled Doser From Novo Nordisk is Now Available in the United States

NovoLog® Mix 70/30 FlexPen® -- Insulin Therapy Made Easy

PRINCETON, N.J., Sept. 30 /PRNewswire/ -- Novo Nordisk announced today that NovoLog® Mix 70/30 (70% insulin aspart [rDNA origin] protamine suspension and 30% insulin aspart [rDNA origin] injection), a new dual-action insulin analog, along with the new NovoLog Mix 70/30 FlexPen® prefilled syringe, is now available nationwide for the treatment of diabetes.

NovoLog Mix 70/30 has a rapid onset and intermediate duration of action, so insulin needs immediately after a meal and between meals can be met through a single injection rather than separate injections of these types of insulins. NovoLog Mix 70/30 is typically dosed twice a day, immediately before breakfast and dinner.

"Our goal with NovoLog Mix 70/30 is to help people with diabetes start insulin therapy simply and easily, and at the same time achieve effective glycemic control," said Peter Aurup, M.D., vice president of drug development, Novo Nordisk Pharmaceuticals, Inc. He said that maintaining glycemic control -- the control of blood glucose levels -- is important in decreasing the risk of long-term complications in type 2 diabetes. Initially, people with type 2 diabetes can control their condition through diet, exercise and oral
hypoglycemic agents, but eventually most require insulin therapy to maintain
adequate control.

"Unfortunately, many people with diabetes delay starting insulin therapy even when it's clearly needed to maintain glycemic control, in part due to fear of injections and perceived or real difficulties following and adhering to an insulin-treatment regimen," said Dr. Aurup. "NovoLog Mix 70/30 FlexPen is suited for those first starting or needing changes in standard insulin therapy. The dual action of NovoLog Mix 70/30 provides mealtime and basal insulin coverage, in most cases with just two daily administrations, before breakfast and dinner. And FlexPen makes injecting insulin discreet," he said. He added that FlexPen is made of environmentally friendly plastic.

Dr. Aurup cited a recent study in which people with type 2 diabetes showed a marked preference for NovoLog Mix 70/30 FlexPen over the lispro mix pen (75% insulin lispro protamine suspension and 25% insulin lispro injection [rDNA origin]), another premixed insulin and prefilled pen.(1)

While the researchers conducting the study found the two devices comparable in terms of safety and efficacy, participants reported preference for the NovoLog Mix 70/30 FlexPen, in terms of overall ease of use, by more than an 8-to-1 margin (73.6% preferred the NovoLog Mix 70/30 FlexPen, compared to 9.1% who preferred the lispro mix pen).1 The researchers also found that 75% of the participants said they wanted to continue using the NovoLog Mix 70/30 FlexPen when the trial ended. The multinational, multicenter, open labeled, randomized two-period crossover study included 137 people with type 2 diabetes.

About NovoLog Mix 70/30
NovoLog Mix 70/30 is indicated for the treatment of patients with diabetes mellitus for the control of hyperglycemia. Because NovoLog Mix 70/30 has peak pharmacodynamic activity one hour after injection, it should be administered with meals. NovoLog Mix 70/30 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to NovoLog Mix 70/30 or one of its excipients. Hypoglycemia is the most common adverse effect of insulin therapy, including NovoLog Mix 70/30.
Any change in insulin should be made cautiously and only under medical supervision.
NovoLog Mix 70/30 is the second of several insulin analog formulations in development from Novo Nordisk. Other products in development include long-acting insulin analogs.

About FlexPen
NovoLog Mix 70/30 FlexPen represents a new generation of prefilled, disposable insulin pens from Novo Nordisk, designed to be discreet to use. Compared to other insulin delivery devices that have to be manually loaded with insulin cartridges, prefilled pens are ready to use, eliminating the step of loading insulin into the delivery device. FlexPen is about six inches long, weighs less than an ounce, and features a single-step dose-setting mechanism, portability and a discreet "non-medical" appearance.

The dose-setting mechanism of FlexPen does not allow a dose larger than that remaining in the pen, permits dose corrections without loss of insulin, and provides doses in one-unit increments up to 60 units per injection (each pen contains 300 units total). The dose scale of FlexPen automatically returns to zero after injection to allow visual confirmation of dose delivery.

Full prescribing information for NovoLog Mix(R) 70/30 is available by contacting Novo Nordisk Pharmaceuticals, Inc.

NovoLog and FlexPen are registered trademarks of Novo Nordisk A/S.

Novo Nordisk is a focused healthcare company and the world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy 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 http://www.novonordisk.com.

Reference:
(1) Vora JP, Nygaard-Pedersen L, Erichsen K, Hansen AB, Niskanen L. Patients with type 2 diabetes using biphasic insulin analog prefer NovoMix 30 FlexPen to the HumaLog Mix 75/25 Pen. Poster 546, presented at: American Diabetes Association annual meeting, San Francisco, CA, June 15, 2002.


SOURCE: Novo Nordisk

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