Hi Gang,
Just parking some boilerplate related to ARDM's inhaled insulin partnership with Novo Nordisk that wouldn't fit at the Yahoo! club:
Damn the formatting! Full speed ahead!
From the '98 10K
In June 1998, Aradigm entered into a product development and commercialization agreement with Novo Nordisk covering the use of the AERx Diabetes Management System for the delivery of blood glucose regulating medicines. Under the agreement, Novo Nordisk also has a two year option to collaborate with Aradigm on the development of products based on the AERx Pulmonary Drug Delivery System in two additional, unnamed fields. Novo Nordisk is also obligated, under certain conditions, to develop at least one additional
compound in the field of blood glucose regulation. The Company and Novo Nordisk will collaborate on product development. Under the terms of the agreement, Novo Nordisk has been granted worldwide sales and marketing rights to any products developed under the terms of the agreement, and Aradigm retains all manufacturing rights. For any system developed under the collaboration that receives regulatory approval, Aradigm expects to receive a share of gross profits on the sales of such products by Novo Nordisk. Gross profits is defined as Novo Nordisk's sales of delivery devices and packets, less both companies
costs of manufacturing the devices, packets and drug included in the packets.
Pursuant to the Novo Nordisk agreement, Aradigm could receive approximately $75 million in milestone and product development payments and approximately $10 million in equity investments by the time the first product from the collaboration is commercialized. As of December 1998, the Company had received $12.5 million in milestone and product development payments and $5.0 million from the purchase of Aradigm Common Stock by Novo Nordisk. Additional milestone payments and product development payments will be paid if Aradigm and Novo Nordisk decide to jointly develop additional AERx products under the terms of the agreement. There can be no assurance that the Company will be able to meet the milestones under this agreement on a timely basis, if at all.
From '99 10K
In 1999, we presented data at the American Diabetes Association meeting on a study of 20 patients with Type 1 diabetes. These patients were given inhaled insulin immediately before a standard meal or injected insulin thirty minutes before the meal. Each patient in the study received insulin by each method twice for a total of four dosing days. There was no significant difference between the blood glucose profiles seen following the meal after AERx insulin or injected insulin dosing. The study concluded that AERx insulin given with a meal to these patients with Type 1 diabetes controlled blood sugar as effectively as insulin given 30 minutes before the meal by injection. This is consistent with our goal of providing a convenient means for dosing insulin without using needles at the time of each meal. By giving patients an alternative to injection and by allowing them to dose insulin with the meal instead of a half-hour before, we believe that people with diabetes will find it easier to comply with recommended
insulin therapy. The next phase of clinical testing will be pivotal trials involving patients with Type 1 and Type 2 diabetes using AERx insulin daily for the management of their diabetes. Some of the patients with Type 2 diabetes are
expected to use AERx insulin as their sole source of insulin. Through our development partnership with Novo Nordisk, we have continued to conduct multiple Phase IIa studies in the United States and Europe throughout 1999 and 2000.
The Collaboration
In June 1998, we entered into a product development and commercialization agreement with Novo Nordisk, the world leader in insulin therapy, covering the use of the AERx Diabetes Management System for the delivery of blood glucose
regulating medicines. While the collaboration is initially focused on the delivery of insulin, Novo Nordisk is also obligated to consider with us the development, under certain conditions, of at least one additional compound in the field of blood glucose regulation. Novo Nordisk has been granted worldwide sales and marketing rights to any products developed under the terms of the agreement, and we retain all manufacturing rights. For any system developed under the collaboration which receives regulatory approval, we expect to receive a share of gross profit on the sales of such products by Novo Nordisk.
Pursuant to the Novo Nordisk agreement, we could also receive approximately $38 million in milestone payments in addition to reimbursement for product development expenses and $10 million in equity investments by the time the first
product from the collaboration is commercialized. As of December 1999, we had received $22.4 million in milestone and product development payments and $5 million from the purchase of our common stock by Novo Nordisk at a 25% premium to market price. Under certain conditions, a second $5 million equity investment may be made at our option at the market price at the time of exercise. Additional milestone payments and product development payments will be paid if we and Novo Nordisk decide to jointly develop additional AERx products under the terms of the agreement.
Whew!
Cheers, Tuck |
