Miljenko,
I used to think EMIS had no competitors in the area of orally delivered insulin. Recently came across this; I have not seen the Nobex/GSK program mentioned here. Do you follow that effort?
>>GlaxoSmithKline (GSK) and Nobex Corporation have announced a strategic alliance for the development and commercialisation of orally administered insulin products for the treatment of diabetes.
The first product to be developed in the collaboration is a novel modified oral insulin for controlling post-meal blood glucose. Nobex has already advanced this novel insulin into Phase I/II clinical trials. Under the terms of the agreement, GSK will fund product development, manufacturing, and marketing. GSK will pay Nobex an upfront fee and milestone payments related to development progress, regulatory submissions and approvals, and to the achievement of certain sales level thresholds, resulting in US$283 million in potential payments to Nobex over the term of the agreement, in addition to royalties on product sales. GSK and Nobex will work collaboratively on product development and will continue to identify additional insulin molecules, modified with Nobex’s proprietary technology, for development in the collaboration. Research for the identification of new insulin molecules for oral delivery will be funded by GSK, and Nobex may receive additional milestone payments and royalties if these efforts are successful.
"The licensing of our lead oral insulin to GSK is a significant development in the treatment of diabetes, a chronic, debilitating disease of near-epidemic proportions," stated Christopher H. Price, President and CEO of Nobex. "As a premier pharmaceutical company well-positioned in diabetes, GSK is an excellent collaborator bringing considerable resources, development and commercial expertise, and an ability to provide global marketing reach to bring this product to patients. The formation of this strategic alliance is a transforming event for Nobex, underscoring both the value of oral insulin products and the quality technology and capabilities that Nobex has developed. This alliance highlights the Nobex mission to provide convenient, medically-superior solutions to difficult drug delivery challenges."
"GlaxoSmithKline has a great deal of experience in development and marketing in the field of diabetes with Avandia and the Nobex oral insulin offers the potential to greatly expand our current franchise in this disease area," said Ken Batchelor, Senior Vice President of the Metabolic and Viral Diseases Centre for Excellence in Drug Discovery at GSK. "We very much look forward to working with Nobex on this exciting product opportunity."
About Oral Insulin
Insulin has been commercially available only in injectable forms since its introduction into medicine about 75 years ago. Nobex has developed a modified insulin under its patented polymer technology that resists enzymatic degradation of insulin in the body and is rapidly absorbed into the bloodstream after the patient takes an oral dose. The convenience of an oral insulin product would be of significant benefit to patients and may increase their compliance in taking insulin, so important to the long-term control of diabetes.
Nobex oral insulin is absorbed across the intestinal wall and follows the same pathway as insulin normally released by the pancreas, entering the body by a blood vessel known as the portal vein and carried immediately to the liver. Insulin from the pancreas or from oral delivery arrives at the liver in a large pulse and may activate the liver to participate in the control of blood glucose. The properly activated liver is thought to stimulate a number of metabolic actions that could help reduce the complications of diabetes, such as vascular disease.
About Diabetes
The pancreas in the patient with type 1 diabetes has lost the ability to produce insulin, and to control blood glucose, insulin must be administered several times per day. In type 2 patients, the pancreas can produce insulin. However as the disease progresses, it does not provide enough insulin at the proper time for effective control of blood glucose. The primary metabolic disorder in type 2 diabetes is insulin resistance, which is often treated with insulin sensitising agents to help patients more effectively use the insulin their bodies naturally produce. If left untreated, a patient with diabetes can develop a number of debilitating medical complications in addition to the inability to control blood sugar. The estimated cost of diabetes and its complications to the U.S. economy is approaching US$100 billion per year.
About Nobex
Nobex Corporation is a privately held, drug delivery company that specializes in medicinal chemistry applied to optimising the delivery of therapeutic drugs. The focus of Nobex is to enable the oral delivery of drugs currently delivered only by injection. The Company currently has two products in clinical study, oral insulin for diabetes and oral calcitonin for osteoporosis. A third product, Apaza™ for inflammatory bowel disease, is expected to enter clinical study by the end of 2002. Nobex has several product and R&D alliances with U.S. and European pharmaceutical and biotechnology companies. For more information, visit www.nobexcorp.com.<<
Here's a link to some 2001 absrtacts:
nobexcorp.com
I believe they presented at this year's ADA meeting, too.
Cheers, Tuck |
