Health Canada Approves GlucaGen(R) For Treatment Of Severe Hypoglycemia In Diabetes Patients

Main Category: Diabetes
Article Date: 25 Sep 2009 - 1:00 PDT

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Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, announced today that the Biologics and Genetic Therapies Directorate of Health Canada has approved GlucaGen® (recombinant glucagon for injection). GlucaGen® is indicated for the treatment of severe hypoglycemia in diabetic patients being treated with insulin, and is the market leader in Europe. GlucaGen® is manufactured by Novo Nordisk A/S (NYSE:NVO), a healthcare company and a world leader in diabetes care.

It is estimated that there are approximately 265,000 Canadians with diabetes that are insulin dependent. Hypoglycemia is the most common adverse effect of intensive insulin therapy in patients with Type 1 diabetes.(1) Sixty percent of insulin users can experience a low sugar reaction.(2) GlucaGen® is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes treated with insulin. Severe hypoglycemia occurs when the blood's glucose level decreases to a point and remains at that level too long, where the brain becomes deprived of sufficient energy to function properly.(3), (4) This level of hypoglycemia results in a loss of consciousness and/or seizure, coma or death.(3)

"The approval of GlucaGen® marks a milestone in the development of our regulatory capabilities. It represents our first approval from the Biologics and Genetic Therapies Directorate of Health Canada. GlucaGen® is a market leading biologic in Europe and we expect GlucaGen® will be an important player in the $8.8 million Canadian glucagon market. We look forward to bringing this product to Canadian patients in the first half of 2010", said Jonathan Ross Goodman, President & CEO Paladin Labs.

Paladin will promote and distribute GlucaGen® on behalf of Novo Nordisk Canada Inc. a subsidiary of Novo Nordisk A/S (NYSE:NVO) pursuant to a pre-existing supply and distribution agreement between the two companies.

About GlucaGen®

GlucaGen® is chemically identical to human glucagon, a naturally occurring peptide that selectively converts liver glycogen to glucose, relaxes smooth muscle, and increases the strength of cardiac contractions. GlucaGen® is indicated for emergency treatment of severe hypoglycemia in diabetic patients using insulin. GlucaGen® rapidly restores blood glucose levels in the unconscious patient to allow them to regain consciousness and permit administration of other sources of glucose.

(1) Canadian Diabetes Association 2008 clinical practice guidelines for the prevention of management of diabetes in Canada. September 2008.
(2) The Diabetes Control and Complications Trial Research Group. Am J Med. 1991
(3) Mayo Clinic. Hypoglycemia and diabetes: What to watch out for. Accessed June 21, 2005.
(4) Aetna InteliHealth. Health A To Z: Hypoglycemia.

Source
Paladin Labs Inc.

View drug information on Glucagon.

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Paladin Labs Inc.. "Health Canada Approves GlucaGen(R) For Treatment Of Severe Hypoglycemia In Diabetes Patients." Medical News Today. MediLexicon, Intl., 25 Sep. 2009. Web.
13 Feb. 2012. <http://www.medicalnewstoday.com/releases/165159.php>

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APA

Paladin Labs Inc.. (2009, September 25). "Health Canada Approves GlucaGen(R) For Treatment Of Severe Hypoglycemia In Diabetes Patients." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/165159.php.

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