Paladin Labs Inc., a leading Canadian specialty pharmaceutical company, announced 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 hypoglycaemia in diabetic patients being treated with insulin, and is the market leader in Europe. GlucaGen is manufactured by Novo Nordisk A/S, 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. Hypoglycaemia is the most common adverse effect of intensive insulin therapy in patients with type 1 diabetes. Sixty per cent of insulin users can experience a low sugar reaction. GlucaGen is used to treat severe hypoglycaemic (low blood sugar) reactions which may occur in patients with diabetes treated with insulin. Severe hypoglycaemia 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. This level of hypoglycaemia results in a loss of consciousness and/or seizure, coma or death.
"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 pursuant to a pre-existing supply and distribution agreement between the two companies.
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.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market.