MONTREAL, QUEBEC--(Marketwire - September 24, 2009) - 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.
About Paladin Labs Inc.
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. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada’s leading specialty pharmaceutical companies. Paladin’s shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Company’s web site at www.paladinlabs.com.
GlucaGen® is a trademark owned by Novo Nordisk A/S
This press release may contain forward-looking statements and predictions. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. The Company considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions that these assumptions regarding the future events, many of which are beyond the control of the Company and its subsidiary, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the annual report as well as in the Company’s Annual Information Form for the year ended December 31, 2008. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events and except as required by law. For additional information on risks and uncertainties relating to these forward-looking statements, investors should consult the Company’s ongoing quarterly fillings, annual report and Annual Information Form and other fillings found on SEDAR at www.sedar.com.
(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.
Contacts:
Paladin Labs Inc.
Samira Sakhia
Chief Financial Officer
514-669-5367
514-344-4675 (FAX)
info@paladinlabs.com
www.paladinlabs.com
