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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. Glucagon is indicated for emergency treatment of hypoglycemia in insulin-dependent diabetics and for relaxation of the gastrointestinal tract during routine radiology procedures.
Exclusive Canadian distributor for:
Novo Nordisk Canada Inc.
Mississauga, Ontario, Canada
GlucaGen® (recombinant glucagon for injection)
For more information on GlucaGen, see product primer in PDF
Diacol®
Diacol®, the first patented sodium phosphate purgative in tablet format. Diacol® which is marketed in the United States under the name Visicol®, is used to cleanse the bowel prior to a colonoscopy. Colonoscopy is a commonly used screening technique for colon cancer. There are approximately 300,000 colonoscopies performed in Canada each year carried out almost exclusively by 300 gastroenterologists. According to IMS Canada, in 2002 the total Canadian market for purgative agents was $5.08 million, up 13% versus 2001.
Exclusive Canadian distributor for:
InKine Pharmaceutical Company, Inc.
Blue Bell, PA, USA
For more information on Diacol®, see product primer in PDF
FidelinT (DHEA)
For Diseases Associated with Aging and Adrenal Insufficiency
FidelinT (DHEA) is a prevalent neurosteroid that decreases with ageing. Literature suggests that if exogenous FidelinT is administered to older patients or patients suffering from depression, there may be beneficial effects on mood and general well-being. Additionally, a recent paper in the New England Journal of Medicine
revealed that in a Phase II trial, women with Addison's Disease (adrenal insufficiency) had statistically significant improvement in well-being and sexual function after taking 50mg of DHEA daily.
FidelinT is not regulated as a drug in the US, and as a result, there is a healthy over the counter market estimated to be in excess of US$50 million in that country. In Canada, however FidelinT is a controlled substance.
Paladin is continuing the development of this product in order to gain regulatory approval in Canada, and make the product available to Canadian specialty physicians. As a first step, in 2000 Paladin co-sponsored a pioneering study of the condition of andropause, or the male equivalent to female menopause. This study, being conducted by prominent Canadian specialists, is attempting to establish that andropause does exist. If proven, a clinical trial will be undertaken to prove that the treatment of andropause with FidelinT, melatonin, testosterone, and/or human growth hormone produces therapeutic benefits. In 2001, Paladin advanced its clinical program by focusing its efforts on furthering the study of the use of FidelinT for the treatment of Addison's Disease, and exploring how to collaborate with international companies in order to expedite the clinical development of FidelinT.
During the third quarter 2003, Paladin announced that it received orphan drug designation for FidelinT (DHEA / prasterone) in the United States and Europe. Orphan drug designation in the U.S. provides FidelinT with seven years of market exclusivity in the U.S. and 10 years of market exclusivity in Europe following regulatory approval. Adrenal insufficiency affects an estimated 100,000 patients in the U.S. and 115,000 patients in Europe.
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