Health Canada Approves DRAXIS' Hectorol.Business Editors MISSISSAUGA, Ontario--(BUSINESS WIRE)--May 3, 2001 DRAXIS Health Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DRAX)(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :DAX.) today announced that it has received a Notice of Compliance (NOC (Network Operations Center) A central or regional location for monitoring a large network. Also called a "network management center" (NMC), "service management center" (SMC) or "network control center" (NCC), a NOC may be used to manage a large enterprise network, ) for Hectorol(R) (doxercalciferol) from the Therapeutic Products Programme (TPP TPP thiamine pyrophosphate. Thiamine pyrophosphate (TPP) The coenzyme containing thiamine that is essential in converting glucose to energy. Mentioned in: Beriberi TPP 1. total plasma protein. 2. ) of Health Canada. Hectorol(R), indicated for the reduction of elevated parathyroid hormone parathyroid hormone or parathormone, a hormone secreted by the parathyroid glands that regulates the metabolism of calcium and phosphate in the body. levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis, will be the first Vitamin D analogue introduced in Canada in over five years. In Canada, there are approximately 25,000 end stage renal dialysis patients currently and future growth projected at 6% per annum. The oral Vitamin D analogue market in Canada is currently estimated at $7 million. Dr. Martin Barkin, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of DRAXIS Health, stated, "With regulatory approvals now received, we intend to make Hectorol(R) available in the Canadian market within the next few months. Hectorol(R), the fourth new product to be introduced by DRAXIS within the past 24 months, will represent the ninth pharmaceutical product in our Canadian sales and marketing portfolio." Secondary hyperparathyroidism is a serious medical condition which affects approximately three-quarters of patients on dialysis for the treatment of end stage renal disease. Patients undergoing dialysis can no longer produce D-hormones which are required for the maintenance of healthy bones. Hectorol is a Vitamin D pro-hormone which is metabolized by the body into two, naturally-occurring active D-hormones. These D-hormones are released into the bloodstream at a rate closely resembling the normal production of these same D-hormones by healthy kidneys. DRAXIS Pharmaceutica markets and sells in-licensed pharmaceutical products in Canada with a current focus in neurology. Products currently marketed by Pharmaceutica include Permax(R) and Eldepryl(R) for Parkinson's disease, Alertec(R) for narcolepsy narcolepsy, a sleep disorder characterized by excessive daytime sleepiness and recurring unwanted episodes of sleep ("sleep attacks"). People with narcolepsy may abruptly fall asleep at almost any time, including while talking, eating, or even walking. , Zanaflex(R) for the treatment of spasticity spasticity /spas·tic·i·ty/ (spas-tis´i-te) the state of being spastic; see spastic (2). spas·tic·i·ty n. 1. A spastic state or condition. 2. Spastic paralysis. , and Mysoline(R) and Diastat(R) for epilepsy. Pharmaceutica currently has six products filed for Canadian regulatory approval including MYOBLOC(TM) (botulinum toxin type B botulinum toxin type B Myobloc, NeuroBloc (UK) Pharmacologic class: Neurotoxin Therapeutic class: Neuromuscular blocker Pregnancy risk category C Action) for the treatment of cervical dystonia.DRAXIS Health Inc. is a diversified specialty pharmaceutical company with operations in three niche markets: radiopharmaceuticals (DRAXIMAGE), contract manufacturing (DRAXIS Pharma), and pharmaceutical sales and marketing (DRAXIS Pharmaceutica). Except for historical information, this news release contains certain forward-looking statements that involve risk and uncertainties, which may cause actual results to differ materially from the statements made. Such factors include, but are not limited to, changing market conditions, clinical trial results, the establishment of new corporate alliances, the impact of competitive products and pricing, the timely development, regulatory approval and market acceptance of the Company's products, and other risks detailed from time-to-time in the Company's filings with the US Securities and Exchange Commission and Canadian securities authorities |
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