Bone Care International Announces Approval of Hectorol by Health Canada.Business Editors MIDDLETON, Wis.--(BUSINESS WIRE)--May 3, 2001 Bone Care International, 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 : BCII BCII Battle Command and Intelligence Integration ) today announced that Draxis Health Inc. (NASDAQ:DRAX) has received a Notice of Compliance (NOC) for Hectorol(R) Capsules 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. Bone Care received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval for Hectorol(R) Capsules in June 1999 and received FDA approval for Hectorol(R) Injection in August 2000. Bone Care has licensed Hectorol(R) to Draxis Health Inc. on an exclusive basis for the Canadian market. Hectorol(R) will be the first Vitamin D analogue introduced in Canada in over five years where there are approximately 25,000 end-stage renal dialysis patients. The oral Vitamin D analogue market in Canada is currently estimated at $7 million. Hectorol(R) is a safe and effective therapy for reducing elevated levels of parathyroid hormone (PTH PTH abbr. parathyroid hormone Parathyroid hormone (PTH) A chemical substance produced by the parathyroid glands. This hormone is a major element in regulating calcium in the body. ) in blood in the management of secondary hyperparathyroidism, a disease characterized by excessive PTH. Secondary hyperparathyroidism is a serious medical condition which affects approximately three-quarters of patients on dialysis for the treatment of end-stage renal disease End-stage renal disease (ESRD) Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity. Mentioned in: Chronic Kidney Failure end-stage renal disease . Patients undergoing dialysis can no longer produce D-hormones which are required for the maintenance of healthy bones. Hectorol(R) 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. Dr. Charles Bishop, 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 Bone Care, stated "We are pleased that Hectorol(R) is now approved in both the United States and Canada. We plan to initiate the European registration process later this year." Bone Care is a pharmaceutical company engaged in discovering, developing and commercializing improved vitamin D-hormone therapies to treat secondary hyperparathyroidism in patients with kidney, or renal disease, and osteoporosis, and other diseases including psoriasis and cancers of the prostate, breast and colon. |
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