DRAXIS Files New Drug Submission for One-Alpha D2 with the Canadian Health Protection Branch.MISSISSAUGA, ONTARIO--(BUSINESS WIRE)--July 30, 1998--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 :DRAXF) (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :DAX.) DRAXIS Health Inc. announced today that it has filed a New Drug Submission with the Canadian Health Protection Branch for the oral formulation of one-alpha D2 for the treatment of secondary hyperparathyroidism secondary hyperparathyroidism Endocrinology ↑ Parathyroid activity with overproduction of PTH due to parathyroid hyperplasia in response to an extraparathyroid defect that results in ↓ Ca2+ Etiology Rickets, vitamin D deficiency, chronic renal failure associated with 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 . DRAXIS holds the Canadian rights to one-alpha D2 from Bone Care International, Inc. (NASDAQ:BCII BCII Battle Command and Intelligence Integration ) for secondary hyperparathyroidism and all indications associated with metabolic bone disease metabolic bone disease Any defect in bone absorption or deposition that alters the PTH/calcium-phosphate/vitamin D axis, often with ↑ bone fragility Etiology Fibrous dysplasia, Langerhans' cell histiocytosis/histiocytosis X, acromegaly, corticosteroid therapy, . On March 9, 1998, Bone Care announced that it had submitted a New Drug Application with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. for the same indication. In the clinical trials conducted by Bone Care, oral one-alpha D2 effectively controlled moderate to severe secondary hyperparathyroidism with no clinically meaningful side effects Side effects Effects of a proposed project on other parts of the firm. in end-stage renal disease patients undergoing hemodialysis. In commenting on the Canadian filing, 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 stated: "All patients with kidney failure, and particularly those on dialysis, are at risk of developing secondary hyperparathyroidism and related bone disease. One-alpha D2 offers an effective and safer alternative to those afflicted with the disease when compared to the current therapy." Bone Care is an emerging pharmaceutical company which is developing D-hormone therapies with improved safety and efficacy profiles for treatment of: (a) secondary hyperparathyroidism associated with renal disease and osteoporosis; and (b) certain hyperproliferative diseases, including psoriasis and cancers of the breast, prostate and colon. DRAXIS Health Inc. is a diversified pharmaceutical company with operations in four niche businesses: Deprenyl Animal Health, Inc. researches and develops prescription pharmaceuticals for companion animals, the lead product of which, Anipryl(R), has been licensed to Pfizer Animal Health on a worldwide basis; SpectroPharm Dermatology researches, develops, markets and sells prescription and non-prescription dermatologicals; Draximage researches, develops, manufactures, markets and sells radiopharmaceuticals for diagnostic and therapeutic purposes; and DRAXIS Pharmaceutica markets and sells prescription pharmaceuticals in Canada. DRAXIS Pharma Inc., DRAXIS' pharmaceutical manufacturing subsidiary, will add a fifth platform to DRAXIS' diversified pharmaceutical base and provide manufacturing support to DRAXIS' other business units. 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.
CONTACT: Draxis Health Inc.
Kendall McAlister, 905/ 677-5500 ext. 248
Kmcalister@draxis.com
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