DRAXIS Receives New Zealand Approval for Anipryl.Business Editors MISSISSAUGA, Ontario--(BUSINESS WIRE)--May 18, 2000 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 Anipryl(R), a veterinary prescription medication licensed to Pfizer Inc. (NYSE NYSE See: New York Stock Exchange : PFE 1. (text, editor) PFE - Programmer's File Editor. 2. (language) PFE - Portable Forth Environment. ), has been cleared by the New Zealand Animal Remedies Board for the treatment of uncomplicated pituitary-dependent hyperadrenocorticism (PDH PDH - Plesiochronous Digital Hierarchy or Cushing's disease) and age associated cognitive dysfunction (CDS) in dogs. New Zealand represents the fourth jurisdiction to approve Anipryl(R) for these two indications. Dr. Martin Barkin, the 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: "We are pleased to report these positive developments regarding Anipryl(R). After it is launched, the worldwide sales base for Anipryl(R) will increase, which in turn will generate additional derivative royalties and manufacturing margins for DRAXIS. The New Zealand approval, however, does not trigger any incoming milestone payments." In December 1997, DRAXIS entered into a worldwide comprehensive alliance with Pfizer Inc. with respect to Anipryl(R). Under the terms of the alliance, DRAXIS licensed the right to market, sell and distribute Anipryl(R) globally in return for milestones, royalty payments, a supply agreement and a research and development (R&D) collaboration. Dr. Barkin continued, "As part of our R&D collaboration, DRAXIS is also involved in a new clinical trial, expected to be completed in 2000. Subject to successful results and regulatory approval, DRAXIS will be entitled to receive up to an additional US$8 million in milestone payments in respect of this new indication." Anipryl(R) is approved in Canada, Australia, the United States and now New Zealand for the control of clinical signs of canine Cushing's disease and CDS and has been submitted for approval in the United Kingdom under the decentralized European registration procedure. CDS, sometimes known as "Old Dog Syndrome", refers to the onset in elderly dogs of behavioral problems unrelated to a generalized medical condition such as neoplasia neoplasia /neo·pla·sia/ (-pla´zhah) the formation of a neoplasm. cervical intraepithelial neoplasia , infection, or organ failure. Typical signs of this disorder can include: confusion, disorientation, decreased activity, changes in sleep/wake cycles, loss of house training and loss of interest in or ability to interact with its owner and environment. Canine Cushing's disease is a disorder that affects mainly older dogs and is associated with persistently elevated blood cortisol cortisol (kôr`tĭsôl') or hydrocortisone, steroid hormone that in humans is the major circulating hormone of the cortex, or outer layer, of the adrenal gland. and the presence of one or more clinical signs such as changes in appetite, obesity, excessive water consumption, frequent urination urination Process of excreting urine from the bladder (see urinary system). Nerve centres in the spinal cord, brain stem, and cerebral cortex control it through involuntary and voluntary muscles. The need to void is felt when the bladder holds 3. , abdominal distention dis·ten·tion or dis·ten·sion n. The act of distending or the state of being distended. distention, n a state of dilation. , loss of hair, lethargy and reduced interaction with owners. DRAXIS Health Inc. is a diversified speciality pharmaceutical company operating in three niche markets: Radiopharmaceuticals (DRAXIMAGE), Canadian sales and marketing (DRAXIS Pharmaceutica) and Companion Animal Health (through its global alliance with Pfizer Inc.). DRAXIS supports its own as well as third party manufacturing requirements through its subsidiary, DRAXIS Pharma, located in Kirkland, Quebec. 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 U.S. Securities and Exchange Commission and Canadian securities authorities. |
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