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DRAXIS - FDA Clears Anipryl - selegiline hydrochloride - For Canine Cognitive Dysfunction Syndrome - New Indication to be Launched in January 1999.


MISSISSAUGA, Ontario--(BUSINESS WIRE)--Dec. 11, 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. 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 U.S. Food and Drug Administration ("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.
") for the control of clinical signs associated with canine Cognitive Dysfunction Syndrome (CDS). Anipryl(R) is already marketed in the United States for the control of clinical signs associated with uncomplicated canine pituitary-dependent hyperadrenocorticism (PDH PDH - Plesiochronous Digital Hierarchy  or Cushing's disease Cushing's disease: see Cushing, Harvey Williams. ), and in Canada for the control of clinical signs of both canine Cushing's disease and canine CDS.

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 to Pfizer Animal Health. DRAXIS also supplies the manufactured product to Pfizer.

The receipt of this FDA clearance for CDS entitles DRAXIS to receive a US$10 million milestone payment from Pfizer which DRAXIS expects will be paid prior to the end of 1998. In addition, DRAXIS will now receive royalties from the revenue generated from sales in the US attributed to CDS, as well as those from Cushing's disease.

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. In clinical studies, the most common side effects Side effects

Effects of a proposed project on other parts of the firm.
 of Anipryl(R) were vomiting, diarrhea or changes in behavior. Pet owners should consult a veterinarian veterinarian /vet·er·i·nar·i·an/ (vet?er-i-nar´e-an) a person trained and authorized to practice veterinary medicine and surgery; a doctor of veterinary medicine.

vet·er·i·nar·i·an
n.
 before using Anipryl(R) with other medications or with tick collars. An estimated 6.5 million dogs age eight and older show at least one clinical sign associated with CDS(1). Until now, owners of afflicted dogs in the United States had limited medical options.

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 stated: "Anipryl(R) has shown steady growth since its introduction in the US marketplace for canine Cushing's disease in March 1997. We are excited that Pfizer will now also be marketing Anipryl(R) in the United States for canine Cognitive Dysfunction Syndrome, a very important indication for the product. We believe Anipryl(R) can significantly improve the quality of life of older dogs suffering from this condition."

(1) Proprietary market research. Data on file at Pfizer Animal Health, March 1998.

The Pfizer Animal Health Group is a global leader in the discovery, development and delivery of innovative drugs for the treatment of disease in companion animals and livestock. Pfizer Inc. is a research-based, global pharmaceutical company. In 1997 the company reported revenues of about US$12.5 billion and this year, expects to spend approximately US$2.2 billion on research and development.

DRAXIS Health Inc. is a diversified and fully integrated pharmaceutical company operating in four niche markets: Veterinary (through its global alliance with Pfizer Inc.) Radiopharmaceuticals (Draximage), Dermatology (SpectroPharm) and Canadian sales and marketing (DRAXIS Pharmaceutica). 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.
COPYRIGHT 1998 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1CANA
Date:Dec 11, 1998
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