DRAXIS - Receives Australian Approval of AniprylR selegiline hydrochloride For Canine Cognitive Dysfunction Syndrome and Cushing's Disease.MISSISSAUGA, ONTARIO--(BUSINESS WIRE)--Dec. 14, 1998-- DRAXIS Health Inc.(NASDAQ NASDAQ
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CORRECTION FROM SOURCE: Please note that the phone number for Lisa Carlton-Wilson should read 212-759-3929 and NOT 212-7459-3929. The correct and complete release follows.
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 National Registration Authority (NRA NRA
(National Rifle Association of America) organization that encourages sharpshooting and use of firearms for hunting. [Am. Pop. Culture: NCE, 1895]
See : Hunting ) for the control of clinical signs associated with canine Cognitive Dysfunction Syndrome (CDS) and for the control of clinical signs associated with uncomplicated canine pituitary-dependent hyperadrenocorticism (PDH PDH - Plesiochronous Digital Hierarchy or Cushing's disease). On December 11, 1998, DRAXIS announced that Anipryl(R) had been cleared by the US Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) for the control of clinical signs associated with 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 the Australian approval entitles DRAXIS to receive a US$3 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 of Anipryl(R) in Australia.
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: "On December 11, 1998, we announced that the FDA had cleared Anipryl(R) for CDS. We are doubly pleased that Pfizer will now also be able to market Anipryl(R) in Australia for canine CDS and Cushing's disease. We believe that Anipryl(R) can significantly improve the quality of life of older dogs suffering from these conditions. We continue to be pleased with the steady growth that Anipryl(R) has shown since its US introduction for canine Cushing's disease in March 1997."
Anipryl(R) is already marketed in the United States for the control of clinical signs of canine Cushing's and in Canada for the control of clinical signs of both canine Cushing's disease and canine CDS.
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 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.
n. before using Anipryl(R) with other medications or with tick collars. In the U.S. an estimated 6.5 million dogs age eight and older show at least one clinical sign associated with CDS(1).
(1)Proprietary market research. Data on file at Pfizer Animal Health, March 1998.
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
The act of distending or the state of being distended.
n a state of dilation. , loss of hair, lethargy and reduced interaction with owners. The disease is progressive and ultimately fatal. In the United States it is estimated that approximately half a million dogs are affected by canine Cushing's disease with about 150,000 new cases developing each year.
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.