DRAXIS and Pfizer Amend License Terms for Anipryl in Europe.Business Editors MISSISSAUGA, Ontario--(BUSINESS WIRE)--Dec. 23, 1999 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.) DRAXIS Health Inc. (TSE: DAX; NASDAQ: DRAX) today announced that it has amended the license terms with Pfizer in respect of Anipryl(r) for the European market. Under the terms of the original licensing agreement, DRAXIS was eligible to receive a maximum US$41.1 million based on receipt of regulatory approvals for Canine Cognitive Dysfunction Syndrome (CDS) and Cushing's disease Cushing's disease: see Cushing, Harvey Williams. in specified countries. DRAXIS has already received US$28 million from Pfizer and under the terms of the amended agreement, will continue to be entitled to receive a further US$4.1 million milestone based on the receipt of approvals in specified non-European jurisdictions. A lower-priced selegiline-based product is now being sold in the European veterinary market for indications other than Cushing's disease or CDS. Under the amended license terms Pfizer will retain its European rights to Anipryl(r) and, notwithstanding potential competition, reaffirms its present intention to launch in Europe after DRAXIS achieves the necessary regulatory approval. US$9 million of milestones related to Europe will be eliminated in exchange for DRAXIS receiving additional funding for the completion of a clinical trial on a new Anipryl(r) indication, additional regulatory support for the new indication as well as manufacturing data. The clinical trial is expected to be completed in 2000, and 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 the new indication. 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 Health stated, "The Company remains encouraged by positive market research results concerning Anipryl(r) and Pfizer's commitment to invest significantly in market development for the CDS and Cushing's claims. The Company will also continue to be entitled to royalties on global Anipryl(r) sales by Pfizer and will retain the manufacturing rights for Anipryl(r). In addition, DRAXIS will retain royalty entitlements in all territories, including Europe, for the new Anipryl(r) indication currently under development." Anipryl(r) is approved in Canada, Australia and the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. 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 de·cen·tral·ize v. de·cen·tral·ized, de·cen·tral·iz·ing, de·cen·tral·iz·es v.tr. 1. To distribute the administrative functions or powers of (a central authority) among several local authorities. 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 disorientation /dis·or·i·en·ta·tion/ (-or?e-en-ta´shun) the loss of proper bearings, or a state of mental confusion as to time, place, or identity. , 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 specialty 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 US Securities and Exchange Commission and Canadian securities authorities. |
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