Kos Pharmaceuticals and Oryx Pharmaceuticals Establish Canadian Commercialization Agreement.Business Editors/Health/Medical Writers MIAMI Miami, cities, United States Miami (mīăm`ē, –ə). 1 City (1990 pop. 358,548), seat of Dade co., SE Fla., on Biscayne Bay at the mouth of the Miami River; inc. 1896. & MISSISSAUGA, Ontario--(BUSINESS WIRE)--Aug. 20, 2003 Oryx oryx (ôr`ĭks), name for several small, horselike antelopes, genus Oryx, found in deserts and arid scrublands of Africa and Arabia. They feed on grasses and scrub and can go without water for long periods. Gains Exclusive Commercialization Rights to Lipid-Modifying Drugs Niaspan(R)and Advicor(TM) in Canada Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) and Oryx Pharmaceuticals today announced a development and commercialization agreement for Niaspan(R)and Advicor(TM), two products internally developed by Kos for the treatment of cholesterol disorders. Pursuant to the agreement, Oryx will receive exclusive commercialization rights to Niaspan and Advicor in Canada. With this agreement, Niaspan and Advicor will potentially be available in every country around the world, except Japan, and obtain broader penetration in the $20 billion worldwide cholesterol market. Niaspan (extended-release niacin niacin: see coenzyme; vitamin. niacin or nicotinic acid or vitamin B3 Water-soluble vitamin of the vitamin B complex, essential to growth and health in animals, including humans. ) and Advicor (extended-release niacin/lovastatin), both approved by 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. (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. ), are two highly differentiated lipid-modifying products that participate in the large and rapidly growing cholesterol market. Oryx is responsible for obtaining marketing authorization for Niaspan and Advicor in Canada and for all promotional investments. Kos will be responsible for manufacturing and supplying Niaspan and Advicor for sale in Canada. Under the terms of the agreement, Kos will receive a significant share of revenue from the sale of the products in the territory. Oryx, a Canadian specialty pharmaceutical company focused on several therapeutic areas, including cardiovascular disease, will deploy a dedicated cardiovascular sales force to commercialize the products beginning late 2005 following the approval of each drug. Oryx currently promotes several prescription pharmaceutical products in Canada including two cardiovascular therapies, Corvert(R), from Pharmacia Canada, and Angiomax(R), from The Medicines Company. The market covered by the agreement represents an attractive opportunity for both Kos and Oryx. In 2002, the Canadian cholesterol market was valued about $1.2 billion and grew at an annual rate of 22 percent. According to the Heart and Stroke Foundation of Canada The Heart and Stroke Foundation of Canada is a registered Canadian charity. The foundation's purpose is centered around educating individuals about the prevention and management of heart disease and strokes, and to fund medical research regarding the causes of these conditions. , more Canadians die from cardiovascular disease than any other disease. In the United States, Kos' cholesterol franchise continues to experience rapid growth, with sales for the six months ended June 30, 2003 of a record $133.1 million, reflecting an 85% increase from the comparable period a year ago. "Our partnership with Oryx to market Niaspan and Advicor in Canada is another major milestone for Kos and is consistent with our goal to further establish a world-wide presence for our drugs," said Adrian Adams, President and Chief Executive Officer, Kos Pharmaceuticals, Inc. "Oryx has the proven expertise in the cardiovascular area to bolster sales for our two already successful products. Due to the large incidence of cardiovascular disease within Canada, we expect Canadian cardiologists to be supportive of Niaspan and Advicor and we look forward to bringing these extremely important and effective treatments to them." "These two products are great additions to our cardiovascular portfolio," said Douglas Reynolds, President of Oryx. "With the existing expertise and reach that our organization possesses in this area, we believe we are in a position to successfully commercialize these innovative and successful therapies that address critical unmet needs, such as raising HDL cholesterol." About Niaspan: Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release formulation of niacin for treating abnormal cholesterol levels. Niacin is a B-vitamin that for decades had been known to be an effective cholesterol medication at high doses but was limited by significant side effects. Kos' solid-dose drug delivery technology transformed niacin, the most powerful agent available for increasing HDL (Hardware Description Language) A language used to describe the functions of an electronic circuit for documentation, simulation or logic synthesis (or all three). Although many proprietary HDLs have been developed, Verilog and VHDL are the major standards. (High-Density Lipoprotein; "good" cholesterol) into a highly effective, patient friendly therapy used by thousands of patients with coronary disease. Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, to reduce elevated total cholesterol, LDL LDL - ["LDL: A Logic-Based Data-Language", S. Tsur et al, Proc VLDB 1986, Kyoto Japan, Aug 1986, pp.33-41]. (Low-Density Lipoprotein; "bad" cholesterol), Apo B, and triglycerides (TG) levels, and to increase HDL in patients with primary hypercholesterolemia Hypercholesterolemia Definition Hypercholesterolemia refers to levels of cholesterol in the blood that are higher than normal. Description Cholesterol circulates in the blood stream. It is an essential molecule for the human body. and mixed dyslipidemia. Additionally, Niaspan is also indicated to reduce the risk of recurrent heart attacks in patients who have a history of heart attack and hypercholesterolemia. About Advicor: Advicor, the first and only FDA-approved combination therapy for the treatment of patients with multiple lipid disorders, combines Niaspan with lovastatin lovastatin /lo·va·stat·in/ (lo´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated with , the first in the class of cholesterol drugs known as statins, in a single tablet formulation. Statins are known to be the most effective class of lipid-modifying drugs for reducing LDL levels, with lovastatin being the most time-tested, while niacin is the most powerful agent available for increasing HDL. Advicor gives physicians a convenient and safe option for the treatment of mixed dyslipidemia. Advicor is a single tablet medication that treats the major lipid parameters: LDL, HDL, and TGs and the emerging risk factor lipoprotein (a). Advicor is a fixed-dose combination product and is not indicated for initial therapy. Advicor is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, for the treatment of primary hypercholesterolemia and mixed dyslipidemia in patients who are taking: lovastatin and need further TG lowering or HDL raising who may benefit from having niacin added to their regimen or; niacin who need further LDL lowering who may benefit from having lovastatin added to their regimen. Niaspan and Advicor are contraindicated in patients with a known hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to their components, active liver or peptic ulcer disease Peptic ulcer disease (PUD) A stomach disorder marked by corrosion of the stomach lining due to the acid in the digestive juices. Mentioned in: Indigestion peptic ulcer disease See Duodenal ulcer, Gastric ulcer, GERD. , or unexplained persistent liver enzyme elevation, arterial bleeding or in pregnant or nursing women. Liver function tests Liver Function Tests Definition Liver function tests, or LFTs, include tests for bilirubin, a breakdown product of hemoglobin, and ammonia, a protein byproduct that is normally converted into urea by the liver before being excreted by the kidneys. should be monitored periodically. Niaspan or Advicor should not be substituted directly for equal doses of immediate-release niacin. Combination therapy with niacin and a statin may increase the risk of myopathy myopathy /my·op·a·thy/ (mi-op´ah-the) any disease of muscle.myopath´ic centronuclear myopathy myotubular m. and a serious but rare condition referred to as rhabdomyolysis rhabdomyolysis /rhab·do·my·ol·y·sis/ (-mi-ol´i-sis) disintegration of striated muscle fibers with excretion of myoglobin in the urine. rhab·do·my·ol·y·sis n. . The most common adverse event with Niaspan and Advicor is flushing. Other commonly reported adverse events include gastrointestinal symptoms and rash. About Kos Pharmaceuticals: Kos Pharmaceuticals, Inc. (http://www.kospharm.com) is a fully integrated specialty pharmaceutical company engaged in developing, commercializing, manufacturing and marketing proprietary prescription products for the treatment of chronic diseases. The Company's principal product development strategy is to reformulate Verb 1. reformulate - formulate or develop again, of an improved theory or hypothesis redevelop formulate, explicate, develop - elaborate, as of theories and hypotheses; "Could you develop the ideas in your thesis" existing pharmaceutical products with large market potential to improve safety, efficacy, or patient compliance. The Company currently markets Niaspan and Advicor for the treatment of cholesterol disorders. Kos is developing additional products and has proprietary drug delivery technologies in solid-dose and aerosol metered-dose inhalation administration. About Oryx Pharmaceuticals: Oryx Pharmaceuticals Inc. (http://www.oryxpharma.com) is a Canadian specialty pharmaceutical company with offices in Mississauga, Ontario. Its mission is to serve the needs of Canadian health care professionals and patients through the licensing and commercialisation of unique pharmaceutical products. Oryx is focused in the therapeutic areas of cardiovascular disease, CNS See Continuous net settlement. CNS See continuous net settlement (CNS). and oncology. Last year, Oryx launched Corvert, an injectable antiarrhythmic antiarrhythmic /an·ti·ar·rhyth·mic/ (-ah-rith´mik) 1. preventing or alleviating cardiac arrhythmias. 2. an agent that so acts. an·ti·ar·rhyth·mic adj. for the rapid conversion of atrial fibrillation and atrial flutter to normal sinus rhythm, under an exclusive marketing and promotion agreement with Pharmacia Canada, Inc. More recently, Oryx established a licensing agreement with The Medicines Company to launch Angiomax, an anticoagulant anticoagulant (ăn'tēkōăg`yələnt), any of several substances that inhibit blood clot formation (see blood clotting). in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty percutaneous transluminal coronary angioplasty n. Abbr. PTCA A procedure for enlarging a narrowed arterial lumen by peripheral introduction of a balloon-tip catheter followed by dilation of the lumen as the inflated catheter tip is (PTCA PTCA abbr. percutaneous transluminal coronary angioplasty PTCA Percutaneous transluminal coronary angioplasty, see there ). Certain statements in this press release, including statements regarding the continued growth in sales of Niaspan and Advicor, the commercialization of Niaspan and Advicor in Canada and other countries around the world, the growth of the Canadian cholesterol market, and expectations of support from Canadian cardiologists are forward-looking and are subject to risks and uncertainties. These risks and uncertainties include the market acceptance of the Advicor and Niaspan products, the ability to obtain regulatory approval for the marketing of Advicor and Niaspan in Canada the protection afforded by Kos' patents, the effect of conditions in the pharmaceutical industry and the economy in general, as well as certain other risks. A more detailed discussion of risks attendant to the forward-looking statements included in this press release are set forth in the "Forward-Looking Information: Certain Cautionary Statements" section of Kos' Annual Report on Form 10-K for the year ended December 31, 2002, filed with the Securities and Exchange Commission, and in other reports already filed with the SEC. |
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