Cardiome Acquires Clinical Program; Gout Program Builds on Congestive Heart Failure Asset.Business Editors & Health/Medical Writers BIOWIRE2K VANCOUVER, British Columbia--(BW HealthWire)--May 16, 2002 Cardiome Pharma Corp. (the "Company") (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :COMRF) (CDNX CDNX See Canadian Venture Exchange (CDNX). :COM (1) (Computer Output Microfilm) Creating microfilm or microfiche from the computer. A COM machine receives print-image output from the computer either online or via tape or disk and creates a film image of each page. ) announced today that it has exercised an option to acquire the rights from ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. (TM) Oncology, Inc. ("ILEX" Nasdaq: ILXO) to clinical trial data for oxypurinol (Oxyprim(TM)) for the treatment of symptomatic hyperuricemia hyperuricemia /hy·per·uri·ce·mia/ (-u?ri-se´me-ah) uricemia; an excess of uric acid in the blood.hyperurice´mic hy·per·u·ri·ce·mi·a n. An unusually high concentration of uric acid in the blood. (gout) in allopurinol-intolerant patients. ILEX completed an open-label Phase II clinical study on Oxyprim(TM) for the treatment of patients with gout who are intolerant to allopurinol allopurinol /al·lo·pur·i·nol/ (al?o-pur´i-nol) an isomer of hypoxanthine, capable of inhibiting xanthine oxidase and thus of reducing serum and urinary levels of uric acid; used in prophylaxis and treatment of hyperuricemia and uric acid , the first-line therapy for gout. Patient treatment has largely been completed and trial data had been transferred to Cardiome. Cardiome obtained the ILEX option pursuant to Cardiome's recent acquisition of Paralex, Inc. "Cardiome is committed to developing oxypurinol for the treatment of congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. ," said Bob Rieder, Cardiome's President & 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. . "The acquisition of rights to the gout clinical program serves three important priorities for Cardiome. First, the data will be an important addition to our IND for the CHF CHF In currencies, this is the abbreviation for the Swiss Franc. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. application. Second, the option exercise adds strength to Cardiome's proprietary position in the CHF program. Finally, the option exercise may result in Cardiome having an FDA-approved drug much earlier than we had previously envisioned." ILEX pursued clinical development of Oxyprim(TM) in gout patients intolerant to allopurinol. About 2% of the four million patients treated for gout worldwide have such allopurinol intolerance. These patients have no other treatment option for the hyperuricemia that underlies their gout symptoms. In the ILEX clinical study, it was found that 70% of the allopurinol intolerant gout patients who received Oxyprim(TM) had no dose-limiting side effects and patients treated with 300mg/day for greater than 3 weeks appeared to benefit (with lower uric acid levels) from their use of the drug. Oxyprim(TM) applied to gout has been granted orphan drug status in the U.S. A compassionate-use program has been underway applying Oxyprim(TM) to allopurinol intolerant gout patients for more than 10 years. The compassionate-use program was initiated by GlaxoSmithKline, continued since 1995 under ILEX, and is now administered by Cardiome. More than 340 patients have been chronically treated in this program. "From a drug development perspective, oxypurinol is a very attractive candidate, given its safety record in gout patients," said Dr. Alan Ezrin, Chief Scientific Officer of Cardiome. "In the setting of congestive heart failure, evidence suggests that we may have a potentially disease-modifying therapy. We are intrigued by oxypurinol's apparent ability to reduce oxygen wastage in CHF patients and attracted to the risk reduction strategy empowered by the published clinical efficacy. The known side-effect profile from the gout compassionate-use program may allow us to proceed directly to a Phase II efficacy study in CHF patients by year-end. In the setting of gout, we are currently evaluating the appropriate strategy for NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any submission to treat allopurinol-intolerant gout patients." About congestive heart failure: CHF is the failure of the heart to pump blood at a rate sufficient for the metabolizing tissue. During CHF, cardiac output decreases, resulting in, among other things, an increase in venous fluid volume. It is characterized by fatigue, shortness of breath Shortness of Breath Definition Shortness of breath, or dyspnea, is a feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity. and fluid retention. It generally occurs when the left ventricle pumping capability begins to fail. About gout: Gout is a painful metabolic disease in which the excess of uric acid in the body causes crystalization of uric acid in the joints of the body. The symptoms include arthritis-like joint pain and progressive loss of kidney function. The elevated uric acid levels are typically caused by inappropriate diet, by excessive uric acid production, or by reduced ability to clear uric acid. First line therapy is a generic drug called allopurinol, which inhibits xanthine oxidase, a critical mediator of uric acid production. About 2% of gout patients are strongly allergic to allopurinol, and are at this time left with few therapeutic alternatives. About Cardiome Pharma Corp. Cardiome Pharma Corp. is a product-focused cardiovascular drug development company. The Company's mission is to prevent and treat heart disease. The Company has four drug programs focused on arrhythmias and congestive heart failure. Cardiome is traded on the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. (COM) and the NASD NASD See: National Association of Securities Dealers NASD See National Association of Securities Dealers (NASD). OTCBB market (COMRF). Further information about Cardiome can be found at www.cardiome.com. About ILEX Founded in 1994 as an oncology drug development company, ILEX is strategically positioned to become a product-driven, oncology-focused biopharmaceutical company. ILEX has a marketed product, CAMPATH(R) in the United States and MABCAMPATH(TM) in the European Union, and is advancing an innovative and diversified pipeline of compounds focused on the treatment of cancer. The ILEX pipeline comprises product candidates at various stages of clinical development, including cytotoxic and cytostatic cytostatic /cy·to·stat·ic/ (sit?ah-stat´ik) 1. suppressing the growth and multiplication of cells. 2. an agent that so acts. cy·to·stat·ic adj. 1. agents with novel mechanisms of action, monoclonal antibodies, angiogenesis inhibitors and signal transduction inhibitors. ILEX maintains a core competency in oncology drug development, with locations in San Antonio, Texas “San Antonio” redirects here. For other uses, see San Antonio (disambiguation). San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S. , and Guildford, England. ILEX also conducts research in angiogenesis inhibition, cell signalling, medicinal chemistry and nuclear receptor biology at its laboratories in Boston, Mass., and Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. , Switzerland. Further information about ILEX can be found on the company's web site at www.ilexonc.com. ON BEHALF OF THE BOARD Robert Rieder, President & Chief Executive Officer Statements contained in this news release relating to future results, events and expectations are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such statements. Such factors include, among others, those described in the Company's annual report on Form 20-F on file with the U.S. Securities and Exchange Commission. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. |
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