ChemTrak and Astra Merck sign agreement for H. pylori test.SUNNYVALE, Calif.--(BUSINESS WIRE)--March 2, 1995--ChemTrak 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 :CMTR CMTR Certified Material Test Report CMTR Combined Marginal Tax Rate ) and Astra Merck Inc. Thursday announced the signing of a distribution and supply agreement for ChemTrak's development-stage test for detecting the presence of Helicobacter pylori Helicobacter pylori A gramnegative rod-shaped bacterium that lives in the tissues of the stomach and causes inflammation of the stomach lining. Mentioned in: Indigestion, Ulcers Helicobacter pylori (H. pylori). H. pylori infection, one of the most common bacterial infections in humans, is thought to be the major cause of peptic ulcers Peptic ulcers Wounds in the stomach and duodenum caused by stomach acid and the bacterium Helicobacter pylori. Mentioned in: Tube Compression of the Esophagus and Stomach . Currently, H. pylori is detected through endoscopy endoscopy Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the procedures performed by physicians, by breath tests using special equipment or by direct immunoassays for antibodies to H. pylori in blood samples. ChemTrak's product is a one-step, whole blood test that will indicate the presence or absence of H. pylori antibodies in minutes. The distribution and supply agreement grants Astra Merck exclusive U.S. marketing rights to ChemTrak's H. pylori test for both professional markets and for over-the-counter ("OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). ") retail outlets. Under the agreement, Astra Merck has the right to sub-license the marketing of the product to other companies; no final decisions have yet been made by Astra Merck concerning OTC marketing. In return, ChemTrak is entitled to receive separate cash payments from Astra Merck upon the realization of certain milestones ultimately leading to the commercialization of the H. pylori test. ChemTrak also will receive a per-unit transfer price for each product unit it manufactures and sells to Astra Merck. Plans are to make the test available to physicians first, then to manufacture a consumer self-test similar to ChemTrak's AccuMeter(R) Cholesterol Self-Test. Pending the completion of product development in mid-year 1995 and subsequent clinical studies, ChemTrak expects to file an application with 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 professional market H. pylori test. "The H. pylori test is expected to provide further validation of the versatility of our AccuMeter technology, and we are delighted to be aligned with Astra Merck, whose product Prilosec(R) (omeprazole) is the most prescribed drug among gastroenterologists," said Prithipal Singh, Ph.D., chairman and chief executive officer of ChemTrak. "The H. pylori agreement along with our test for total cholesterol, our high-density lipoprotein ("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. ") cholesterol test and our home access HIV test exemplify ChemTrak's commitment to become a leading consumer medical diagnostics company." Dr. Singh added that the company's professional HDL test and its home access HIV test have been submitted to the FDA for marketing clearance. ChemTrak's total cholesterol test is marketed to U.S. OTC retail outlets under the Johnson & Johnson Advanced Care(TM) Cholesterol Test brand name. Wayne Yetter, president and chief executive officer of Astra Merck, stated "Our agreement with ChemTrak underscores Astra Merck's commitment to providing quality products for physicians and patients in the anti-ulcer therapeutic area. In addition to being able to distribute the ChemTrak test, which will be a quick and easy way to identify the H. pylori bacterium, we signed an agreement last year with Applied Microbiology of Tarrytown, N.Y. to develop an antimicrobial peptide bacteriocin bacteriocin /bac·te·rio·cin/ (bac-ter´e-o?-sin) any of a group of substances, e.g., colicin, released by certain bacteria that kill other strains of bacteria by inducing metabolic block. , Ambicin N, which has the potential to cure the H. pylori infection. Abbott Pharmaceuticals has filed an SNDA SNDA Supplemental New Drug Application SNDA Student National Dental Association SNDA Subordination, Non-Disturbance and Attornment SNDA Singapore Nutrition and Dietectics Association SNDA Southern Nevada Darts Association (Las Vegas, Nevada) for use of our product Prilosec in combination with Abbott's antibiotic Biaxin(R) (clarithromycin) to cure the infection, and we are also conducting our own studies of Prilosec plus amoxicillin amoxicillin /amox·i·cil·lin/ (ah-mok?si-sil´in) a semisynthetic derivative of ampicillin effective against a broad spectrum of gram-positive and gram-negative bacteria. a·mox·i·cil·lin n. ." H. pylori, which afflicts an estimated 40% of the U.S. population, is found in approximately 90% of patients with duodenal ulcers and 70% of patients with gastric ulcers. About 10% to 15% of the world's population have peptic ulcers at some time in their lives. Research shows that once H. pylori is eliminated, the average one-year ulcer recurrence rate is approximately 10%, compared with a 50% to 70% one-year recurrence rate for ulcers treated with anti-ulcer drugs alone. Astra Merck, previously a unit of Merck & Co., Inc., became America's newest pharmaceutical company on Nov. 1, 1994, when it was reorganized as a separate company, owned equally by Merck and Astra AB. In addition to its anti-ulcer and gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. drug Prilosec, the company markets the cardiovascular drugs Plendil(R) (felodipine) and Tonocard(R) (tocainide HCl). ChemTrak develops and manufactures easy-to-use tests to screen, monitor and diagnose health conditions with accuracy comparable to physician office and laboratory instrumented tests. The company markets its products to OTC and professional markets worldwide directly and through corporate alliances with established healthcare and consumer products companies. ChemTrak's patented, noninstrumented, palm-size AccuMeter cassette system is an enabling technology expected to be applicable to a broad range of general chemistry and immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. tests. CONTACT: ChemTrak Inc., Sunnyvale, Calif. Bruce Voss, 408/773-8156 Astra Merck Inc., Wayne, Pa. Cathy Kernen, 610/695-1230 |
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