Metra Biosystems Inc. Announces Distribution Agreement with Amersham International; Company Also Announces 510k Filing by Ciba Corning Diagnostics, Reorganization of Marketing and Sales Organization.MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Sept. 18, 1996--Metra Biosystems 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 :MTRA MTRA Monster Truck Racing Association MTRA Money Transmitter Regulators Association MTRA Medical Technical Research Associates (San Bruno, CA) MTRA Medizinisch Technische Radiologie Assistentinnen ) today announced an agreement with Amersham International plc to market Metra's bone metabolism It is a common misconception that bones are static in nature and hardly change once an individual becomes an adult. On the contrary, bones are continuously undergoing a dynamic process of resorption and deposition known as bone metabolism. immunoassays to the research community. Metra also announced that Ciba Corning Diagnostics Corp., a subsidiary of Chiron Corp., has filed a 510(k) premarket notification with the U.S. Food and Drug Administration for clearance to market Metra's Pyrilinks-D bone resorption Bone resorption is the process by which osteoclasts break down bone and release the minerals, resulting in a transfer of calcium from bone fluid to the blood. The osteoclasts are multi-nucleated cells that contain numerous mitochondria and lysosomes. technology for clinical use on Ciba Corning's ACS (Asynchronous Communications Server) See network access server. :180 automated 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. system. Finally, Metra announced a reorganization of its marketing and sales organization to address more closely current market demands. Amersham Agreement "Amersham will now have co-exclusive rights to distribute all of Metra's immunoassay products to the research community in 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. , United Kingdom, Eire, Denmark and Italy," said George Dunbar, Metra's president and chief executive officer. "We are confident that Amersham's leading presence will help Metra realize the commercial potential of our products in the academic clinical and pharmaceutical research markets, while enabling our sales force to focus its efforts on the clinical marketplace." Amersham's co-exclusive rights will include all of Metra's currently available immunoassays: Pyrilinks and Pyrilinks-D, Alkphase-B, NovoCalcin and Prolagen-C. The Pyrilinks products and Alkaphase-B are marketed by Metra for clinical use in the U.S., while NovoCalcin and Prolagen-C are distributed for research use only. All of Metra's assays are available for research or clinical use in Europe, and for research use in Japan. Amersham K.K. has distributed Metra's assays for research use in Japan since 1993. Ciba Corning 510(k) Filing "The 510(k) filing by Ciba Corning for an automated deoxypyridinoline crosslinks urine assay (the Pyrilinks-D technology) is an important advance in our plan to provide Metra assays through the installed base of automated testing systems in clinical laboratories worldwide," Dunbar said. "We now anticipate Metra's Pyrilinks-D technology will form the basis for the first bone resorption assay cleared for use in one of the cost-effective, high-throughput test systems," Dunbar added. Under Metra's 1993 agreement with Ciba Corning, Metra will receive royalty payments on sales through Ciba Corning's systems and Ciba Corning will purchase the required reagents from Metra. In addition to its collaboration with Ciba Corning, Metra has established alliances with Abbott Laboratories, Bayer Corp., and Diagnostic Products Corp. to incorporate Metra's assays into their automated immunoassay systems. Metra believes these companies together comprise up to 80% of the installed base of such systems worldwide. Pyrilinks-D is also marketed by Metra for clinical and research use in a manual test format to laboratories in the U.S., Europe and Asia Pacific. Ciba Corning combines biological technologies, chemistry and advanced systems to empower physicians with information to better manage therapies and help patients understand their disease. Ciba Corning's products include automated instrumentation, reagents, controls and nucleic acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis. systems to quantify viral load viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. . Ciba Corning focuses its advanced diagnostics technologies in Critical Blood Analysis, Clinical Chemistry, Endocrinology, Infectious Disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. , Allergy and Oncology, and is a wholly-owned subsidiary of Chiron Corp., Emeryville, Calif. Marketing and Sales Reorganization Metra also announced a reorganization of marketing and sales. George Dunbar temporarily assumes the direct responsibility for those functions domestically, concurrent with the resignation of the vice president of marketing and sales, Colette Z. Andrea, who is pursuing other interests but will continue to provide consulting services to the company. John Coombes Coombes is a hamlet and civil parish in the Adur District of West Sussex, England. It is located three miles (5km) north of Shoreham by Sea on the River Adur. The 11th century village church has frescoes, some of the most important in England, and painted about 1100 A.D. , recently promoted to vice president, international, will assume international marketing responsibility. Dunbar stated, "Successful penetration of the clinical diagnostics business is a sophisticated marketing challenge which requires strong, simultaneous efforts on many fronts. We intend to accomplish our goal by adding experienced resources to our diagnostic and ultrasound commercial activities going forward." Metra, which recently ended the last fiscal year with approximately 50% of the worldwide diagnostic market for bone resorption (loss) products, will now refocus some if its marketing and sales programs to further develop and penetrate the growing clinical market and enhance its dominant position on a worldwide basis. About Metra Biosystems Metra Biosystems Inc. is a leader in developing and commercializing diagnostic products for the detection and management of metabolic bone diseases metabolic bone disease Any defect in bone absorption or deposition that alters the PTH/calcium-phosphate/vitamin D axis, often with ↑ bone fragility Etiology Fibrous dysplasia, Langerhans' cell histiocytosis/histiocytosis X, acromegaly, corticosteroid therapy, and disorders. The company's strategy is to offer a portfolio of diagnostic products that will provide physicians with comprehensive clinical information regarding the metabolism of bone and other connective tissues. The company has developed and is currently marketing for either research use or clinical use: two immunodiagnostic immunodiagnostic pertaining to diagnosis by immune reactions. tests to measure bone resorption (loss); two immunodiagnostic tests to measure bone formation and one immunodiagnostic test to measure bone growth disorders. In addition, the company is developing a portable ultrasound device designed to assess bone fragility and biochemical markers to detect cartilage disorders. The matters contained in this news release, except for the historical information set forth herein, are forward-looking statements that are dependent on certain risks and uncertainties including such factors, among others, as the uncertainty of market acceptance for biochemical markers, Metra's dependence upon international sales, the uncertainty of international regulations, Metra's reliance upon collaborative relationships, the uncertainty of ultrasound technology development, competition and regulation and the other risk factors listed in the company's prospectus dated April 23, 1996 and Quarterly Report of Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 1996 under "Item 2: Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations." CONTACT: Metra Biosystems Inc. Kurt Amundson, 415/903-9100 |
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