BioChem Pharma: European CPMP Gives Positive Opinion on Combivir, the First Tablet To Combine Two Anti-HIV Drugs.LAVAL, Quebec--(BUSINESS WIRE)--Nov. 21, 1997--BIOCHEM PHARMA (ME:BCH.) (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BCH.) (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 :BCHE BChE abbr. Bachelor of Chemical Engineering ) BioChem Pharma Inc. announced today that the European Union's Committee for Proprietary Medicinal Products (CPMP CPMP Committee for Proprietary Medicinal Products CPMP Core-Plus Mathematics Project CPMP Crew Procedures Management Plan (NASA) CPMP Canadian Project Management Professional CPMP Corporate Planning and Management Practices ) this week recommended the approval of Combivir, the first tablet to combine two anti-retroviral drugs in one tablet formulation. One tablet of Combivir, which contains 3TC(R)/Epivir(TM) (150mg lamivudine; 3TC) and Retrovir (300mg zidovudine zidovudine /zi·do·vu·dine/ (zi-do´vu-den) a synthetic nucleoside (thymidine) analogue that inhibits replication of some retroviruses, including the human immunodeficiency virus; used in the treatment of HIV infection and AIDS. ; AZT AZT or zidovudine (zīdō`vy  dēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called ) can be taken twice daily, offering the advantage of reducing the number of tablets a person on an Epivir/Retrovir based treatment regimen needs to take by up to six tablets per day. Depending on which treatment regimen is used, this can equate to a reduction of between 700 and 2000 tablets per year. This reduction in pill burden is an important step in simplifying complex multi-drug treatment regimens and assisting patient adherence to therapy schedules. The CPMP's opinion, which itself does not constitute an approval or final decision will now be considered by the European Commission, who will further evaluate the marketing application and come to a final decision. The marketing application was submitted to the European Medicines Evaluation Agency (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) on June 30, 1997 under the centralized procedure in which a single license is granted for all 15 Member States of the European Union. Combivir was cleared for sale in the U.S. by U.S. 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. in September 1997. 3TC/Epivir was discovered by BioChem Pharma. Under the terms of a license agreement between BioChem Pharma and Glaxo Wellcome, BioChem receives royalties based on sales of 3TC. Under the agreement, Glaxo Wellcome has the right to develop, manufacture and sell 3TC worldwide, subject to special arrangements for Canada, where BioChem and Glaxo Wellcome have formed a partnership which commercializes 3TC. BioChem Pharma is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the prevention, detection and treatment of human diseases. The Company lists its common shares on the Montreal and Toronto exchanges (BCH) and on the Nasdaq National Market (BCHE). BioChem Pharma news releases and other company information can be found on the World Wide Web at http://www.biochem-pharma.com. Epivir, Retrovir, AZT, 3TC and Combivir are trade marks of the Glaxo Wellcome Group of Companies. CONTACT: BioChem Pharma Inc. Christine Lennon, 514/978-7771 corpcom@biochem-pharma.com Michele Roy, 514/978-7771 corpcom@biochem-pharma.com |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion