ROCHE TO SUBMIT MORE TAMIFLU DATA TO EURO AUTHORITIES.Roche and Gilead Sciences Gilead Sciences NASDAQ: GILD is a biopharmaceutical company that discovers, develops and commercializes therapeutics to advance the care of patients suffering from life-threatening diseases. , Inc. (Nasdaq:GILD) have announced that Roche has decided to withdraw the European application for the antiviral antiviral /an·ti·vi·ral/ (-vi´ral) destroying viruses or suppressing their replication, or an agent that so acts. an·ti·vi·ral adj. Tamiflu (oseltamivir) for the treatment of influenza in order to have more time to submit further data. Some members of the 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 ) raised questions, for which additional data will be available in the near future. Withdrawal of the application allows Roche the opportunity to provide this information to European regulatory authorities. The application will be resubmitted as soon as possible. Roche is continuing to pursue regulatory approvals around the world. The first submission for the prophylaxis prophylaxis (prō'fĭlăk`sĭs), measures designed to prevent the occurrence of disease or its dissemination. Some examples of prophylaxis are immunization against serious diseases such as smallpox or diphtheria; quarantine to confine of influenza was recently submitted to the 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. ) 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. . Tamiflu is already available for the treatment of influenza in nine countries worldwide including the United States, Canada, Switzerland and many Latin American countries based upon its demonstrated safety, efficacy and tolerability. Hundreds of thousands of sufferers were treated with Tamiflu during the last influenza season. Roche believes that Tamiflu will play an important role both in the prevention and the treatment of influenza, a disease affecting 100 million people worldwide annually, which is still not treated effectively. Treatment studies involving more than 7,000 patients with oral Tamiflu have shown a significant reduction in both duration and severity of symptoms, including fever and cough. Tamiflu, co-developed with Gilead Sciences, USA, is a systemic treatment for influenza, designed to reach all key sites of infection in the body including the upper and lower respiratory tracts. The medication targets one of two major surface structures on the influenza virus influenza virus n. Any of three viruses of the genus Influenzavirus designated type A, type B, and type C, that cause influenza and influenzalike infections. , the neuraminidase neuraminidase /neu·ra·min·i·dase/ (-ah-min´i-das) an enzyme of the surface coat of myxoviruses that destroys the neuraminic acid of the cell surface during attachment, thereby preventing hemagglutination. protein. The neuraminidase is virtually the same in all common strains of influenza. If neuraminidase is inhibited, the virus is not able to infect new cells. Gilead Sciences, Inc., headquartered in Foster City, CA is an independent biopharmaceutical company that seeks to provide accelerated solutions for patients and the people who care for them. Gilead discovers, develops, manufactures and commercializes proprietary therapeutics for challenging infectious diseases (viral, fungal and bacterial infections) and cancer. Gilead maintains research, development or manufacturing facilities in Foster City, CA; Boulder, CO; San Dimas, CA; Cambridge, UK and Dublin, Ireland and sales and marketing organizations in United States, Europe and Australia. Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people's well-being and quality of life. For more information, call 973/562-2212. |
|
||||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion