Lilly announces marketing approval of new cancer drug in South Africa.INDIANAPOLIS--(HealthWire)--Jan. 18, 1995--Eli Lilly and Company announced today that it has received approval from South Africa's Medicine Control Council (MCC (The Microelectronics and Computer Technology Corporation, Austin, TX) The first high-tech research and development consortium in the U.S., created in 1982 by leading companies within the electronics industry. ) to market Gemzar(R) (gemcitabine hydrochloride) for the indication of non-small-cell lung cancer in South Africa. The MCC action marks the first approval for the drug worldwide. Gemzar is an anticancer agent with a mechanism of action that disrupts the normal process of cell replication. The approval was based on global clinical trials for the indication of non-small-cell lung cancer. ``We are pleased to have the first approval for Gemzar, an innovative product that targets an unmet medical need,'' said August M. Watanabe, M.D., a vice president of the company and president of Lilly Research Laboratories Lilly Research Laboratories is the organizational name of the global pharmaceutical research and development organization of Eli Lilly and Company, one of the world's largest pharmaceutical corporations. . ``Non-small-cell lung cancer accounts for 75 percent of all lung cancer cases, and the 5-year survival rate stands at less than 10 percent. Lilly is proud to make a contribution to the treatment of this devastating disease.'' Lilly has filed for regulatory approval of Gemzar for the indication of non-small-cell lung cancer in several European countries, as well as in Canada, Australia, and New Zealand. The company plans to file a New Drug Application with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. during the first quarter of this year seeking an indication for pancreatic cancer. Gemzar is not approved for marketing for any indication at this time in the United States Time in the United States, by law, is divided into nine standard time zones covering the states and its possessions, with most of the United States observing daylight saving time for part of the year. . Cancer is one of five therapeutic areas in which Lilly is focusing its research efforts. Additional Lilly initiatives in this therapeutic area include a global strategic alliance entered into last year with Seragen, Inc., to develop and market fusion toxins as cancer therapy. Also in 1994, Lilly participated in the discovery and isolation of BRCA BRCA One of two genes (designated BRCA1 and BRCA2) that help repair damage to DNA, but when inherited in a defective state increase the risk of breast and ovarian cancer. 1, a novel tumor suppressor gene tumor suppressor gene n. A gene that suppresses cellular proliferation. When inherited in a mutated state, it is associated with the development of various cancers, including most familial cancers. Also called antioncogene. that produces susceptibility to breast and ovarian cancer. Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Indiana, that is working with its customers worldwide to help ensure that diseases are prevented, managed, and cured with maximum benefit and minimum cost to patients and society. -0- Gemzar(R) (gemcitabine hydrochloride, Lilly) CONTACT: Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. , Indianapolis Farnaz Khadem, 317/277-1172 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion