Lilly announces new cancer drug cleared for marketing in Sweden and Finland.INDIANAPOLIS--(BUSINESS WIRE)--June 28, 1995--Eli Lilly and Company announced today that it has received permission to market its new cancer drug, Gemzar(R) (gemcitabine hydrochloride gemcitabine hydrochloride Warning - Hazardous drug! Gemzar Pharmacologic class: Antimetabolite (pyrimidine analog) Therapeutic class: Antineoplastic ), in two additional countries. The Swedish Board of Drugs has granted Lilly permission to market Gemzar in that country to treat advanced or metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. pancreatic cancer. This is the first time the drug has been cleared for marketing for the treatment of advanced or metastatic pancreatic cancer anywhere in the world. In the United States, Lilly has filed a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) 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. ) seeking an indication for the treatment of advanced or metastatic pancreatic cancer. Although Gemzar is not cleared 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. , the drug is available in that country through a Treatment Investigational New Drug (IND) program to patients with advanced or metastatic pancreatic cancer who meet certain medical eligibility criteria. The Treatment IND program will continue while the FDA reviews the NDA to determine the drug's safety and efficacy. Lilly also has received permission from Finland's National Agency for Medicines to market Gemzar in that country to treat non-small-cell lung cancer. Gemzar has previously been cleared for marketing in South Africa and the Netherlands for the treatment of non-small-cell lung cancer. Lilly has filed for permission to market Gemzar for this indication in several European countries, as well as in Canada, Australia and New Zealand. Gemzar represents Lilly's renewed commitment to cancer research. That commitment began with the company's successful efforts to develop the vinca alkaloids, which are used in the United States and across the globe. Today Lilly's cancer research division and clinical investigations at 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. are studying a number of promising new anticancer products, ranging from compounds to enhance the benefits of chemotherapeutic products to therapies that focus on the molecular genetics of human cancer. In addition to ongoing clinical trials for Gemzar, researchers are focusing on oncogenes oncogenes 1. genes carried by tumor viruses that are directly and solely responsible for the neoplastic transformation of host cells. Many oncogenes function after integration into the DNA of the host cell and some up-regulate normal downstream host cell genes to cause neoplasia. and tumor-suppressor genes, like 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 gene that indicates susceptibility to developing breast and ovarian cancer, as well as multidrug resistance modulators designed to enhance the benefits of existing chemotherapy options. Cancer is one of five therapeutic areas in which Lilly is focusing its research efforts. Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering superior health care solutions -- by combining pharmaceutical innovation, existing pharmaceutical technology, disease prevention and management, and information technologies -- in order to provide customers worldwide with optimal clinical and economic outcomes. -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 Edward A. West, 317/276-3655 |
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