La Jolla Pharmaceutical Company, a biopharmaceutical company, focuses on the discovery, development, and commercialization of therapeutics for chronic organ failure and cancer. Product Portfolio The company has a product portfolio consisting of both development-stage and discovery-stage products. Its drug development efforts are focused on three product candidates, GCS-100, LJPC-501, and LJPC-401. GCS-100 targets the protein galectin-3, which, when overproduced by the human body, which has been associated with chronic organ failure and cancer. In 2013, the company conducted a Phase 1 trial and a randomized, placebo-controlled phase 2 clinical trial with GCS-100 for the treatment of chronic kidney disease (CKD). In March 2014, the company announced positive top-line results from the Phase 2 trial of GCS-100 in CKD. LJPC-501 is a peptide agonist of the renin-angiotensin system, which is designed to help restore kidney function in patients with hepatorenal syndrome (HRS). The Food and Drug Administration accepted its Investigational New Drug Application for LJPC-501 for the treatment of HRS and the company plans to initiate a Phase 1 clinical trial in 2014. The company has conducted two preclinical studies examining the effect of GCS-100 on liver fibrosis in mice. In February 2014, the company announced the licensing of technology related to hepcidin (LJPC-401), which would be evaluated for the treatment of iron disorders. The use of hepcidin would be evaluated as a treatment for disorders of iron overload including hemolytic anemia. The active form of hepcidin is a 25 amino acid protein that serves as a master regulator of iron metabolism. Hepcidin synthesis in the liver is regulated by multiple signals, including iron stores, erythropoietic activity (the production of red blood cells) and inflammatory cytokines. Iron levels control hepcidin synthesis via the coordinated activity of cell surface receptors. Patents and Proprietary Technologies As of March 21, 2014, the company had three issued patents, one allowed patent and three pending patent applications in the United States; one pending patent applications in Canada; and one pending patent application in Europe. The issued and allowed patents provide, and, if issued, the pending patent applications would provide, protection for its drug candidate GCS-100. The issued and allowed patents expire between 2025 and 2028, not taking into account any potential patent-term extensions that may be available in the future. In addition, the company has a patent application covering methods of use for LJPC-501 and it has in-licensed a patent from Inserm in France covering compositions of matter including LJPC-401. The in-licensed patent would expire in 2025. Manufacturing The company obtains the active pharmaceutical ingredient for GCS-100 from Johnson Matthey Pharma Services in Devens, Massachusetts and for LJPC-501 and LJPC-401 from Polypeptide Laboratories in San Diego, California. All drug product is prepared by Irvine Pharmaceutical Services in Irvine, California. Government Regulation In the United States, the Federal Food, Drug and Cosmetic Act and the Public Health Service Act govern the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising and promotion, and distribution of the company’s drug candidates. History La Jolla Pharmaceutical Company was founded in 1989. The company was incorporated in 1989 in Delaware and reincorporated in California in 2012.
la jolla pharmaceutical co
4660 La Jolla Village Drive
San Diego, CA 92122
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