La Jolla Pharmaceutical Company, a biopharmaceutical company, focuses on the discovery, development, and commercialization of therapies intended to improve outcomes in patients suffering from life-threatening diseases. LJPC-501 LJPC-501 is the company’s proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension (CRH) and hepatorenal syndrome (HRS). The company is developing LJPC-501 for the treatment of CRH, which is an acute, life-threatening condition in which blood pressure drops to dangerously low levels and is poorly responsive to current treatments. In 2014, the company presented positive data from a preclinical study of LJPC-501 for the treatment of CRH. The company plans to initiate a Phase 3 clinical trial with LJPC-501 for the treatment of CRH, called the Athos3 trial, in the first quarter of 2015. In February 2015, the company reached agreement with the Food and Drug Administration (FDA) on a special protocol assessment for this multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial. The company is enrolling patients in a Phase 1/2 clinical trial of LJPC-501 in HRS. GCS-100 GCS-100 is the company’s galectin-3 inhibitor for the potential treatment of chronic kidney disease. GCS-100 is a complex polysaccharide derived from pectin that binds to, and blocks the activity of, the pro-fibrotic mediator galectin-3. The company plans to initiate a large, multicenter, randomized, placebo-controlled, Phase 2b clinical trial of GCS-100 in chronic kidney disease in the first quarter of 2015. LJPC-1010 LJPC-1010 is the company’s second-generation galectin-3 inhibitor. LJPC-1010 is a more potent and purified derivative of GCS-100 that could be delivered orally. The company is developing LJPC-1010 for the treatment of nonalcoholic steatohepatitis (NASH) and other diseases characterized by tissue fibrosis. In 2014, the company announced positive preclinical data of LJPC-1010 in NASH. The company plans to file an Investigational New Drug Application (IND) with the FDA and initiate a Phase 1 clinical trial of LJPC-1010 in the second quarter of 2015. LJPC-401 LJPC-401 is the company’s novel formulation of hepcidin. Hepcidin is a naturally occurring peptide hormone that controls and regulates iron metabolism. By suppressing iron release, hepcidin prevents iron accumulation in tissues, such as the heart, where it could cause significant damage and even result in death. The company is developing LJPC-401 for the treatment of conditions characterized by iron overload, such as hemochromatosis and beta thalassemia. The company expects to file an IND and commences a Phase 1 clinical trial of LJPC-401 in the second half of 2015. Patents and Proprietary Technologies The company owns two U.S. patent applications and one international application covering methods of use for LJPC-501. The company’s license with the George Washington University provides rights in a U.S. application and an international application directed to methods of using LJPC-501. These applications, if issued as patents, would have expiration dates in 2034 or 2035. The company owns eight issued patents and three pending patent applications in the United States; one pending patent application in Canada; and one pending patent application in Europe, related to GCS-100. The issued patents protect GCS-100 and would expire between March 2025 and March 2028, not taking into account any potential patent term extensions that might be available in the future. The pending applications include the U.S. applications directed to compositions and methods of use of GCS-100 that, if issued as patents, would expire between April 2024 and 2025, and a provisional application directed to methods of use of GCS-100 that would support the U.S. and foreign applications that, if issued as patents, would expire in March 2035. The company’s license from Inserm in France provides rights in a portfolio of patents and applications covering methods of use of LJPC-401. This portfolio includes one issued U.S. patent; one pending U.S. application; issued patents in Canada, China, Europe, and Japan; and pending applications in Europe, China, and Japan. The issued U.S. patent would expire in May 2022. In addition, the company plans to file additional patent applications that, if issued, would provide further protection for LJPC-501, GCS-100, LJPC-1010, and LJPC-401. 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 and any products that the company might develop. Research and Development As of December 31, 2014, the company incurred $9.9 million in research and development. 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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