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La Jolla Pharmaceutical Company (LJPC) Announces FDA Agreement With Proposed IND Submission for LJPC-501 in Hepatorenal Syndrome


3/4/2013 9:35:25 AM

SAN DIEGO, CA--(Marketwire - March 04, 2013) - La Jolla Pharmaceutical Company (www.ljpc.com) (OTCQB: LJPC) ("La Jolla" and "Company"), a leader in the development of therapeutics targeting galectin proteins (www.ljpc.com/technology-galectins.html), announced today that the FDA Division of Cardiovascular and Renal Products agreed that the Company has sufficient data to support an investigational new drug application ("IND") for LJPC-501 in patients with hepatorenal syndrome ("HRS"), a life-threatening form of progressive renal failure in patients with liver cirrhosis or fulminant liver failure.

"We are pleased that the FDA has accepted our proposal for an IND to pursue LJPC-501 in patients with HRS," said George Tidmarsh, M.D. Ph.D., President and Chief Executive Officer of La Jolla Pharmaceutical Company. "HRS affects a large patient population with no approved therapies. We look forward to initiating our Phase 1 study in the third quarter and hope that LJPC-501 may someday help those suffering."

LJPC-501 is a peptide agonist of the renin-angiotensin system that acts to help the kidneys balance body fluids and electrolytes. Studies have shown that LJPC-501 may improve renal function in patients with HRS.

HRS is a life-threatening form of progressive renal failure in patients with liver cirrhosis. In these patients, the diseased liver secretes vasodilator substances (e.g., nitric oxide and prostaglandins) into the bloodstream that cause under-filling of blood vessels. This low blood pressure state causes a reduction in blood flow to the kidneys. As a means to restore systemic blood pressure, the kidneys induce both sodium and water retention, which contribute to ascites, a major complication associated with HRS.

HRS is categorized into two types based on the rapidity of the progression of renal failure as measured by serum creatinine. Type 1 HRS is the more rapidly progressing type and is characterized by a 100% increase in serum creatinine to > 2.5 mg/dL within two weeks. Less than 10% survive hospitalization, and the median survival is only a few weeks. Type 2 HRS is slower progressing, with serum creatinine rising gradually; however, these patients can develop sudden renal failure and become diagnosed with Type 1 HRS. Although ascites occurs in both Type 1 and Type 2 HRS, recurrent ascites is a major clinical characteristic of Type 2 HRS patients, and median survival is only four to six months.

Initiation of a Phase 1 trial is dependent on the Company first filing an IND application with the FDA. A clinical study cannot begin before that filing is accepted. La Jolla plans to file the IND during the first half of this year.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company dedicated to the development of medical treatments that significantly improve outcomes in patients with life-threatening diseases. GCS-100, the Company's lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. For more information on the Company please visit http://www.ljpc.com.

Forward-Looking Statement Safe Harbor

This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings from time to time with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC's web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the development of GCS-100, the success and timing of future preclinical and clinical studies of this compound, and potential indications for which GCS-100 may be developed. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company's reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.


Company Contact

George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264
Email: GTidmarsh@ljpc.com

Or

Chester S. Zygmont, III
Director of Finance
La Jolla Pharmaceutical Company
Phone: (858) 207-4262
Email: czygmont@ljpc.com



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