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La Jolla Pharmaceutical Company Receives Notice of Allowance for Patent Claims Covering Modified Pectin for Treatment of Chronic Inflammation

Treatment of Inflammatory Diseases Such as Non-Alcoholic Steatohepatitis (NASH) Covered

SAN DIEGO--()--La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the “Company” or “La Jolla”), a biotechnology company developing therapeutics targeting significant unmet, life-threatening diseases, today announced that the United States Patent and Trademark Office (“USPTO”) has issued a notice of allowance for patent application number 13/888,158 covering methods of treating chronic inflammation using modified pectin. Specifically, the patent, which expires in 2025 without taking into account patent term extension, provides proprietary protection for methods of treating chronic inflammation by administration of modified pectin with a molecular weight greater than 25 kilodaltons.

“Chronic inflammation is the principal underlying cause of fibrosis in multiple chronic ailments such as kidney, liver, heart and lung disease,” said James Rolke, Senior Director of Research and Development at La Jolla and an inventor on the allowed patent application. “These newly allowed claims solidify our proprietary position for using modified pectin as a treatment for organ disease that results from chronic inflammation.”

The Company’s intellectual property portfolio also includes several issued patents covering various modified pectin compositions and methods for preparing biologically active modified pectins, as well as pending patent applications directed to additional modified pectin compositions and methods of use. Chronic inflammation is the hallmark of many serious, debilitating and prevalent conditions such as NASH and chronic kidney disease (CKD). The Company’s lead product candidate GCS-100, which is covered by this issued patent, is being studied in a randomized, placebo-controlled Phase 2 clinical study in patients with CDK. Data on the primary efficacy endpoint from this study is due to be released in March of this year.

La Jolla Pharmaceutical Company also announced confirmation of previously reported data demonstrating GCS-100 activity in a mouse model of NASH. When compared to placebo-treated control animals, GCS-100, showed a statistically significant reduction in liver fibrosis, a statistically significant improvement in the Non-Alcoholic Fatty Liver Disease (“NAFLD”) score and a statistically significant improvement in liver function as measured by the liver enzyme alanine transaminase (“ALT”), in some cases returning to near normal levels. The study was performed in collaboration with the Stelic Institute & Co. (Tokyo, Japan) using an established, benchmark preclinical STAM model for Non-Alcoholic Steatohepatitis-Hepatocellular Carcinoma (“NASH-HCC”).

According to the National Institute of Diabetes and Digestive and Kidney Diseases, NASH affects between 7 million and 17.5 million Americans. In addition, an estimated 5.5 million Americans have chronic liver disease or cirrhosis. Together, chronic liver disease and cirrhosis are currently the 12th leading cause of death, accounting for approximately 27,000 deaths annually, in the United States. Chronic Liver disease affects Americans of all ages and walks of life.

“The results of this study confirm that GCS-100 is able to prevent and potentially reverse chronic liver disease through the remediation of fibrosis,” said James Rolke, “In addition, the significant improvement in liver function, fibrosis and NAFLD suggests a preservation of functional tissue which is a clear clinical objective and benefit.”

A full study report provided to the company by Stelic Institute is available on the company’s web site. In addition, updates will be posted as they become available.

About Pectin and GCS-100

Pectins are high molecular weight, complex polysaccharides that can be obtained from multiple sources (e.g., citrus, apple), all of which share a common basic structure comprising a block co-polymer of 1,4-linked galacturonic acid and 1-2-linked rhamnose with side branches of either 1,4-linked β-D-galactose or 1,5-α-linked L-arabinose. In addition, some portion of the galacturonic acid backbone can be esterified or exist as the uronic acid salt.

GCS-100, the company’s lead product candidate, is a modified pectin and is covered by the newly allowed claims and several other issued patents. GCS-100 is currently being tested in a Phase 2 clinical trial in patients with chronic kidney disease.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics for chronic organ failure and cancer. 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. LJPC-501, the Company’s second product candidate, is a natural peptide for the treatment of hepatorenal syndrome. LJPC-401, the Company’s third product candidate, is a natural peptide for the treatment of iron overload. For more information on the Company please visit

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 with the U.S. Securities and Exchange Commission (“SEC”), all of which are available free of charge on the SEC’s web site These risks include, but are not limited to, risks relating to the development of GCS-100, LJPC-501 and LJPC-401, the success and timing of future preclinical and clinical studies of these compounds, and potential indications for which GCS-100, LJPC-501 and LJPC-401 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.

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D., 858-207-4264
President & Chief Executive Officer
Chester S. Zygmont, III, 858-207-4262
Director of Finance

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