-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, TzpqyH5TuvBLSy7qFXDqRoHiGtMYOx2q1l2qGWnKqg+EBsLGmXXMX8wPx2qTE5QM 17WPJ4kj9jb+c01gC9KKeQ== 0000892569-99-002475.txt : 19990920 0000892569-99-002475.hdr.sgml : 19990920 ACCESSION NUMBER: 0000892569-99-002475 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 19990914 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19990917 FILER: COMPANY DATA: COMPANY CONFORMED NAME: LA JOLLA PHARMACEUTICAL CO CENTRAL INDEX KEY: 0000920465 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 330361285 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-24274 FILM NUMBER: 99713355 BUSINESS ADDRESS: STREET 1: 6455 NANCY RIDGE DR CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6194526600 MAIL ADDRESS: STREET 1: 6455 NANCY RIDGE DR CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 FORM 8-K 1 ================================================================================ SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 --------------- FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of report (Date of earliest event reported): September 14, 1999 ------------------------ La Jolla Pharmaceutical Company - -------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in Charter) Delaware 0-24274 33-0361285 - -------------------------------------------------------------------------------- (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 6455 Nancy Ridge Drive, San Diego, California 92121 - -------------------------------------------------------------------------------- (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code: (858) 452-6600 N/A - -------------------------------------------------------------------------------- (Former Name or Former Address, if Changed Since Last Report) ================================================================================ 2 ITEM 5. OTHER EVENTS On September 14, 1999, La Jolla Pharmaceutical Company (the "Company") issued a joint press release with Abbott Laboratories ("Abbott") announcing that the Company had regained the rights to its experimental lupus drug, LJP 394, following termination by Abbott of a license and development agreement between the Company and Abbott. A copy of this press release is attached hereto as Exhibit 99.1. On September 14, 1999, the Company issued a press release announcing that it is restructuring operations while it is evaluating the results of a clinical trial of its experimental lupus drug, LJP 394. The Company further announced that its Board of Directors had set a special meeting of stockholders, the primary purpose of which is to put forth to the stockholders a proposed one-for-five reverse split of the Company's Common Stock. A copy of this press release is attached hereto as Exhibit 99.2. ITEM 7. EXHIBITS Pursuant to General Instruction F of Form 8-K, the following documents are incorporated by reference herein and attached as exhibits hereto:
EXHIBIT DESCRIPTION ------- ----------- 99.1 La Jolla Pharmaceutical Company and Abbott Laboratories joint press release of September 14, 1999 regarding the termination by Abbott Laboratories of the license and development agreement between La Jolla Pharmaceutical Company and Abbott Laboratories. 99.2 La Jolla Pharmaceutical Company press release of September 14, 1999 regarding the restructuring of La Jolla Pharmaceutical Company and the scheduled special meeting of stockholders.
2 3 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this current report to be signed on its behalf by the undersigned hereunto duly authorized. La Jolla Pharmaceutical Company Date: September 16, 1999 By: /s/ WOOD C. ERWIN ----------------------------------- Wood C. Erwin Chief Financial Officer 3 4 EXHIBIT INDEX
EXHIBIT DESCRIPTION ------- ----------- 99.1 La Jolla Pharmaceutical Company and Abbott Laboratories joint press release of September 14, 1999 regarding the termination by Abbott Laboratories of the license and development agreement between La Jolla Pharmaceutical Company and Abbott Laboratories. 99.2 La Jolla Pharmaceutical Company press release of September 14, 1999 regarding the restructuring of La Jolla Pharmaceutical Company and the scheduled special meeting of stockholders.
4 EX-99.1 2 PRESS RELEASE - LUPUS DRUG 1 EXHIBIT 99.1 LJP THERAPEUTICS FOR ANTIBODY MEDIATED LA JOLLA PHARMACEUTICAL DISEASES AND INFLAMMATION COMPANY DATE: September 14, 1999 CONTACT: Richard W. Krawiec, Ph.D., VP, Investor Relations La Jolla Pharmaceutical Co. Matt Kuhn, Abbott Laboratories, 847-937-2993 RELEASE DATE: Immediate LA JOLLA PHARMACEUTICAL REGAINS RIGHTS TO EXPERIMENTAL LUPUS DRUG FOLLOWING TERMINATION OF LICENSE AGREEMENT BY ABBOTT LABORATORIES San Diego, CA/Abbott Park, IL, September 14, 1999 - La Jolla Pharmaceutical Company (Nasdaq: LJPC) and Abbott Laboratories (NYSE: ABT) today announced that Abbott has terminated its license and development agreement for the experimental lupus drug, LJP 394. Abbott is returning all rights to the compound to La Jolla Pharmaceutical, based on the results of analyses conducted by Abbott and an independent third-party of a Phase II/III clinical trial of LJP 394, which studied the compound's effects on patients with systemic lupus erythematosus, including those with lupus nephritis. The analyses confirmed the findings of the independent Data Monitoring Committee that were announced on May 12, 1999: 1) that at the time the trial was stopped, efficacy, as defined by the primary chosen endpoint, time to renal flare, was not significantly different between the treatment and placebo groups and 2) in patients receiving LJP 394, circulating antibodies to double-stranded DNA (dsDNA) were reduced by a statistically significant amount in the presence of the drug. Despite the reduction in dsDNA antibodies, no correlations with clinical endpoints were observed. There were no statistically significant serious safety issues, and clinical site investigators did not report that any thrombotic events were related to drug administration. When all reported thrombotic events, including cerebrovascular accident, embolus, mesenteric occlusion, myocardial infarction, and thrombophlebitis were pooled, there were more events, though the number was still not statistically significant, in the group receiving LJP 394 than in the placebo group. La Jolla Pharmaceutical is continuing to analyze results from the LJP 394 clinical program. In a separate press release issued today, La Jolla Pharmaceutical stated that while it is still evaluating the lupus results, it is restructuring operations to reduce expenses. It will use its resources to 2 accelerate the development of its antibody-mediated thrombosis Toleragen(R) candidate and to partner its xenotransplantation drug candidate. San Diego-based La Jolla Pharmaceutical Company develops disease-specific therapeutics using its proprietary Tolerance Technology(R) for major diseases and conditions caused by antibodies such as lupus, antibody-mediated thrombosis, a clotting disorder associated with stroke, myocardial infarction, deep-vein thrombosis, and recurrent fetal loss, and organ rejection in xenotransplantation. Toleragens under development by the Company are designed to reduce the levels of disease-causing antibodies in patients suffering from these conditions. The Company's common stock and warrants trade on The Nasdaq Stock Market under the symbols: LJPC and LJPCW, respectively. For more information about the Company, visit our web site: http://www.ljpc.com. Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 56,000 people and markets its products in more than 130 countries. In 1998, the company's sales and net earnings were $12.5 billion and $2.3 billion, respectively, with diluted earnings per share of $1.51. Abbott's news releases and other information are available on the company's web site at http://www.abbott.com. Statements regarding the analysis of results from clinical trials, as well as La Jolla Pharmaceutical's drug candidates and drug development plans, are forward-looking statements involving risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from those anticipated. Clinical trials of LJP 394 may continue to have negative or inconclusive results. Further, delays in continued testing of LJP 394 and/or termination of development by the Company would result in delays or lack of government approval to market the compound. Tolerance or the specific inactivation of pathogenic B cells is a new technology that has not been proven, and the development of LJP 394 involves many risks and uncertainties, including, without limitation, whether LJP 394 can provide a meaningful clinical benefit, and any positive results observed to date may not be indicative of future results. La Jolla Pharmaceutical's other drug candidates, none of which has progressed to clinical trials, involve comparable risks. Interested parties are urged to review the risks detailed from time to time in La Jolla Pharmaceutical Company's Securities and Exchange Commission (SEC) filings, including the report on Form 10-K for the year ended December 31, 1998 and the report on Form 10-Q for the quarter ended June 30, 1999. ### 2 EX-99.2 3 PRESS RELEASE - RESTRUCTURING DATED SEPT. 14, 1999 1 EXHIBIT 99.2 LJP THERAPEUTICS FOR LA JOLLA PHARMACEUTICAL ANTIBODY-MEDIATED DISEASES COMPANY DATE: September 14, 1999 CONTACT: Richard W. Krawiec, Ph.D., Vice President, Investor Relations RELEASE DATE: Immediate LA JOLLA PHARMACEUTICAL RESTRUCTURES, FOCUSES ON THROMBOSIS TOLERAGEN(R) WHILE REVIEWING LUPUS RESULTS LUPUS ANTIBODY REDUCTION SUPPORTS TOLERANCE TECHNOLOGY(R) San Diego, CA - September 14, 1999 - La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced that while it is still evaluating results from a Phase II/III clinical trial of LJP 394 in lupus, it is restructuring operations to reduce expenses and will use its resources to accelerate the development of an experimental drug for the treatment of antibody-mediated thrombosis and to partner its xenotransplantation drug candidate. The Company will reduce its workforce from approximately 95 to 54 full-time employees. "We are restructuring our operations to maintain sufficient cash resources to conduct our programs through the end of next year," said Steven B. Engle, La Jolla Pharmaceutical's Chairman and Chief Executive Officer. "Our cash and cash equivalents at June 30, 1999, end of the second quarter, were $17.8 million." In a separate press release issued today, La Jolla Pharmaceutical Company and Abbott Laboratories announced that Abbott has terminated its license and development agreement for LJP 394. Abbott is returning all rights to the compound to La Jolla Pharmaceutical. ANTIBODIES REDUCED BY 45% "We believe that the results from the double-blind, placebo-controlled Phase II/III clinical trial involving approximately 200 patients and additional clinical studies of LJP 394 confirm the ability of the Company's Tolerance Technology to reduce disease-specific antibodies in lupus, which reinforces our belief that our technology is applicable to other antibody-mediated diseases," stated Mr. Engle. "We are continuing forward with an experienced team, who will concentrate on the preclinical work necessary to advance a Toleragen(R) drug candidate into clinical trials next year for antibody-mediated thrombosis. Furthermore, if additional clinical 2 trials in lupus are warranted, we have significant inventories of LJP 394 that could be used in the next study." During the first four months of weekly drug treatment with 100 mg of LJP 394, the mean level of dsDNA antibodies were reduced approximately 45% compared to placebo, and the difference was statistically significant. The mean level of antibodies rose during the following two-month "off" period, during which there was no drug treatment, and were suppressed again in each succeeding three-month "on" period of 50 mg weekly drug treatment over the 18 month study. The Company believes that this finding supports the ability of Tolerance Technology(R) to reduce specific antibodies. Despite the reduction in dsDNA antibodies, no correlations with clinical endpoints were observed. In a separate double-blind, placebo-controlled, Phase II dose-ranging study involving 68 participants, those patients receiving a 100 mg weekly dose of LJP 394 had a statistically significant mean antibody reduction of approximately 50% compared to placebo. This is the fifth clinical study in which LJP 394 has reduced mean antibody levels in lupus patients. La Jolla Pharmaceutical is continuing to analyze results from the LJP 394 clinical program. The management of La Jolla Pharmaceutical Company is grateful to the hundreds of patients and the dozens of clinical investigators who participated in these studies. TOLERAGEN FOR STROKE, HEART ATTACK, DEEP-VEIN THROMBOSIS ADVANCED "While we complete the lupus analysis, our goals are to streamline expenses and to maximize shareholder value by advancing a clinical candidate for antibody-mediated thrombosis to the point where it is attractive to potential pharmaceutical partners," explained Mr. Engle. Antibody-mediated thrombosis is a serious blood-clotting disorder that leads to recurrent stroke, heart attack, and deep-vein thrombosis and afflicts approximately 500,000 people in the U.S. and Europe. Company scientists have constructed a thrombosis Toleragen candidate that is designed to reduce the levels of pathogenic antibodies, confirmed the biochemical mechanism of action underlying this antibody-mediated defect in blood clotting, developed an assay to quantify the effects of these antibodies on clotting, and are conducting preclinical testing in a mouse model. A second Toleragen for antibody-mediated organ rejection in xenotransplantation has generated positive results in primate and mouse models - a reduction of disease-causing antibodies and their related B cells. Based on these preclinical results, the Company is approaching pharmaceutical companies to create a strategic alliance for its xenotransplantation program. Additional preclinical results from both of these research programs are expected in the coming months. STOCKHOLDER'S SPECIAL MEETING SCHEDULED The Company also announced that the Board of Directors has set a special meeting of stockholders to be held on November 8, 1999, the primary purpose of which is to put forth to stockholders a proposed one-for-five reverse split of the Company's Common Stock. The Company received notice from The Nasdaq Stock Market, Inc. that its Common Stock will be delisted from the Nasdaq National Market unless the Company can comply with the Nasdaq requirement that its Common Stock maintain a minimum bid price greater than or equal to $1.00 2 3 per share. The Board is proposing the reverse split in response to this notice. The Company expects to distribute proxy materials on approximately October 8, 1999. San Diego-based La Jolla Pharmaceutical Company develops disease-specific therapeutics using its proprietary Tolerance Technology for major diseases and conditions caused by antibodies such as lupus, antibody-mediated thrombosis, a clotting disorder associated with stroke, myocardial infarction, deep-vein thrombosis, and recurrent fetal loss, and organ rejection in xenotransplantation. Toleragens under development by the Company are designed to reduce the levels of disease-causing antibodies in patients suffering from these conditions. The Company's common stock and warrants trade on The Nasdaq Stock Market under the symbols: LJPC and LJPCW, respectively. For more information about the Company, visit our web site: http://www.ljpc.com. Statements regarding the analysis of results from clinical trials, as well as La Jolla Pharmaceutical's drug candidates and drug development plans, are forward-looking statements involving risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from those anticipated. Clinical trials of LJP 394 may continue to have negative or inconclusive results. Further, delays in continued testing of LJP 394 and/or termination of development by the Company would result in delays or lack of government approval to market the compound. Tolerance or the specific inactivation of pathogenic B cells is a new technology that has not been proven, and the development of LJP 394 involves many risks and uncertainties, including, without limitation, whether LJP 394 can provide a meaningful clinical benefit, and any positive results observed to date may not be indicative of future results. La Jolla Pharmaceutical's other drug candidates, none of which has progressed to clinical trials, involve comparable risks. Interested parties are urged to review the risks detailed from time to time in La Jolla Pharmaceutical Company's Securities and Exchange Commission (SEC) filings, including the report on Form 10-K for the year ended December 31, 1998 and the report on Form 10-Q for the quarter ended June 30, 1999. ### 3 -----END PRIVACY-ENHANCED MESSAGE-----