-----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, RLyyjZKneoLMlu/hcIWBgEaEvhxlOVwtJcHwi6ae0u9HiIixJRMIH356hs8S/49i IhEvHwy/soK/f6vIjvBp5A== 0000936392-03-001602.txt : 20031117 0000936392-03-001602.hdr.sgml : 20031117 20031117172129 ACCESSION NUMBER: 0000936392-03-001602 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20031114 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031117 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: 1934 Act SEC FILE NUMBER: 000-24274 FILM NUMBER: 031008742 BUSINESS ADDRESS: STREET 1: 6455 NANCY RIDGE DR CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 8584526600 MAIL ADDRESS: STREET 1: 6455 NANCY RIDGE DR CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a94700e8vk.htm FORM 8-K La Jolla Pharmaceutical Company
Table of Contents



SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): November 14, 2003

La Jolla Pharmaceutical Company

(Exact Name of Registrant as Specified in Charter)
         
Delaware

(State or Other Jurisdiction
of Incorporation)
  0-24274

(Commission
File Number)
  33-0361285

(IRS Employer
Identification No.)
     
6455 Nancy Ridge Drive, San Diego, California

(Address of Principal Executive Offices)
  92121

(Zip Code)
     
Registrant’s telephone number, including area code:   (858) 452-6600

N/A


(Former Name or Former Address, if Changed Since Last Report)



 


Item 5. Other Events and Required FD Disclosure.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1
EXHIBIT 99.2


Table of Contents

Item 5. Other Events and Required FD Disclosure.

                   On November 14, 2003, La Jolla Pharmaceutical Company (the “Company”) issued a press release announcing that it had been selected to be added to the NASDAQ Biotechnology Index effective November 24, 2003. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

                   On November 17, 2003, the Company issued a press release announcing that Matthew Linnik, Ph.D., the Company’s Chief Scientific Officer and Executive Vice President of Research, and two of the Company’s principal investigators, presented analyses showing associations between changes in levels of antibodies to double-stranded DNA and the relative risk of renal flare in the Company’s Phase 2/3 and Phase 3 trials of Riquent(TM) at the American Society of Nephrology Annual Meeting. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.

              (c) Exhibits. The following exhibits are filed with this report on Form 8-K:

     
Exhibit    
Number   Description of Exhibit

 
99.1   Press Release announcing that the Company has been selected to be
added to the NASDAQ Biotechnology Index
 
99.2   Press Release announcing that the Company presented
at the American Society of Nephrology Annual Meeting

 


Table of Contents

SIGNATURES

                   Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

         
    LA JOLLA PHARMACEUTICAL COMPANY
         
Date: November 17, 2003   By:   /s/ Gail A. Sloan
       
      Gail A. Sloan
Senior Director of Finance and Controller

 


Table of Contents

EXHIBIT INDEX

     
Exhibit    
Number   Description of Exhibit

 
99.1   Press Release announcing that the Company has been selected to be
added to the NASDAQ Biotechnology Index
 
99.2   Press Release announcing that the Company presented
at the American Society of Nephrology Annual Meeting

  EX-99.1 3 a94700exv99w1.txt EXHIBIT 99.1 Exhibit 99.1 LA JOLLA PHARMACEUTICAL COMPANY ADDED TO NASDAQ BIOTECHNOLOGY INDEX SAN DIEGO, NOVEMBER 14, 2003 -- La Jolla Pharmaceutical Company (Nasdaq: LJPC) today announced that it has been selected to be added to the NASDAQ Biotechnology Index (Nasdaq: NBI) effective November 24, 2003. The NASDAQ Biotechnology Index includes companies primarily engaged in using biomedical research for the discovery or development of novel treatments or cures for human disease. All securities in the Index are listed on the NASDAQ National Market and meet minimum requirements, including market value, average daily share volume, and seasoning as a public company. The Index is ranked on a semi-annual basis in May and November and serves as the basis for the iShares Nasdaq Biotechnology Index Fund(SM) (Amex: IBB). For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit www.nasdaq.com. La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases afflicting several million people in the United States and Europe. The Company is developing Riquent(TM), formerly known as LJP 394, for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events. The Company's common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Readers are cautioned to not place undue reliance upon forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2002, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time. ### EX-99.2 4 a94700exv99w2.txt EXHIBIT 99.2 Exhibit 99.2 LA JOLLA PHARMACEUTICAL COMPANY PRESENTS RESULTS LINKING ANTIBODIES TO dsDNA WITH RENAL FLARES - FOUR POSTERS PRESENTED AT AMERICAN SOCIETY OF NEPHROLOGY ANNUAL MEETING - SAN DIEGO, NOVEMBER 17, 2003 -- La Jolla Pharmaceutical Company (Nasdaq: LJPC) today presented analyses showing statistically significant associations between changes from baseline in levels of antibodies to double-stranded DNA (dsDNA) and the relative risk of renal flare in both the Phase 2/3 and Phase 3 clinical trials of Riquent(TM). These results, in studies of approximately 500 patients, were presented at the American Society of Nephrology Annual Meeting being held November 14-17, 2003 in San Diego, CA. Analyses of data using Cox's Proportional Hazards Regression Model predict that a 50% reduction in antibodies to dsDNA from baseline is associated with a 52% lower risk of renal flare in the Phase 2/3 trial (p=0.0007) and a 53% lower risk in the Phase 3 trial (p<0.0001). These findings are consistent with previously released data showing that patients with sustained reductions in antibodies to dsDNA had fewer renal flares. These results will be submitted as part of the Company's planned regulatory filings regarding Riquent. SUMMARY OF FOUR POSTER PRESENTATIONS AT THE AMERICAN SOCIETY OF NEPHROLOGY: James Tumlin, M.D., Associate Professor of Medicine, Emory University School of Medicine, presented a poster entitled, "Efficacy Results from a Randomized Controlled Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease." The poster summarized data from the Phase 3 trial of Riquent in which 298 lupus patients with high affinity antibodies to Riquent at baseline were treated with Riquent or a placebo for up to 22 months. Dr. Tumlin also presented a poster entitled, "Renal Flare in SLE Patients with Impaired Renal Function in a Randomized Controlled Trial of LJP 394." This poster summarized data from a subpopulation of patients in the Phase 3 and Phase 2/3 trials with impaired renal function. Matthew Linnik, Ph.D., Chief Scientific Officer and Executive Vice President of Research at La Jolla Pharmaceutical, presented a poster entitled, "Reductions in Anti-dsDNA Antibodies and Reduced Risk of SLE Renal Flare and Major SLE Flare." This poster presented Cox regression analyses and sustained reduction analyses on data from the Phase 2/3 and Phase 3 trials. Daniel Wallace, M.D., F.A.C.P., F.A.C.R., Clinical Chief of Rheumatology, Cedars-Sinai Medical Center, Los Angeles, and Clinical Professor, UCLA School of Medicine, presented an abstract entitled, "Safety Results from a Randomized Controlled Trial of LJP 394 in SLE Patients with a History of Renal Disease." The abstract summarized safety data from the Phase 3 trial of Riquent that showed that Riquent was well tolerated for the duration of the trial in which patients were treated for periods of up to 22 months. La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases afflicting several million people in the United States and Europe. The Company is developing Riquent(TM), formerly known as LJP 394, for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis and other thrombotic events. The Company's common stock is traded on The Nasdaq Stock Market under the symbol LJPC. For more information about the Company, visit its Web site: http://www.ljpc.com. Except for historical statements, this press release contains, and the presentations referred to above contained, forward-looking statements involving significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from our current expectations. Forward-looking statements include those which express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Although we plan to submit a New Drug Application ("NDA") for Riquent(TM), there is no guarantee that regulatory authorities will approve Riquent in a timely manner, or at all. Our analyses of clinical results of Riquent, previously known as LJP 394, our drug candidate for the treatment of systemic lupus erythematosus ("lupus"), and LJP 1082, our drug candidate for the treatment of antibody-mediated thrombosis ("thrombosis"), are ongoing and could result in a finding that these drug candidates are not effective in large patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of Riquent has shown that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare. Although we plan to submit an NDA for Riquent, the results from our clinical trials of Riquent may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the U.S. or Europe, and we may be required to conduct additional clinical studies to demonstrate the safety and efficacy of Riquent in order to obtain marketing approval. There is no guarantee, however, that we will have the necessary resources to complete any additional trial, that we will elect to conduct an additional trial, or that any additional trial will sufficiently demonstrate the safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is experimental, has not been validated by independent laboratories, may require regulatory approval, and will likely be necessary for the approval and the commercialization of Riquent. Our other potential drug candidates are at earlier stages of development and involve comparable risks. Analysis of our clinical trials could have negative or inconclusive results. Any positive results observed to date may not be indicative of future results. In any event, regulatory authorities may require additional clinical trials, or may not approve our drugs. Our ability to develop and sell our products in the future may be affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; the clear need for additional financing; FDA approval of our manufacturing facilities and processes; the increase in capacity of our manufacturing capabilities for possible commercialization; successfully marketing and selling our products; our lack of manufacturing, marketing, and sales experience; generating future revenue from product sales or other sources such as collaborative relationships; future profitability; and our dependence on patents and other proprietary rights. Readers are cautioned to not place undue reliance upon forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date hereof. Interested parties are urged to review the risks described in our Annual Report on Form 10-K for the year ended December 31, 2002, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time. ### -----END PRIVACY-ENHANCED MESSAGE-----