-----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, N3e0uuOgRoY8sQ5IkHJGLC9Gw5OFzIBPW+WGEG648v2jVhJuad21gIOA09e/zYOI oAl+lo5DMLMOj3D9rNKasg== 0000950137-04-008590.txt : 20041015 0000950137-04-008590.hdr.sgml : 20041015 20041014220010 ACCESSION NUMBER: 0000950137-04-008590 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041014 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041015 DATE AS OF CHANGE: 20041014 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: 041079840 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 a02423e8vk.htm FORM 8-K (10/14/04) La Jolla Pharmaceuticals
 

UNITED STATES
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): October 14, 2004

LA JOLLA PHARMACEUTICAL COMPANY

(Exact name of registrant as specified in its charter)
         
Delaware   0-24274   33-0361285
(State or other jurisdiction
of incorporation) 		  (Commission
File Number) 		  (IRS Employer
Identification No.)

6455 Nancy Ridge Drive
San Diego, California 92121
(Address of principal executive offices, including zip code)

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

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

     
o
  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

Item 8.01 Other Events.

     On October 14, 2004, La Jolla Pharmaceutical Company announced that the Company had receieved a letter from the United States Food and Drug Adminisration (the “FDA”) indicating that the Company’s lupus drug candidate, Riquent® (abetimus sodium), is approvable, but that an additional radomized, double-blind study demonstrating the clinical benefit of Riquent would need to be completed prior to approval. The Company’s press release is attached hereto as Exhibit 99.1 and the FDA’s letter is attached hereto as Exhibit 99.2, and each is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

     (c) Exhibits

     The following exhibits are filed with this Current Report on Form 8-K:

     
Exhibit No.
   Description
99.1
  Press Release, dated October 14, 2004
99.2
  Letter from the United States Food and Drug Administration

 

 

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.
         
Date: October 14, 2004   LA JOLLA PHARMACEUTICAL COMPANY
 		  
  By:   /s/ Steven B. Engle    
    Steven B. Engle   
    Chairman and Chief Executive Officer   

 

 

         

EXHIBIT INDEX

     
Exhibit No.
   Description
99.1
  Press Release, dated October 14, 2004
99.2
  Letter from the United States Food and Drug Administration

 

EX-99.1 2 a02423exv99w1.txt EXHIBIT 99.1 EXHIBIT 99.1 COMPANY CONTACT: MEDIA CONTACTS: - ---------------- -------------- Andrew Wiseman, Ph.D. Virginia Amann or Trista Morrison Sr. Director of Business Development Atkins + Associates and Investor Relations for La Jolla Pharmaceutical Company La Jolla Pharmaceutical Company 608-274-6046 or 858-527-3490 858-646-6615 vamann@irpr.com andrew.wiseman@ljpc.com tmorrison@irpr.com LA JOLLA PHARMACEUTICAL COMPANY RECEIVES LETTER FROM FDA ABOUT RIQUENT SAN DIEGO, OCTOBER 14, 2004 - La Jolla Pharmaceutical Company (Nasdaq: LJPC) announced today that the Company has received a letter from the United States Food and Drug Administration (FDA) indicating that its lupus drug candidate, Riquent(R) (abetimus sodium), is approvable, but that an additional randomized, double-blind study demonstrating the clinical benefit of Riquent would need to be completed prior to approval. The FDA letter indicated that the ongoing clinical trial initiated in August 2004 would appear to satisfy this requirement. The Company continues to review the letter and has requested a meeting with the FDA to discuss the next steps in the development of Riquent. Until that meeting is held, the Company will be able to provide only limited guidance. The Company will host a conference call tomorrow, Friday, October 15, 2004, at 8:00 a.m. Eastern Time. The dial in number is 800-329-9097 for U.S. callers and 617-614-4929 for international callers. The passcode is 44429115. A live audio webcast of the conference call will be available through La Jolla Pharmaceutical Company's Web site at www.ljpc.com. A replay of the conference call can be accessed for approximately one week by dialing (888) 286-8010 (US) or (617) 801-6888 (International). The passcode for the replay is 49457212. La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent(R) 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, miscarriage and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. 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. The forward-looking statements in this press release 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. Forward-looking statements include those that express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. The analyses of clinical results of Riquent(R), 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"), including the results of any trials that are ongoing or that we may initiate in the future, 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 showed that the trial did not reach statistical significance with respect to its primary endpoint, time to renal flare, or with respect to the secondary endpoint, time to treatment with high-dose corticosteroids or cyclophosphamide. The results from our clinical trials of Riquent, including the results of any trials that are ongoing or that we may initiate in the future, may not ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United States 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 can be no assurance, however, that we will have the necessary resources to complete any 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 and will likely be reviewed as part of the Riquent approval process. 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 clinical trials in addition to our current clinical trial, or may not approve our drugs. Our ability to develop and sell our products in the future may be adversely affected by the intellectual property rights of third parties. Additional risk factors include the uncertainty and timing of: our clear need for additional financing; obtaining required regulatory approvals, including delays associated with any approvals that we may obtain; our ability to pass all necessary FDA inspections; 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; our ability to make use of the orphan drug designation for Riquent; 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, 2003, and in other reports and registration statements that we file with the Securities and Exchange Commission from time to time. ### EX-99.2 3 a02423exv99w2.txt EXHIBIT 99.2 EXHIBIT 99.2 [United States Food and Drug Administration Letterhead] La Jolla Pharmaceutical Company Attention: Lisa I. Koch 6455 Nancy Ridge Drive San Diego, CA 92121 Dear Ms. Koch: Please refer to your new drug application (NDA) dated December 14, 2003, received December 16, 2003, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Riquent (abetimus sodium) 50 mg/ml Injection. We acknowledge receipt of your submissions dated December 14, 2003 and January 8, 22, February 6, March 2, 15 (two), 19, 24, 30, April 2, 5 (two), 9, 13 (two), 15, 28, May 28, June 8, 11, 15, 17, 24 (two), 25, 29, 30, July 6, 13, 20, 21 (two), 22, August 2, 4 (two), 11 (two), 12, 13, 18, 19 (two), 20 (three), 31, (two), September 9, 10, 27, and October 1, 2004. We have completed our review of this application, as amended, and it is approvable. Before the application may be approved, however, it will be necessary for you to address the following concerns: Your study 90-05 was designed to show a clinical benefit (delayed time to renal flare) associated with treatment, but it failed to do so. An unplanned analysis of patients with high affinity antibodies to dsDNA appeared to show benefit, leading to study 90-09, designed to study benefit in that high affinity subgroup. Study 90-09 also failed to show benefit, thus failing to support the hypothesis raised by the subgroup analysis in study 90-05. Whether these results indicate that the hypothesis that lowering anti-dsDNA antibodies slows disease progression is wrong or that the effect was too small to affect disease progression cannot yet be known. Only another, better powered outcome trial, perhaps with a larger dose, will resolve this issue. The combined analysis of the high affinity subgroup of study 90-05 and study 90-09 is not a credible analysis as it is driven by the retrospective analysis of study 90-05. To gain approval, you will need to conduct a further randomized, double-blind study that successfully distinguishes abetimus from placebo on an endpoint of clinical benefit, such as time to renal flare. Your ongoing clinical study (90-14) would appear to satisfy this requirement, although we think that it could be valuable to learn more about the dose-response for the effect of abetimus on antibody titer before carrying out a large clinical trial of long duration. Because a description of the drug's effects and proper use are yet to be determined, at this time, we are deferring comments on labeling. In addition, we have the following request: We remind you that before we can establish a definitive expiration dating period for the drug product, you should develop a more sensitive stability indicating analytical method for the drug product. Within 10 days after the date of this letter, you are required to amend this application, notify us of your intent to file an amendment, or follow one of your other options under 21 CFR 314.110. If you do not follow one of these options, we will consider your lack of response a request to withdraw the application under 21 CFR 314.65. Any amendment should respond to all the deficiencies listed. We will not process a partial reply as a major amendment nor will the review clock be reactivated until all deficiencies have been addressed. Under 21 CFR 314.102(d), you may request an informal meeting or telephone conference with this division, the Division of Cardio-Renal Drug Products, to discuss what steps need to be taken before the application may be approved. The drug product may not be legally marketed until you have been notified in writing that this application is approved. If you have questions, please contact: Dianne C. Paraoan Regulatory Health Project Manager (301) 594-5308 Sincerely, /s/ Robert Temple, M.D. Robert Temple, M.D. Director Office of Drug Evaluation I Center for Drug Evaluation and Research -----END PRIVACY-ENHANCED MESSAGE-----