0001181431-12-043334.txt : 20120803 0001181431-12-043334.hdr.sgml : 20120803 20120802191541 ACCESSION NUMBER: 0001181431-12-043334 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20120802 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120803 DATE AS OF CHANGE: 20120802 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: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24274 FILM NUMBER: 121004887 BUSINESS ADDRESS: STREET 1: 4370 LA JOLLA VILLAGE DR. STREET 2: SUITE 400 CITY: SAN DIEGO STATE: CA ZIP: 92122 BUSINESS PHONE: 858-452-6600 MAIL ADDRESS: STREET 1: 4370 LA JOLLA VILLAGE DR. STREET 2: SUITE 400 CITY: SAN DIEGO STATE: CA ZIP: 92122 8-K 1 rrd352039.htm CKD PRESS RELEASE Prepared By R.R. Donnelley Financial -- Form 8-K
 
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):  08/02/2012
 
LA JOLLA PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
 
Commission File Number:  0-24274
 
CALIFORNIA
  
33-0361285
(State or other jurisdiction of
  
(IRS Employer
incorporation)
  
Identification No.)
 
4370 La Jolla Village Drive, Suite 400, San Diego, California 92122
(Address of principal executive offices, including zip code)
 
(858) 452-6600
(Registrant’s telephone number, including area code)
 
(Former name or former address, if changed since last report)
 
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:

[  ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]   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 July 31, 2012, La Jolla Pharmaceutical Company (the "Company") issued a press release. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K.
 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibits. The following exhibit is filed with this report on Form 8-K:
 

 

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: August 02, 2012
     
By:
 
/s/    George Tidmarsh

               
George Tidmarsh
               
President and Chief Executive Officer
 
 


 

EXHIBIT INDEX
 
Exhibit No.

  
Description

EX-99.1
  
Press Release dated July 31, 2012.
EX-99 2 rrd352039_38241.htm PRESS RELEASE DATED JULY 31, 2012.

La Jolla Pharmaceutical Company Announces FDA Agreement with Proposed Phase 1 Clinical Trial of GCS-100 in Chronic Kidney Disease

SAN DIEGO, CA. -(MARKETWIRE-July 31, 2012)- La Jolla Pharmaceutical Company (OTCQB: LJPC), a leader in the development of therapeutics that target galectin-3, announced today that the FDA Division of Cardiovascular and Renal Products agreed that the Company has sufficient data to support a short-term clinical trial of GCS-100 in patients with chronic kidney disease (CKD) or end-stage renal disease (ESRD).

"Having FDA accept our data in support of a clinical trial in patients with CKD is a major milestone for La Jolla," said George Tidmarsh, M.D. Ph.D., Chief Executive Officer of La Jolla. "We are pleased with our progress and look forward to initiating the study."

"The scientific rational supporting the potential role of GCS-100 in organ failure is very strong," Tidmarsh added. "This kidney disease program will complement our program with GCS-100 in cancer immune modulation."

The National Institute of Diabetes and Digestive and Kidney Diseases estimated that in 2008, 20 million US adults suffered from chronic kidney disease, 547,982 were under treatment for end-stage renal disease resulting in 88,630 deaths per year. In total,  $40 billion was spent in 2008 in the US on end-stage renal disease. To date, there are no FDA approved therapies for end-stage renal disease.

Initiation of the Phase 1 trial is dependent on the Company first filing an Investigational New Drug application (IND) with the FDA. The study cannot begin before that filing is accepted. La Jolla plans to file the IND this year.

About GCS-100

GCS-100 is a complex polysaccharide that has the ability to bind to and block the effects of galectin-3. Galectin-3 is a soluble protein, over-expression of which has been implicated in a number of human diseases including cancer and chronic organ failure.  The unique ability of GCS-100 to bind and sequester galectin-3 makes it an ideal candidate to prevent and treat diseases in which galectin-3 plays an important role.

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: (650) 208-3191 
Email: GTidmarsh@ljpc.com

Media Contact: 
Michael Rice 
LifeSci Advisors, LLC
Phone: (646) 597-6979
Email: mrice@lifesciadvisors.com

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