0000920465-14-000061.txt : 20140714 0000920465-14-000061.hdr.sgml : 20140714 20140714171453 ACCESSION NUMBER: 0000920465-14-000061 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20140714 ITEM INFORMATION: Other Events FILED AS OF DATE: 20140714 DATE AS OF CHANGE: 20140714 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: 001-36282 FILM NUMBER: 14974119 BUSINESS ADDRESS: STREET 1: 4660 LA JOLLA VILLAGE DRIVE, SUITE 1070 CITY: SAN DIEGO STATE: CA ZIP: 92122 BUSINESS PHONE: 858-207-4264 MAIL ADDRESS: STREET 1: 4660 LA JOLLA VILLAGE DRIVE, SUITE 1070 CITY: SAN DIEGO STATE: CA ZIP: 92122 8-K 1 a8-k501disclosures.htm 8-K 8-K 501 Disclosures


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): July 8, 2014
_______________________

LA JOLLA PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
_______________________

California
1-36282
33-0361285
(State or other jurisdiction of incorporation or organization)
(Commission
File Number)
(I.R.S. Employer
Identification No.)


4660 La Jolla Village Drive, Suite 1070, San Diego, California 92122
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (858) 207-4264
_______________________

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 (see General Instruction A.2. below):
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 July 8, 2014, La Jolla Pharmaceutical Company (the “Company”) announced that the Company plans to begin a phase 3 registration program for LJPC-501 (angiotensin II) for the treatment of catecholamine-resistant hypotension (CRH), a new indication. Initiation of this registration program is the result of a recent meeting between the Company and the U.S. Food and Drug Administration at which agreement was reached that blood pressure could serve as an appropriate primary endpoint for approval.

Hypotension, if uncorrected, is life-threatening and occurs as the result of various underlying conditions such as blood loss due to trauma, septic shock, poor heart function or drug reactions. The first line of treatment is catecholamine infusion. Catecholamines are derived from the amino acid tyrosine and include epinephrine (adrenaline), norepinephrine (noradrenaline), and dopamine, which act as neurotransmitters that increase blood pressure. While largely effective, some patients fail to respond to adequate doses and are defined as catecholamine-resistant.

LJPC-501 is a peptide agonist of the renin-angiotensin system that acts to stabilize blood pressure. One of the most widely prescribed classes of blood pressure medication, angiotensin converting enzyme inhibitors, inhibits the production of angiotensin II, thereby reducing blood pressure.

Due to the estimated size of the patient population in the United States for this indication, the Company has filed for Orphan Drug status for LJPC-501 for the treatment of CRH.

 
*    *    *
 





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:
July 14, 2014
By:
/s/    George F. Tidmarsh
 
   
Name:
George F. Tidmarsh, M.D., Ph.D.
 
   
Title:
President and Chief Executive Officer