0000920465-20-000041.txt : 20200313 0000920465-20-000041.hdr.sgml : 20200313 20200313090920 ACCESSION NUMBER: 0000920465-20-000041 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20200313 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200313 DATE AS OF CHANGE: 20200313 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: 20710878 BUSINESS ADDRESS: STREET 1: 4550 TOWNE CENTRE COURT CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 858-207-4264 MAIL ADDRESS: STREET 1: 4550 TOWNE CENTRE COURT CITY: SAN DIEGO STATE: CA ZIP: 92121 8-K 1 a20208-k13mar2020.htm 8-K Document


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): March 13, 2020
_______________________
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.)

4550 Towne Centre Court, San Diego, California 92121
(Address of Principal Executive Offices) (Zip Code)

(858) 207-4264
(Registrant’s telephone number, including area code)

Not Applicable
(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 (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))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Common Stock, Par Value $0.0001 per share
 
LJPC
 
The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company o
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o






Item 8.01
Other Events.

On March 13, 2020, La Jolla Pharmaceutical Company issued a press release announcing that it is providing GIAPREZA™ (angiotensin II) in Italy for compassionate use in patients with septic shock associated with COVID-19. A copy of the press release is furnished as Exhibit 99.1.

The information in this Item 8.01 and in Exhibit 99.1 will not be treated as "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or into another filing under the Exchange Act, unless that filing expressly incorporates this information by reference.

Item 9.01        Financial Statements and Exhibits.

(d) Exhibits.







SIGNATURE

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:
March 13, 2020
By:
/s/ Dennis Mulroy
 
 
 
Dennis Mulroy
 
 
 
Chief Financial Officer


EX-99.1 2 exhibitfy20compassionateuse.htm EXHIBIT 99.1 Exhibit
Exhibit 99.1



ljpc8kimage001.jpg
La Jolla Pharmaceutical Company to Provide GIAPREZA™ (Angiotensin II) in Italy for Compassionate Use in Patients with Septic Shock Associated with COVID-19


SAN DIEGO, CA - March 13, 2020 - La Jolla Pharmaceutical Company (Nasdaq: LJPC), which is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases, today announced that it is providing GIAPREZA™ (angiotensin II) in Italy for compassionate use in patients with septic shock associated with COVID-19. GIAPREZA is being made available for compassionate use based on a request from Alberto Zangrillo, M.D., Full Professor of Anesthesia and Intensive Care and Giovanni Landoni, M.D., Associate Professor of Anesthesia and Intensive Care at San Raffaele Hospital in Milan, Italy. According to Italian law, authorized medicines for life-threatening and rare illnesses can be made available prior to commercial availability under a compassionate use program. GIAPREZA has been recently approved by the European Commission but is not yet commercially available in Europe.

In a report on 44,672 confirmed cases of COVID-19 (Wu et al, JAMA 2020; doi:10.1001/jama.2020.2648), approximately 14% of patients required hospitalization, and, among those, one-third became critically ill. Patients who became critically ill developed respiratory failure, septic shock and/or multiple organ failure. Approximately one-half of the critically ill patients died.

“La Jolla is committed to helping patients suffering from life-threatening diseases, and we hope that GIAPREZA will positively impact these patients,” said Lakhmir Chawla, M.D., Chief Medical Officer, La Jolla Pharmaceutical Company.

About GIAPREZA

In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. In August 2019, GIAPREZA was approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. GIAPREZA mimics the body’s endogenous angiotensin II peptide, which is central to the renin-angiotensin-aldosterone system, which in turn regulates blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com. The European Summary of Product Characteristics is available on the EMA website: https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza. GIAPREZA is marketed in the U.S. by La Jolla Pharmaceutical Company on behalf of La Jolla Pharma, LLC, its wholly owned subsidiary.

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis.

Adverse Reactions

The most common adverse reactions that were reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events.

Drug Interactions





Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may reduce response to GIAPREZA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information, please see Full Prescribing Information for the United States and the Summary of Product Characteristics for the European Union.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is dedicated to the development and commercialization of innovative therapies that improve outcomes in patients suffering from life-threatening diseases. In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. In August 2019, GIAPREZA was approved by the European Commission (EC) for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies. LJPC-0118 (artesunate) is La Jolla’s investigational product for the treatment of severe malaria. For more information, please visit www.ljpc.com.

Forward-looking Statements

This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: GIAPREZA™ (angiotensin II) sales; regulatory actions relating to La Jolla’s products by the U.S. Food and Drug Administration (FDA), European Commission and/or other regulatory authorities; cash used in operating activities and our capital requirements; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances.





Company Contacts

Sandra Vedrick
Senior Director, Investor Relations
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1135
Email: svedrick@ljpc.com

and

Dennis Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264 Ext: 1040
Email: dmulroy@ljpc.com


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