Source: La Jolla Pharmaceutical Company
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GIAPREZA™ (angiotensin II) Significantly Improved Survival and Reduced Time on Renal Replacement Therapy in Patients with Acute Kidney Injury

Analyses to Be Presented in Oral and Poster Sessions at The 23rd International Conference on Advances in Critical Care Nephrology AKI & CRRT 2018

Manuscript Published Online in Critical Care Medicine

SAN DIEGO, March 06, 2018 (GLOBE NEWSWIRE) -- La Jolla Pharmaceutical Company (Nasdaq:LJPC) today announced the release of data from analyses of the impact of GIAPREZA™ (angiotensin II) on outcomes of a subset of patients with acute kidney injury requiring renal replacement therapy (AKI-RRT) enrolled in the ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) study.

The presentation, entitled “Outcomes in Patients with Acute Kidney Injury Receiving Angiotensin II for Vasodilatory Shock,” will take place during The 23rd International Conference on Advances in Critical Care Nephrology - AKI & CRRT 2018, being held March 6-9, 2018 in San Diego, California. The manuscript, entitled “Outcomes in patients with vasodilatory shock and renal replacement therapy treated with intravenous angiotensin II” was published online in Critical Care Medicine.

“Acute kidney injury requiring dialysis associated with distributive shock, also referred to as vasodilatory shock, represents a significant medical risk for patients and a significant financial burden to the health care system,” said James Tumlin M.D., Professor of Medicine and Director of NephroNet Clinical Trials Consortium. “These analyses of the effect of angiotensin II on AKI patients requiring dialysis in the ATHOS-3 study demonstrated angiotensin II is a promising therapy to address this unmet need.”

The presentations and manuscript detail the outcomes of patients with acute kidney injury (AKI) and vasodilatory shock enrolled in the ATHOS-3 study of GIAPREZA. In this post-hoc analysis, the data from 105 AKI patients (GIAPREZA n=45; placebo n=60) requiring renal replacement therapy (RRT) at study drug initiation were analyzed. Survival through day 28 was 53% (95% CI: 38%-67%) for the GIAPREZA group compared to 30% (95% CI: 19%-41%) for the placebo group (p = 0.012). By day 7, 38% (95% CI: 25%-54%) of patients treated with GIAPREZA discontinued RRT compared to 15% (95% CI: 8%-27%) of patients treated with placebo (p = 0.007). Mean arterial pressure (MAP) response at hour 3 was achieved in 53% (95% CI: 38%-68%) of patients treated with GIAPREZA compared to 22% (95% CI: 12%-34%) of patients treated with placebo (p = 0.001).

23rd International Conference on Advances in Critical Care Nephrology - AKI & CRRT 2018 Presentation Details
    
Presentation Title:  Outcomes in Patients with Acute Kidney Injury Receiving Angiotensin II for Vasodilatory Shock
    
Presenter:  James Tumlin, M.D., Professor of Medicine and Director of NephroNet Clinical Trials Consortium
    
Poster Presentation Date:  Tuesday, March 6, 2018 5:30 pm - 7:00 pm and Wednesday, March 7, 2018 6:00 pm - 8:00 pm Pacific Time
    
Oral Presentation Date:  Friday, March 9, 2018 11:00 am – 12:25 pm Pacific Time
    
Location:  Manchester Grand Hyatt, San Diego, CA
    

About GIAPREZA

In December 2017, GIAPREZA™ (angiotensin II) was approved by the U.S. Food and Drug Administration (FDA) to increase blood pressure in adults with septic or other distributive shock. GIAPREZA mimics the body’s endogenous regulatory peptide that is central to the renin-angiotensin-aldosterone system to increase blood pressure. Prescribing information for GIAPREZA is available at www.giapreza.com.

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 reported in greater than 10% in GIAPREZA treated patients were thromboembolic events.

Drug Interactions

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

About Shock and Septic or Other Distributive Shock

Over 1 million Americans are affected by shock on an annual basis, with 1 in 3 patients being treated for shock in the intensive care unit. Distributive shock is the most common type of shock in the inpatient setting with approximately 800,000 distributive shock cases in the United States per year. Of these cases, an estimated 90% are septic shock patients. Approximately 300,000 do not achieve adequate blood pressure response with standard of care vasopressor therapy (catecholamines and vasopressin). The inability to achieve or maintain adequate blood pressure results in inadequate blood flow to the body’s organs and tissue and is associated with a mortality rate exceeding most acute conditions requiring hospitalization.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. GIAPREZA™ (angiotensin II), formerly known as LJPC-501, was approved by the U.S. Food and Drug Administration (FDA) on December 21, 2017 as a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. LJPC‑401 (synthetic human hepcidin), a clinical-stage investigational product, is being developed for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome. For more information, please visit www.ljpc.com.

Forward-looking Statements

This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to expectations regarding future events or La Jolla’s future results of operations. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. La Jolla 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 La Jolla’s filings with the U.S. Securities and Exchange Commission (SEC), all of which are available free of charge on the SEC’s website www.sec.gov. These risks include, but are not limited to, risks relating to: unforeseen safety issues from the administration of GIAPREZA in patients; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities; potential market sizes, including for septic or other distributive shock; our ability to successfully commercialize, market and achieve market acceptance of GIAPREZA; and other risks and uncertainties identified in our filings with the SEC. La Jolla expressly disclaims any intent to update any forward‑looking statements to reflect the outcome of subsequent events.

Company Contacts

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

and

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