SAN DIEGO, Calif., Feb. 22, 2018 (GLOBE NEWSWIRE) — La Jolla Pharmaceutical Company (Nasdaq:LJPC), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced financial results for the three and twelve months ended December 31, 2017 and highlighted recent corporate progress.
Recent Corporate Progress
- In December 2017, GIAPREZA™ (angiotensin II), injection for intravenous infusion, formerly known as LJPC-501, 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 December 2017, La Jolla announced the initiation of LJ401-HH01, a multinational, multicenter, randomized, placebo-controlled, double-blind, Phase 2 study that is designed to evaluate the safety and efficacy of LJPC-401 (synthetic human hepcidin) as a treatment for hereditary hemochromatosis (HH). Approximately 60 patients in 5 countries will be randomized to receive weekly subcutaneous injections of either LJPC-401 or placebo for 12 weeks. The primary efficacy endpoint of the study is the change in transferrin saturation, a standard measurement of iron levels in the body and one of the two key measurements used to detect iron overload, from baseline to end of treatment. Secondary efficacy endpoints include: (i) the change in serum ferritin, the other key measurement used to detect iron overload, from baseline to end of treatment; and (ii) the requirement for and frequency of phlebotomy procedures used during the study.
- In December 2017, La Jolla announced the initiation of LJ401-BT01, a pivotal, multinational, multicenter, randomized, controlled study of LJPC-401 in patients with transfusion-dependent beta thalassemia who, despite chelation therapy, have cardiac iron levels above normal. Approximately 100 patients in 9 countries, including the U.S., will be randomized 1:1 to receive either: (i) weekly subcutaneous injections of LJPC-401, while continuing standard-of-care chelation therapy (LJPC-401 treatment arm); or (ii) a continuation of standard-of-care chelation therapy only (observation arm). After 6 months of treatment, patients randomized to the observation arm will cross over to receive LJPC-401 (plus standard-of-care chelation therapy) for 6 months, while patients randomized to the LJPC-401 treatment arm will continue with LJPC-401 (plus standard-of-care chelation therapy) for an additional 6 months (for a total of one year). The primary efficacy endpoint of this study is the change in iron content in the heart after 6 months, as measured by cardiac magnetic resonance imaging (MRI). If this study is successful, we would anticipate filing a market authorization application (MAA) for LJPC-401 in Europe.
“2017 was an exciting year for La Jolla, highlighted by the FDA’s approval of GIAPREZA,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. “We are excited to bring this new treatment option to the many critically ill patients suffering from septic or other distributive shock.”
Results of Operations
As of December 31, 2017, La Jolla had $90.9 million in cash and cash equivalents, compared to $65.7 as of December 31, 2016. La Jolla’s net cash used for operating activities for the twelve months ended December 31, 2017 was $84.9 million compared to net cash used for operating activities of $58.7 million for the same period in 2016. La Jolla’s net loss for the three and twelve months ended December 31, 2017 was $38.5 million and $114.8 million, or $1.74 per share and $5.41 per share, respectively, compared to a net loss of $24.9 million and $78.2 million, or $1.44 per share and $4.54 per share, respectively, for the same periods in 2016.
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. In the ATHOS-3 Phase 3 study, the primary endpoint of: (i) a mean arterial pressure (MAP) increase of ≥ 10 mmHg; or (ii) a MAP of ≥ 75 mmHg, was achieved by 70% of patients randomized to GIAPREZA, compared to 23% of patients randomized to placebo (p < 0.0001); both arms were treated with standard-of-care vasopressors. The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg/min via continuous intravenous infusion. Close monitoring during the first 5 minutes of GIAPREZA initiation is recommended. GIAPREZA is available in 1 mL single dose vials, each containing 2.5 mg of angiotensin II (as a sterile liquid). Prescribing information for GIAPREZA is available at www.giapreza.com.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled Phase 3 study, ATHOS-3. There was a higher incidence of venous and arterial thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo-treated patients in the ATHOS-3 study [13% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.
Adverse reactions that occurred in ≥4% of patients treated with GIAPREZA and ≥1.5% more often than placebo-treated patients in the ATHOS-3 study were thromboembolic events (including deep vein thrombosis), thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia and peripheral ischemia.
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 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.
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: our ability to successfully commercialize, market and achieve market acceptance of GIAPREZA and other product candidates; potential market sizes, including for septic or other distributive shock; the success of development activities for LJPC-401 and other product candidates; and other risks and uncertainties identified in our filings with the SEC. Forward-looking statements are presented as of the date of this press release, and La Jolla expressly disclaims any intent to update any forward‑looking statements to reflect the outcome of subsequent events.
Director, Investor Relations & Human Resources
La Jolla Pharmaceutical Company
Phone: 858 207 4264 Ext: 1135
Dennis M. Mulroy
Chief Financial Officer
La Jolla Pharmaceutical Company
Phone: 858 207 4264 Ext: 1040