On October 26, 2017 La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, reported financial results for the three and nine months ended September 30, 2017 and highlighted recent corporate progress (Press release, La Jolla Pharmaceutical, OCT 26, 2017, View Source [SID1234521288]).
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Recent Corporate Progress
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In August 2017, La Jolla announced that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s New Drug Application (NDA) for the investigational drug LJPC‑501, La Jolla’s propriety formulation of synthetic human angiotensin II, for the treatment of hypotension in adult patients with distributive or vasodilatory shock (dangerously low blood pressure with adequate cardiac function) who remain hypotensive despite fluid and vasopressor therapy (catecholamines and/or vasopressin). The review classification for the application is Priority, and the user fee goal date under the Prescription Drug User Fee Act (PDUFA) is February 28, 2018. In its letter to the Company, the FDA stated that it does not currently plan to hold an advisory committee meeting to discuss this application. The NDA for LJPC-501 is based on data from the ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study of LJPC-501 in patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy, which were published by The New England Journal of Medicine in May 2017.
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In September 2017, an analysis from ATHOS-3 entitled, "Baseline angiotensin levels and ACE effects in patients with vasodilatory shock treated with angiotensin II," was presented during the 30th European Society of Intensive Care Medicine Annual Congress. The pre-specified analysis showed that a relatively low angiotensin II state (as measured by the ratio of angiotensin I to angiotensin II) predicted increased mortality in patients with vasodilatory shock, suggesting that a low angiotensin II state is a negative prognostic indicator of outcomes. Furthermore, the analysis showed a statistically significant treatment effect of LJPC-501 compared to placebo on mortality in these patients with a relatively low angiotensin II state (relative risk reduction of 36%; HR=0.64; 95% CI: 0.41-1.00; p=0.047).
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In September 2017, La Jolla announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued favorable Scientific Advice regarding the EU regulatory pathway for LJPC‑501 for the treatment of hypotension in adult patients with distributive or vasodilatory shock who remain hypotensive despite fluid and vasopressor therapy. Based on this Advice, La Jolla intends to submit a Marketing Authorization Application (MAA) for LJPC-501 in the third quarter of 2018.
"The first nine months of 2017 have been exciting for La Jolla, highlighted by the positive results from ATHOS-3, the publication of these results in The New England Journal of Medicine and the FDA acceptance of our NDA for LJPC-501," said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We look forward to building on this momentum with the preparation for the potential commercial launch of LJPC-501, if approved by the FDA, and the initiation of our pivotal study of LJPC-401 in beta thalassemia patients suffering from iron overload."
Results of Operations
As of September 30, 2017, the Company had $120.8 million in cash and cash equivalents, compared to $65.7 million of cash and cash equivalents at December 31, 2016. Cash used in operating activities for the nine months ended September 30, 2017 was $60.4 million, compared to $40.1 million for the same period in 2016. Net loss for the three and nine months ended September 30, 2017 was $26.3 million and $76.3 million, or $1.19 per share and $3.65 per share, respectively, compared to a net loss of $21.3 million and $53.3 million, or $1.23 per share and $3.10 per share, respectively, for the same periods in 2016.