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BioCryst Submits Japanese New Drug Application for Oral, Once Daily Berotralstat
RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has submitted a new drug
About this update from Biocryst Pharmaceuticals, Inc.
[{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has submitted a new drug application (JNDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for approval of oral, once daily berotralstat for the prophylactic treatment of hereditary angioedema (HAE).\n “The data from APeX-J and the berotralstat clinical program are very exciting for HAE patients in Japan,” said Dr. Isao Ohsawa, president of Saiyu Soka hospital and principal investigator of the APeX-J trial. “Based on the clinical benefit observed in patients in APeX-J, I expect many patients in Japan will want to use this new treatment, once it becomes available,” he added. BioCryst received Orphan Drug and Sakigake designations for berotralstat. Under the Sakigake timeline, the company expects potential approval in the second half of 2020. “Berotralstat would be the first approved chronic therapy for HAE patients in Japan and would address a significant unmet medical need,” said Jon Stonehouse, president and chief executive officer of BioCryst. Torii Pharmaceutical, Co. is BioCryst’s commercial partner in Japan for berotralstat. Under the terms of its commercial agreement with Torii, BioCryst received a $22 million upfront payment and is eligible to receive an additional milestone payment of up to $20 million based on the timing of PMDA approval and upon receipt of a reimbursement price approval from Japan’s National Health Insurance system in excess of the threshold specified in the agreement. In addition, BioCryst will receive tiered royalties of up to 40 percent of Japanese net sales of berotralstat. The JNDA contains data from both the APeX-J and APeX-2 clinical trials. The company recently announced that the APeX-J trial in Japan met its primary endpoint (p=0.003) of a reduction in HAE attacks from baseline for berotralstat 150 mg compared to placebo, and berotralstat was safe and generally well-tolerated in the trial. In APeX-2, berotralstat also met its primary endpoint (p","length":2989,"tagName":"div"}]