BioCryst Pharmaceuticals, Inc. has licensed commercialization rights in Japan to Torii Pharmaceutical, Co. for BCX7353, an oral, once-daily treatment for the prevention of HAE attacks.
“We are excited to partner with Torii to accelerate access for Japanese patients to BCX7353,” said Jon Stonehouse, president and CEO of BioCryst. “Torii has a strong and recent history of significant commercial success as a Japanese partner, and the breadth of experience and infrastructure to build the prophylactic HAE market with BCX7353.”
BioCryst received Orphan Drug and Sakigake designation for BCX7353 and plans to submit a Japanese New Drug application (JNDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in the first quarter of 2020.
“Given its clinical profile and the tremendous unmet need of HAE patients here in Japan, we are honored to add BCX7353 to our portfolio,” said Goichi Matsuda, president of Torii. “We are well positioned to use our experience in building disease awareness, in driving patient identification, and our broad reach across the base of treaters, including dermatologists, allergists, and other specialists, to bring this important treatment to HAE patients.”
“With no approved treatments in Japan for the prevention of HAE attacks, there is a significant unmet need today,” said professor Beverley Yamamoto, president of the Japanese Hereditary Angioedema Patient Association. “A safe, effective oral prophylactic therapy would offer tremendous benefit to Japanese HAE patients and their families.”