Agreement includes up to $42 million of upfront and potential milestone payments plus royalties on net sales—
JNDA submission to PMDA on track for Q1 2020—
Deal leverages Torii’s proven track record to deliver innovative therapies to Japanese patients—
RESEARCH TRIANGLE PARK, NC, USA I November 05, 2019 IBioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that it has licensed commercialization rights in Japan to Torii Pharmaceutical, Co. for BCX7353, an oral, once-daily treatment for the prevention of hereditary angioedema (HAE) attacks.
BioCryst will receive a $22 million upfront payment and is eligible to receive up to an additional $20 million upon achievement of certain milestones. In addition, BioCryst will receive tiered royalties ranging from the mid-teens to potentially 40 percent of Japanese net sales of BCX7353.
“We are excited to partner with Torii to accelerate access for Japanese patients to BCX7353,” said Jon Stonehouse, president and chief executive officer 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.”
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.
About Torii Pharmaceutical Co., Ltd.
The corporate mission of Torii Pharmaceutical Co., Ltd. is to contribute to the improvement of human health and to fulfill its responsibilities to customers, shareholders, society and employees, by supplying world-class pharmaceutical products. Torii Pharma focuses on Renal diseases, Hemodialysis, Allergy and Skin diseases as its therapeutic areas of importance. Torii is a member of Japan Tobacco Inc. (JT) group. Collaboration with JT takes the form of functional focus, with JT undertaking R&D on new compounds and Torii integrating manufacture and marketing. In addition to Torii’s independent activities, Torii‘s partnership with JT includes in-licensing of high-quality pharmaceuticals. More details can be found on the corporate website https://www.torii.co.jp/ en/
SOURCE: Torii Pharmaceutical Co
Post Views: 387
Agreement includes up to $42 million of upfront and potential milestone payments plus royalties on net sales—
JNDA submission to PMDA on track for Q1 2020—
Deal leverages Torii’s proven track record to deliver innovative therapies to Japanese patients—
RESEARCH TRIANGLE PARK, NC, USA I November 05, 2019 IBioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that it has licensed commercialization rights in Japan to Torii Pharmaceutical, Co. for BCX7353, an oral, once-daily treatment for the prevention of hereditary angioedema (HAE) attacks.
BioCryst will receive a $22 million upfront payment and is eligible to receive up to an additional $20 million upon achievement of certain milestones. In addition, BioCryst will receive tiered royalties ranging from the mid-teens to potentially 40 percent of Japanese net sales of BCX7353.
“We are excited to partner with Torii to accelerate access for Japanese patients to BCX7353,” said Jon Stonehouse, president and chief executive officer 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.”
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.BioCryst.com.
About Torii Pharmaceutical Co., Ltd.
The corporate mission of Torii Pharmaceutical Co., Ltd. is to contribute to the improvement of human health and to fulfill its responsibilities to customers, shareholders, society and employees, by supplying world-class pharmaceutical products. Torii Pharma focuses on Renal diseases, Hemodialysis, Allergy and Skin diseases as its therapeutic areas of importance. Torii is a member of Japan Tobacco Inc. (JT) group. Collaboration with JT takes the form of functional focus, with JT undertaking R&D on new compounds and Torii integrating manufacture and marketing. In addition to Torii’s independent activities, Torii‘s partnership with JT includes in-licensing of high-quality pharmaceuticals. More details can be found on the corporate website https://www.torii.co.jp/ en/
SOURCE: Torii Pharmaceutical Co
Post Views: 387
