Forty Seven, Inc. and Ono Pharmaceutical Co., Ltd. Sign Regional License Agreement to Develop, Manufacture and Commercialize 5F9 in Japan, South Korea, Taiwan and Select Countries in Southeast Asia
-- Ono to Receive Exclusive License for All Therapeutic Uses of 5F9 in Select Asian Markets ---- Forty Seven to Receive up to $120M in Combined Upfront and Potential Development and Commercial Milestone Payments, in Addition to Royalties on Net Sales --
MENLO PARK, Calif., July 11, 2019 (GLOBE NEWSWIRE) -- Forty Seven, Inc., a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, and Ono Pharmaceutical Co., Ltd. today announced an exclusive license agreement for the development, manufacture and commercialization of 5F9, Forty Seven’s monoclonal antibody against CD47. The agreement includes all therapeutic uses of 5F9 as a monotherapy or combination agent in Japan, South Korea, Taiwan and the ASEAN countries (the “Territory”). Forty Seven will retain all rights to 5F9 in the rest of the world including the United States, Europe and China.
Under the terms of the agreement, Forty Seven will receive a one-time upfront payment of approximately $15.8 million from Ono. Forty Seven is eligible to receive up to an additional approximately $104 million at current exchange rates if specified future development and commercial milestones are achieved by Ono, in addition to tiered percentage royalties, spanning from the mid-teens to the low-twenties, on future net sales of 5F9 in the Territory. In exchange, Ono will receive exclusive rights to develop, manufacture and commercialize 5F9 in the Territory, at its own cost and expense. Additionally, Ono will have the right to participate in global clinical studies of 5F9 by bearing the development cost in the above countries.
“Ono is an established leader in oncology, with a track record of successfully developing and commercializing immuno-oncology and in-licensed targeted-therapeutics for East Asian markets, including OPDIVO® (nivolumab), KYPROLIS® (carfilzomib), BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib). Importantly, with Bristol-Myers Squibb, Ono secured the first regulatory approval for OPDIVO worldwide,” said Craig Gibbs, Ph.D., Chief Business Officer of Forty Seven. “We are confident Ono is the ideal partner as we enter into our first commercial collaboration and look to accelerate our delivery of 5F9 to patients in select Asian countries, while also maintaining a sharp focus on executing our internal development programs.”
“We are delighted to enter into this collaboration with Forty Seven, a pioneer in understanding the role of CD47 in cancer evasion and a leader in the development of new immunotherapies that harness the therapeutic potential of the innate immune system,” said Kiyoaki Idemitsu, Corporate Officer and Executive Director, Clinical Development of Ono. “Based on compelling data in multiple hematologic malignancies, we believe 5F9 has the potential to deliver benefit to a broad range of patients. We will explore possibilities of 5F9 for the treatment of various cancers including solid tumors, as we advance our efforts to develop and deliver innovative and breakthrough pharmaceutical products to patients in Japan, South Korea, Taiwan and the ASEAN countries.”
About 5F95F9 is a monoclonal antibody against CD47 that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, thus blocking the “don’t eat me” signal used by cancer cells to avoid being ingested by macrophages. Forty Seven, Inc. is initially developing 5F9, an investigational medicine, for the treatment of patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), non-Hodgkin’s lymphoma (NHL), ovarian cancer and colorectal cancer. 5F9 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), two forms of B-cell NHL, and Orphan Drug designation by the U.S. Food and Drug Administration and European Medicines Agency for the treatment of AML. Based on FDA feedback the Company believes that single arm pivotal trials may be sufficient to support registration of 5F9+azacitidine in MDS and 5F9+rituximab in heavily pre-treated r/r DLBCL patients, respectively.
About Forty Seven Inc.Forty Seven, Inc. is a clinical-stage immuno-oncology company that is developing therapies targeting cancer immune evasion pathways based on technology licensed from Stanford University. Forty Seven’s lead program, 5F9, is a monoclonal antibody against the CD47 receptor, a “don’t eat me” signal that cancer cells commandeer to avoid being ingested by macrophages. This antibody is currently being evaluated in multiple clinical studies in patients with solid tumors, myelodysplastic syndrome, acute myeloid leukemia, non-Hodgkin’s lymphoma, ovarian cancer and colorectal carcinoma.
About Ono Pharmaceutical Co., Ltd.Ono Pharmaceutical Co., Ltd., headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. It focuses especially on the oncology, autoimmune disease, neurology and diabetes areas. For more information, please visit the company’s website at http://www.ono.co.jp/eng/index.html.
Forward Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” “potential,” “believe” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the success of Forty Seven’s collaboration with Ono; the potential of 5F9 as a monotherapy or combination agent in the Territory; the timing and receipt of future milestone payments and royalties under the license agreement; participation by Ono in global clinical studies of 5F9; the integration of 5F9 into Ono’s oncology pipeline; and whether 5F9 will be successfully commercialized in the Territory.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The product candidates that Forty Seven develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. Such product candidates may not be beneficial to patients or successfully commercialized. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Forty Seven’s stock price. Additional information concerning these and other risk factors affecting Forty Seven’s business can be found in Forty Seven’s periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Forty Seven disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.
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