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ABVC BioPharma Executes A Global Licensing Term Sheet For Oncology/Hematology Products, Expecting Licensing Income Of $55M And Royalties Of Up To $50M

Author: Benzinga Newsdesk | April 10, 2024 08:38am

 ABVC BioPharma, Inc. (NASDAQ:ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in ophthalmology, CNS (central nervous systems), and Oncology/Hematology, announced today that the Company together with its affiliates BioLite, Inc., and Rgene Corporation entered into a term sheet with OncoX BioPharma, Inc. (OncoX) for the Company's Oncology/Hematology pipeline(the "Licensed Products"). Subject to negotiation and execution of the definitive agreement, this license would cover the Licensed Products' clinical trial, registration, manufacturing, supply, and distribution rights. ABVC is set to receive $50,000,000 as licensing fees in the form of Cash/Shares within 30 days of execution of the Definitive Agreement, with an additional milestone payment of $5,000,000 in cash after the first fundraising round and Royalties of 5% of net sales, up to $50,000,000, after the launch of the Licensed Products.

 

The United States Food & Drug Administration (US FDA) has approved four INDs: ABV-1519 (IND 129575) for Triple Negative Breast Cancer (TNBC), ABV-1501 (IND 161602) for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 (IND 131300) for Myelodysplastic Syndrome (MDS), and ABV-1703 (IND 136309) for Pancreatic Cancer Therapy. The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient. The active ingredient of BLEX 404 is the β-glucan extracted from Grifola frondosa (maitake mushrooms), an edible fungus with high medical and commercial values in Asia; it contains various bioactive constituents such as polysaccharides, pyrrole alkaloids, ergosterol, etc., and has been widely served as functional foods for a long time in daily life.[1]

"We are thrilled to announce that the term sheet for a potential groundbreaking licensing deal with OncoX has been successfully executed. The agreement sets the stage for a strategic partnership that we hope will revolutionize the Oncology/Hematology sector with our products that are valued at $105M by third-party valuer," said Dr. Uttam Patil, ABVC's Chief Executive Officer.  "After extensive negotiations and meticulous legal scrutiny, both parties have reached mutually beneficial terms that pave the way for a collaborative venture we believe is poised to redefine industry standards and drive innovation. This licensing deal marks a significant milestone for ABVC and OncoX, affirming their commitment to excellence and shared vision for the future. By leveraging each other's strengths, resources, and expertise, the partnership is set to unlock new opportunities and create unparalleled value for stakeholders."

"We are delighted to formalize this partnership with ABVC," said Wen-Pin Yen, CEO of OncoX. "This collaboration underscores our dedication to delivering cutting-edge solutions and reinforces our position in the Oncology/Hematology sector. We believe we are poised to profoundly impact and shape the Oncology/Hematology sector's future." He added that they've spent time actively marketing dietary supplements produced at BioKey, Inc., CDMO of ABVC. This experience involves researching their efficacy, managing their production process, and promoting them to consumers. It has led to a deep understanding of the supplement industry, including knowledge about various supplements, their ingredients, potential benefits and risks, regulatory requirements, and consumer preferences. We intend to use this exposure in new development, and it is essential for creating products that meet user needs, are easy to use, and ultimately drive user satisfaction and engagement.

Under the proposed agreement, ABVC would grant OncoX an exclusive global rights license to develop and commercialize the Licensed Products within the Field of Use. ABVC would also grant OncoX the right to sublicense to a third party, pre-agreed by ABVC. ABVC would be responsible for securing the supply of the Licensed Products to OncoX with an agreed price and quantity. In contrast, OncoX would secure the purchase of the Licensed Products from ABVC with a committed volume. OncoX would be responsible for completing the regulatory filing of IND. ABVC would provide the Licensed Products to OncoX at a cost to support clinical development in the Field of Use.

OncoX would be responsible for further development and commercialization of the Licensed Products in the Field of Use, including any clinical development, regulatory affairs (including regulatory filings and approvals), and commercialization of the Licensed Products. As part of this license, OncoX would grant ABVC a perpetual, royalty-free right to use and reference any development, regulatory, and market data associated with the Licensed Products in OncoX's control.

The terms discussed or agreed upon are conditional and not final until a formal Definitive Agreement is executed by all parties involved.

Management believes the Company's product pipeline has excellent market potential. The global cancer therapeutics market is expected to be worth around US$393.61 billion by 2032, up from US$164 billion in 2022, growing at a CAGR of 9.20% from 2023 to 2032.[2]

Posted In: ABVC

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