AFT Pharmaceuticals Licenses Non-Opioid Maxigesic IV to Mikasa Seiyaku for Japan
核心洞察
AFT Pharmaceuticals (搜索) signed an exclusive development, license and supply agreement with Mikasa Seiyaku (搜索) for its intravenous fixed-dose analgesic Maxigesic IV (搜索) in Japan.
Mikasa will lead regulatory submissions to Japan's PMDA and handle registration and commercialization, while AFT develops and supplies the finished product.
Maxigesic IV (搜索) combines paracetamol 1000 mg and ibuprofen 300 mg as a non-opioid injectable intended for post-operative pain (搜索) when intravenous treatment is appropriate.
AFT Pharmaceuticals (搜索) has entered an exclusive development, license and supply agreement with Mikasa Seiyaku (搜索) Co., Ltd. for the development and commercialization of Maxigesic IV (搜索), its intravenous fixed-dose combination analgesic, in Japan. Japan is described as the third largest pharmaceutical market in the world.
Under the terms of the agreement, AFT grants Mikasa an exclusive license to seek marketing authorization for and commercialize the product throughout Japan. Mikasa will lead regulatory submissions to Japan's Pharmaceuticals and Medical Devices Agency (搜索) (PMDA), pursue marketing authorization, and handle development and commercialization in the Japanese market. AFT will be responsible for developing and supplying the product.
Product Profile
Maxigesic IV (搜索), also known as Combogesic IV (搜索), is a proprietary, patented, non-opioid injectable combination of paracetamol (1000 mg) and ibuprofen (300 mg) developed by AFT for the management of pain. The product is intended for post-operative pain (搜索) when intravenous treatment is appropriate, and is designed to provide pain relief while supporting reduced opioid use.
The collaboration is intended to make this treatment option available to patients and healthcare providers in Japan, with AFT stating the aim of providing a non-opioid post-operative pain (搜索) management alternative for Japanese healthcare providers.
Commercial Terms
AFT will receive an upfront license fee and development milestones linked to regulatory submission progress and reimbursement pricing in Japan, with royalties earned on commercial sales following launch. AFT will also supply the finished product to Mikasa.
Hyloris Pharmaceuticals (搜索) SA, AFT's partner, said most milestone payments are payable upon regulatory approval in Japan, while a smaller portion is conditional on achieving a minimum reimbursement price in Japan. Hyloris is entitled to a substantial minority share of the product-related margin received by AFT, including recurring royalties and milestone payments.
AFT was assisted with the licensing agreement in Japan by Shin Nippon Biomedical Laboratories (搜索) Ltd.
Market Context
The Japanese analgesics market generated $785.4 million in revenue in 2022 and is expected to reach $1.32 billion by 2030, according to Hyloris. The agreement expands the global commercial footprint of the intravenous analgesic into that market.
AFT Pharmaceuticals (搜索) develops, licenses, and distributes a wide range of proprietary prescription and over-the-counter health products globally.