Japan’s Shionogi & Co., Ltd (TYO: 4507) announced on June 26, 2023, its planned acquisition of US anti-infectives specialist Qpex Biopharma Inc., for USD 100 million upfront and an additional USD 40 million based on certain development and regulatory milestones. This deal has significant implications for China-based biotech Brii Biosciences Ltd (HKG: 2137), which previously signed an agreement with Qpex in 2019, granting Brii exclusive Greater China rights to three anti-infective drugs.
Territorial Rights Expansion and Rights Return
As a result of Shionogi’s buyout, Brii will expand the territorial rights for one of the drugs, BRII-693/QPX9003, to a global scale. Concurrently, Brii will return the exclusive rights to the two QPX7728-based products, BRII-636 and BRII-672, to Qpex. This transition eliminates all existing cost-share, milestone, and royalty payments associated with BRII-693 that were to be made to Qpex, and cancels all obligations related to the two drugs returned to Qpex. Upon completion of Qpex’s merger with Shionogi, Brii is set to receive approximately USD 24 million in relation to the QPX7728-based program and may also receive milestone-related payouts in the US for those products.
BRII-693: A Novel Synthetic Lipopeptide for MDR/XDR Infections
BRII-693, discovered by the Biomedicine Drug Discovery Institute of Monash University in Australia, is a novel synthetic lipopeptide in development for the treatment of critically ill patients with multi-drug resistant (MDR/XDR) gram-negative bacterial infections, particularly carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa. Brii considers BRII-693 to have the potential to be the safest and most effective polymyxin for treating gram-negative bacterial infections and now stands to benefit from the global development of a drug that has completed Phase I trials in the US.
Regulatory Designations and Development Progress
The US FDA has awarded BRII-693 the Qualified Infectious Disease Product (QIDP) designation, which includes incentives such as priority review, fast-track status, and potential extended market exclusivity in the US. Brii filed a pre-IND application for the molecule with the National Medical Products Administration (NMPA) in April 2023, following Qpex’s initiation of discussions with the US FDA for the drug’s Phase III program.-Fineline Info & Tech
