Fedora Pharmaceuticals and Meiji Seika Pharma Sign Basic Agreement to Establish NacuGen Therapeutics Inc., a Joint Venture

Fedora Pharmaceuticals, Inc and Meiji Seika Pharma announced today that they have signed a basic agreement to establish NacuGen Therapeutics Inc., a joint venture that will be dedicated to the development and commercialization of novel anti-infectives including beta-lactamase inhibitors. During the next several months Fedora and Meiji will work together to formalize the details of NacuGen’s formation based on this basic agreement. NacuGen operations are scheduled to start in the first half of 2019, subject to the approval of the applicable authorities.

The joint venture’s first asset is nacubactam (formerly FPI-1459; OP0595; RO7079901), a beta-lactamase inhibitor currently being developed for the treatment of complicated urinary tract infection (cUTI), hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP) and complicated intra-abdominal infections (cIAI). Worldwide rights (except Japan) to nacubactam were acquired from Roche (SIX: RO, ROG; OTCQX: RHHBY), which had previously been developing nacubactam under a January 2015 license agreement with Fedora and Meiji.

The rapid rise of antimicrobial resistance (AMR) is widely recognized as a significant global health threat. If unchecked, deaths from AMR infections and their complications are projected to increase from 700,000 to up to 10 million annually. Direct healthcare costs are expected to increase concurrently, with an estimated US$100 trillion projected to be spent between now and 2050 on patients with AMR infections. BLIs thwart an important resistance mechanism in beta-lactam antibiotics, returning the resistant pathogen to a susceptible state. They therefore represent a crucial component in the global effort to address the spread of resistant microbes.

"Roche made significant progress in the early stage clinical development of nacubactam and in the characterization of its mechanism of action," stated Mr. Micetich. "We are particularly excited about the degree of activity nacubactam demonstrated in combination with meropenem and believe it has significant potential in the treatment of complicated infections such as those caused by carbapenem-resistant Enterobacteriaceae (CRE). We are looking forward to working together under our joint venture to advance the product expeditiously through its remaining late-stage clinical requirements."

Mr. Kobayashi of Meiji added, "We and our partners at Fedora are currently assessing our options to fund the clinical development of nacubactam?meropenem as well as the future growth of the NacuGen joint venture. In addition to ensuring the rapid and efficient development of nacubactam?meropenem, we intend NacuGen to explore nacubactam’s utility in combination with other beta-lactam antibiotics, either via in-licensing or partnership agreements. In addition, the joint venture may consider in-licensing opportunities to expand the NacuGen pipeline with complementary candidates in the anti-infectives space."

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