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07-Jan-2019

Fedora Pharmaceuticals and Meiji Seika Pharma Sign Basic Agreement to Establish NacuGen Therapeutics Inc., a Joint Venture to Develop and Commercialize Nacubactam for Bacterial Infections

Joint Venture to Initially Focus on Development of Nacubactam, a Beta-Lactamase Inhibitor (BLI) for Severe Gram-Negative Enterobacteriaceae Infections

Fedora Pharmaceuticals, Inc. (headquarters: Edmonton, Alberta, Canada; Chief Executive Officer: Christopher G. Micetich, hereinafter "Fedora") and Meiji Seika Pharma (headquarters: Tokyo, Japan; President and Representative Director: Daikichiro Kobayashi, hereinafter “Meiji”) 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.”

About Nacubactam
Nacubactam is a Phase 3-ready beta-lactamase inhibitor with a dual mechanism of action, inhibiting a number of beta-lactamase enzymes as well as certain bacterial cell wall enzymes, lending the candidate a broad spectrum of activity when used in combination with beta-lactam antibiotics. In non-clinical studies, nacubactam-meropenem was shown to have potent antimicrobial activity against complicated urinary tract and severe respiratory tract infections, including those caused by meropenem-resistant strains, and against infections caused by CRE. In previously reported Phase 1 clinical studies, it was demonstrated that intravenous nacubactam was well tolerated among healthy volunteers when administered alone or in combination with meropenem. In these studies, nacubactam had no effect on ECG or vital signs parameters, and no trends in laboratory tests were observed. Pharmacokinetic studies in renal impaired patients and in cUTI patients have also been completed.

Nacubactam had been licensed by Fedora and Meiji to Roche in January 2015 as part of an agreement under which Meiji and Fedora were eligible to receive upfront plus development, regulatory and sales milestone payments of up to US$750 million. Fedora and Meiji regained rights to nacubactam in 2018. To date, nacubactam has received Fast Track and Qualified Infectious Disease Product (QIDP) designations from the U.S. Food and Drug Administration (FDA) and previously secured funding commitment from the U.S. Biomedical Advanced Research and Development Authority (BARDA).

About Meiji Seika Pharma Co., Ltd.  - Ethical Pharmaceuticals Business
Since beginning penicillin production in 1946, Meiji Seika Pharma (Meiji) has become a leading maker of antibacterial drugs. Through the years, Meiji has been accumulating a wealth of proprietary technologies on R&D and manufacturing and providing pharmaceutical products of excellent quality to customers in Japan and overseas. Drawing on accumulated know-how in the specialty drug business, Meiji has recently begun supplying generic drugs that are comparable to specialty drugs in terms of quality, thereby serving as a "Specialty and Generic Pharmaceuticals Company" to accommodate customer’s diverse medical requirements.

About Fedora Pharmaceuticals
Fedora Pharmaceuticals is developing a pipeline of antimicrobial drug candidates designed to have activity against multi-drug resistant pathogens. Fedora was founded in 2012 and is headquartered in Edmonton, Alberta, Canada. In 2015, the company received the Alberta Life Sciences’ "Company of the Year" award and the Alberta Science and Technology Leadership (ASTech) Foundation’s award for Outstanding Commercial Achievement. For more information, please visit Fedora Pharmaceutical’s website at www.fedorapharma.com.  

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Last Updated: 02-Apr-2019