Shots: 

• Nathan McCutcheon, President, and Chief Executive Officer of Shionogi, shares the highlights of the recent acquisition of Qpex Biopharma by Shionogi  

• Nathan believes that Qpex’s specialized expertise and extensive experience in chemistry and molecular design are sure to strengthen and be useful for the combined antibiotic pipeline  

• The acquisition provides Shionogi exclusive development, manufacturing, and marketing rights for xeruborbactam, an investigational novel β-lactamase inhibitor   

Saurabh: What strategic rationale led Shionogi to acquire Qpex Biopharma, and how does Qpex align with Shionogi's overall vision and goals?   

Nathan: As a leader in infectious disease drug discovery and development, Shionogi is deeply committed to addressing bacterial resistance to antibiotics, one of the biggest threats to global health. However, even with significant internal R&D investment, the complex and evolving nature of infectious diseases requires constant innovation to stay ahead of current and future resistance.1 

The acquisition demonstrates Shionogi’s commitment to novel antimicrobial drug research and development and has the potential to accelerate critically needed innovation in infectious disease. Qpex’s leadership team has a proven track record of discovering novel compounds that target bacteria that are resistant to available antibiotics. This is directly aligned with our commitment to “Protect people worldwide from the threat of infectious diseases.” Qpex’s pipeline, including xeruborbactam, an investigational ß-lactamase inhibitor, along with its significant R&D capabilities and expertise are complementary to our own ongoing efforts to address unmet needs in infectious disease. 

Saurabh: How will the acquisition of Qpex enhance Shionogi's capabilities and expertise in the field of antimicrobial research and development? 

Nathan: The Qpex acquisition is a strategic decision that will accelerate Shionogi’s efforts to develop new antibiotic treatments to address antimicrobial resistance. Shionogi is gaining access to a powerful R&D engine that may enhance our ability to innovate new antimicrobial agents to address current and future pathogens. Qpex has a proven track record of discovering novel compounds for bacteria that are resistant to available antibiotics. Further, we are confident that Qpex’s talented and dedicated team brings unique and fresh perspectives that will complement Shionogi’s own drug discovery process. 

Saurabh: What are the specific areas of chemistry and molecular design that complement Shionogi's existing strengths? 

Nathan: Qpex has specialized expertise in areas of chemistry and molecular design that are complementary to Shionogi’s own capabilities, and extensive experience in the development and progression of antimicrobial products, by themselves and in collaboration, which will be immediately useful for the advancement of our combined antibiotic pipeline. 

Qpex applies its expertise in understanding class-based drug resistance with intrinsic drug resistance mechanisms to create novel products and development strategies that overcome multi-drug resistance. By discovering new chemical classes of drugs that can be used in combination with known antibiotics, Qpex aims to restore antibiotic potency against drug-resistant bacteria. 

Saurabh: Could you provide more information about the investigational ß-lactamase inhibitor, xeruborbactam, discovered by Qpex, and its potential in combating drug-resistant Gram-negative bacteria? 

Nathan: Xeruborbactam is an investigational novel β-lactamase inhibitor with a broad inhibitory spectrum against the β-lactamases that induce resistance to β-lactam antibiotics. β-lactamases have diverse structures and enzymes that degrade β-lactam antibiotics such as penicillins, cephems, and carbapenems. Bacteria acquire resistance by inactivating the effects of antibiotics with these enzymes. Xeruborbactam inhibits multiple classes of β-lactamases including metallo-type β-lactamases, found in Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii that cannot be inhibited by existing β-lactamase inhibitors, which may provide improved activity when combined with antibiotics. 

We will evaluate all options to determine how xeruborbactam may provide the greatest impact in helping reduce resistance to antibiotics. We cannot speculate about potential future products, product combinations or revenues. 

Saurabh: Please offer us more information on the development, manufacturing, and marketing opportunities that the acquisition of Qpex provides to Shionogi, specifically in relation to xeruborbactam. 

Nathan: The acquisition enables Shionogi to: 

1.  Acquire the exclusive development, manufacturing and marketing rights for xeruborbactam globally. 
2.  Advance the development of xeruborbactam, which may be used in combination with other antibiotics to protect against potential future resistance challenges. 
3. Accelerate R&D strategies and create opportunities for collaboration and pipeline expansion in the infectious disease area by leveraging Qpex's internal capabilities and external network, which align well with Shionogi’s own. 

Saurabh: What role does the collaboration with the Biomedical Advanced Research and Development Authority (BARDA) play in the development of Qpex's portfolio? 

Nathan: The development of the products in Qpex’s portfolio is funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA) under OTA number HHSO100201600026C), a collaboration Shionogi and Qpex intend to continue. 

Saurabh: How does Shionogi plan to leverage Qpex's capabilities and external network to accelerate research and development strategies in the infectious disease area? 

Nathan: Shionogi will provide Qpex researchers with access to the substantial resources and expertise of the global Shionogi organization to enrich, expand and accelerate its current R&D efforts. Shionogi will explore all options for further development of Qpex’s programs, including potential combinations with existing or future Shionogi compounds. Additionally, Shionogi and Qpex plan to continue the existing collaboration with BARDA to develop a portfolio of antibiotics to address drug-resistant infections. 

Image Source: Canva 

About the Author

Nathan McCutcheon

Nate joined Shionogi Inc. in December 2019 as Executive Vice President and Chief Commercial Officer, overseeing all aspects of the U.S. commercial business and named to the Executive Committee. In November 2020, after leading the commercial organization to exceed financial expectations, Mr. McCutcheon was promoted to Chief Operating Officer with increased responsibilities across commercial operations, distribution and business development activities and was subsequently named President and Chief Executive Officer in July 2022. He is also a member of the Shionogi Inc. board. 

Mr. McCutcheon brings more than 25 years of general management and commercialization experience in large, mid-sized and startup pharmaceutical companies to this role. In his previous positions, he has served as general manager of multiple business units, led multiple product launches and held roles in both global and U.S. capacities. Mr. McCutcheon has held leadership roles at Mallinckrodt, Allergan and Eli Lilly, among others. 

He earned his MBA from the Kelley School of Business and a bachelor’s degree in science from Ball State University. 

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