Decades of Innovation

Timeline Key

  • Infectious disease and antimicrobial resistance (AMR) events
  • Qpex company evolution milestones

1990s

Emerging Infections Programs (EIPs) are established in response to the Centers for Disease Control and Prevention’s (CDC) 1994 report, Addressing Emerging Infectious Disease Threats: A Prevention Strategy for the United States.1

Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) outbreaks emerge when cases of MRSA are documented in healthy individuals outside of healthcare settings. MRSA strains, including USA300, become a global concern due to their virulence and resistance to standard antibiotics.2

Shionogi develops third-generation oral cephalosporin antibiotics, introducing ceftibuten in 1992, followed by cefcapene in 1997.3

Qpex leaders start work at Microcide Pharmaceuticals, a company focused on genomics-based antibiotic discovery. The company goes on to discover bacterial efflux pump inhibitors and MC-02479, the first anti-MRSA cephalosporin to enter clinical development.

2000s

The Infectious Diseases Society of America (IDSA) publishes Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates…A Public Health Crisis Brews in 2004. The report documents the need for innovation for antibiotic-resistant infections.4

Outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) are first reported in hospitals in New York.5

Qpex leaders join Mpex Pharmaceuticals. The company develops QUINSAIR® (levofloxacin nebuliser solution), an antibiotic for treatment of chronic pulmonary infections in patients with cystic fibrosis, which advances into clinical development in 2006. Mpex is acquired by Aptalis Pharmaceutical Technologies in 2011.

The Global Antibiotic Resistance Partnership (GARP) is established to address the growing global challenge of AMR in 2009.6

2010s

Qpex leaders found Rempex Pharmaceuticals, Inc. in 2011. The company goes on to discover a new class of boronate beta-lactamase inhibitors and begins clinical development of vaborbactam. Rempex is acquired by The Medicines Company in 2013 and continues as a wholly owned subsidiary.

The CDC publishes the first Antibiotic Resistance Threats in the United States report in 2013. The report represents the first systematic effort to quantify the number of antibiotic-resistant infections and classify pathogens as urgent, serious or concerning.7

Rempex begins its first partnership with BARDA in 2014 to develop meropenem-vaborbactam.

QUINSAIR (levofloxacin nebuliser solution) is approved in the EU in 2015.

Rempex begins its second partnership with BARDA in 2016 to develop a portfolio of antibiotics.

Shionogi and dozens of other companies sign the Davos Declaration on Antimicrobial Resistance in 2016. The declaration calls for collective action to create a sustainable and predictable market for antibiotics.8

Rempex and The Medicines Company obtain U.S. Food and Drug Administration (FDA) approval for ORBACTIV® (oritavancin) in 2014, a novel formulation of MINOCIN® (minocycline) for injection in 2015 and VABOMERE™ (meropenem and vaborbactam) for injection in 2017.

Qpex Biopharma is formed in 2018 and advances three drugs into clinical development in three years, including xeruborbactam, an investigational beta-lactamase inhibitor for oral or intravenous treatment of infections caused by resistant Gram-negative bacteria.

The CDC publishes an updated Antibiotic Resistance Threats in the United States report in 2019. The report classifies carbapenem-resistant Enterobacterales and Acinetobacter spp. as urgent, and multidrug-resistant Pseudomonas aeruginosa and extended-spectrum beta-lactamase-producing Enterobacterales as serious threats.9

2020s

The COVID-19 pandemic disrupts global health systems, leading to unprecedented efforts in vaccine development, diagnostics and therapeutics.10

Qpex is acquired by Shionogi Inc. in 2023 and continues to operate as a wholly owned Shionogi Group Company.

Shionogi and Qpex announce plans to establish a new drug discovery laboratory in San Diego, California in 2024. The new laboratory expands the companies’ infectious disease and antimicrobial research operations in the U.S.

Today, Shionogi and Qpex are working together to address the unmet medical needs of patients and healthcare professionals through innovating new solutions for current and emerging pathogens.

References

  1. Addressing Emerging Infectious Disease Threats: A Prevention Strategy for the United States Executive Summary. Centers of Disease Control (1994). Accessed January 17, 2025. Available at: https://www.cdc.gov/mmwr/pdf/rr/rr4305.pdf. ↩︎
  2. DeLeo FR, Chambers HF. Reemergence of antibiotic-resistant Staphylococcus aureus in the genomics era. J Clin Invest. 2009 Sep;119(9):2464-74. doi:10.1172/JCI38226. ↩︎
  3. Long-term commitment to improving R&D to provide novel treatments for infectious diseases. Shionogi & Co., Ltd. (n.d.). Accessed February 13, 2025. Available at: https://www.shionogi.com/global/en/sustainability/amr/commitment.html. ↩︎
  4. Podolsky SH. The evolving response to antibiotic resistance (1945–2018). Palgrave Commun 4, 2018;4:Article 124. doi:10.1057/s41599-018-0181-x. https://doi.org/10.1057/s41599-018-0181-x. ↩︎
  5. Park SO, Liu J, Furuya EY, Larson EL. Carbapenem-Resistant Klebsiella pneumoniae Infection in Three New York City Hospitals Trended Downwards From 2006 to 2014. Open Forum Infect Dis. 2016 Dec 2;3(4):ofw222. doi:10.1093/ofid/ofw222. ↩︎
  6. Carlet J, Pulcini C, Piddock LJV. Antibiotic resistance: a geopolitical issue. Clinical Microbiology and Infection. 2014 20(10):949-953. https://doi.org/10.1111/1469-0691.12767.ISSN 1198-743X. ↩︎
  7. Antibiotic Resistance Threats in the United States. Centers for Disease Control and Prevention (2013). Accessed January 17, 2025. Available at: https://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf. ↩︎
  8. Our Promise. Shionogi. Accessed January 17, 2025. Available at: https://www.shionogi.com/global/en/sustainability/amr/promise.html. ↩︎
  9. CDC’s Antibiotic Resistance Threats Report, 2019. Centers for Disease Control and Prevention. Accessed January 17, 2025. Available at: https://www.hhs.gov/sites/default/files/michael-craig-cdc-talk-thursday-am-508.pdf. ↩︎
  10. Soumyanarayanan U, Choong M, Leong J, Lumpkin MM, Rasi G, Skerritt JH, Vogel S, Lim JCW. The COVID-19 crisis as an opportunity to strengthen global regulatory coordination for sustained enhanced access to diagnostics and therapeutics. Clin Transl Sci. 2021 May;14(3):777-780. doi:10.1111/cts.12954. ↩︎
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