Achaogen Announces Data on Epidemiological Trends

-- Data suggest high prevalence of CRE with rapid rate of increase --

-- Company’s late-stage candidate, plazomicin, may provide an important new option in treating MDR infections, including those caused by CRE --

SOUTH SAN FRANCISCO, Calif., March 29, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ: AKAO ), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multidrug-resistant (MDR) gram-negative infections, today announced an upcoming data presentation at the Society for Healthcare Epidemiology in America (SHEA) Spring 2017 Conference. The presentation highlights the use of the Cerner Health Facts electronic health record dataset to estimate the prevalence of carbapenem-resistant Enterobacteriaceae (CRE).

“Carbapenem resistance poses a serious threat to public health. Its escalating prevalence, limited treatment options, and associated high rates of mortality have prompted organizations such as the CDC and WHO to designate CRE as an urgent threat,” said Marya Zilberberg, MD, MPH, President and Chief Executive Officer of EviMed Research Group, LLC, and Adjunct Associate Professor of Public Health at the University of Massachusetts Amherst. “Our multi-center analysis of CRE burden in the U.S. between 2009 and 2015 being presented by Dr. Schneider suggests that CRE may be at least three times more prevalent than previously estimated.”

“Patients with life-threatening infections due to CRE face unacceptably high mortality because of the lack of alternative effective antibiotic treatment options,” said Kenneth Hillan, M.B. Ch.B, Achaogen’s Chief Executive Officer. “In our Phase 3 CARE trial, a lower rate of mortality or serious disease-related complications was observed for our lead drug candidate, plazomicin, compared to colistin, which is considered as one of the only remaining antibiotics for the treatment of CRE infections.”

The oral presentation is summarized as follows:

Epidemiological trends of Carbapenem-Resistant Enterobacteriaceae (CRE) in the US from 2009-2015 Gary Schneider, MSPH, ScD, Boston Health Economics, Hina N Patel, PharmD, Achaogen, Marya Zilberberg, MD, MPH, EviMed Research Group and University of Massachusetts Amherst CRE has been characterized by the CDC as an urgent threat to public health. The present study sought to examine CRE and its sources in the U.S. over time. All inpatient hospitalizations with laboratory confirmed CRE infection data were extracted from the Cerner Health Facts EMR data from the period 2009 to 2015. The dataset analyzed more than 3 million admissions across 192 hospitals to calculate the national burden of CRE. The trends identified by the researchers suggest the following:

• A total of 20,137 CRE infections were identified during the study interval, yielding a U.S. national projection of 227,828 cases;
• CRE infections increased rapidly over the seven-year period; projected counts increased from 8,191 in 2009 to 65,408 infections in 2015; and
• As expected, over the study interval, the three most common sources for CRE were urinary (43.5%), respiratory (21.2%), and blood (8.8%). As a proportion of all CRE, urinary cultures increased from 2009 to 2015, while respiratory and blood cultures decreased.

Details of the oral presentation, based on research funded in part by Achaogen, are provided below. Presentation slides will be available at 9:30am CT on Friday, March 31, 2017 at www.achaogen.com .

About Achaogen Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with a contract from the Biomedical Advanced Research and Development Authority. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections. All product candidates are investigational only and have not been approved for commercialization. For more information, please visit www.achaogen.com .

Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding potential regulatory approval of plazomicin, Achaogen’s commercial objectives and Achaogen’s pipeline of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; and the risk when bacteria will evolve resistance to plazomicin. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward- looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.

Source: Achaogen, Inc. AKAO-G

Investor Contact: Hans Vitzthum 212.915.2568 hans@lifesciadvisors.com Media Contact: Denise Powell 510.703.9491 denise@redhousecomms.com