Strategic milestone achieved in TDM assay development
Thermo Fisher Scientific to develop and then commercialize its assay for measuring the concentration of
plazomicin
SOUTH SAN FRANCISCO, Calif., Feb. 22, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical
company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that they
have achieved a strategic milestone in their ongoing efforts to develop an assay enabling therapeutic drug management (TDM) of
plazomicin. Achaogen is developing plazomicin for the potential treatment of serious bacterial infections due to MDR
Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
In Achaogen’s Phase 3 CARE trial in patients with serious infections due to CRE, an investigational assay enabling plazomicin
TDM was used to help ensure that targeted exposures of plazomicin were achieved in the critically ill patients enrolled in the
trial. If plazomicin is approved, Achaogen and Thermo Fisher plan to develop and have a commercial assay for plazomicin available
at product launch. Achaogen plans to submit a New Drug Application (NDA) for plazomicin to the Food and Drug Administration (FDA)
in the second half of 2017. Achaogen also plans to submit a Marketing Authorization Application (MAA) to the European Medicines
Agency (EMA) in 2018.
“Thermo Fisher is a world leader in developing and providing high-quality commercial assays to achieve precise and accurate
quantitative results crucial for monitoring drug levels. We are pleased with the progress made in our collaboration with Thermo
Fisher and with achieving this important milestone of demonstrating assay feasibility, a key step toward enabling therapeutic drug
management of plazomicin for those patients most likely to benefit from TDM,” said Blake Wise, Achaogen’s Chief Operating Officer.
“In certain high-risk patient populations, such as the critically ill, we believe TDM has the potential to provide significant
utility in optimizing plazomicin dosing.”
The two companies have been collaborating on assay development since 2015. Under terms of their collaboration agreement, Thermo
Fisher leads the development, regulatory approval, and commercialization of an assay for measuring plazomicin drug levels. Achaogen
brings plazomicin expertise to the collaboration, including the discovery of plazomicin-specific antibodies utilizing their
state-of-the-art antibody discovery platform.
“The agreement reflects our mutual commitment to providing a broadly-available plazomicin assay at launch so that healthcare
providers can measure plazomicin drug levels in critically ill patients with bacterial infections,” said John Kody, Vice
President/General Manager Clinical Diagnostics - Niche Products at Thermo Fisher Scientific. “During the feasibility period, our
two teams have developed an assay that compares very well to traditional analytical chemistry techniques. Thermo Fisher’s QMS™ TDM
assays are conveniently ready-to-use, with excellent precision and accuracy, and are optimized for performance on a wide range of
analyzers.”
In December 2016, Achaogen announced positive results from its plazomicin Phase 3 clinical trials in complicated urinary tract
infections (cUTI) and infections due to CRE. In the Phase 3 EPIC registration trial in patients with cUTI and acute pyelonephritis
(AP), plazomicin met the objective of non-inferiority compared to meropenem for FDA-specified primary efficacy endpoints, and
achieved superiority for the EMA-specified primary efficacy endpoints. In addition, in the Phase 3 CARE trial in patients with
serious infections due to CRE, a lower rate of mortality or serious disease-related complications was observed for
plazomicin-treated patients compared with those on colistin therapy. In the Phase 3 CARE trial, TDM with an investigational assay
helped to confirm that the targeted-exposure of plazomicin was achieved in these critically ill patients.
About Therapeutic Drug Management and Plazomicin
Therapeutic Drug Management is the practice of measuring the concentration of medication in blood and adjusting the dose of that
drug based on the results. Healthcare providers routinely use TDM for certain drugs to help improve patient care by individually
adjusting the dose as appropriate. Critically ill patients with bacterial infections often have abnormal and fluctuating
renal function as well as an altered volume of drug distribution in the body. This can lead to these patients being either under or
over-dosed with what are potentially life-saving therapies. Initial data from Achaogen’s plazomicin CARE study in critically ill
patients with CRE infections confirmed drug concentration variability within and among patients and importantly, showed that TDM
helped to ensure that the targeted-exposure of plazomicin was achieved in these patients.
About Achaogen
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization
of novel antibacterials to treat 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 Federal funds from the Biomedical Advanced Research and
Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of
Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s
gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR
gram-negative infections, including LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative
bacteria. Achaogen's LpxC inhibitor program has been funded in part with Federal funds from the National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C.
LpxC inhibitors are the second class of molecules from Achaogen's gram-negative antibiotic discovery engine. 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 risk of failure to successfully validate, develop
and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and
uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance;
the risk when bacteria will evolve resistance to plazomicin; Achaogen's reliance on third-party contract manufacturing
organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; risk of
third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or
proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product
candidates. 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 Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016, and its Annual Report on Form 10-K for the fiscal year ended December 31, 2015. 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.
Achaogen Investor Contact: Hans Vitzthum 212.915.2568 hans@lifesciadvisors.com Achaogen Media Contact: Denise Powell 510.703.9491 denise@redhousecomms.com
