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Achaogen Provides Update on Corporate Progress and Key Preliminary Fourth Quarter 2018 Results
-- Company provides update on ZEMDRI® commercialization and launch --
-- Data from both the EPIC and CARE Phase 3 clinical studies of plazomicin are expected in peer-reviewed publication --
“As our previously announced review of strategic alternatives continues, I am pleased with the steady progress of the ZEMDRI commercial launch and especially the commitment of the entire company to bringing this important medicine to the infectious disease community,” said
Recent Highlights and Upcoming Milestones
- ZEMDRI Launch Update: Overall, we believe that positive progress is being made with the launch of ZEMDRI.
• Product Use: The proportion of ZEMDRI outpatient sales continues to increase and accounts for 75% of sales to date. We expect to see continued progress in outpatient treatment given the advantages of ZEMDRI’s once-daily 30 minute infusion. The Company continues to establish contracts with physician-owned infusion centers, 200 of which have requested or are under contract for ZEMDRI.
• Formulary Approvals: The Company currently has 153 hospital formulary approvals for ZEMDRI, including approval at six major hospital systems. The formulary approval rate is 98% to date. Given recent formulary approvals and the receipt of a permanent C-code in
January 2019, we believe that both hospitals and hospital outpatient departments have improved access to, and reimbursement for, ZEMDRI.
• Testing: The Thermo Scientific QMS Plazomicin Immunoassay became commercially available in the fourth quarter of 2018, enabling assay validation in hospital labs.
Achaogenexpects this assay to also be available through reference labs in the second quarter of 2019. New accounts also continue to adopt ZEMDRI antibiotic susceptibility testing (AST) in their microbiology laboratories to support appropriate patient selection.
- BSI Dispute Resolution: In
December 2018, Achaogenfiled a Formal Dispute Resolution Request with the FDAregarding the indication for plazomicin for the treatment of bloodstream infections (BSI), for which the FDAissued a Complete Response Letter in June 2018. The Company believes that the data submitted in the New Drug Application for plazomicin provides substantial evidence of efficacy in treating BSI and believes that plazomicin should be approved for the proposed BSI indication. As part of this process, the Company has received questions from, and submitted responses to, the FDA. The Company is now awaiting a first-round response from the FDA.
- Peer-Reviewed Publication of Phase 3 Data: A prestigious medical journal has accepted for publication the data from both the EPIC and CARE Phase 3 clinical studies of plazomicin. The Company expects these publications to become available shortly.
- European Marketing Authorization Application (MAA): The Company filed an MAA for plazomicin with the
European Medicines Agency(EMA) in the fourth quarter of 2018. The Company anticipates receiving the Day 120 questions by the end of the first quarter of 2019, after which it will continue to advance the regulatory process with the rapporteurs and the EMA.
- C-Scape: The Company recently completed in vitro and in vivo experiments with a revised drug product and, based on these results, is starting a Phase 1 clinical pharmacology study with the revised drug product in 2019. The Company believes that these data may also potentially support extended intellectual property protection of C-Scape beyond the eight years of regulatory exclusivity granted by Qualified Infectious Disease Product (QIDP) status.
- Strategic Review Continues: In November 2018, the Company announced the beginning of a review of strategic alternatives to maximize stockholder value, including but not limited to the potential sale or merger of the Company or its assets. The strategic review continues alongside the Company’s continued focus on the commercialization of ZEMDRI and other corporate initiatives.
Key Preliminary Fourth Quarter 2018 Financial Results (Unaudited)
Net Product Sales: Achaogen expects to report net product sales of ZEMDRI of approximately
The Company has not completed the preparation of its financial statements for the quarter ended
While reviewing potential strategic alternatives, the Company is focused on making progress on its key priorities: ZEMDRI commercialization, EMA approval for plazomicin and C-Scape development.
Achaogen is a biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram-negative infections. Achaogen’s first commercial product is ZEMDRI, for the treatment of adults with complicated urinary tract infections, including pyelonephritis. The Achaogen ZEMDRI program was funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA). The Company is currently developing C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination, which is also supported by BARDA. C-Scape is investigational, has not been determined to be safe or efficacious, and has not been approved for commercialization.
The 2018 preliminary cash and net product sales contained in this news release are subject to finalization in connection with the preparation of the Company's Annual Report on Form 10-K for the year ended
Source: Achaogen, Inc
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Investor and Media Contact:
Denise Powelldenise@redhousecomms.com 510.703.9491
Source: Achaogen, Inc.