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AKAO FDA Breakthrough designation


Achaogen Gets FDA Breakthrough Therapy Status for Plazomicin

Achaogen (AKAO)
Achaogen’s Plazomicin is Granted Breakthrough Therapy Designation for
Bloodstream Infections
On May 23rd, Achaogen (NasdaqGM: AKAO) announced that the FDA granted plazomicin
Breakthrough Therapy Designation (BTD) for the bloodstream infection (BSI) indication.

The Company is developing plazomicin, a novel aminoglycoside antibiotic, for the treatment
of multi-drug resistant (MDR) gram-negative infections. Achaogen has reported positive
results from the EPIC and CARE Phase III studies, paving the way for a New Drug
Application (NDA) submission for plazomicin in the second half of 2017. BTD allows the
Company to have greater communication with the FDA, and may enable a quicker regulatory
review process. The granting of BTD for BSIs suggest that the FDA takes a positive view of
the CARE data and may be willing to allow its inclusion into the drug’s label.

¦ BTD Designation for BSI Suggests FDA Takes Positive View of CARE Data. Due
to slower-than-expected enrollment, Achaogen stopped the CARE Phase III trial early to
coincide with the readout from the EPIC study. Although the CARE study includes a small
number of patients, the Company plans to include CARE data in the NDA and plans to
discuss its inclusion in the drug’s label, which would likely promote the use of plazomicin
to treat a broader subset of MDR infections.

At the 2017 meeting of the European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID), Achaogen presented data from the subset of patients from cohort 1
of the CARE study with BSIs, which made up roughly 80% of the CARE study population.
Since the FDA historically has approved antibiotic indications based on infection type
not pathogen type, our expectation was that Achaogen’s ability to present a robust and
supportive BSI dataset would likely help in their discussions with regulators. In our view,
the granting of BTD for the BSI indication suggest that the FDA has a positive view of
the CARE data and may be amenable to its inclusion in the plazomicin label.

¦ BTD Could Accelerate Approval Process. Achaogen plans to submit an NDA in the
second half of 2017 supported by data from the EPIC and CARE Phase III studies.
The Company has Fast Track, Qualified Infectious Disease Product (QIDP), and now
Breakthrough Therapy designations, which could reduce the timeline to a potential
commercial launch if approved. The NDA for plazomicin, expected to be filed in the
second half of 2017, may be reviewed in as little as 6 months under the priority review
process

Kiwi
( sorry ..unable to link and credit source ...except to say its not Streetsweeper