Nabriva Therapeutics PLC (NBRVF)

[ErnieBilco]

From the 10K

The recent coronavirus outbreak is the most recent reminder of the impact infectious diseases have on humanity. Similar
to influenza virus infection, patients infected with the coronavirus are at increased risk for secondary bacterial pneumonia. Based
on the information available from China, up to 15% of COVID-19 infected patients have also developed secondary bacterial
pneumonia. Given high mortality in the setting of concomitant viral and bacterial infection, timely and appropriate empiric
antibacterial therapy should be considered and promptly administered to patients with suspected or documented bacterial
superinfection in the setting of COVID-19, particularly in patients with risk factors for increased mortality such as older age,
diabetes, and immunosuppressive conditions. Nabriva is working closely with the Biotechnology Innovation Organization (BIO),
a biotechnology trade association, in organizing an industry response. Nabriva is also monitoring efforts by the U.S. Biomedical
Advanced Research and Development Authority (BARDA) in its preparation for the potential need for widespread CABP
treatment and has proactively submitted a brief via https://www.medicalcountermeasures.gov/ to make XENLETA available as a
potential treatment option in patients infected with the coronavirus with suspected or documented secondary bacterial
pneumonia. In addition, Nabriva is supporting Sinovant – its development and commercialization partner in greater China for
lefamulin – who is working closely with the National Medical Products Administration in China to be prepared to offer lefamulin,
should it be needed for the treatment of suspected or documented secondary bacterial pneumonia.

XENLETA
Discovered and developed by our team, XENLETA is a semi-synthetic pleuromutilin antibiotic that is the first in its
class for IV and oral administration in humans. It inhibits the synthesis of a specific protein on the bacterial ribosome, which is
required for bacteria to grow. By binding with high affinity and specificity at molecular targets that are different than other
antibiotic classes causing cell death. Based on results from two global, Phase 3 clinical trials, we believe XENLETA is
well-positioned for use as first-line monotherapy for the treatment of CABP due to its novel mechanism of action, short five day
course of therapy for oral XENLETA, targeted spectrum of activity, resistance profile, achievement of substantial drug
concentrations in lung tissue and fluid, availability of oral and IV formulations and a generally well-tolerated profile. We believe
XENLETA represents a potentially important new treatment option for the five to six million adults in the United States
diagnosed with CABP each year.
We believe that pleuromutilin antibiotics can help address the major public health threat posed by bacterial resistance,
which the World Health Organization, or WHO, characterized in 2017 as one of the biggest threats to human health. Increasing
resistance to antibiotics used to treat CABP is a growing concern and has become an issue in selecting the appropriate initial
antibiotic treatment prior to determining the specific microbiological cause of the infection, referred to as empiric treatment. For
example, the U.S. Centers for Disease Control and Prevention, or CDC, has classified Streptococcus pneumoniae, the most
common respiratory pathogen, as a serious threat to human health