Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) Q3 2018 Earnings Conference Call Transcript
Nov 06, 2018 • 04:30 pm ET
Greetings and welcome to the Paratek Pharmaceuticals' Third Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded.
It is now my pleasure to turn the call over to your host, Ben Strain, Executive Director of IR and Corporate Communications for Paratek Pharmaceuticals. Ben, please go ahead.
Good afternoon and welcome to Paratek's Third Quarter 2018 Earnings and Corporate Update Conference Call. A press release for the company's third quarter results was issued earlier today and we have also posted slides on our website that will be referred to on this call. Both can be found at www.paratekpharma.com. Participants on today's call are Michael Bigham, CEO and Chairman of the Board; Douglas Pagan, CFO; Adam Woodrow, Chief Commercial Officer; and Evan Loh, President, COO and Chief Medical Officer will also be available for Q&A.
(Forward-Looking Cautionary Statements)
Thank you, Ben. Good afternoon and thank you all for joining our third quarter earnings call and corporate update. It has been an exciting and productive three months for Paratek, during which we achieved several significant milestones. Most notably, we received two drug approvals within a single 24-hour period, remarkable. The FDA approved NUZYRA, the brand name for omadacycline, for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in both IV and oral formulations.
The FDA also approved SEYSARA, for the treatment of inflammatory lesions of non-nodular, moderate-to-severe acne vulgaris. Adam and his team continue to make significant progress with our NUZYRA pre-commercialization activities as we move toward a February 2019 launch in the US. We are very much looking forward to this long-awaited opportunity to make a meaningful difference in the future treatment landscape for community-acquired pneumonia and skin infections. We'll continue to keep you informed of our progress in the months ahead as we approach the US commercial launch of NUZYRA.
We are also in active discussions with the FDA with respect to the CABP study design of our agreed post-marketing requirement. We expect the additional CABP study will require no more than 800 patients, a size similar to that of our OPTIC study. We anticipate having additional clarity around the study design in early 2019. Outside the US, we recently submitted the Marketing Authorization Application in the EU for omadacycline, that review process has already started. As a reminder, we are seeking approval on both community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
We also continue to make important progress towards advancing our life cycle initiatives with omadacycline by expanding our efforts to explore its potential to treat urinary tract infections. Recall that our first Phase II study was focused on treating uncomplicated urinary tract infections. This study is actively enrolling patients. Our second Phase II study will be evaluated in the potential utility of omadacycline for the treatment of acute pyelonephritis, a common subset of complicated