Submission to EMA for Nuzyra in ABSSSI and CABP withdrawn.- Paratek Pharma

Paratek Pharmaceuticals announced that the company has withdrawn its submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for Nuzyra (omadacycline). Based on the review of the data and the application, the EMA has recommended approval for Nuzyra for the treatment of acute bacterial skin and skin structure infections (ABSSSI) but not for community-acquired bacterial pneumonia (CABP). The EMA noted a second study is required for this indication; this position is consistent with EU guidance that typically requires two phase III studies per indication for approval.

Paratek�s original MAA was conducted in accordance with the scientific advice process and supported by the company�s Phase III program for Nuzyra, which included three pivotal registration studies: two studies in ABSSSI and one study in CABP. Nuzyra met all required EMA primary endpoints in all three pivotal phase III studies and demonstrated a generally safe and well-tolerated profile.

Comment: in Europe, the ten-year market exclusivity for Nuzyra would begin with the first approval. Ensuring an approval of both indications concurrently remains the Company�s top priority in order to maximize the value of Nuzyra upon an EU launch.