Shares of Paratek Pharmaceuticals Inc. (NASDAQ: PRTK) saw a handy gain on Thursday after the firm announced in conjunction with Allergan PLC (NYSE: AGN) that the U.S. Food and Drug Administration (FDA) accepted their New Drug Application (NDA). Specifically, the NDA is for the review of Seysara (sarecycline) for the treatment of moderate to severe acne vulgaris in patients nine years of age and older.
The application includes two Phase 3 studies, which demonstrated that sarecycline significantly improved acne severity based on Investigator’s Global Assessment (IGA) success and significantly reduced inflammatory lesion count versus the placebo at week 12. Back in March 2017, Allergan announced positive results of these Phase 3 studies, which met their primary efficacy endpoints.
Allergan completed the NDA submission in October 2017 and expects the Prescription Drug User Fee Act (PDUFA) action date to occur in the second half of 2018.
In terms of ownership, Allergan has U.S. rights to the development and commercialization of Seysara, while Paratek retains all ex-U.S. rights.
David Nicholson, chief research and development officer at Allergan, commented:
We are pleased that the FDA has accepted our application and look forward to advancing our conversations toward a potential U.S. approval of Seysara in the second half of 2018. This milestone reinforces our commitment to advancing research and bringing new therapies to patients, and our dermatology customers.
Evan Loh, MD, president, COO and chief medical officer of Paratek, added:
The FDA’s NDA acceptance is encouraging as results shown in the Seysara (sarecycline) Phase 3 trials involving 2,002 patients demonstrate that Seysara if approved, has the potential to be a new, effective, safe and well-tolerated treatment option for physicians treating patients with moderate to severe acne.
Shares of Allergan traded up 1% at $167.48 on Thursday, with a consensus analyst price target of $226.81 and a 52-week range of $160.07 to $256.80.
Paratek traded up 5.5% at $18.73 a share, with a 52-week range of $13.20 to $29.00 and a consensus price target of $3.80.