Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) announced that the FDA has accepted two new drug applications (NDAs), seeking approval of its antibiotic candidate, omadacycline. The NDAs were granted priority review, thus speeding up the review process. A decision is expected in October 2018.
The NDAs are seeking approval of once-daily oral and intravenous ("IV") dosing of omadacycline for treating community-acquired bacterial pneumonia (“CABP”) and acute bacterial skin and skin structure infections (“ABSSSI”).
The candidate already enjoys Qualified Infectious Disease Product and Fast Track designation for both the indications.
Shares of the company were up almost 3% in after-market trading on Apr 4. However, Paratek’s shares have declined 25.7% so far this year, underperforming the industry’s decline of 7.4% in the said period.
The NDAs submitted included positive data from phase III program evaluating omadacycline in ABSSSI and CABP patients. The candidate was also well tolerated.
In April 2017, Paratek had announced non-inferiority of omadacycline to Bayer’s (OTC:BAYRY) CABP drug, Avelox, in a phase III study.
The chief medical officer of Paratek stated that resistance to antibiotics is on the rise, increasing the need for new antibiotics.
Paratek is also planning to file a marketing authorization in the European Union for omadacycline in similar indications.
The candidate is also being developed for the treatment of urinary tract infections.
However, there are approved therapies available for the treatment of CABP and ABSSSI, which includes Allergan plc’s (NYSE:AGN) Teflaro. Moreover, Nabriva Therapeutics plc (NASDAQ:NBRV) is evaluating its antibiotic candidate lefamulin in late stage studies in CABP and ABSSSI.
Apart from omadacycline, Paratek’s acne candidate, Seysara, is under review in the United States.
Zacks Rank
Paratek has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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