Paratek Pharmaceuticals provides update on pipeline progress
Paratek Pharmaceuticals (PRTK) announced recent progress across its product pipeline.
Paratek has initiated the rolling submission of a New Drug Application to the FDA for the indications of acute bacterial skin and skin structure infections, or ABSSSI, and community-acquired bacterial pneumonia, or CABP, and is on track to submit the final components during the first quarter of 2018.
Rolling submission allows completed portions of an NDA to be reviewed by the FDA on an ongoing basis.
The FDA had previously granted omadacycline Qualified Infectious Disease Product designation and Fast Track designation, which provides for a Priority Review of the NDA, once accepted.
In addition, The company has initiated sites for the first of the two planned Phase 2 studies evaluating its investigational antibiotic, omadacycline, for the treatment of urinary tract infections, or UTI.
This first study will evaluate the safety, tolerability and pharmacokinetics of omadacycline in female patients with uncomplicated UTI.
The second study, which will be initiated later this year, will evaluate the safety, tolerability and pharmacokinetics of omadacycline in patients with acute pyelonephritis.
The Company plans to enroll approximately 200 patients in each study at multiple sites. Paratek also announced that it has earned a $5 million milestone payment from Allergan (AGN) under the terms of the parties’ collaboration for the development of Seysara, a new, narrow-spectrum oral antibiotic for the treatment of moderate to severe acne.
The milestone payment became payable upon the FDA’s acceptance of Allergan’s NDA for Seysara, announced in December 2017.
Allergan (AGN) plans to commercialize Seysara in the U.S. Paratek retains all ex-U.S. rights to the product.
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