Paratek Wins Two FDA Drug Approvals for Three Conditions in Same Day

Xconomy Boston — 

Yesterday was a good day for Paratek Pharmaceuticals.

The FDA approved a Paratek antibiotic as a treatment for pneumonia and serious skin infections. That regulatory decision late Tuesday for the drug, omadacycline (Nuzyra), followed approval earlier that day for a different drug, sarecycline (Seysara), a treatment for moderate-to-severe acne.

The stock price of Boston-based Paratek (NASDAQ: PRTK) perked up, trading for as much as $10.26 per share Wednesday, an 11 percent increase. However, that’s still more than 60 percent below the stock’s high mark in the past year.

Approval of omadacycline covers the pill and intravenous forms of the drug, both of which are given once a day. The drug was developed to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), which are serious skin infections that require treatment with antibiotics.

Pneumonia is one of the leading causes of hospitalization for both children and adults, according to the Centers for Disease Control and Prevention. The approval of the Paratek antibiotic in both IV and pill forms means that patients can start IV treatment in the hospital and complete the course of antibiotics at home—which is what patients did in Phase 3 studies testing the drug.

In addition to the ability to treat a wide swath of bugs, including drug-resistant strains, Paratek has said its antibiotic’s value includes enabling patients to return home earlier, which would reduce hospitalization costs. Paratek says it expects to launch omadacycline in the first quarter of next year.

The FDA decision for omadacycline was based on data from clinical trials that tested the drug in nearly 2,000 patients. The most common side effects Paratek reported included high blood pressure, nausea, vomiting, and diarrhea. Two months ago, an independent FDA advisory panel voted to recommend approval of the Paretek antibiotic as a treatment for both pneumonia and skin infections. As a condition of the drug’s approval, Paratek has agreed to conduct post-marketing studies testing the drug.

The other Paratek drug, sarecycline, is a once-daily pill developed to treat acne in patients age 9 and older. In 2007, Paratek licensed the drug’s U.S. rights to a company that is now part of Allergan (NYSE: AGN). Those rights transferred to Almirall after the Spain-based pharmaceutical company acquired Allergan’s dermatology portfolio in August.

Almirall will launch sarecycline in the U.S. Paratek earned a $12 million milestone payment for winning U.S. approval, and it stands to gain royalties from Almirall’s sales of the drug. Paratek still holds rights to sarecycline outside of the U.S.

Photo by Paratek Pharmacueuticals