FDA Recommends Approval for Paratek’s Omadacycline

On Thursday (August 9), the US Food and Drug Administration’s (FDA) Antimicrobials Drug Advisory Committee voted in favor of approvals for two of Paratek Pharmaceuticals’ (NASDAQ:PRTK) drugs.

The committee voted 17-1 in favor of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections, and 14-4 in favor of IV and oral omadacycline for the treatment of community-acquired bacterial pneumonia.

Paratek expects to hear back from the FDA about these approvals in early October 2018, as per the Prescription Drug User Fee Act (PDUFA) date for both new drug applications.

To form these votes, the committee analyzed data sets from omadacycline’s global development program, including three Phase 3 studies for the safety and efficacy of the drug candidate, in which all trials met primary and secondary outcomes.

Omadacycline is a modernized tetracycline in development as a once-daily IV and oral broad-spectrum antibiotic to treat serious community-acquired infections. This investigational antibiotic was granted priority review for both New Drug Applications (NDA) by the FDA.

Another indication still in Phase 2 development is urinary tract infections. All of the indications have received Qualified Infectious Disease Product designation and Fast Track status from the FDA.

The company is also preparing to submit marketing authorizations in the European Union, and previously entered into a collaboration agreement with Zai Lab for the development and commercialization of the drug in the Greater China region, while retaining all global rights.

The US Department of Defense and Paratek are involved in a research deal regarding pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

Paratek’s expertise is built on novel tetracycline chemistry. The company’s second product candidate, Seysara, is being developed with Allergan (NYSE:AGN) and has also finished its Phase 3 clinical trial. Its NDA was filed in Q4 2017, which gives a PDUFA date for the drug in the second half of 2018. Paratek retains all rights to sarecycline, aside from in the US.

Investor takeaway

Over the trading day on Thursday, Paratek’s share price decreased less than 1 percent to US$10.45.

According to TipRanks, three analysts have given recommendations on the company since yesterday with all-around “buy” targets. This includes a high price target of US$55 from H.C. Wainwright analyst Ed Acre, and a low price target of US$20 from Wedbush analyst Robert Driscoll.

Keen investors looking to hear more about the company can follow Paratek’s news, and can expect to hear about these omadacycline NDAs in early October 2018, as well as the NDA response for Seysara.

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Securities Disclosure: I, Gabrielle Lakusta, hold no investment interest in any of the companies mentioned.