PRTK - Paratek antibiotic Nuzyra to receive EU orphan drug status
2023-06-27 13:48:31 ET
Paratek Pharmaceuticals ( NASDAQ: PRTK ) said that a European Medicines Agency advisory committee has issued a positive opinion on its drug Nuzyra receiving orphan drug status in the treatment of nontuberculous mycobacterial lung disease, or NTM.
The antibiotic developer said that the European Commission should grant the designation within 30 days, which would entitle the drug to ten years of market exclusivity if it is approved.
Nuzyra, also known as omadacycline, was granted orphan drug status by the FDA in August 2021 and fast track status in June 2022 for the treatment of two species of NTM. The drug is already approved for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
Paratek is slated to be take private by investment firms Gurnet Point Capital and Novo Holdings through a deal worth up to $462M.
Earlier Tuesday, Paratek investor NexPoint Asset Management said that it may vote against the deal if it determines it's not in the best interests of shareholders.
More on Paratek:
- Paratek investor NexPoint warns it may vote against takeover deal
- Paratek Pharmaceuticals to be taken private in deal worth up to $462M
- Paratek Pharamceuticals jumps amid report about takeover interest
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Paratek antibiotic Nuzyra to receive EU orphan drug status