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Paratek gets FDA green light for two drugs

Paratek Pharmaceuticals has received the FDA's blessing for Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia, or CABP, and acute skin and skin structure infections, or ABSSSI.

The product, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and drug-resistant strains.

"In the face of ever-increasing antibiotic resistance, the FDA approved Nuzyra with a label having full approval for both CABP and ABSSSI. We are excited to bring to physicians an effective, well tolerated monotherapy option for patients," Paratek president, COO, and chief medical officer Evan Loh said in a statement. "Nuzyra offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays."

"The approval of NUZYRA is an historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections," Paratek chairman and CEO Michael Bigham said in a statement."There are countless champions of Nuzyra who have been tireless in their efforts to ensure its advancement to commercialization — from patients, clinicians and study investigators to our Paratek team. We are grateful to all who played a role in making NUZYRA available to patients in need. We are excited to launch Nuzyra early next year."

In a separate development, Paratek also received the FDA's nod for Seysara (sarecycline) for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of old and older.

The product is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate-to-severe acne in the community setting.

Paratek has exclusively licensed U.S. development and commercialization rights of Seysara for the treatment of acne to Allergan, who has assigned such rights to Almirall SA. Paratek retains development and commercialization rights in the rest of the world.
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