China's National Medical Products Administration Approves NUZYRA® (omadacycline) for the Treatment of Bacterial Pneumonia and Skin Infections |
Paratek earns $6 million milestone payment from Zai Lab BOSTON, Dec. 16, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced that the company's partner in China, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), received approval from the National Medical Products Administration (NMPA) of China of NUZYRA® (omadacycline) for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek commercially launched NUZYRA in the United States in February 2019. Paratek granted Zai Lab an exclusive license to develop, manufacture and commercialize NUZYRA in the greater China territory, specifically the People's Republic of China, Hong Kong, Macau and Taiwan markets. Paratek retains all remaining global rights. Pursuant to the terms of the license agreement, Paratek earned a $6 million milestone payment upon NMPA approval. All milestone payments under the Zai Lab License and Collaboration Agreement are retained by Paratek and excluded from the company's loan facility with R-Bridge Healthcare Investment Advisory. Approved by the U.S. Food and Drug Administration (FDA) in October 2018, NUZYRA is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of CABP and ABSSSI. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals and other drug-resistant strains. "The NMPA approval further validates the safety and efficacy of NUZYRA in treating pneumonia and serious skin infections at a time when antimicrobial resistance remains one of the world's most pressing public health threats and provides further validation that antibiotics are truly global products. The U.S. launch of NUZYRA has proven to be one of the most successful antibiotic launches of the last five years, driven by NUZYRA's well-defined product profile, including its once-daily oral formulation, broad spectrum of coverage and dosing flexibility," said Evan Loh, M.D., Paratek chief executive officer. "We anticipate that NUZYRA will play an important role in helping physicians stay ahead of the evolving resistance landscape in China. We are excited that our partner, Zai Lab, will be bringing this life-saving medication to clinicians and patients in China at a time when the need for new treatment options to address antimicrobial resistance is more urgent than ever." About Paratek Pharmaceuticals, Inc. The company's lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b Study in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex with NUZYRA. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States. Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world. In 2019, Paratek was awarded a contract from the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), now valued at up to approximately $304 million, to support the development and U.S.-based manufacturing of NUZYRA for pulmonary anthrax. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter. About NUZYRA Indications and Usage Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae and Chlamydophila pneumoniae. Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae and Klebsiella pneumoniae. Usage Important Safety Information Contraindications Warnings and Precautions The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth. Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is structurally similar to tetracycline-class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions Drug Interactions Use in Specific Populations To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information for NUZYRA at www.NUZYRA.com. Forward Looking Statements CONTACT: For Investors: For Media: |
12/16/2021 11:36:00 AM |