pharmaceutical-technologyApril 26, 2017
Tag: Pharmaceuticals , Lab
Paratek Pharmaceuticals has entered a collaboration with Chinese biopharmaceutical company Zai Lab (Shanghai) to support the development and commercialisation of omadacycline in China.
Omadacycline is a once-daily, oral and intravenous broad-spectrum antibiotic designed to be used as empiric monotherapy in patients suffering from serious community-acquired bacterial infections, as well as show antibiotic resistance.
It is used on patients suffering from acute bacterial skin and skin structure infections, bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections.
Under the collaboration, Zai Lab has received an exclusive licence to develop, manufacture and commercialise omadacycline in greater China territory, including People’s Republic of China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China.
Paratek chairman and CEO Michael Bigham said: "Our successful Phase 3 efficacy studies in both skin infections and pneumonia demonstrate the potential of omadacycline to be a promising new therapeutic option for the treatment of patients with serious bacterial infections.
"This agreement with Zai Lab further validates that potential, and represents an exciting step toward making omadacycline available to the many patients in the greater China territory where there is a proven need for a new, effective, well-tolerated, IV and once-daily oral, broad-spectrum antibiotic, particularly when resistance is of concern."
"We are very pleased to partner with Paratek to potentially bring omadacycline to Chinese patients."
Both companies have agreed to form a joint steering committee that will review and monitor all development, manufacturing and commercialisation activities.
Paratek will receive $7.5m as upfront payment for providing this licence and is also eligible for additional milestone payments based on development, regulatory and commercial milestones.
Furthermore, Paratek is entitled to receive royalty payments on omadacycline sales within the licenced territory.
Zai Lab chairman and CEO Samantha Du said: "We are very pleased to partner with Paratek to potentially bring omadacycline to Chinese patients.
"It is estimated that per capita use of antibiotics in China is significantly higher than that in the United States.
"Consequently, antibiotic resistance is becoming an increasing and severe problem for China.
"Based on the data generated by Paratek to date, we believe omadacycline has the potential to be a valuable new tool for physicians in China as they try to combat the growing antibiotic resistance problem."
Omadacycline has already received Qualified Infectious Disease Product designation and fast-track status from the US Food and Drug Administration for the target indications.
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