The deal – details of which were set out in a US Securities and Exchange Commission (SEC) filing – will see Patheon turn the active pharmaceutical ingredient (API) into the dosage form at its facility in the UK.
The contractor – which is part of Netherlands-headquartered contractor Patheon NV - will also conduct quality control, quality assurance, analytical testing and stability testing and packaging.
Tetraphase also said it expects to sign two further agreements with Patheon covering the manufacture of eravacycline at its sites in Greenville, North Carolina and Ferentino, Italy.
More contracts
The Massachusetts-based developer will manufacture the active pharmaceutical ingredient (API) and supply it to the three Patheon sites.
Tetraphase has “agreed to order from Patheon at least a certain percentage of its annual commercial requirements for eravacycline in the United States and European Union each year for the term of the Master Agreement.”
The agreement ends in December 2022, however, it will renew automatically for four two year terms.
The manufacturing contract is the first made public by Patheon since Thermo Fisher Scientific announced its intention to acquire the contractor in May.
Synthetic antibiotic
Eravacycline, Tetraphase’s lead candidate, is designed to treat infections caused by multidrug-resistant (MDR) Gram-negative bacteria.
The US Food and Drug Administration (FDA) has assigned the drug Qualified Infectious Disease Product (QIDP) and Fast Track status. It is currently being examined in a Phase III trial.
Eravacycline, like others in Tetraphase's pipeline, was developed using synthesis know how detailed in a paper published by researchers at Harvard Univerity in 2005.