Taiwan-based ScinoPharm announced it had been named as the sole supplier of delafloxacin today, explaining it will make the API at its facility in Tainan.
A spokeswoman for the firm told us "We has assisted in the development of the API of Baxdela since its IND submission in 2006, including process development services, clinical trial manufacturing, scale-up, and regulatory registration assistance, etc.
"We had shipped for its prelaunch demand at the end of last year. By the end of this year, we will have another two shipments."
She added: "We anticipate the API demand with be in tons next year with sales of several million USD per year."
CRAM business
ScinoPharm CEO Yung Fa Chen said the deal will “will further improve our momentum in CRAM business.”
This was echoed by the spokeswoman who told us "we expect our CRAM business will regain the momentum as we have 4 more CRO projects in Phase III now including products for diabetes, prostate cancer, parkinson’s disease, and advanced hepatocellular carcinoma."
The deal is in keeping with the strategy ScinPharm set out in its 2016 financial report in February.
The firm said "to expand the existing CRAM business operations, the company is focusing on mid- to late-phase projects. The current portfolio includes agents in the indications of oncology, anti-hypertension, diabetes, and other therapeutics."
Commercialization deals
Baxdela was approved by the US Food and Drug Administration (FDA) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in June.
News of the contract comes just a month after Melinta secured a $90m (€75m) loan from Oberland Capital Management LLC that is said would partly be used to fund commercial launch of Baxdela in the US market.
In March Melinta licensed rights to sell delafloxacin in Europe, Asia-Pacific and the Commonwealth of Independent States (CIS) to the Menarini Group.
The firm has separate commercialization deals with Malin Plc, which will sell the drug in the Middle East and Africa, and Brazil’s Eurofarma Laboratorios.