UK-based SCM Pharma, a leading specialist in the global contract drug manufacturing market, will develop and manufacture an injectable neonatal product for Ireland-based BrePco BioPharma to be used in clinical trial researching and treating critically ill premature babies suffering from hypotension.
The product is based on an established and approved inotropic agent. However, the currently approved drugs were developed for adults and are not specifically licensed for use in children.
Paul Breen, co-founder and chairman at BrePco Biopharma, said: “With a few years of research already completed on the project, we needed a drug manufacturing partner like SCM Pharma that has a proven track record both in terms of quality and its capability to manufacture products for clinical trials.
“It was vital for us to have a contract manufacturing organisation that not only understood the challenges of clinical manufacturing but could also provide the potential to scale up to commercial production when required.
“The project is progressing well and already the SCM Pharma team has shown its technical ability and commitment to meet our deadlines and deliver the project to the available budget.”
BrePco along with 12 research partners across Ireland, Europe and Canada led by Cork University Maternity Hospital secured €5.6 million from the European Commission's Healthcare FP7 Programme for the project last year. This was based on hypotension (low blood pressure) being a common problem amongst very premature infants and is often associated with tragic outcomes, including brain injury and death.
At present, the existing licensed product is typically diluted before use depending on the dosage required but involves a challenging administration process, as it is usually needed immediately following birth of a low weight child.
Dianne Sharp, managing director at SCM Pharma, said: “This project with BrePco is a very significant one given the beneficiaries of the product. With our established vial filling capability, we will be working closely with the BrePco team to fast track their project as quickly as possible to help them meet their clinical trial deadlines.”
Last year, SCM Pharma launched its own formulation development capability after acquiring new facilities at the University of Sunderland. The company now provides developmental services for liquid formulations including emulsions and suspensions for parenteral, oral and topical administration using either proprietary or customers’ novel delivery systems.