Under the agreement, PolyTherics will transfer its HiPEG PEGylation method to DSM for the scale-up, while DSM will develop, scale-up and manufacture the recombinant of his-tagged IFN a-2a.
According to the companies, this process will produce material for preclinical studies to support a planned clinical trial application to develop a treatment for Hepatitis C.
It is estimated that 170m people worldwide are infected with Hepatitis C, and 99 per cent of infected patients have not been treated. “There is therefore an overwhelming requirement for a cost effective PEGylated IFN a, such as PolyTherics’ HiPEG IFN a,” Keith Powell, CEO of PolyTherics, told Outsourcing-Pharma.
PolyTherics produced HiPEG IFN a-2a by applying its HiPEG site-specific PEGylation technology to interferon alpha. The company claim that in comparison to a marketed PEGylated interferon in an in vitro assay, HiPEG IFN a-2a showed eight-fold higher activity in a preclinical study, with a comparable half-life.
PolyTherics’ HiPEG technique works by attaching a PEG molecule to a histidine tag at the end of the IFN protein as there is less interference of the PEG with the active side of the protein. “The resulting product is more homogeneous than that produced by more traditional PEGylation techniques. This means the safety and efficacy of HiPEG IFN a will be more predictable and its production more efficient,” said Powell.
He added that because the company’s product can be administered less frequently than others containing PEGylated IFN “the patient has fewer injections, improving compliance, the cost of treatment, and fewer occurrences of the flu-like side effects that IFN produces following its injection.”
Marco Oomen senior director of new business development at DSM told Outsourcing-pharma the collaboration to develop HiPEG IFN a-2a is important for the firm going forward.
“We can leverage all DSM BioSolutions' strengths like strain construction, process and analytical development, scale-up and cGMP manufacturing into one program and bring added value as such towards our customer, PolyTherics.”
With the current market for PEGylated IFN a having already reached $2.4bn due to an increase of demand in the drug industry, this figure is expected to grow beyond $4.5bn by 2017. Financial terms of the agreement between DSM and PolyTherics remain undisclosed.