WIT helps EirgGen Pharma overcome potential obstacles to cancer drug registration
Founded in 2005 by Tom Brennan and Patsy Carney, Waterford-based EirGen Pharma specialises in the development, manufacture and registration of high potency cancer therapy products for global pharmaceutical markets. It recently developed a new formulation of a drug for the treatment for breast cancer.
However, as can often happen in the pharmaceutical industry, unidentified impurities were observed to form in the new formulation under storage conditions. This was a significant potential barrier to international registration, for which any impurities above a certain level have to be identified.
So EirGen turned to Dr. Niall O’Reilly, manager of the Pharmaceutical and Molecular Biotechnology Research Centre (PMBRC) at Waterford Institute of Technology (WIT) to help it with the necessary analysis. The Centre is an Enterprise Ireland-funded Technology Gateway with particular expertise in pharmaceutical characterisation, formulation, drug delivery, biomedical research and biotechnology.
The detailed analysis commissioned by EirGen was funded through Enterprise Ireland’s Innovation Voucher scheme. The analysis used a combination of techniques to determine the precise structure and identity of three impurities, generating data which the company was then able to use to support its filing of the new formulation with the European Medicine Agency (EMA). The new formulation subsequently obtained EMA approval and was launched commercially in key European and US markets. Sales are projected to be worth in the region of €20 million over the five years 2014-2019.
Tom Brennan, EirGen's CTO and Co-Founder, says that the partnership with the PMBRC in Waterford "is a key part of our vision for EirGen Pharma." He says this working relationship has already been very productive on several levels, "perhaps most starkly when research at the Centre allowed us proceed with a key drug in our portfolio that might otherwise have been abandoned.
“We hear a lot of commentary about the ‘Smart Economy’ and the need for Ireland to move up the value chain," he adds. "The research work of the PMBRC is a firm example of that going beyond rhetoric in the pharmaceutical sector."
Publish date: 2014