Repurposing, old products and new opportunities

Jackie Roberts talks about her involvement in the first repurposing project in England.

I was fortunate to be involved in the first national repurposing project in England. The aim of the project was to include a new indication on all the Marketing Authorisations for the generic product, anastrazole, in England to allow for the use in prevention of breast cancer. This project was lead by NHS England, working with the BGMA and the cancer charity, Breast Cancer Now.

There was a competitive tender to find the industry champion who would be the pilot for this work. The tendering process is not for the faint hearted and I was very lucky to have commercial colleagues who were used to NHS tendering. We were fortunate enough to be selected and started working with NHS England to update our Marketing Authorisation using clinical data from a non-commercial study. It was a very collaborative process involving the NHS, the regulator (MHRA), industry and charity. As this was the first time this had been done we had regular meetings, a project plan and worked together to meet the regulatory needs. We had to demonstrate to the regulator, of course, that this indication extension was supported by the data and the prophylactic use provided more benefit to the patients than risks. There are a few things I would have done differently, the initial meetings were between the regulator and the NHS and I think it would have been useful to have had industry involved at this stage to fully understand the requirements of the MHRA and how to address any gaps in data earlier.

The process was involved and complicated as we were working with clinical data that had not been created for regulatory purposes. However, we were successful in getting the new indication approved, which then allowed subsequent companies to also get this indication, which is beneficial for both patients and the NHS. It was a great opportunity to be involved with this first of its kind application and working collaboratively across the health sector.

There is now another opportunity which has been listed on the government’s contract finder site. NHS England has published a Preliminary Market Engagement Notice to look at repurposing spironolactone for use in treating women with acne. It is anticipated that there will be two separate contracts to deliver this:• Contract A: Prepare an application for a major (type II) MHRA Marketing Authorisation variation for spironolactone.• Contract B: Submit the pre-prepared application to the MHRA. Only current Marketing Authorisation Holders of spironolactone are eligible to bid for contract B.

If you would be interested in our support for this or other repurposing work my partner Lisa and I have a great deal of experience that we would love to share with you and support you in achieving your company goals. Contact us via the website form or email us at info@pharmaguard.co.uk