Updated on 12 June 2013
Also, Imugene is committing $1.5 million to take forth its three chosen targets for regulatory approval in the UK and limited EU territories initially. Once approved in Europe, we plan to apply for regulatory approval in Australia followed by selected Asian countries.
What is the regulatory landscape for getting approval for a drug delivery technology that reformulates an existing drug?
Imugene's focus is on developing drugs for the EU market, which offers a more streamlined path for regulatory approval. EU approvals also provide a strong flow on effect for other regulatory markets including Australia and selected Asian countries. Our first target, a Linguet form of Vitamin D has now completed feasibility testing and formulation development. We are ready to file for regulatory approval in the UK and license the product to a third party in 2014. In addition, strengthening our IP in Asian markets, we have been allowed key Chinese and Japanese patents for Linguet.
What are the challenges you see in enabling this technology for pharmaceutical companies?
All drug development processes come with risks and challenges, be it technical, market driven or access to capital. Therefore, we undertake rigorous approach to mitigating risk and creating value for our technology. This includes establishing clinical efficacy, developing a ‘go to market' strategy, clarifying regulatory pathways, and strengthening Linguet's IP.