Eurartesim®, the first novel chemical entity developed by MMV (in partnership with Sigma-Tau) was awarded MMV Project of the Year 2011. With the European Medicines Agency (EMA) approval, this medicine can now be used safely and effectively, and be deployed widely. Dr Marco Corsi speaks about the lessons learnt and about what the future holds.
1. As an Italian pharmaceutical company, what motivated Sigma-Tau to embark on the development of a medicine to treat malaria?
Our Founder and President, Dr Claudio Cavazza’s vision was to improve health and quality of life for people worldwide. He also felt it was Sigma-Tau’s responsibility to continue Italy’s scientific contribution to malaria. In 2003, Dr Cavazza was in touch with the Italian Minister of Health who suggested the idea of the initial collaboration between Sigma-Tau, WHO, MMV, Hollykin and the University of Oxford. Dr Cavazza took a keen interest in the development of the drug but unfortunately, passed away a few weeks before Eurartesim’s approval by the EMA. We dedicate our work on Eurartesim to his memory.
2. Why did the project team work towards regulatory approval in Europe for a drug that will be predominantly used in Africa and Asia?
As a small company we knew that we did not have the resources and the contacts to submit a regulatory dossier in all malaria-endemic countries. We also didn’t want to discriminate against European patients. Submission to the EMA was the best option as the agency can act as a kind of consultant to endemic countries. As such, with EMA approval in hand the dossier can now be filed and accepted much more quickly in disease-endemic countries.
3. What did you gain from working in partnership with MMV?
Without MMV, donor and procurement bodies would not have been able to obtain what is now considered one of the best antimalarials.
MMV and Sigma-Tau were both integral to the project. In terms of timing and deadlines for each stage of the project, the extra attention from MMV was really valuable. Together we agreed on what to do and when, and ensured we were ready to modify the planning if needed. Each time there was a hurdle or issue to discuss we were able to overcome it via the ingenuity of the group – we always found a way to move forward. The experience certainly proved that two organizations are better than one!
On a more personal note, we received lots of support at critical moments in the early stages of the project from Chris Hentschel and Carl Craft (former MMV CEO and CSO, respectively). David Ubben (MMV Project Director) became a superb friend as well as partner. For me the development of Eurartesim has been the highlight of my professional career. Few drugs for western diseases could be defined as real breakthroughs. Working on a medicine with the potential to save and change so many lives is really the opportunity of a lifetime.
4. What are the next steps to ensure Eurartesim reaches as many patients in need as possible?
We are looking to work with a commercial partner for the distribution of the medicine across disease-endemic countries. We will first need to register Eurartesim in these countries and, with the help of MMV, implement an access and delivery plan to guarantee the distribution of the medicine to the remotest villages. To continue to improve our understanding of the medicine and potentially expand its use beyond treatment to, for example prevention, postapproval studies are important. There are already plans to use Eurartesim in about 20 independent studies.