Sigma-Tau is one of the few Italian pharmaceutical groups involved in research and development, with offices across Europe, as well as in India and the USA. For more than half a century the company has been involved in projects to actively promote quality of life and health.
Since 2004, Sigma-Tau has been working in collaboration with MMV on a project with major social and healthcare impact – the development of an artemisinin combination therapy (ACT) for malaria, Eurartesim® (dihydroartemisinin-piperaquine or DHA/PQP). Now, in 2011, the combination has been approved by the European Medicines Agency (EMA) – the first new European antimalarial medicine for over a decade. This is a huge achievement, and takes the medicine a step closer to the patients that so sorely need it.
1. Why did Sigma-Tau decide to get involved in antimalarial drug research and, in particular, to develop Eurartesim?
Sigma-Tau’s mission is to improve health and quality of life for people worldwide. Research, innovation and business must be firmly linked to social betterment. Our Founder and President, Dr Claudio Cavazza, also felt it was Sigma-Tau’s responsibility to continue the heritage of Italian scientific contribution to malaria. Unfortunately, Dr Cavazza passed away a few weeks before Eurartesim’s approval by the EMA. It is in his memory we wish to dedicate our work on Eurartesim.
Over the last 10 years DHA/PQP has been widely investigated and has demonstrated much promise as a weapon against malaria. Currently available versions of the drug, however, have not been approved by a stringent regulatory authority, such as the EMA or US-FDA. With the approval of Eurartesim, the EMA has confirmed that sigma-tau and MMV completed the development of the combination therapy to international standards, including manufacturing the product to the highest quality. Stringent regulatory authority approval facilitates WHO prequalification, which is needed to allow international agencies to fund the medicine.
2. What is most promising about Eurartesim as an antimalarial?
This medicine is given once per day over 3 days (doses are based on the patient’s body weight), it has a prolonged protective activity in comparison to other ACTs (up to 60 days), which reduces the occurrence of new infections should the patient be bitten anew. It should also be stressed that clinical studies showed a low incidence of side-effects and the drug is as well-tolerated as other ACTs.
3. What were the main challenges you faced in developing Eurartesim and how did you overcome them?
When we started our collaboration with MMV, we had very limited knowledge of how to manufacture the DHA/PQP tablet according to ICH current Good Manufacturing Practice (cGMP) standards.1 Nonetheless, over the course of 3 years we were able to develop and scale-up – at an industrial level – competitive processes for the production of the tablet using state-of-the-art technologies and strict quality criteria (i.e. cGMP2, EH&S3). The Sigma-Tau Eurartesim supply chain now complies with the most recent and stringent legislative requirements.
4. What is the biggest hurdle in developing drugs for malaria?
The biggest hurdle is the limited money available for developing drugs that ultimately have to be produced on a no-profit/no-loss basis. This is why the public–private partnership model is so important.
The trouble is, developing and delivering good medicines for malaria and ensuring their effective use is still not enough. The threat of drug resistance is always on the horizon. We believe that all steps should be taken to minimise its development.
One method to do so is to provide more than one first-line therapy in disease-endemic countries. Should a resistant parasite emerge in a community, treatment with a second medicine will ensure that it will be killed. It is our hope that Eurartesim will bolster the ACT arsenal and therefore make the development of drug resistance less likely.
5. How have you and your team benefited from working with MMV as a partner?
Sigma-Tau’s industrial experience was complemented by MMV’s well-established knowledge of malaria research and regulatory issues. The MMV–Sigma-Tau project team contained all the right ingredients and skills to guarantee a positive outcome for this interesting and challenging project.
6. With stringent regulatory approval in hand, what are the next steps for Eurartesim to ensure it reaches as many patients as possible?
In terms of actually treating patients, the EMA approval is just the beginning. We now need to register Eurartesim in malaria-endemic countries and, with the help of MMV, to implement an access and delivery plan to guarantee the distribution of the medicine to the remotest villages.
1 ICH: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use brings together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration.
2 cGMP: current Good Manufacturing Practice
3 EH&S: Environmental Health and Safety Office