Developing a drug is an expensive business. Conventional drugs need budgets in the range of half a billion up to one billion Euros. In comparison to these classical developments, it is much easier to bring a radiopharmaceutical onto the market. In fact, radiopharmaceuticals benefit from a great advantage. Due to their radioactivity it is possible to directly show in vivo (in the patient) the drug distribution in the body. If the molecule does not clearly accumulate in the tumor, it can be discarded at a very early stage, reducing by a factor of ten the cost of development of unwanted substances. Therefore, the number of patients that have to be tested to demonstrate efficacy are reduced accordingly. The cost of the overall development of a radiotherapeutic can be reduced largely under one hundred million Euros.
In fact, as the Foundation will consider only the funding of late stage development of drugs by investing in phase III clinical trials and regulatory affairs, it is anticipated that each molecule could be brought on the market for a remaining budget of less than 20 million Euros. The chances of success at this stage are pretty high as the main hurdles have been passed and this phase III is a large scale demonstration of efficacy. The budget for the clinical trial can even be reduced, as in some specific indications, most of clinical trial centers are ready to participate on a voluntary basis and already accepted to take in their own budget the costs per patient provided they can get access to the molecule in exchange.
In terms of timing, the full remaining development time up to marketing may take between 2 and 4 years.
Actually, it makes no sense to build such a structure to push only one molecule to the market. At least 5 molecules should be developed in parallel which results in the need of a budget of about 100 M€ over 4 to 5 years. This figure may seem to be huge but this is the reality in this world and it should be unveiled. For this reason, the Foundation will remain a concept until there is a guarantee that a large part of this amount can be collected. The Foundation will start working when we will have identified the individuals or entities that have understood the advantages of this technology and will financially support this initiative at the level announced above. In the meantime everybody can help supporting the project by spreading the information with the help of this documentation.
