SFJ Pharmaceuticals II

The target group was patients with differentiated thyroid cancer (the most common type of thyroid cancer, responsible for 90% of cases) who were refractory to treatment with radioactive iodine. The prognosis for these patients was poor with a 10 year survival rate of 10%.

At the time of the investment, Eisai had shown encouraging Phase II data in the target patient population. A global Phase III trial had started but no data was available. In March 2011, the Fukushima power plant in Japan suffered a nuclear disaster following a tsunami. Exposure to radiation is a known risk factor for thyroid cancer and the Japanese FDA equivalent was keenly aware of this. We felt that positive clinical data in a radioactive-iodine-resistant thyroid cancer would be likely to receive a favourable review.

Deal progress

The pivotal trial ran to plan, producing highly impressive results. Progression free survival in the lenvatinib-treated patients was 18.4 months, compared with 3.6 months in the placebo-treated patients, a fivefold increase. Based on the unmet need for this indication, the FDA granted the marketing application Priority Review and approved it in February 2015, triggering a significant payment to EFV-Thyroid. Subsequently, the drug was approved in both Japan and Europe.