R&D MODEL & PORTFOLIO
Development and translation increase with several new projects entering into pre-clinical stage or clinical development 11.8
9.1 7.7 9.7 7.7 9.5
2.3 0.2 0.7 Research Translation Development
in million EUR
Costs per clinical stages include a proportional part of the R&D coordination costs.
Overall R&D expenditure increased by 18% between 2014 and 2015 to reach a total of EUR 32.7 M. The most important ﬂuctuation relates to growth of development projects (+23%), and the progress of translational projects including pre-clinical, Phase I, and Phase IIa/proof of concept (+22%). The R&D coordination & supervision costs (EUR 4.3 M) are included proportionally in the R&D expenditure per stage (+EUR 1.2 M). Implementation Projects costs decreased by 31% (- EUR 0.7 M) in 2015 compared to 2014. With six projects in implementation (the ﬁrst one entered in 2007), four projects are now terminated: ASMQ for Malaria, NECT for HAT, and SSG&PM combination therapy for VL in Africa were ﬁnalized in 2014, with some expenses related to publication still ongoing (-EUR 0.4 M). The paediatric benznidazole for Chagas project was closed in 2015 (-EUR 0.1 M). The activity of New Treatments for VL in Asia is decreasing since the adoption of the treatment policy by the Indian Ministry of Health (-EUR 0.2 M). Development Projects costs increased by 23% (+EUR 1.8 M) in 2015 compared to 2014. This progression is mainly due to the clinical activities for fexinidazole for HAT in the DRC. 88% of data concerning the 359 patients included in the fexinidazole Phase II/III clinical study have been cleaned. The complementary cohort trials, for stage 1 and early stage 2 in adults completed recruitment, with 230 patients and 95% of data cleaned. The clinical trial with children aged between 6 and 14 years completed recruitment, with 125 patients (last patient included mid-January 2016) and 95% of data cleaned. A total of 714 patients are thus included in the three clinical trials. Expenditures related to the HIV/VL co-infection and the new VL treatment in Latin America projects remain stable. Translation
Expenditures increased by 22% (+EUR 2.1 M) in 2015 compared to 2014. The three main drivers of this growth are the following: - the paediatric HIV projects (+EUR 1.1 M), with development work including the bioequivalence CMC work, and equipment purchase with Cipla in order to select the best formulation for the “4-in-1”; - the ﬁlarial portfolio (+EUR 1.2 M), with the ﬁrst-in-human Single Ascending Dose Study (SAD), the emodepside study, and the on-going evaluation - via pre-clinical activities - of opportunities from partners, including rifampicin, oxfendazole, and TylAMac; - and the fexinidazole projects for Chagas disease: the Phase II study is on hold (-EUR 0.6 M), while the fexinidazole/miltefosine combination for VL in phase II is ongoing (+EUR 0.4 M). Research Screening and lead optimization expenditure increased by 18% (+EUR 1.4 M) in 2015 compared to 2014. This was mainly due to more work on PK, chemistry, efﬁcacy studies, API scale up, and exploratory toxicity studies (+EUR 0.9 M). In addition, three series were in late-stage lead optimization instead of the usual two series and candidate selection stage (DNDi-0690; DNDi-6148). The NTD Drug Booster project was also implemented during the entire year (+EUR 0.3 M) and a special effort was made for the Lead Optimization Latin America programme (LOLA), with an increase of chemist FTE from 1 to 4 during the last part of the year (+EUR 0.2 M). Screening and lead optimization efforts were entirely redirected towards leishmaniasis and Chagas disease. Exploratory In relation to the new business plan launched in 2015, exploratory activities were implemented for hepatitis C, mycetoma, and antiinfectives (+EUR 0.5 M).
Leveraging partners’ resources