The CHMP stated, upon completion of the assessment
of the application for conditional marketing
authorization of masitinib in second line treatment
of GIST and in pancreatic cancer, that “[...] there were concerns about the quality control of the medicineduring manufacture, which led to uncertainties aboutthe impurities that patients would be exposed to”.
This statement has been perceived as an indication
that there were problems in the manufacturing of
masitinib leading to the inadequate presence of imp
urities, and that such problems could be an obstacle
to the clinical development program or the registration of masitinib.
AB Science would like to reassert that the manufacturing
process of masitinib is robust and well under
control, meaning that batches produced consistently
meet the specifications, and in particular meet the
specifications set in recent guideline on acceptable
limit on mutagenic impurities.

Observing the negative reaction from the market following
the clarification published on 10 August 2014,
AB Science (NYSE Euronext – FR0010557264 – AB) reasserts that:
-
The key message is that masitinib is not carcinogenic in humans.
-
Data collected to date from above 1600 patients who
received masitinib, some patients exposed
more than 7 years, show no sign of secondary malignancies.
-
Data in rodents were generated at the high dose from
80 to 160 times the dose administered to
humans and are not transposable to humans.
-
Those data from animal studies were communicated to
health authorities five years ago and were
validated by these authorities and do not represent
a new finding.
-
The clinical development program in non-oncology in
dications is on-going and will be carried-out
up to its term.