ABSCIENCES (EPA:AB) AB Science authorised to commercialise masitinib in the USA for treatment in canine mast cell tumor

Transparency directive : regulatory news

16/12/2010 18:00

Paris, 16 December 2010, 6pm

AB Science authorised to commercialise masitinib in the USA for treatment in
canine mast cell tumor

AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company
specialising in the research, development and commercialisation of protein
kinase inhibitors (PKIs), received today notification from the US Food and Drug
Administration (FDA) that masitinib received conditional approval for treatment
in canine mast cell tumor.

Masitinib will be made available to US veterinarians, for treatment of
recurrent or nonresectable Grade II and  Grade  II cutaneous mast cell tumors
in dogs that have not previously received radiotherapy and/or chemotherapy
except corticosteroids. It will be marketed under the brand name KINAVET-CA1.

Masitinib was already approved by European Medicine Agency (EMA) and
commercialised in Europe in treatment of canine mast cell tumor, under the
name MASIVET.

Alain Moussy, Chairman and CEO of AB Science declared: " This decision opens
the USA market for masitinib in veterinary medicine, which is expected to be
our largest market. It is therefore a significant milestone. We thank FDA for
this fruitful collaboration in oncology for unmet medical need and we will
continue to collaborate closely  with FDA to pursue the development of
masitinib in the USA, both in veterinary and in human medicine ".

Dr Albert Ahn, President of AB Science USA commented " As we continue to
generate further data, we are confident that we can establish masitinib as the
reference treatment for canine mast cell tumors ".

About conditional approval and MUMS
In the USA, KINAVET-CA1 has been declared a designated new animal drug by FDA
under the designation provision of the Minor Use Minor Species (MUMS) Act.
This entitles KINAVET-CA1 to seven years of exclusive marketing rights
beginning on the date of conditional approval. The conditional approval is a
response to an application which demonstrated reasonable expectations of
effectiveness. During the five year period of conditional approval, AB Science
will continue to gather additional data to further support the safety and
efficacy of masitinib in designated indication.

About Canine Mast Cell Tumor
Mast cell tumour (MCT), also known as a mastocytoma, is the most common
cutaneous malignant neoplasm in dogs, accounting for 16 to 21% of all skin
tumours. The behaviour and progression of MCTs are highly heterogeneous. They
range from slow-growing tumours with a low potential for metastasis (grade I)
to undifferentiated, aggressive tumours (grade II and III) with a high
potential for metastasising to local lymph nodes, the liver, spleen and bone
marrow

About masitinib
Masitinib is a new orally administered tyrosine kinase inhibitor that targets
mast cells, important cells for immunity, as well as a limited number of
kinases that play key roles in various cancers. Owing to its novel mechanism
of action, masitinib can be developed in a large number of conditions in
oncology, in inflammatory diseases and in certain diseases of the central
nervous system. Through its activity of inhibiting certain kinases that are
essential in some oncogenic processes, masitinib may have an effect on tumour
regression, alone or in combination with chemotherapy. Through its activity on
the mast cell and certain kinases essential to the activation of the
inflammatory cells and fibrosing tissue remodelling, masitinib can have an
effect on the symptoms associated with some inflammatory and central nervous
system diseases.

About AB Science
Founded  in  2001, AB  Science is a pharmaceutical company specialising
in the research, development and commercialisation of protein kinase
inhibitors (PKIs), a new class of targeted molecules whose action is to modify
signalling pathways within cells. Through these PKIs, the Company targets
diseases with high unmet medical needs (cancer, inflammatory diseases and
central nervous system diseases), in both human and veterinary medicines.
Thanks to its extensive research and development capabilities, AB Science has
its own portfolio of molecules. Masitinib, a lead compound, has already been
registered in veterinary medicine in Europe and is pursuing nine phase
3 studies in human medicine, including three studies on-going in pancreatic
cancer, GIST and mastocytosis.

Further information is available on AB Science's website:  www.ab-science.com

This document contains prospective information. No guarantee can be given as
for the realisation of these forecasts, which are subject to those risks
described in documents deposited by the Company to the Authority of the
financial markets, including trends of the economic conjuncture, the financial
markets and the markets on which AB Science is present.

                                *  *   *

AB Science - Financial Communication & Press Relations
Contacts Citigate Dewe Rogerson :
Agnès Villeret - Tel: +33 1 53 32 78 95 - agnes.villeret@citigate.fr

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ABSCIENCES (EPA:AB) AB Science authorised to commercialise masitinib in the USA for treatment in canine mast cell tumor

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