ABSCIENCES (EPA:AB) AB Science : authorisation to directly launch a phase 3 clinical study for the treatment of melanoma

Transparency directive : regulatory news

05/10/2010 18:00

Paris, 5th October 2010 - 6 pm

AB Science receives authorisation to directly launch a phase 3 clinical
study for the treatment of melanoma

The Company currently has nine phase 3 studies in human medicine

AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company
specialising in the research, development and commercialisation of protein
kinase inhibitors (PKIs), announces having received regulatory approval to
initiate a pivotal phase 3 study for the treatment of metastatic melanoma
carrying a mutation in the juxtamembrane (JM) domain of c-Kit.

Following independent evaluation of the proposed pivotal phase 3 study in
melanoma, AB Science received:
  - Positive scientific opinion from the European Medicines Agency (EMA),
    including its accord on the study design, which will support a future
    application for market authorisation of masitinib in the treatment of
    this type of metastatic melanoma;
  - Investigational New Drug (IND) authorisation from the US Food and
    Drug Administration (FDA) to conduct this phase 3 study at centres in the
    USA.

Exceptionally, AB Science has been authorised to launch this clinical
development program directly to phase 3. The major regulatory agencies have
judged that results obtained from other masitinib studies conducted by AB
Science, provide sufficiently compelling scientific evidence to accelerate the
development of this program; namely:

  - Masitinib is already registered for treatment of canine mastocytoma (mast
    cell tumours) with confirmed mutation of c-Kit, and is currently
    commercially available across Europe. In this population, it has been
    shown that subjects receiving masitinib have a statistically significant
    longer median survival time (241 days versus 83 days).

  - Masitinib is under development in a phase 3 study for treatment of
    gastro-intestinal stromal tumour (GIST), which is caused by the same JM
    mutation of the c-Kit receptor. In a phase 2 study for this indication,
    with over 4 years of patient follow-up, the median survival has not yet
    been reached and the rate of survival at 4 years was 76%. Median survival
    without progression was 41.3 months.

Alain Moussy, Chairman and CEO of AB Science declared: "There exists a
strong scientific rationale for developing masitinib in melanoma that express
the JM mutation of c-Kit. It was essential for us to be able to initiate this
pro gram rapidly. For this reason, we are very happy to have obtained
authorisation from the FDA to proceed straight to the phase 3 study, without
first having to conduct a preliminary phase 2 study, based upon the scientific
rationale and clinical data of masitinib in other related cancers (mastocytoma
of dogs and GIST in humans)".

In parallel with this phase 3 study in metastatic melanoma carrying a mutation
in the JM domain of c-kit, AB Science has also initiated a phase 2 study in
other forms of metastatic melanoma.

AB Science currently has nine phase 3 studies in human medicine, of which
eight have received all necessary authorisations to commence recruitment.

This new authorisation is the 8th phase 3 study in human medicine for which AB
Science has received the green light to commence.

  - The Company continues development of three phase 3 studies that were in
    progress before its initial public offering (IPO) last April, in
    pancreatic cancer, GIST and mastocytosis.

  - In accordance with objectives communicated at the time of its IPO, it has
    obtained authorisation for four new phase 3 studies in multiple myeloma,
    rheumatoid arthritis, asthma, and multiple sclerosis.

  - In addition, two new major opportunities have been established: one in
    melanoma, for which phase 3 authorisation has been secured, and the other
    in Alzheimer's disease. The latter has already received a positive
    scientific opinion from the EMA on the design of its proposed pivotal
    phase 3 study, following highly encouraging results from a related phase 2
    study. AB Science now awaits the necessary regulatory authorisations before
    launching this phase 3 study.

In addition, AB Science continues its advances in veterinary medicine, where
its lead compound masitinib is already registered and marketed in Europe
(under the name Masivet(r)). This was a notable landmark, making AB Science the
first pharmaceutical laboratory in the world to produce an approved targeted
therapy in veterinary oncology; Masivet(r) having been registered by the EMA in
November  2008.

AB Science will present detailed advances in its clinical development program on
Friday 8th October 2010 at 8.30 am.
Please contact us if you want to attend this meeting or the conference call
(in English) that is scheduled the same day at 11.00 am (Paris time).

Citigate       Contacts Citigate Dewe Rogerson :
Dewe Rogerson  Agnès Villeret - Tel: +33 1 53 32 78 95 -
                             agnes.villeret@citigate.fr

About melanoma
The incidence of melanoma has been rapidly increasing for several years. The
incidence of melanoma has increased ten-fold over the past 50 years, and has
steadily increased since the 1970s. The American Cancer Society estimated there
were 68,000 newly diagnosed melanoma cases in the US with 8,700 related deaths
in 2009.

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 eight 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.

                                     * * *

DETAILS OF THE CLINICAL DEVELOPMENT PROGRAM (on the following pages)

Scientific rationale for developing masitinib in metastatic melanoma expressing
the JM mutation of c-Kit.

There exists a strong scientific rationale for developing masitinib in the
treatment of metastatic melanoma expressing the JM mutation of c-Kit.

1. A large proportion of mucosal melanoma (39%), acro-lentiginous melanoma
(36%), and melanomainduced by sun exposure (28%) express the JM mutation of
c-Kit.

2. Clinical data has shown that the single agent administration of imatinib
(Glivec), an inhibitor of c-Kit, could induce a prolonged partial tumour
response in patients with melanoma expressing the JM mutation of c-Kit.

3. Masitinib is a potent and highly specific inhibitor of c-Kit, and in
particular the JM mutation of c-Kit.
  - Masitinib is registered in treatment of canine mast cell tumours with
    confirmed JM mutation of c-Kit.
    In this population, it has been shown that subjects receiving masitinib
    have a statistically significant longer median survival time (241 days
    versus 83 days).
  - Masitinib is under development in a phase 3 study for treatment of GIST,
    which is caused by the same JM mutation of the c-Kit receptor. In a phase 2
    study for this indication, with over 4 years of patient follow-up, the
    median survival has not yet been reached and the rate of survival at 4
    years was 76%. Median survival without progression was 41.3 months.

  Characteristics of the phase 3 study in metastatic melanoma

This is a prospective, multicentre, open-label, active-controlled, two-arm,
phase 3 study to compare the efficacy and safety of masitinib at
7.5 mg/kg/day to dacarbazine in the treatment of patients with nonresectable
or metastatic stage 3 or stage 4 melanoma carrying a juxta-membrane mutation
c-kit

A total of 200 patients will be randomised in 2 groups:
Group 1: 100 patients will receive masitinib;
Group 2: 100 patients will receive dacarbazine.

The primary criterion will be the Overall Progression
Free Survival (PFS), defined as the delay between the date of randomisation to
the date of documented progression or any cause of death during the study.
Overall Survival will be the main secondary criterion.

Positioning of masitinib in the treatment of melanoma

Melanoma is a malignant tumour that develops from
cells called melanocytes, which are present primarily in the skin but are also
found in the eye and mucous membranes of the mouth, nose, sinus, rectum and
genitals.

The incidence of melanoma has multiplied ten-fold in 50 years. The American
Cancer Society estimated there were 68,000 newly diagnosed melanoma cases in
the US with 8,700 related deaths in 2009. In France, it is estimated that
7,000 new cases of melanoma are diagnosed each year.

Positioning of masitinib within targeted therapies

Of the new targeted therapies currently under development in the various forms
of melanoma:
  - For metastatic melanoma expressing the BRAF mutation (i.e. 40% to 60% of
    melanoma patients), one compound developed by Plexxikon and Roche is
    currently undergoing phase 3 evaluation.
  - For metastatic melanoma expressing the JM mutation of c-Kit (i.e. 5% of
    melanoma patients), other than masitinib, two other molecules are under
    development for this indication. Nilotinib (Novartis) has recently
    initiated a phase 3 study and dasatinib (Bristol-Myers Squibb) is currently
    in phase 2.

There exist important differences between nilotinib and masitinib
beyond their common capacity to inhibit the JM mutation of c-Kit; namely,
masitinib also blocks the signalling pathways of WNT/betacatenine and LYN/FAK,
two pathways that are important for the proliferation of metastatic
melanoma.

Positioning of masitinib within other forms of metastatic melanoma

Chemotherapy is proposed for treatment of metastatic melanoma; however, it
does not generate satisfactory clinical results, with a median survival of
between just 6 to 12 months (palliative chemotherapy). In metastatic melanoma,
a monoclonal antibody developed by Bristol-Myers Squibb, ipilimumab,
aimed at stimulating the response of certain cells of the immune system against
the melanoma, has been shown to improve median survival by 3.7 months (10.1
months compared to 6.4 months with standard treatment). This product has been
filed for registration.

Masitinib is positioned at phase 2 in the treatment of these forms of
metastatic melanoma, as monotherapy or in combination with standard
chemotherapy.

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Transparency directive : regulatory news

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