ABSCIENCES (EPA:AB) AB Science - Quarterly Information - Third Quarter 2010
Transparency directive : regulatory news
06/10/2010 17:59
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Paris, October 6th, 2010 - 6. 00 pm
Quarterly Information - Third Quarter 2010
Sales in veterinary medicine continue to rise
Authorisation granted to start five new phase 3 human clinical trials
Launch of a clinical development programme for the treatment of Alzheimer's
disease
AB Science SA (NYSE Euronext - FR0010557264 - AB), a pharmaceutical company
specialising in research, development and commercialisation of protein kinase
inhibitors (PKIs), today announced its sales for the third quarter of 2010 and
presents key highlights for this period.
Commenting on this announcement, Alain Moussy, CEO of AB Science declared: "In
the third quarter of 2010, regulatory authorities validated six new phase 3
studies with mas itinib. Four of these studies were part of the objectives
presented during the launch of our initial public offering, and two represent
new opportunities. We are pleased to see this strengthening of our development
portfolio for our lead compound, masitinib, in such a short time."
1. Highlights of the third quarter 2010
During the quarter, AB Science saw significant new advances in its development
pipeline.
In Human Medicine
As of today, AB Science has received regulatory approval for eight phase 3
clinical trials and a positive scientific opinion from the European Medicines
Agency (EMA) to launch a phase 3 study for the treatment of Alzheimer's
disease.
- In accordance with the objectives presented during its initial public
offering, AB Science has obtained authorisation for four new phase 3
studies in multiple myeloma, rheumatoid arthritis, asthma, and multiple
sclerosis.
- The company is moving ahead with three phase 3 studies that were in
progress before its initial public offering last April, in pancreatic
cancer, gastrointestinal stromal tumours (GIST), and mastocytosis.
- 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.
Following positive and statistically significant results of phase 2 studies in
the treatment of Alzheimer's disease, the company has recently received a
positive scientific opinion from EMA. AB Science now awaits regulatory
authorisation before starting this phase 3 study.
In the treatment of melanoma, AB Science announced the launch of a new clinical
development programme directly in phase 3 for the treatment of metastatic
melanoma in patients presenting a mutation in the juxtamembrane region of
c-kit, following a positive opinion from FDA and EMA.
In Veterinary Medicine
The company continues its advances in veterinary medicine.
AB Science has recently completed a phase 3 study for the treatment of atopic
dermatitis in dogs as well as a phase 2 study for the treatment of asthma in
cats. The company intends to publish these clinical results demonstrating the
effectiveness of masitinib and the role of mastocytes in inflammatory
conditions.
As previously announced, AB Science currently has a registered drug that is
marketed in Europe (as Masivet(r)). AB Science was the first pharmaceutical
company in the world to obtain marketing authorization for a tyrosine kinase
inhibitor in veterinary medicine, which was granted last year.
II. Financial Statement for the Third Quarter 2010
The income of AB Science was 240 kEUR in the third quarter of 2010, versus
88 kEUR in the third quarter of 2009.
It stems exclusively from its activities in veterinary medicine and is divided
between:
- 181 kEUR, from sales in Europe, which continue to grow at a steady pace:
+ 129% compared to the third quarter 2009, which was the first quarter of
marketing MASIVET(r).
- and 59 kEUR in charges to veterinarians for shipping and handling fees for
import requests masitinib to the United States. These revenues increased by
555% compared to the third quarter of 2009.
Overall, AB Science reported an income of EUR 663 kEUR for the first nine
months of fiscal year 2010 through the commercial exploitation of masitinib
veterinary medicine.
III. Financial Status on September 30th 2010
The cash outflow was 5.3 MEUR for the first nine months of 2010, compared
to 8.3 MEUR for the same period in 2009. This apparent decrease in cash
consumption, in spite of increasing operational expenses related to ongoing
programmes, is due to an increase in resources collected over the period (sales
income, research tax credit, grants).
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specialising in
research, development and commercialisation of protein kinase inhibitors
(PKIs), a new class of targeted therapy 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 including masitinib, which has already been
registered in veterinary medicine in Europe and is being developed in nine
phase 3 studies in human medicine, including three ongoing studies in
pancreatic cancer, gastric intestinal tumors (GIST) and mastocytosis.
Further information is available on AB Science's website: www.ab-science.com
This document contains forward looking statements. 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 Communications & Public Relations
Contacts Citigate Dewe Rogerson :
Agnès Villeret - Tel: +33 1 53 32 78 95 - agnes.villeret@citigate.fr
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