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AB Science — Interim / Quarterly Report 2010
Oct 6, 2010
1059_10-q_2010-10-06_50e1762a-1945-4f5f-b0a0-16e0865b685a.pdf
Interim / Quarterly Report
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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 masitinib. 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®). 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 k€ in the third quarter of 2010, versus 88 k€ in the third quarter of 2009.
It stems exclusively from its activities in veterinary medicine and is divided between:
- 181 k€, 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®.
- and 59 k€ 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 € 663 k€ 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 M€ for the first nine months of 2010, compared to 8.3 M€ 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 : |
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| Agnès Villeret - Tel: +33 1 53 32 78 95 - [email protected] |
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