Press Release
BioImpact.org 2007 New findings - Biotechnologies: serving patients and our society Lyon, March, 12th 2007 - On the occasion of Biovision, the World Life Sciences Forum in Lyon, the partners of the BioImpact.org project, France Biotech, the French Biotechnology Industry Association, at the origin of the project, BIA, the UK BioIndustry Association, EuropaBio, the European Bioindustry Federation, Leem- Les Entreprises du Médicament, the French pharmaceutical industry association, and LIR- Laboratoires Internationaux de Recherche, present the new version of www.bioimpact.org and new findings about the impact of biotechnology on the treatment of diseases heavily affecting millions of patients: breast cancer, cardio-vascular diseases, inflammatory bowel diseases and chronic inflammatory joint diseases in particular. With a renewed website, BioImpact.org provides the visitor with patient testimonials and science-based information, presented in simple and accessible fact sheets, videos and detailed reports including all scientific references, for those who are willing to learn more about the pathologies, the biotechnology treatments and how they save lives, help patients and serve our society. With more than 250 medicines and vaccines already available and more than 400 therapeutic products under development in 2006, the socio-economic impact of biotechnology is highly significant. BioImpact.org’s previous edition already showed the value of medicines discovered and developed by biotechnology and pharmaceutical companies; improved product safety, reduced side effects, new therapeutic strategies addressing unmet medical needs, or technologies improving public health coverage. The 2007 version of BioImpact.org includes additional information such as extensive European epidemiologic data (incidence, prevalence and mortality), quality of life data and economic data (economic costs of the disease, cost of biotherapy, cost/efficiency, target populations). It helps to understand how biotechnology is contributing to therapeutic progress and to public health and what is its real added-value for our society, in terms of public health and in economic terms. Biomedicines and other biotechnologies represent a large and growing segment of innovative medicines (around 40 % of the authorizations for commercialization). Many of these molecules were developed in the United States. To guarantee continued access to the most innovative care, BioImpact.org partners recall that it is vital to create an optimal environment for the discovery, development of innovative biotech medicines in Europe. Annex 1: Summary of BioImpact.org 2007 Biotechnology for cardio-vascular diseases: Thrombolytics Heart attacks, strokes and pulmonary embolisms are the primary cause of death and the primary cause of major disability and cognitive loss in the European Union. Over 3 million new cases occur every year as consequences of blood clots (thrombus). 700 000 persons die every year from coronary heart disease and more than 500 000 persons die from stroke. Before biotechnology developed thrombolytic agents, cardiovascular events linked to thrombi were treated with anticoagulant agents. Anticoagulants play a preventive role but have little, or no, ability to destroy a blood clot once it has formed. Thrombolytic – or “clot-busting” – agents developed by biotech researchers during the 1980s dissolve a blood clot rapidly, and almost totally. When administered sufficiently quickly after a vascular accident, they reduce mortality rates in myocardial infarction by almost 30%, and reduce by 20% the neurological deficit resulting from ischaemic stroke. The total cost of these diseases (excluding pulmonary embolisms), including healthcare and production losses, was estimated in 2003 at €78 billion in the European Union, (4% total healthcare costs). Thrombolytic agents provide in some cases an efficient alternative to coronary angioplasty and are cost / effective. Biotechnology for Inflammatory Bowel Diseases: anti-TNF alpha Inflammatory bowel disease is the result of inappropriate and persistent over stimulation of the intestinal mucosa by the immune system. Inflammation of the wall of the digestive tract can be observed along with the development of ulcers. It can cause diarrhoea, abdominal pain and cramps, blood in faeces, fatigue, fever, weight loss and nutritional deficiency. In the EU, Crohn’s disease account for 450 000 cases and ulcerative colitis for 450 000 to 900 000 cases. There is a significant excess mortality rate for patients with Crohn’s disease in comparison with the general population and patient's life is impaired in all functional categories. Traditional therapeutic approach is based on the use of 5-ASA, immunosuppressive agents and surgery. Understanding the role of TNF alpha (Tumour Necrosis Factor, a molecule produced by various cells in the body) in the inflammatory process of intestinal lesions in patients with inflammatory bowel disease has enabled the development of new drugs. These new biological agents, whose role is to inhibit TNF alpha and prevent it from acting to excess, have shown spectacular results. Response rate is superior to 60% for active forms resistant to conventional treatment. Total costs of the disease range from €4.5 to €13.5 billion for the EU. Anti-TNF alpha allow a reduction in direct costs (surgery= 50% of direct costs) and in indirect costs (return to work). Biotechnology for Chronic Inflammatory Joint Diseases: anti-TNF alpha Rheumatoid arthritis (RA), spondylitis, psoriatic arthritis and juvenile rheumatoid arthritis affect 3 million adults and 50 000 children in the European Union. There is an excess mortality in adults and children. 30% of patients with Rheumatoid Arthritis endure slight to serious disability after 10 years. Patients suffer from a progressive inability to continue working. Traditional therapeutic approach is based on drugs with a low specificity (DMARDs, NSAIDs for spondilytis), which have no effect on joint destruction. Three TNF inhibitors (infliximab, adalimumab and etanercept), developed thanks to biotechnology improve the symptoms, slow down progression of joint damage and preserve patients’ abilities to lead normal lives. There are other active biotech drugs (rituximab, abatacept, anakinra) and one monoclonal antibody (tocilizumab) in development. Total healthcare costs for these diseases amount to €30-45 billion in the EU. Biotherapies do reduce costs, in part offsetting their high price and have a favourable cost/effectiveness ratio. Biotechnology for Breast Cancer: trastuzumab 1.5 million women are affected in the European Union. More than 360 000 new cases occur every year and 130 000 women die every year. Conventional treatment consists of two stages-regional treatment (surgery followed by radiotherapy) and systemic treatment (chemotherapy and hormone therapy) to prevent metastases. This combination enables a large number of breast cancers to be cured, particularly if the tumour is small and local and regional invasion is limited. Biotechnology allowed the identification of specific markers (HER2) and the development of drugs specific to HER2+ cancer cells: monoclonal antibodies which only attack the cancer cells and have few side effects. In use since 1998, Trastuzumab (Herceptin®) is indicated in about a quarter of all breast cancers. In early-stage breast cancer, and administered after chemotherapy, it reduces the risk of relapse by almost a half. In secondary cancers, trastuzumab in combination with chemotherapy is significantly superior to chemotherapy alone, extending survival by 4 to 8 months. Lapatinib (Tykerb®) is currently in registration and could be approved in 2007. Total costs for breast cancer amount to € 8 billion in the EU (15% of total cancer costs). The effectiveness of trastuzumab justifies a relatively high individual cost of treatment (€ 20 000 in the EU)
Dr Philippe Cramer presentation, scientific director of BioImpact
About BioImpact.org partners BIA The BIA exists to promote the human health benefits of new bioscience technologies, encouraging the commercial success of the bioscience industry by focusing on emerging enterprise and the related interests of companies with whom such enterprise trades. The BIA supports member interests by lobbying Government and Parliament in the UK and Brussels, providing high quality information and business services, and attracting investment from both private and Government sources. www.bioindustry.org EUROPABIO EuropaBio, the European Association for Bioindustries, has 80 direct members operating Worldwide, 12 associate members and 5 bioregions as well as 24 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of products. www.europabio.org FRANCE BIOTECH France Biotech is the French biotechnology association and the industry representative. Its mission is to contribute to position France and Europe as leaders in the Life sciences industry. France Biotech gathers 150 members, representing most of the French biotechnology investments, pipeline and employees. www.france-biotech.org LEEM Leem is the french medicine companies association, and brings together companies operating in France which represent 98.7% of the French medicines market. Leem is committed to representing the companies which joined the association, facilitating meetings and exchanges between its members, elaborating the ethic code, and ensuring it is respected. The Leem Biotechnology Committee was founded in March 2004 to gather French biotechnology actors involved in medicine companies. www.leem.org LIR LIR is the international association of research laboratories whose activities are focused on research and development. LIR was founded to raise awareness and promote the role of innovation in the improvement of public health; to highlight the contributions of medicines from both an economical and therapeutic stand points; to make understand the need for a medicine politics that takes into account industrial, research, exportations and jobs factors while taking into account patients' interests and financial balance of Health Insurance. www.lir.asso.fr Press contacts Alize Public Relations – Caroline Carmagnol Tel: +33 (0)6 64 18 99 59 – Fax : + 33 (0)1 34 89 90 39 caroline.carmagnol@wanadoo.fr EuropaBio – Adeline Farrelly Tel: + 32 475 93 17 24 - Fax: +32 2 735 49 60 a.farrelly@europabio.org