| Roche’s pipeline strengthened, with a fifth oncology transaction including a product in phase II Roche and Beaufour Ipsen (Paris, France) announced today that they have signed a global agreement to co-develop and market Beaufour Ipsen’s new anticancer candidates. Roche will have worldwide rights, excluding Europe, to market two Beaufour Ipsen products in development (diflomotecan and BN80927). Beaufour Ipsen retains these rights for Europe. In addition, mutual rights have been granted to future follow-on products in the same chemical family, the homocamptothecines, a new class of anticancer molecules discovered by Beaufour Ipsen. |    |
Diflomotecan, which is entering Phase II clinical development, and a second compound (BN80927), currently in pre-clinical development, are being assessed for their efficacy in solid tumours, including colorectal, lung and breast cancer. Combination studies of diflomotecan and Roche’s Xeloda are expected to begin during the first quarter of 2003.
Diflomotecan is the first of a new generation of topoisomerase-1 inhibitors, with a proven mechanism of action, improved safety and efficacy profile. The second compound, BN80927, has a novel mechanism of action, including dual inhibition of topoisomerases I and II, and will be developed for a broad spectrum of indications.
"We are very pleased that Beaufour Ipsen has selected Roche to commercialise these promising drug candidates, especially in the US oncology market. With the completion of our fifth oncology deal this year and the continuous progress of our in-house pipeline, the strength of our portfolio continues to increase." said William M. Burns, Roche’s Head of Pharmaceuticals.
"We are delighted to be working with such a world class company and one of the world’s leading oncology companies to develop and market novel topoisomerase inhibitors discovered by Beaufour Ipsen" said Jean-Luc Belingard, CEO of the Beaufour Ipsen Group.
Financial Terms
Under the terms of the agreement Roche will have all rights to market and sell diflomotecan and BN80927 in the USA, Japan, and rest of the world, whereas Beaufour Ipsen will have the sole right to market and sell the products in Europe. Roche and Beaufour Ipsen will jointly pay all future research and development costs for selected indications according to their market potential. Beaufour Ipsen will receive up to US$150 million, consisting of over $20 million in committed payments, and additional payments contingent upon achievement of clinical, regulatory and commercial milestones. Beaufour Ipsen will receive royalties on net sales in the USA, Japan and rest of the world, while Roche will receive royalties on net sales in Europe.
About the Agreement
Roche and Beaufour Ipsen will jointly conduct clinical development of the products. The principal focus of the collaboration will be the clinical development and marketing of diflomotecan and BN80927. Roche and Beaufour Ipsen will also have mutual rights to follow-on compounds and improvements over the next three years. Any such products would also be co-developed and co-commercialised by Roche and Beaufour Ipsen for the treatment of cancer or other therapeutic areas.
Roche in Oncology
Roche is the world leader in oncology. Its franchise includes three drugs with survival benefit: MabThera (Rituximab), Xeloda (capecitabine), and Herceptin (Trastuzumab). It also includes NeoRecormon (epoetin beta), Roferon-A (interferon alfa-2a), and Kytril (granisetron HCL). In addition, Roche has entered several agreements in the current year with Antisoma, Kosan, Gryphon, and GeneMab to develop and commercialise various promising compounds in the oncology field. The Roche Group’s oncology program is supported by four Research sites (two in the USA, Germany and Japan) and five Development sites (two in the USA, UK, Switzerland and Japan).
Roche also offers a broad portfolio of tumor markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests running on the LightCycler. Within its Integrated Cancer Care Unit the company develops new tests which will have a significant impact on disease management of cancer patients in the future.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-orientated healthcare groups. The company's two core businesses in pharmaceuticals and diagnostics provide innovative products and services, that address prevention, diagnosis and treatment of 3 diseases, thus enhancing people’s health and quality of life. The two core businesses achieved a turnover of 19.3 billion Swiss Francs in the first three quarters of 2002 and employed about 57,000 employees worldwide.
Beaufour Ipsen in oncology
Endocrinology/oncology is a significant line of development for Beaufour Ipsen, representing 33.2% of its turnover in 2001. Sales are based on two major products, Decapeptyl, a sustainedrelease (28 days and 3 months) peptide analogue of the hypothalamus hormone (GnRH), mainly indicated in the treatment of prostate cancer, and Somatuline, a sustained-release (28 days) somatostatin peptide analogue and inhibitor of growth hormone used in the treatment of carcinoid tumors.
About Beaufour Ipsen
Present in over 80 countries with a total staff of 3423, the Beaufour Ipsen Group had a turnover of €704 million in 2001, 57% of which was outside France. The Group develops products for four targeted disease area franchises: oncology, endocrinology, neurology and haematology. It currently has a portfolio of 30 products on the market which are either peptides, derived from biotechnology, or products based on natural sources. In 2001, 16.4% of Beaufour Ipsen's turnover was reinvested in Research and Development, which is carried out in four research centres (Paris, Boston, Barcelona and London) by an international network of around 500 scientific staff. The Group's website is www.beaufour-ipsen.com.
Source: Ipsen
