Roche and Antisoma plc will form a broad strategic alliance which grants Roche exclusive worldwide rights to the Antisoma pipeline of oncology products. This alliance will use the established development, manufacturing and commercial capabilities of Roche to facilitate the rapid commercialisation of Antisoma's promising oncology drugs.
Agents covered by the agreement include Pemtumomab, which is already in phase III development for ovarian cancer and could be the subject of product license applications as early as 2004. Also included are three other oncology compounds, Therex, TheraFab and DMXAA that are currently in phase I clinical trials. Roche will also have rights to opt in to pre-clinical programs that advance into clinical trials during a 5-year period.
In exchange for a minority equity stake and cash payments, Roche will have rights to the oncology products currently in clinical development at Antisoma as well as those developed to the stage of human use over the next five years. Under the terms of the agreement, Antisoma will be responsible for advancing new oncology compounds into clinical development. Roche will gain the right, for five years, to opt in to any program upon entry to human clinical trials and then to co-develop and commercialise products on a worldwide basis.
Roche will initially pay 4.15 million GBP to acquire new Antisoma shares equivalent to just under 10% of the current share capital and make a cash payment to gain access to the existing Antisoma portfolio. Roche will also provide Antisoma with further access, development and milestone and commercial payments based on compounds successfully reaching critical stages.
Key milestones will be entry into phase III trials and marketing approvals. Payments to Antisoma could exceed 500 million USD if all existing pipeline products were successfully launched. In addition, Antisoma will receive royalties on product sales. Roche will cover in full the remaining development costs of Pemtumomab and Therex.
Roche has agreed to maintain its equity stake in Antisoma until at least the earliest of the following: the approval for marketing of Pemtumomab, the termination of the agreement, or the elapse of 3 years from completion.
"We feel very fortunate to have identified such an attractive biotech partner as Antisoma in an area of strategic importance to Roche. Considering its size and resources, Antisoma has demonstrated an ability to create a significant portfolio of promising product candidates. The partnership will ensure that we deploy the necessary resources and expertise to fully develop this pipeline and create yet another source of products for our growing oncology franchise," said William M. Burns, Head of Roche's Pharmaceuticals Division.
Glyn Edwards, Chief Executive of Antisoma, said: "This is a ground-breaking agreement for the European biotechnology industry. The commitment by Roche underlines the quality and depth of our portfolio of oncology products and will enable us to bring them to market in the broadest range of indications and the fastest possible time. It will also significantly increase our cash reserves and reduce our cash burn, placing us in a strong position to acquire new products."