GTC and LFB collaborate on transgenically produced products
collaboration, which focuses on recombinant plasma proteins and
monoclonal antibodies (mAbs) to eventually develop a robust
pipeline for treating conditions such as haemophilia.
The agreement focuses on developing selected proteins and mAbs using GTC's transgenic production platform, which eventually will produce a transgenically produced recombinant form of human factor VIIa (rhFVIIa).
Factor VIIa is a clotting factor in the coagulation of blood. A research program on rhFVIIa was initiated by LFB three years ago.
The total worldwide sales of the current recombinant factor VIIa product in all indications were reported to be $845m in 2005. An independent market research report estimates the worldwide sales of rhFVIIa will reach $2bn by 2012.
Both plasma-derived and recombinant products are used in treating haemophilia caused by genetic conditions in which patients' failure to express enough coagulation factors on their own may lead to excessive bleeding.
The application of transgenic technology may enable the production and pricing of rhFVIIa at appropriate levels for broader utilisation of rhFVIIa, as well as expanding its use to the treatment of the unmet needs of patients in developing countries and to the treatment of other acquired bleeding conditions.
Under the terms of the agreement, GTC will be responsible for development of the production system for the products and will retain exclusive commercial rights to the products in North America.
LFB Biotechnologies will be responsible for clinical development and regulatory review of the first program of this collaboration, and will have exclusive commercial rights in Europe.
GTC and LFB Biotechnologies will hold co-exclusive rights in the rest of the world to the products developed through their collaboration.
Additional terms will see LFB Biotechnologies purchase $25m of GTC shares of which $19m is subject to GTC shareholder approval. Subject to such approval, the investment will occur in three instalments.
"This collaboration with LFB Biotechnologies is a significant step in the execution of our strategic plan to develop a robust pipeline of recombinant plasma proteins and monoclonal antibodies," said Geoffrey Cox, GTC's Chairman and Chief Executive Officer.
"Thanks to this strategic alliance with GTC, we have assembled all the assets and skills of a worldwide success for our rhFVIIa," said Christian Béchon, LFB's Chairman and Chief Executive Officer.
