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news.GTC Biotherapeutics and LFB Biotechnologies have initiated development of a monoclonal antibody produced in the milk of genetically engineered goats under an existing agreement between the two companies.
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The CD20 antibody is expected to have target specificity similar to Genetech’s Rituxan (rituximab) and to have relatively higher antibody dependent cell-mediated cytotoxicity.
The existing relevant CD20 antibody patents will expire by 2014. The transgenically produced CD20 antibody is anticipated to be commercially developed for oncology and auto-immune indications. Rituximab is used in the treatment of B-cell non-Hodgkin’s lymphoma, B-cell leukemia and rheumatoid arthritis.
It is also under investigation for a range of auto-immune conditions such as systemic lupus erythematosus, immune thrombocytopenic purpura, and type-I diabetes. Rituximab had worldwide sales of nearly $4 billion in 2006 and is projected to have a $5 billion market by 2010, according to the companies.
This CD20 antibody may be considered for clinical development as a follow-on biologic in the US and a biosimilar in the EU as the appropriate legislation is enacted and regulatory guidance is established.
The transgenically produced CD20 antibody is being developed under the agreement between GTC and LFB established in October 2006. Costs and profits from the program are anticipated to be shared 50/50. Production in the milk of transgenic goats is anticipated to be established in 2008 with an investigational new drug application to the FDA planned for 2010.