Genmab’s MabThera rival enters phase III
pharmafile | January 24, 2008 | News story | Sales and Marketing |Â Â Â
Genmab and GSK's new biotech drug HuMax has entered phase III trials for use in rheumatoid arthritis, the first of several indications in which it could challenge Roche's blockbuster MabThera.
Roche's MabThera (Rituxan in the US) has become a blockbuster product thanks to its use in non-Hodgkins Lymphoma and has also been used to treat rheumatoid arthritis since 2006.
Genmab and GSK's HuMax (ofatumamab) works in the same way as MabThera, by targeting the CD20 protein found on the surface of B cells, which play a key role in blood cancers and in autoimmune diseases.
Genmab and GSK believe their drug will eventually demonstrate distinct advantages over MabThera, including working for longer, and could also be used when patients become resistant to Roche's drug.
Genmab hope to file HuMax in its first indication of chronic lymphocytic leukaemia by late 2008 or early 2009, and several further licensing applications are set to follow.
HuMax could then be on the market by mid-2009, after which analysts predict peak annual sales will reach at least $500 million.
Commencement of phase III trials in rheumatoid arthritis, as well as a phase II trial in large B-Cell Lymphoma (DLBCL), has triggered milestone payments to Genmab from GSK.
Genmab stands to earn over $2 billion in milestone payments and other incentives from GSK if the drug reaches its full commercial success.
Lisa Drakeman, chief executive of Genmab, said: "The successful initiation of the Ofatumamab RA and DLBCL programmes are a testament to the co-operative spirit of our companies.
"We believe that [HuMax] has real potential. Now that phase III studies are underway in multiple indications, we are moving closer to realising this potential and bringing this important treatment to patients."
HuMax differs from MabThera in that it targets a distinct small loop epitope on the CD20 receptor, which allows it to stick to the cells for a far longer period after the drug is administered, helping to fight the disease for longer.
Genmab is also working with GSK to develop a version of the drug given by subcutaneous injection, which could speed up its administration process.
Among the numerous planned trials of the drug, the next will be a phase II study of HuMax to treat relapsing multiple sclerosis, which is expected to begin in the first quarter of 2008.
The Danish biotech firm won Scrip's 2007 Biotech Company of the Year award in December, the judges recognising the company numerous accomplishments during 2006 and 2007.
These included the clinical progress of products, its success in raising capital and licensing agreements, and the development of UniBody, a new proprietary antibody technology that creates a stable, smaller antibody format which is anticipated to produce a longer therapeutic window than current small antibody formats.
