In December 2006, Genmab announced a worldwide agreement with
GlaxoSmithKline (GSK) to co-develop and commercialize ofatumumab. Ofatumumab is in development for CD20 positive B-cell chronic lymphocytic leukemia (CLL), follicular non-Hodgkin's lymphoma (NHL), rheumatoid arthritis (RA), diffuse large B-cell lymphoma (DLBCL), Waldenstrom's macroglobulinemia and relapsing remitting multiple sclerosis (RRMS).
Under the terms of the agreement, Genmab received a license fee of DKK 582 million (approx. $102 million), and GSK invested DKK 2,033 million (approx. $357 million) to purchase 4,471,202 ordinary shares of Genmab. In addition, Genmab will be entitled to receive royalties on global sales of ofatumumab.
GSK received an exclusive worldwide license to ofatumumab as well as any other antibodies with affinity for the CD20 antigen which Genmab may develop. GSK also has an exclusive option to a CD20 UniBody® to be developed in collaboration with Genmab. GSK and Genmab will co-develop ofatumumab. GSK will be solely responsible for the manufacturing and commercialization of ofatumumab.
Under the original terms of the agreement, Genmab had an option to co-promote ofatumumab in a targeted oncology setting in the US and in the Nordic region. In addition, if Genmab exercised the co-promotion option, Genmab would have had the option to co-promote Bexxar™ and Arranon™ in the US and Atriance™ in the relevant countries of the Nordic region. Under the terms of a December 2008 amendment to the agreement, Genmab received a one-time payment of $4.5 million from GSK upon the FDA's acceptance for review of the filing of the first Biologcis License Application (BLA) for ofatumumab in an oncology indication in the USA in exchange for terminating its option to co-promote ofatumumab.
Under the terms of an amendment to the agreement in July 2010, GSK has taken responsibility for developing ofatumumab in autoimmune indications while continuing to jointly develop ofatumumab with Genmab in oncology indications. Genmab receives an up front payment of GBP 90 million (DKK 815 million) from GSK. Genmab’s future funding commitment for the development of ofatumumab in oncology indications will be capped at a total of GBP 145 million (DKK 1,314 million), including a yearly spending cap of GBP 17 million (DKK 154 million) each year forsix years starting with 2010. Future milestones due to Genmab under the oncology development program will be reduced by 50%. There will be no change in royalty tiers to Genmab in the oncology program. GSK will be solely responsible for funding the development in autoimmune indications and Genmab will forego development milestones for autoimmune indications and the first two sales milestones while retaining a double digit royalty on sales.
To date, Genmab has received nine milestone payments for an approximate total of DKK 842 million (approximately USD 164 million) under the GSK collaboration, as follows:
• June 2007 - DKK 116 million (approximately USD 21 million) for positive results in the Phase II RA study
• December 2007 - DKK 87 million (approximately USD 18 million) when the first patient was treated in the Phase II DLBCL study
• January 2008 - DKK 87 million (approximately USD 18 million) when the first patient was treated in the Phase III RA program
• June 2008 - DKK 29 million (approximately USD 6 million) when the first patient was treated in the Phase II study for RRMS
• August 2008 - DKK 232.7 million (approximately USD 48.5 million) for the achievement of positive results in the ofatumumab Phase III CLL study
• October 2008 - approximately DKK 29 million (approximately USD 5.6 million) when the first patient received treatment in the ofatumumab Phase I study in relapsed/refractory follicular non-Hodgkin's lymphoma and chronic lymphocytic leukemia in Japan
• February 2009 - DKK 58 million (approximately USD 10 million) in connection with EMEA's acceptance of the MAA for ofatumumab in refractory CLL
• March 2009 - DKK 87 million (approximately USD 15 million) when the FDA accepted the BLA for ofatumumab in refractory CLL
• October 2009 - DKK 116 million ( approximately USD 23 million) when the FDA approved ofatumumab for the treatment of CLL that is refractory to fludarabine and alemtuzumab
• April 2010 – DKK 87 million (approximately USD 16 million) when the European Commission granted a conditional marketing authorization for ofatumumab for the treatment of refractory CLL