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GEN News Highlights : Oct 27, 2009

Genmab and GSK Achieve Accelerated FDA Clearance of CLL Drug

Sanction triggers $23 million milestone fee to Genmab.

Genmab received an approximately $23 million milestone payment from GlaxoSmithKline through the company’s achievement of accelerated FDA approval of the CD20-targeting mAb Arzerra™ (ofatumumab) as a treatment for chronic lymphocytic leukemia (CLL).

Approval covers the use of Arzerra in patients with CLL that is refractory to fludarabine and alemtuzumab.  A regulatory filing in the EU for the CLL indication was made in February.

The antibody is also in Phase III development against non-Hodgkin’s lymphoma and rheumatoid arthritis. Additionally, Phase II trials are under way in multiple sclerosis and diffuse large B-cell lymphoma. “This approval marks a key milestone for Genmab as it is our first antibody to reach the market,” notes Lisa N Drakeman, Ph.D., CEO.

GSK and Genmab signed their worldwide agreement to co-develop and commercialize ofatumumab for multiple indications in December 2006. Under terms of the original agreement Genmab received a license fee of some $102 million. GSK also made a $357 million investment in the Danish company. The firms estimated the total value of the deal could reach about $2.1 billion, including future milestones in the various indications. 

In December 2008, Genmab decided to sell back its U.S. and Nordic region co-promotion rights to GSK for a one-time fee of $4.5 million. This was due upon the successful filing of ofatumumab in the U.S. for an oncology indication. The amendment means GSK is now fully responsible for sales of the antibody worldwide.