Lonza wins contract for Genmab/GSK’s Arzerra
pharmafile | November 12, 2009 | News story | Manufacturing and Production | GSK, Lonza
Swiss contract manufacturer Lonza will manufacture a newly-approved treatment for chronic lymphocytic leukaemia after signing a deal with Genmab and GlaxoSmithKline, the drug’s developers.
Lonza has already carried out the process development for manufacturing Arzerra (ofatumumab), a monoclonal antibody targeting the CD20 protein found on the surface of B lymphocytes, and said it will take over responsibility for Good Manufacturing Practice (GMP) production of the drug substance.
“We are looking forward to a long-term relationship between Lonza and GSK,” said Dr Stephan Kutzer, chief operating officer of Lonza’s Custom Manufacturing APIs division.
Arzerra was granted accelerated approval in the US on October 26 for use in patients with CLL that is refractory to fludarabine and alemtuzumab. The go-ahead was given on the back of a pivotal study which found a 42% response rate among those treated with the antibody, with a median response duration of 6.5 months.
In addition to its lead second-line CLL indication, Arzerra is in development for first-line use (phase III trial ongoing), non-Hodgkin’s lymphoma (phase III), rheumatoid arthritis (phase III), diffuse large B-cell lymphoma (phase II), multiple sclerosis (phase II) and a rare cancer called Waldenstrom’s macroglobulinaemia (phase II).
Arzerra is expected to be “a key biopharmaceutical for both companies”, said Kutzer.
GSK acquired the global rights to the drug in December 2006 for a $2.1 billion. Analysts have estimated that the antibody could bring in $2 billion a year at peak if it fulfils its promise in follow-up indications.
Last week Genmab said it had put a facility that was scheduled to make Arzerra and other materials up for sale, saying that it expected little short-term demand for its production capacity and that its “future manufacturing requirements will … be met through working with contract manufacturing vendors”.
The factory, based in Brooklyn Park, Minnesota, was purchased for $240 million from PDL in 2004 and employs around 130 staff. Genmab has said its current value is around $150 million.
Genmab also published its nine-month financial results yesterday, with revenues of 435 million kroner ($86 million), down 35% from the same period of 2008. The Danish firm posted an operating loss of 536 million kroner, up 5%.
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