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GSK settles cancer patent dispute

pharmafile | March 28, 2012 | News story | Research and Development, Sales and Marketing GSK, Genmab, Roche, ofatumumab, patents 

GlaxoSmithKline has settled a long-running patent dispute over its cancer treatment ofatumumab. 

The US patents, which relate to recombinant antibody production, were issued to Roche-owned Genentech and California-based medical research organisation City of Hope. 

No financial details have been disclosed, but the deal brings to an end a case brought by GSK, which has been pending before the US District Court for the Central District of California since October 2009. 

In a statement, GSK said: “The parties have entered into a settlement and licence agreement that gives GSK a licence under the Cabilly Patents for the manufacture, use, and sale of ofatumumab.” 

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Both patents are set to expire in December 2018.

Since 2006 GSK has partnered with Danish biotech company Genmab, which discovered the CD20 antibody, in marketing ofatumumab as Arzerra. 

Genmab says the settlement should not affect its financial guidance for 2012. Ofatumumab was its first marketed antibody since the company formed in 1999. 

Approved to treat chronic lymphocytic leukemia, Arzerra is still not approved by NICE despite GSK offering a patient access scheme.

Even with the discount, NICE ruled that it was too costly for an ‘uncertain benefit’.

The companies are pursuing other indications for ofatumumab in autoimmune diseases.

Their work includes developing a subcutaneous delivery of the drug to treat multiple sclerosis – and possibly rheumatoid arthritis – in a bid to make it more commercially viable and patient-friendly. 

Adam Hill 

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