GSK licences RA drug
pharmafile | June 5, 2013 | News story | Research and Development, Sales and Marketing | GSK, RA, morphosys
GlaxoSmithKline is gambling millions of euros on an investigational drug in a bid to get an edge in the fight against rheumatoid arthritis (RA).
GSK has signed a global licence agreement with MorphoSys, a German biotech company specialising in human antibodies, to develop MOR103, an anti-inflammatory which has finished Phase I/II development in mild to moderate RA.
MorphoSys hailed the deal as a ‘major milestone’ – small wonder since it is receiving €22.5 million up front from GSK and could be in line for up to another €423 million plus tiered, double-digit royalties on net sales.
The firm has – or has had – partnerships with a variety of big pharma firms, including Novartis, Bayer and Roche.
“We hope this alliance will result in a significant return on investment for the MOR103 programme and to become a major value driver for MorphoSys,” said chief executive Simon Moroney, who founded the German company near Munich in 1992.
Current RA blockbusters are Abbott’s Humira, Pfizer’s Enbrel and Janssen’s Remicade, all of which are injections or infusions.
“The pre-clinical and clinical data we have generated show that MOR103 has the potential to offer new treatment options for RA,” said MorphoSys chief development officer Arndt Schottelius. “We also believe that this molecule has potential in other indications as well.”
MOR103 targets GM-CSF (granulocyte macrophage-colony stimulating factor), which has diverse functions in the immune system and is therefore a possibility for targeting in a variety of anti-inflammatory conditions.
What has captured GSK’s interest is the news last year that in a Phase Ib/IIa trial in RA, MOR103 became the first anti-GM-CSF antibody to demonstrate clinical efficacy – meanwhile a Phase I study in healthy volunteers showed that its subcutaneous administration was safe and well tolerated.
MorphoSys is now looking at MOR103 in a Phase Ib trial in multiple sclerosis.
RA is an area in which pharma companies are showing a lot of interest: AbbVie and Galapagos recently signed a worldwide licence agreement to develop and commercialise JAK inhibitor GLPG0634 in RA – and potentially other inflammatory diseases – after Phase IIb.
But it is also an area in which many programmes fall on stony ground. In December AstraZeneca and Lilly both suffered setbacks in their attempts to push their respective investigational RA treatments forward.
AstraZeneca’s oral drug fostamatinib failed to prove non-inferority in its Phase IIb trial against Humira – a major blow since it is the first oral SYK (spleen tyrosine kinase) inhibitor in development as a novel therapeutic approach for RA.
It was thought to reversibly block signalling in multiple cell types involved in inflammation and tissue degradation in the disease but its DAS28 score – a composite endpoint assessing signs and symptoms of RA – was disappointing.
Lilly decided to stop one of its three Phase III studies of tabalumab, an anti-BAFF monoclonal antibody, in RA as it is not effective enough.
Adam Hill
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