Roche has declared it expects to become the biggest rheumatology company in the world by 2012, with MabThera marking its first entry into the burgeoning rheumatoid arthritis market after winning approval in North America and recently Europe for use in treating the 30% of adults with severe active disease who have failed on therapy with anti-TNF drugs such as Wyeth and Amgen’s big-seller Enbrel (etanercept).

MabThera is already a multi-billion dollar drug, having first been launched to treat non-Hodgkin’s lymphoma, and now this new indication set to expand its potential significantly, with a European roll-out kicking off this week in UK, to be shortly followed by Germany. But Roche does not intend to sit pretty, with a number of agents stacking up in its pipeline designed to boost its profile in this area.

As well as investing heavily in making MabThera available for early-stage disease – an indication it expects to launch onto the market in 2008 – the Swiss firm is currently evaluating the interleukin-12 inhibitor tocilizumab in Phase III clinical trials, with a launch slated for early 2009, while coming up behind that is the MabThera follow-up ocrelizumab. This is a fully-humanised anti-CD20 antibody, while MabThera is part human and part mouse, which mean it may have broader application in conditions such as lupus erythematosus and multiple sclerosis. Currently in Phase II/III, a spokesperson for Roche told PharmaTimes World News it hopes to market this offering in 2012 along with an oral mitogen activated protein-38 kinase inhibitor that acts to lower TNF-alpha, which is in Phase II development along with two other compounds it’s also investigating for RA. There are more in earlier stage research, which will come to the market through to 2020.

But the competition is intense. Having been barren until the introduction of the TNF-inhibitors in the late 1990s, the world’s biggest pharmaceutical companies are now falling over themselves to develop novel compounds in this therapy area. Also in late-stage trials is certolizumab (CDP870) from UCB Pharma and Pfizer, as well as Lymphostat-B (belimumab) from Human Genome Sciences. Meanwhile, not far behind is AZD9056 from GlaxoSmithKline and AstraZeneca, Humax IL-15 from Amgen, CCR2 from Pfizer and Incyte, and HuZAF (fontolizumab) from PDL and Biogen Idec.