The Opportunity That Wasn't
By Brian Orelli
March 9, 2010
Opportunistic infections aren't an opportunity for Roche and Biogen Idec (Nasdaq: BIIB). In fact, they have ocrelizumab, the follow-up to the companies' near-blockbuster Rituxan, on the ropes and headed for a TKO.
Yesterday, the companies said they're suspending development of ocrelizumab for rheumatoid arthritis because patients were coming down with opportunistic infections. These infections don't normally happen in healthy people, and some of them were fatal. The stoppage isn't a major surprise; Roche and Biogen had previously halted a trial in early stage rheumatoid arthritis, and another in lupus.
That's the problem with treating autoimmune diseases like rheumatoid arthritis and lupus, where the body is attacking itself. Drugs have to dial back the immune system enough to treat the disease, but not so much that the immune system can't fight infections like it's supposed to.
Ocrelizumab is also in development for multiple sclerosis. That line of research hasn't been terminated. Yet.
Multiple sclerosis is more severe than rheumatoid arthritis, so a higher level of side effects is often tolerated by regulators and doctors. For instance, Biogen and Elan's (NYSE: ELN) Tysabri is associated with a potentially fatal brain infection, Teva Pharmaceutical's (Nasdaq: TEVA) Copaxone has a warning about modifying the immune response, and both Rebif from EMD Serono and Pfizer (NYSE: PFE) and Novartis' (NYSE: NVS) Extavia are associated with liver toxicity or signals for it.
The side effects might be a reasonable risk for multiple sclerosis; it's hard to tell because the companies didn't quantify the rate of opportunistic infections. But lupus is also a pretty serious disease with limited treatment options. Besides Human Genome Sciences (Nasdaq: HGSI) and GlaxoSmithKline's (NYSE: GSK) Benlysta, there hasn't been a drug developed specifically for the disease in decades. If ocrelizumab's side effects are too severe for lupus, I'm guessing multiple sclerosis will be the next to see the ax.
That's just the way of life for drug development. Sometimes drugs bring opportunity; other times, opportunistic infections.
Dxed Jan 2006. Sx since 2002. Rebif since March 2006. "When one door closes, another opens but we often look so long and so regretfully upon the closed door that we do not see the one which has opened for us." Alexander Graham Bell