Roche's ($RHHBY) much-hyped multiple sclerosis treatment ocrelizumab kept up its momentum with the release of detailed late-stage data, burnishing hopes the injected drug is a blockbuster in the making.
In a deeper look at previously disclosed Phase III trials, Roche said its investigational therapy, compared with placebo, reduced the risk of disability progression by 24% in patients with the particularly debilitating primary progressive form of MS. In a pair of identical trials comparing ocrelizumab to Merck KGaA's Rebif, Roche's therapy reduced relapses by about 46% over two years in patients with the more common relapsing form of MS. Each study met its primary endpoints.
The results further stoke expectations that Roche may have a multibillion-dollar product on its hands, poised to shake up the roughly $20 billion market for MS drugs.
Until now, no treatment in the history of MS has succeeded in a Phase III primary progressive trial, so if Roche can win approval in that indication, it will have at least temporary market exclusivity. And while there's already a wealth of approved therapies for the more common relapsing-remitting form of the disease, ocrelizumab's safety and efficacy profile could position it as a stronger alternative to oral drugs and a more tolerable option than other injectables.
As it stands, patients with milder MS are generally prescribed oral therapies like Biogen's ($BIIB) Tecfidera or Novartis' ($NVS) Gilenya, while more advanced cases get heavier intravenous therapies like Sanofi's ($SNY) Lemtrada or Biogen's Tysabri. But ocrelizumab's safety--on par with Rebif and placebo in its Phase III program--could change the paradigm in MS, cutting into the market share of both oral and injected therapies.
Now Roche is planning to file ocrelizumab for global approvals early next year, seeking a label that includes both forms of MS. If everything goes according to plan, the antibody treatment could be worth up to $7 billion a year, Bernstein analyst Tim Anderson said in a research note, assuming its success in primary progressive MS creates a "halo effect" that bolsters its reputation in the other form of disease.
Ocrelizumab began its development path as a Biogen-partnered arthritis therapy with blockbuster potential before serious safety issues derailed its Phase III program in 2010. Biogen exited the partnership and left Roche to go it alone in MS that same year, with the U.S. company hanging onto double-digit royalties on future stateside sales.
- read the statement (PDF)