UPDATED: Roche heralds PhIII successes for MS, but some tough rivals lie in wait

Roche heralded the late-stage success of two big trials for its multiple sclerosis drug ocrelizumab today, which they say puts them on a straight road to regulatory filings for the IV antibody drug in early 2016. But even under the best-case scenario for the future, the Big Pharma player will face a tough task squaring off against the new oral drugs that have been divvying up this big market recently.

Roche ($RHHBY) is holding back the data for now, but the pharma giant says that their drug beat out Rebif on both primary and secondary endpoints in their Opera I and Opera II studies. Investigators say the drug was better at reducing the rate of annualized relapses over two years while slowing the "progression of clinical disability" (essentially, the decline patients experience over time). And there were also fewer lesions found in the brains of patients taking the new drug.

Roche--which has one of the biggest R&D budgets in the business--needed the Phase III win. Analysts have begun to grow restive over the apparent lack of progress that the pharma giant has shown in the clinic recently and Roche CEO Severin Schwan has touted ocrelizumab's likely progress this year as cause for hope in seeing important new products coming out of the pipeline.

Dr. Sandra Horning, Roche's head of global product development

The late-stage data, though, will be crucial to Roche's success here, as Rebif is no longer the standard of care it once was. Patients have been moving over to pills in preference to injectables, with Biogen Idec's ($BIIB) blockbuster Tecfidera, Novartis' ($NVS) Gilenya and Sanofi's ($SNY) Aubagio chomping into Rebif's revenue stream. Roche will have to compete on price with a less convenient drug that is delivered by intravenous infusion twice a year, if it goes on to win an approval late next year or early in 2017. A third Phase III study will read out later in the year for primary progressive MS, which is much harder to treat than the more common relapsing/remitting form of the disease.

Barclay's Geoff Meacham quickly picked up on the potential, and pitfalls, that lie in wait for this drug.

"These efficacy/safety data, combined with a semi-annual dosing schedule, (by iv infusion) may offer ocrelizumab differentiated positioning in the MS marketplace, and we would argue will offer differentiation vs. other less intensive dosing regimens (i.e., Lemtrada)," he noted. "Against Biogen's core business, ocrelizumab could be a mid-term incremental headwind to further growth as we would expect it to take share from the dynamic portion of the market (e.g., switchers from the ABCRs, patients dissatisfied with the convenience of their current therapy)--though we note that patients looking for more convenient options than the traditional ABCRs have multiple products available today. Importantly, we would not expect these data to drive meaningful adoption from stable patients already on convenient, efficacious regimens (e.g., Tecfidera)."

After years in the clinic, Roche doesn't have much room to maneuver on the product. Roche's flagship experimental project remains its anti-PD-L1 program, which is looking to vault over market leaders Bristol-Myers Squibb ($BMY) and Merck ($MRK).  

"Ocrelizumab showed remarkable improvements over a standard-of-care medicine across clinical and imaging endpoints in two pivotal studies," said Dr. Sandra Horning, Roche's head of global product development. "Ocrelizumab has the potential to make a meaningful difference for people with MS, a chronic and debilitating disease. Based on these compelling results, we plan to submit the data for review to US and EU regulatory authorities in the first quarter of 2016."

- here's the release

Special Reports: Top women in biotech 2014 - Sandra Horning, Roche/Genentech | The top 10 best-selling multiple sclerosis drugs of 2013 - Rebif

Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.