- In the second biologics approval of the day, Roche scored a green light for its multiple sclerosis drug Ocrevus (ocrelizumab) for the treatment of both relapsing and primary progressive forms of the disease.
- The Food and Drug Administration had delayed the approval of the drug in December after granting priority review for ocrelizumab in June 2016. The delay was reportedly tied to manufacturing issues — something that has plagued multiple biopharmas over the last year.
- Analysts expect Ocrevus will be a major market disrupter, and say it has the potential to bring in more than $4 billion annually by 2022. Roche plans to launch the drug in two weeks.
Amidst recent outcry that multiple sclerosis drug costs have been rising too much despite increased competition on the market, Roche opted to price its drug at an annual cost of $65,000. Without accounting for rebates and discounts, that figure represents a 20% discount to the average price of other MS meds, Roche said.
Beyond its broad label and lower price, Ocrevus also has an advantage of convenience — the drug is given as a 600mg infusion twice per year after two initial 300mg onramp doses. Meanwhile, the majority of drugs on the market are either pills or injectables that have to be taken sometimes once or even twice daily.
Most multiple sclerosis patients have the relapsing/remitting form of the disease, meaning they have an attack but then return to normal function afterwards. Eventually, virtually all of these patients will evolve and go into a state of constant decline, reaching the secondary progressive form of the disease.
Yet, there is a small subset of patients who do not have regular attacks, but instead show a long, steady decline. These are the primary progressive patients.
All forms of MS medication currently on the market are meant to treat the relapsing/remitting form of the disease, making Ocrevus the first medication approved to treat the rarer, primary progressive form.
Ocrevus was tested in two Phase 3 studies —OPERA 1 and OPERA 2 — that showed the drug drastically increased the time where patients didn’t show signs of disease activity (defined by no relapses, no confirmed disability progression, and no new or enlarging MRI lesions) compared with Merck KGaA’s blockbuster Rebif (interferon beta-1a). The drug reduced the annualized relapse rate by 50% compared with Rebif over two years.
Roche used a composite endpoint to measure disease control in its post-hoc analysis of a third Phase 3 trial, ORATORIO, among patients with primary progressive MS (PPMS), showing the drug bested placebo in this patient group. Ocrevus was able to reduce signs of the disease, including the spread of MRI lesions.
Ocrevus inhibits the CD20-positive B cells of the immune system and is closely related to Roche’s other blockbuster CD-20 inhibitor Rituxan (rituximab). The lymphoma treatment is often used off-label to treat MS and has a much cleaner safety profile than other MS treatments, according to Michael Racke, a neurologist at The Ohio State University Wexner Medical Center.
Racke, through his work at Wexner Medical Center worked on both the ORATORIO and OPERA studies testing Ocrevus. He noted in a call with BioPharma Dive that despite being similar, Rituxan did not show the same levels of efficacy in patients as Ocrevus. He attributed this to the patient population being slightly younger (and likely healthier) on average in the Ocrevus studies than those earlier studies testing Rituxan.
He also pointed to a much cleaner safety profile than that of other MS drugs on the market. Ocrevus showed virtually no serious adverse events in clinical studies. While a warning about the deadly brain disease PML is included in the Ocrevus label, no cases of the disease were seen in Ocrevus patients. PML has been a problem that has plagued other MS drugs.
"If this safety profile continues to hold up, it’s going to be a very highly used drug," said Racke.
The approval of Ocrevus sets Roche up to compete with some heavyweights in the MS space, including Biogen’s Tysabri (natalizumab) and Tecfidera (dimethyl fumarate), Novartis’ Gilenya (fingolimod), and Sanofi’s Lemtrada (alemtuzumab) and Aubagio (teriflunomide). Roche’s advantage is that it has both high-efficacy as well as a largely clean safety profile, whereas most of the competition in the MS space can only claim one of those.
Jefferies analyst Brian Abrahams expects Ocrevus to steal about a third of Tysabri's sales, but to hit Tecfidera to a lesser degree. He also pointed out in a note to investors that Biogen has a stake in Ocrevus and will receive a 13% to 24% royalty on U.S. sales of the drug from Roche.