- Multiple sclerosis (MS) drugmakers may already be feeling the effects of Roche's recently greenlit, potentially game-changing therapy, as evidenced by sales from Biogen's first quarter.
- The big biotech described in its first quarter earnings call on Tuesday a slight cooling off of the MS market at the end last year that continued into the early months of 2017. Though CEO Michel Vounatsos said the decline was "nothing dramatic," he also hypothesized Ocrevus (ocrelizumab) might have played a roll in it through warehousing — when doctors hold off on prescribing current treatments in anticipation of a newer one slated for approval.
- Biogen co-developed Ocrevus, and will receive sales royalties as high as 24%. But those gains won't offset the losses, as Biogen expects the drug to take a bite out of revenues from its other products, including Tysabri (natalizumab) and even Tecfidera (dimethyl fumarate). On the flip side, the company's older interferon MS treatments appear safer from the competition.
Roche's hot, new drug Ocrevus could be a huge threat to the bottom lines of other MS drugmakers, and not just because it has proven more effective and safe in the clinic.
The drug outperformed Merck KGaA's Rebif (interferon beta-1a) as a therapy for patients with relapsing MS in two Phase 3 trials dubbed OPERA 1 and OPERA 2. It was also superior to placebo at fighting disease progression in a third late-stage trial, ORATORIO, in patients with primary progressive MS, a hard to treat form of the disease.
Follow-on analyses of those trials evaluated two composite endpoints — No Evidence of Disease Activity (NEDA) and No Evidence of Progression (NEP) — and found Ocrevus treatment led to a 75% higher proportion of relapsing MS patients reaching NEDA compared to Rebif and a 47% higher proportion of primary progressive MS patients reaching NEP compared to placebo.
What's more, Ocrevus had very few serious adverse events in these trials, which is a big bargaining chip given the safety risks of other drugs in the space. Biogen's Tysabri, for instance, was pulled from the market in 2005 after multiple people receiving the drug developed a rare and deadly brain disease called progressive multifocal leukoencephalopathy (regulators allowed the drug to return to market a year later, but under restricted use). In 2014, Biogen reported the first case of a patient developing the brain disease while taking Tecfidera.
Ocrevus also differentiates itself in that it's the first Food and Drug Administration approved medication for primary progressive MS — the most advanced form of the disease. With such success in the clinic, as well as a $65,000 a year price tag that falls below some other high-priced options, the drug stands to hamper bottom lines for Biogen's top MS performers.
"We think that Ocrevus plays in the high efficacy segment, and as a result the likelihood is that it impacts Tysabri vis a vie the products in our portfolio more than others," CEO Michel Vounatsos said during the call. 'There's a chance it impacts Tecfidera as well; we think that the platform therapies, inclusive of Avonex and Plegridy, are the least impacted."
Ocrevus regulates the immune system by binding to B-cells with the CD20 proteins on their surface. The mechanism is used by other MS and cancer therapies, including Novartis' Arzerra (ofatumumab) and Genentech and Biogen's Rituxan (rituximab), and is seen as both promising and lucrative.
Despite the added threat, Biogen reported a 3% increase in MS revenue during the first quarter from the same period in 2016. The number of patients with the disease taking Biogen's drugs also increased 5%, bolstered by increased demand for Tysabri, according to an earnings presentation.