3. Ocrevus

Roche's Ocrevus, the first drug approved for both relapsing and primary progressive multiple sclerosis, smashed the blockbuster threshold in its first 12 months on the market. (Roche)

3. Ocrevus
Company: Roche
Disease: Multiple sclerosis
Approved: March 28, 2017
First four full quarters sales: CHF 1.35 billion ($1.38 billion)

Multiple sclerosis drug Ocrevus has been hailed as the most successful launch in Roche's history, earning blockbuster status in its first 12 months on the market.

The antibody drug came as a real disrupter to the already-competitive MS market. It’s the first drug approved both for relapsing MS and, more importantly, for harder-to-treat primary progressive MS. Other therapies before it, such as Biogen’s megablockbuster Tecfidera, are only cleared for more the common relapsing form.

Even with that breakthrough, though, Roche surprised the industry by pricing Ocrevus at a 25% discount to Merck KGaA’s Rebif—a drug it had beat in head-to-head clinical trials in relapsing MS—and an average 20% discount to other MS rivals.

Roche’s strategy paid off. By the end of its first 12 months on the market, Ocrevus had already nabbed a 7% share. In relapsing MS, about 70% of its scripts came from patients who had switched from other drugs.

Fast forward to 2019, and Ocrevus’ growth momentum continued strong despite some new entrants, such as Novartis’ Mayzent and Merck KGaA’s Mavenclad. The Roche med's sales jumped 57% to CHF 3.71 billion for the year; by December 31, it owned about 40% new-to-brand share in the U.S., and more than 150,000 people had been treated with the drug globally.

But it could soon face an in-class competitor in Novartis’ repurposed ofatumumab, currently an unsuccessful leukemia drug marketed under the brand name Arzerra. Both drugs are monoclonal antibodies to CD20, believed to play a part in the autoimmune attack on nerve cells in MS.

The Novartis drug recently topped Sanofi’s Aubagio at reducing relapse rates and slowing disability progression in relapsing forms of the disease. And physicians appear to like ofatumumab’s convenience of self-administration, while Ocrevus is given intravenously by a healthcare provider.

RELATED: Roche's COVID-19 hopeful Actemra soars amid pandemic as Lucentis, Ocrevus falter

Roche has been rolling out long-term data to pad Ocrevus’ case, most recently showing that starting treatment earlier in the disease course—specifically in relapsing MS—nearly halved the risk of needing a walking aid, as compared to switching from Rebif.

On the convenience front, Roche has applied to shorten the infusion time to 2 hours from the current 3.5 hours, a bid recently accepted for review by U.S. and EU regulators.

However, the CD20 mechanism has its shortcomings. By tampering with B cells key to humoral response, Ocrevus could lead to a weakened immune system. A Roche-sponsored phase 3b study previously linked Ocrevus treatment to weakened immune responses to several vaccines, including seasonal flu shots. Ocrevus’ label also includes descriptions about an increased risk of respiratory tract infections.

The COVID-19 pandemic only accentuates those concerns, as Ocrevus’ first-quarter 2020 sales growth slowed down. Some countries have suggested patients delay the drug rather than visit their healthcare providers for the IV treatment, though Roche’s pharma chief Bill Anderson said the company hasn’t seen any alarms.

3. Ocrevus