With Biosimilar Competition Looming, Roche Takes a Hit with Failure of High-Dose Ocrevus

Roche, the Swiss pharmaceutical giant, is facing a significant setback as the company strives to maintain its market share with Ocrevus, a leading treatment for multiple sclerosis (MS). With patent protection on Ocrevus set to expire by the end of this decade, Roche was exploring a high-dose version of the drug as a potential solution to extend its market exclusivity. However, a recent phase 3 trial of this high-dose formulation has delivered disappointing results, casting doubt on the drug’s future.

Trial Results: A Disappointing Outcome

The phase 3 study focused on high-dose intravenous formulations of Ocrevus, specifically 1,200 mg and 1,800 mg doses, compared to the approved 600 mg dose administered every 24 weeks. Roche announced that the trial failed to meet its primary endpoint, which was to demonstrate additional benefits in slowing disease progression over at least 120 weeks of treatment.

The primary endpoint evaluated the time to the first onset of a 12-week composite disability progression, incorporating various measures including the time required to complete a 25-foot walk test and a nine-hole peg test. Levi Garraway, M.D., Ph.D., the chief medical officer of Roche’s subsidiary Genentech, noted in a release, “These findings reaffirm that the current Ocrevus IV 600 mg is optimally dosed to significantly slow disability progression.” Roche has indicated that further data from this trial will be presented at an upcoming medical conference.

Market Implications for Roche

Roche’s failure to demonstrate the benefits of a high-dose formulation is particularly impactful against the backdrop of increasing competition in the MS treatment landscape. With the success of Ocrevus, generating sales of approximately 7.6 billion Swiss francs (around $8.1 billion) last year, the company had high hopes that a high-dose version could secure its intellectual property rights further.

In early 2023, Theresa Graham, CEO of Roche Pharmaceuticals, expressed optimism regarding the potential of a high-dose formulation to enhance the company’s IP rights. She stated, “Should high dose be positive and we begin to look at putting it into devices, I think there is definitely some opportunity for expanded IP.” Here, “devices” refer to Roche’s previous success regarding a new formulation of Ocrevus, which can be administered biannually via a subcutaneous injection instead of an infusion.

Rising Competition from Novartis

Roche’s challenges are compounded by the rise of competitors, particularly Novartis and its drug Kesimpta, which has rapidly gained traction in the market. Kesimpta, administered as a monthly subcutaneous shot that can be taken at home, achieved sales of $3.2 billion last year, marking a staggering 49% increase. In contrast, Ocrevus’s growth has slowed significantly, experiencing only a 6% year-over-year gain.

Amidst this competitive landscape, Roche needs to strategize on how best to defend its leading position in the MS market, especially with biosimilar competition looming as patent protections expire. The failure of the high-dose Ocrevus trial underscores the urgency for Roche to explore other avenues for innovation and differentiation.

The Road Ahead for Roche

As Roche navigates through these setbacks, the pharmaceutical company faces the critical task of assessing how to maintain its competitive edge amidst a rapidly changing industry. Future strategies may include focusing on other formulations, enhancing patient convenience with delivery methods, or further investments in research and development to remain at the forefront of MS treatment options.

Ultimately, Roche still has opportunities to cultivate its Ocrevus franchise. However, the company must act swiftly and strategically to fortify its position, as the pharmaceutical landscape will likely continue to evolve with the introduction of new competitors and technologies in the coming years.

As Roche aims to maintain its leadership in the MS market while facing the dual challenges of patent expiration and increasing competition, its pursuit of innovative solutions will be pivotal for its long-term success.