Exton, Pennsylvania, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Despite outward appearances of being a stagnant market, the relapsing remitting multiple sclerosis (RMS) market continues to offer drug developers opportunities to break in – if their new assets offer what neurologists and patients seek.
There have been eight (8) disease-modifying therapies (DMTs) FDA- approved since 2017; some high efficacy oral products have not met forecast expectations; and it appears some manufacturers are scaling back budgets for MS marketing. What will it take for a pipeline product to succeed?
According to Spherix Global Insights’ ongoing RealTime Dynamix™: Multiple Sclerosis (US) report series, MS specialists and neurologists have widely adopted a “high efficacy first” treatment approach, a significant practice change over the last few years that should guide positioning for any new product. The most recent report (n=102 US based neurologists) shows that what motivates neurologists’ prescribing is efficacy in both minimizing relapses and delaying disability progression. Other drivers of brand choice from the past, such as patient support services, do not appear to be major considerations of first therapy choice today. Spherix’s data shows that the anti-CD20 class of B-cell depleting monoclonal antibodies (mABs; e.g., Ocrevus from Genentech and Kesimpta from Novartis) are rated by neurologists as best minimizing relapses and disease progression. With this efficacy advantage, the anti-CD20 class - which now includes Briumvi from TG Therapeutics – is the only RMS treatment category projected by neurologists to grow in the next 6-months.
Beyond understanding evolving treatment patterns and challenges, the RealTime Dynamix™ study also evaluated neurologists’ expectations for products in development. Knowing that prescribing attitudes and preferences change over time, study results suggest that the following brand positionings may be a successful way to break into the crowded RMS market.
1. Proven Efficacy + Dosing/Administration Advantage
Any new DMT will need to prove it is at least as effective as the anti-CD20 class of mABs. But if several treatments of the future demonstrate equivalently-high efficacy, other benefits will grow in differentiating value, such as administration advantages. As an example, Briumvi was the third-to-market anti-CD20 launched in 2023, six years after Ocrevus. Despite launching with a more limited sales force than its peers, TG Therapeutics touted Briumvi’s well-known anti-CD20 mechanism and some administration advantages, and Briumvi is now projected by Spherix’s network of neurologists to grow more in the next 6-months than any other RMS therapy.
2. Outstanding Risk-Benefit Profile
A new market entry could succeed by demonstrating an excellent risk-benefit profile. The anti-CD20 mABs greatly outperform the high efficacy orals (and other RMS therapy classes as well) on this measure in Spherix’s tracking data, indicating neurologists’ safety perceptions for anti-CD20s are proportionally positive to their efficacy expectations. However, Spherix’s measurement of brand loyalty suggests Ocrevus and Kesimpta are not juggernauts among neurologists, signaling available ‘white space’ for new products to enter the market and demonstrate a strong balance of safety and efficacy.
3. Comparable RMS Efficacy + Efficacy in PPMS or SPMS
Although relapsing forms of MS make up 60% of MS patients, survey data indicate that neurologists see the greatest unmet need in effectively managing primary progressive MS (PPMS) and secondary progressive MS (SPMS, active or not-active). Findings indicate that seven in ten PPMS, and only six in ten not-active SPMS patients, are treated with a DMT because most available therapies have not been shown to be effective in these MS subtypes (Ocrevus being the exception). A new therapy gaining a PPMS or SPMS indication is projected to have significant market success.
Launch Success
With a new mechanism of action, will the forthcoming Bruton tyrosine kinase (BTK) inhibitors be able to successfully gain share in this crowded RMS market? Our surveyed neurologists believe so. Overall familiarity with this new mechanism has increased quarter over quarter. Sanofi’s tolebrutinib and EMD Serono’s evobrutinib were both rated as “highly likely to be prescribed” by the majority of sampled neurologists. Note, a subcutaneous formulation of Ocrevus, potentially due for approval in early 2024, will also be interesting to watch to see if its purported convenience advantage over its infused formulation moves the needle. Spherix will be monitoring this as part of its Launch Dynamix™ series.
Breaking into the RMS market will certainly not be easy, so deep market insights will be key along with outstanding clinical data.
About RealTime Dynamix™
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly (US) or semiannual (EU) reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.
About Launch Dynamix™
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
About Spherix Global Insights
Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company’s unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.
A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.
To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter.
NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement by any company, brand, or product aforementioned.
