Technology is propelling enormous change across the pharmaceutical market. Limitations of current multiple sclerosis therapies in tackling aggressive progressive forms of the illness are hopefully going to be overcome.
This bodes well for market growth overall, and is something that is demonstrated by newcomer drugs that have already affected market conditions. Further innovations will only fuel investors’ involvement in a market with everything to play for.
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system. It has no permanent cure. Products are marketed as disease-modifying therapies (DMT) aimed at reducing the frequency with which patients relapse and at slowing the progression of disability.
There are 4 main types of MS that can be divided into two groups, ‘relapsing’ and ‘non-relapsing’. The most common MS diagnosis is relapsing-remitting (RRMS). Given the 16 registered products on the market for RRMS and the slower progression of symptoms, sufferers can live a long life, though their mobility is likely to be affected by the disease.
A more severe form of MS, secondary progressive (SPMS), can be either ‘active’, which follows a similar relapsing-remitting pattern to RRMS and is typically treated with the same drugs, or ‘non-active’, which does not follow the relapsing pattern, with symptoms advancing more steadily. In these non-active (non-relapsing) cases, SPMS resembles the even more severe primary progressive (PPMS) form, in which symptoms advance more steadily.
For non-relapsing cases, that is to say PPMS and non-active SPMS, there is a considerable lack of available treatment options, and therefore, a high unmet need.
All current MS medications can also only be used for limited therapeutic durations as a result of their immunosuppressive side-effects. As such, there is a further need for newly discovered therapies that can be used in longer cycles of treatment so that MS patients are not required to change their medications so often.
A considerable demand
A new study has confirmed that nearly one million people are living with MS in the United States alone. This is more than twice the original estimate from an earlier study.
According to Fortune Business Insight, the global MS Therapeutics market is growing at a rate of 6.7%. The launch of novel therapeutics is a key factor that could accelerate market growth over the next 5 to 6 years. The average cost of treatment has been rising significantly over the last decade. Patients can expect treatment to cost around $60,000 per year.
The MS population is understood to be divided into two halves, one patients with relapsing MS and the other those with non-relapsing MS. Within the relapsing half of the patient population, there are 40% living with RRMS and 10% living with active SPMS. In the non-relapsing half, 35% suffer from non-active SPMS and 15% from PPMS.
For relapsing courses of the disease there are around 15 registered drugs, which are also being applied in active SPMS cases.
However, there is only 1 registered drug for non-relapsing courses – specifically targeting PPMS. Next to this only treatment dedicated to PPMS patients, there are currently only two drugs (Mayzent – siponimod, and Ocrevus – ocrelizumab) for those with non-active/non-relapsing SPMS. Evidently, while the market of available drugs for relapsing courses of the disease is crowded and products experience stiff generic competition, there is scope for significant disruption within the non-relapsing market.
In the United States and Europe combined, there are around 500,000 sufferers of non-relapsing courses of MS, and around 490,000 sufferers of relapsing courses. These markets are both worth around $30 billion: but there are almost no products for one half of these patients.
New possibilities in a changing market
Several players are presently trialing new therapies. There have been some recent successes in the medical field regarding treatments that add to the existing market of drugs for relapsing courses of MS.
Janssen Pharmaceuticals’ head-to-head phase 3 trial, saw ponesimod reportedly compared favourably against Aubagio in the treatment of patients with relapsing MS. The company has not yet revealed the data for its S1P5 modulator, but it is moving ahead with application for FDA approval.
In a phase 3 trial, Celgene’s ozanimod (RPC1063) was well tolerated and produced a significantly lower rate of relapses than intramuscular interferon beta-1a. The incidence of adverse events as a result of treatment by both drugs were similar.
Novartis disclosed details of robust phase 3 findings for the anti-body and repurposed cancer therapy, ofatumumab. The data suggests that the drug outperforms Sanofi’s Aubagio by about 50%. If approved, it will become the first B-cell therapy that can be maintained with a monthly self-administered injection at home – the kind of convenience that could drive sales success.
There have also been exciting developments in the non-relapsing market, where an impact in available products will be felt most.
French pharmaceutical AB Science is trialing masitinib, a tyrosine kinase inhibitor with broad applications for inflammatory diseases, neurodegenerative diseases, and oncology. The compound is currently being tested for its effectiveness in non-relapsing MS cases in a phase 3 trial for sufferers of PPMS.
The company recently posted results of its phase 3 ALS trial, showing promising signs. And masitinib also met the interim success parameters in a phase 3 trial testing its effectiveness against Alzheimer’s disease. Final results for this are expected soon.
The industry is also anticipating the results this year of the phase 3 trial of MedDay Pharma’s biotin treatment, MD1003. In phase 2, trialing demonstrated that the treatment could slow or stop disease symptom progression in some PPMS sufferers.
Accord Healthcare’s simvastatin is also in a phase three study for treatment of non-relapsing MS. While results are not expected until 2023, phase 2 showed promising signs of potency against SPMS. Simvastatin is believed to have the potential to effectively treat both active/relapsing and non-active/non-relapsing courses of SPMS.
Additionally, Biocad is concluding its phase 3 trial of BCD-054 for RRMS patients, for which results are expected in the first half 2020. And TG Therapeutics is trialing ublituximab in a phase 3 long-term safety study for RRMS sufferers. Results for this are expected in 2023. Both could add further competition and options to the relapsing MS market.
