Ocrelizumab is the first drug in its class to show positive results in both the hard-to-treat form of the disease and the forms that often relapse. Analysts expect that the new drug would generate at least $5 billion in sales worldwide on an annual basis.
The number is a lot more than what analysts had previously predicted for 2020 – $720 million.
The drug maker’s CEO told reporters that the new drug was already set to bring high revenues when it was proven efficient in treating relapsing multiple sclerosis. Finding out in phase 3 trials that it can also successfully treat PPMS was just a bonus.
Roche announced that it is preparing papers to apply for approval in the U.S.A. The FDA expects to receive the application in early 2016. The new drug should hit the market at some point in 2017.
A Phase 3 study showed that ocrelizumab reined in the progression of multiple sclerosis in PPMS patients, and the effect lasted for at least three months. Moreover, the new drug showed almost no side effects just like the placebo did in the control group.
Yet, researchers are very cautious when they try to develop a drug for multiple sclerosis because the disease can develop real fast if the patient receives the wrong treatment. The disease is very debilitating since the patient’s own immune system attacks the outer layer of nervous cells, so a wrong drug could boost the immune response to new levels.
So far, multiple sclerosis drugs gather around $20 billion every year. About 85 percent of this sum is due to the relapse of the disease in former MS patients. The most common treatments are interferons from Merck, pills from Novartis and Biogen, and injections from Biogen and Sanofi.
But Roche Group has high expectations of the new drug and expects it to propel the company to a top position in the multiple sclerosis drug market. Its drug has another advantage – a patient will only need a couple of injections per year.
Experts expect the drug to be quite expensive because of its effectiveness, fewer side-effects, and high costs of production. Roche, which is world leader on cancer drugs market declined to provide an approximate price.
The study results following the Phase 3 clinical trial will be presented on Oct. 10 at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis.
Image Source: Roche