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Ofatumumab has reached only Phase 2 but here it is, a new drug that just might work.
From PubMed, January 24, 2014:QuoteNeurology. 2014 Jan 22.
Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: A phase 2 study
Sorensen PS, Lisby S, Grove R, Derosier F, Shackelford S, Havrdova E, Drulovic J, Filippi M.
Author information
From the Danish Multiple Sclerosis Center (P.S.S.), Rigshospitalet, Copenhagen; Genmab (S.L.), Copenhagen, Denmark; GlaxoSmithKline (R.G.), Uxbridge, Middlesex, UK; GlaxoSmithKline (F.D.), Research Triangle Park; GlaxoSmithKline (S.S.), Raleigh, NC; Charles University (E.H.), Prague, Czech Republic; School of Medicine University of Belgrade (J.D.), Serbia; and San Raffaele Scientific Institute and Vita-Salute San Raffaele University (M.F.), Milan, Italy.
OBJECTIVES:
We present the first study to explore safety and efficacy of the human CD20 monoclonal antibody ofatumumab in relapsing-remitting multiple sclerosis (RRMS).
METHODS:
In this randomized, double-blind, placebo-controlled study, patients received 2 ofatumumab infusions (100 mg, 300 mg, or 700 mg) or placebo 2 weeks apart. At week 24, patients received alternate treatment. Safety and efficacy were assessed.
RESULTS:
Thirty-eight patients were randomized (ofatumumab/placebo, n = 26; placebo/ofatumumab, n = 12) and analyzed; 36 completed the study. Two patients in the 300-mg group withdrew from the study because of adverse events. No unexpected safety signals emerged. Infusion-related reactions were common on the first infusion day but not observed on the second infusion day. None of the patients developed human anti-human antibodies. Ofatumumab was associated with profound selective reduction of B cells as measured by CD19+ expression. New brain MRI lesion activity was suppressed (>99%) in the first 24 weeks after ofatumumab administration (all doses), with statistically significant reductions (p < 0.001) favoring ofatumumab found in new T1 gadolinium-enhancing lesions, total enhancing T1 lesions, and new and/or enlarging T2 lesions.
CONCLUSIONS:
Ofatumumab (up to 700 mg) given 2 weeks apart was not associated with any unexpected safety concerns and was well tolerated in patients with RRMS. MRI data suggest a clinically meaningful effect of ofatumumab for all doses studied. Results warrant further exploration of ofatumumab in RRMS.
CLASSIFICATION OF EVIDENCE:
This study provides Class II evidence that in patients with RRMS, ofatumumab compared with placebo does not increase the number of serious adverse events and decreases the number of new MRI lesions.
PMID: 24453078
The abstract can be seen here. -
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From the New York Times, August 21, 2015:Quote
Novartis to Buy Multiple Sclerosis Drug From Glaxo
By AMIE TSANG and ANDREW POLLACK
Novartis bolstered its portfolio of multiple sclerosis treatments on Friday by agreeing to buy an experimental drug from GlaxoSmithKline for up to $1 billion, the company said.
Novartis, the Swiss pharmaceutical giant, acquired the rights this year to use the drug, ofatumumab, to treat cancer, and sells it under the name Arzerra. This was part of a broader swap of assets completed in March, in which Novartis took over Glaxo’s cancer drugs and Glaxo took on much of Novartis’s vaccine business.
The deal announced on Friday gives Novartis all remaining rights to ofatumumab, which is being developed to treat relapsing, remitting multiple sclerosis and other autoimmune conditions.
Having the rights under one ownership would avoid the complications that could arise from having two companies selling the same drug for different uses. The deal also bolsters a portfolio of drugs Novartis is developing for multiple sclerosis, centered around its blockbuster pill Gilenya.
Novartis will pay $300 million upfront to Glaxo and another $200 million once late-stage clinical trials start. Novartis would make payments of up to $534 million on top of that, depending on whether development targets are reached. The company will also pay royalties of up to 12 percent to Glaxo on any future net sales of the drug.
“Novartis is pleased to further reinforce our commitment to neuroscience and to add an exciting new treatment to our strong MS portfolio,” David Epstein, the division head of Novartis Pharmaceuticals, said in a news release.
In addition to Gilenya, Novartis sells a multiple sclerosis drug called Extavia and recently began marketing a generic version of Teva’s Copaxone, one of the most widely used drugs for the disease. It also has some other drugs in development. Gilenya could lose patent protection starting in 2019. So filling the loss could be another reason for Novartis to want a new drug.
But the market for multiple sclerosis drugs is crowded, which could limit the sales any new drug like ofatumumab could have. Moreover, ofatumumab is only now ready to enter late-stage clinical trials, putting it a couple of years behind ocrelizumab, a similar drug being developed by Roche.
Both drugs deplete B cells, which are white blood cells that are part of the immune system. B cells are necessary to fight infections, but if they go awry, they can contribute to autoimmune diseases like multiple sclerosis or to lymphomas. Both drugs bind to the same molecule on the surface of B cells — known as CD20 — as Roche’s big-selling cancer drug Rituxan. Rituxan is not approved for multiple sclerosis, but it is approved to treat rheumatoid arthritis, another autoimmune disease.
Ofatumumab, a type of protein called a monoclonal antibody, was developed initially by Genmab, a Danish biotechnology company, which receives royalties on sales.
David Redfern, the chief strategy officer at Glaxo, said in a news release that the sale would allow the company to focus on core areas, including H.I.V., oncology and vaccines.
“We are pleased to have completed this transaction to divest the remaining rights in ofatumumab, crystallizing significant additional value for G.S.K. shareholders,” Mr. Redfern said.
The deal is expected to be completed by the end of the year. -
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A couple of drug companies are competing with each other. It's Ocrevus against ofatumumab according to this press release from Reuters (August 29, 2019)--"Novartis Takes Aim at Roche's Star MS Drug":
https://reut.rs/2ZttMEj -
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An update on ofatumumab--from Nasdaq.com (January 21, 2020), "Novartis gets approval for MS drug Mayzent in Europe." (The article contains information about ofatumumab.)
https://www.nasdaq.com/articles/novartis-nvs-gets-approval-for-ms-drug-mayzent-in-europe-2020-01-21 -
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From the New England Journal of Medicine (August 6, 2020)--"Ofatumumab versus Teriflunomide in Multiple Sclerosis":
https://www.nejm.org/doi/full/10.1056/NEJMoa1917246?query=TOC
It might be worth noting that the study was funded by Novartis. -
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