While new multiple sclerosis drugs from Novartis, Merck KGaA and Biogen have hit the market this year, all bearing blockbuster hopes, one group of doctors wasn't all that interested in them.
Instead, a repurposed therapy not yet approved for MS attracted “unanimous excitement,” an analyst said.
Recent MS drug entrants—Novartis’ Mayzent, Merck’s Mavenclad and Biogen’s Vumerity—only have “distinctions without differences” from existing products, five MS physicians told SVB Leerink analyst Geoffrey Porges’ team.
“The comments suggest that these new products are likely to gain only limited share, and will not justify a significant price premium over future generic versions of the category pioneers,” Porges said in a Friday note to clients.
Surprisingly, Novartis cancer drug Arzerra (ofatumumab), being repurposed and yet unapproved for multiple sclerosis, is well received across the board. The physicians argue it offers Roche’s “‘Ocrevus-like’ efficacy, with the convenience of self-administration,” according to SVB Leerink.
Approved by the FDA in late March for the treatment of relapsing forms of MS, including active secondary progressive MS and relapsing remitting MS, Mayzent’s potential might reach $1.30 billion in 2024 sales, according to an earlier Evaluate Pharma projection.
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Since its launch, Novartis keeps rolling out new Mayzent data in the hopes of backing its blockbuster case. It showed Mayzent can improve a patient’s cognitive processing speed and can delay wheelchair use by more than four years versus placebo.
Nonetheless, the five physicians viewed the drug as only slightly better than Novartis’ own older MS pill Gilenya “based on its improved (but not totally removed) cardiac toxicity profile,” Porges noted, adding that Mayzent appears to have more complicated drug-drug interactions than Gilenya.
And Mayzent is the better received among the three drugs the doctors discussed. For Mavenclad and Biogen’s Tecfidera follow-up drug Vumerity, physicians expressed very little interest.
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Vumerity is billed as a better-tolerated version of its predecessor, with signs of improved gastrointestinal side effects. However, the physicians “broadly dismissed” the drug’s potential as a replacement for Tecfidera, Porges said, “suggesting that the actual rate of gastrointestinal tolerability issues with Tecfidera was very low (particularly after the first week or two).”
To make it worse, as Biogen’s Tecfidera patent is being challenged by Mylan, the doctors are even more reluctant to adopt the new drug when a generic could be priced at only a fraction of the new brand's cost.
That same sentiment holds true for their preference for generic Gilenya over Mayzent, even though such copycats are now temporarily barred from launching amid a legal battle.
When Merck KGaA's Mavenclad scored its FDA nod on the heels of Mayzent, Bernstein analyst Wimal Kapadia noted that the oral drug boasts a convenience advantage, with a dosing schedule of two cycles one month apart in the first and second year.
As Kapadia noted, the only drug that seems comparable to Mavenclad’s dosing is Roche’s Ocrevus, which requires only one infusion every six months after the initial two.
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However, the five physicians suggested that “they would use the medicine in effectively none of their patients,” Porges said. That result might highlight Merck KGaA’s low presence in the U.S. MS community.
According to Porges, the 3 products the group preferred are Ocrevus, Tecfidera and Sanofi’s Aubagio. In primary progressive MS, which accounts for the smallest MS subpopulation, the physicians said more than half of their patients are already on fast-growing Ocrevus.
They also rank Ocrevus as the preferred drug for SPMS, a population Mayzent and Mavenclad are both chasing.
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The real surprise came from Arzerra, though. At the recent European Committee for Treatment and Research in Multiple Sclerosis annual meeting, Novartis showed the drug—a once-monthly self-administered injection—could cut relapse rates in RMS patients by more than half compared with Aubagio.
It also cut the risk of disabilities progressing by about a third and was better at suppressing brain lesions and inflammation.
“Four of five of the physicians were already very familiar with [Arzerra],” Porges noted, “and thought that over time 50% or more of their practices may be switched to ofatumumab based on its dosing schedule.”