Novartis’ multiple sclerosis pill Gilenya may soon be in trouble on the generics front. But the Swiss drugmaker has another MS product in the works that it thinks could break the billion-dollar sales mark.
Following the release of positive data for experimental med siponimod Saturday at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting, the company told Bloomberg it may have a blockbuster on its hands.
The reason? Siponimod cut the risk of disease progression by 21% in patients with secondary progressive multiple sclerosis (SPMS)--a “highly disabling” form of the disease for which there are currently no approved treatments.
“This population hasn’t had an effective therapy,” Novartis Chief Medical Officer Dr. Vas Narasimhan told the news service. “For the first time, we have a medicine that can slow the progression of this disease in a proportion of these patients, so we view it as a significant breakthrough.”
Considering the population’s lack of options, Novartis is hoping regulators may speed up its wannabe’s path to approval, Narasimhan said--“but we still have to have those conversations first,” he noted. The pharma company is planning to talk with regulators over the next four to 6 months to determine whether they’ll require another study for approval.
Industry watchers weren’t necessarily expecting much from siponimod, as Gilenya--which targets the same group of protein molecules siponimod does--has in the past failed to show a significant benefit in primary progressive MS.
But now that results suggest the med could become a key treatment for SPMS, siponimod may be able to step in just in time for the Basel-based company. Just under a year ago, the U.S. Patent Trial and Appeal Board knocked off a long-term Gilenya patent, setting up Novartis’ blockbuster pill for earlier-than-expected generic competition. Analysts expect copycat rivals to arrive in full force in 2019.
Meanwhile, Novartis isn’t the only drugmaker trying to tap into an untreated patient pool within the MS space. Crosstown rival Roche is readying Ocrevus, a candidate for primary progressive multiple sclerosis. That drug, also known as ocrelizumab, topped placebo at stymieing disease activity, a new analysis found last week. The prospect is set to shake up the relapsing MS space, too; the Roche med also beat out Merck KGaA standard Rebif on the same measure.
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