Novartis sees brain-atrophy data as an edge for MS pill Gilenya

The multiple sclerosis market is a bit like a trendy nightclub: It's hot, and it's getting increasingly crowded. Interferons, other injectables, oral treatments--they're all available in multiple, with more on their way.

So, drugmakers are spending millions to study their MS offerings, looking for data that may help gain market share--and help protect the sales they already have. Witness Novartis ($NVS) and the data it's rolling out this week on Gilenya, its first-to-market oral treatment. Fresh off winning European backing for broader use--which could prompt more MS patients to switch to Gilenya--the pill's ability to protect patients' brains is at center stage at this week's American Academy of Neurology (AAN) meeting.

The number of AAN presentations focused on Gilenya runs into the dozens. But one clear focus is data showing the drug can cut the rate of brain-volume loss in MS patients. The brain lesions characteristic of the disease cause atrophy and tissue loss at rates three to 5 times faster than the rates in healthy people; in several studies presented at AAN, Gilenya put the brakes on that volume loss, said Gordon Francis, who heads up Novartis' Neuroinflammation Clinical Science Unit. And that's something that could give Gilenya an edge on competing treatments.

"Of the therapies available to date in the U.S., none has shown in Phase III that it can alter the rate of loss of brain volume relative to a comparison group," Francis told FiercePharma in an interview. "Gilenya can slow the rate of volume loss by one-third, either versus placebo or interferon. ... In comparison with Avonex, Gilenya patients also had a slower rate of volume loss."

Protecting the brain from atrophy is obviously important; losing brain tissue affects cognitive functions and physical abilities. In one study pitting Gilenya against placebo, 29% of patients on the Novartis drug saw their volume loss equal that in placebo patients. In people who don't suffer from MS, a loss of 0.2% of brain volume per year is at the low end of average, Francis said. In the study, 20% of MS patients on placebo lost brain volume at that rate, compared with 29% of Gilenya patients. "More patients taking Gilenya have a rate of brain volume loss consistent with healthy individuals," Francis said. 

And in another analysis of data from long-term extension studies, Gilenya continued to slow the rate of volume loss over time--not just in the first year or two in a placebo-controlled study. "Some of these studies have been going on for 7-8 years," Francis said. "We are finding that the slowing of brain volume loss at early stages of treatment are still present in later stages."

Thanks to other AAN studies, Novartis can also tout Gilenya's results in patients switched from competing meds. Study data showed that patients on injectable drugs--interferon treatments or Copaxone (glatiramer acetate), Teva's novel drug--saw their rate of relapses decline substantially, Francis said. So did the rate of increase in disability. Another study--in which researchers analyzed insurance claims data--showed that patients on interferon who switched to Gilenya fared better than did patients who switched from interferons to Copaxone. "Patients on Gilenya had a 60% reduction rate in relapse versus those on Copaxone," Francis said.

Of course, it helps with both patients and doctors that Gilenya is an oral treatment rather than an injectable. It's easier to take, so patients are more likely to stick to their dosing. For a couple of years, the Novartis drug was the only pill in the MS market. But now, it has two oral rivals: Sanofi's ($SNY) Aubagio and, most particularly, Biogen Idec's ($BIIB) Tecfidera, which has hit the market at a run. How can Gilenya compete? Francis points out that Tecfidera is taken twice daily, versus once a day for Gilenya; patients are more likely to miss doses on twice-daily meds, and missing doses causes drug levels in the body to drop. The two drugs have different side-effect profiles, and real-world use will show which drug is better tolerated, he said.

The brain-volume loss data comes in handy here, too: There are no head-to-head studies of the relative performance of the two drugs, so relapse rates and disability progression can't be compared, at least not reliably. But so far, only Gilenya has the brain-volume loss talking point. "It's a key distinguishing feature," Francis said of the reduction in brain atrophy. "Only Gilenya has demonstrated that."

Of course, Novartis isn't the only company rolling out data at AAN; Biogen has a variety of new studies on Tecfidera and on its prospective treatment, Plegridy. And Sanofi, whose Genzyme unit developed Lemtrada, actually has data showing that the drug slowed brain atrophy, too--even after treatment stopped. "[T]wo courses of treatment led to a meaningful change in the disease course that is long lasting," Genzyme's group VP for MS, Mike Panzara, told FierceBiotech of the AAN data. And the company's MS chief, Bill Sibold, said that the drug potentially "changes the long-term prognosis of a chronic disease. It's new and exciting."

Lemtrada is approved in the EU but not yet in the U.S.; the FDA was concerned about some serious side effects that cropped up in clinical trial patients. Sanofi is hoping that the new data will help its case when the FDA next reviews its Lemtrada app, scheduled for later this year.

- see the release from Novartis
- get the Sanofi release on Lemtrada

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