Multiple sclerosis drugmakers are in a fix: These days, the U.S. market isn’t delivering the kind of growth that had been fueling big increases in sales.
For high-flying pills from Biogen (Tecfidera) and Novartis (Gilenya), that could mean an unwelcome comedown. It definitely means the coming market-share battle will grow even more competitive than before. If the quickest way to grow sales is to steal share, you can bet Tecfidera and Gilenya--and their up-and-coming rival med from Sanofi, Aubagio--will be working hard to do just that.
Thing is, Biogen isn’t on that sort of growth trajectory. It’s the market leader--with 51% share of the oral market and 20% of MS overall, as EVP Michel Vounatsos hastened to point out during the company’s earnings call with analysts last week. But Tecfidera’s 10% growth during the quarter largely depended on price increases, the company disclosed in a securities filing the next day.
Gilenya, on the other hand, grew by 15%, and in its earnings announcement, the Swiss drugmaker said that growth wasn’t based on price, but volume. That’s not to say Gilenya doesn’t have some troubling signs in its Q3 stats; pharma chief Paul Hudson said script numbers have been “broadly flat but a little bit down”--which suggests the overall market slowdown hasn’t been without its effect on Gilenya, too.
Neither Biogen nor Novartis plans to stick with the status quo. Biogen is grappling with Tecfidera’s gastrointestinal side effects, and various MS specialists are working on ways to manage that; 22% of Tecfidera patients quit because of GI issues, and keeping patients on therapy would obviously help sales.
The Tecfidera team is pilot-testing a new “engagement model” at top treatment centers, with plans to roll it out by January. “The team in the U.S. is all up and running,” Vounatsos said during the call. “I’m very pleased to see the perception improvement, and now we have to continue to execute.”
On the advertising side, Biogen recently backed off a TV campaign that had stirred up some controversy in the MS community, and the company said at the time that it didn’t plan more television in the immediate future, though it is running other DTC promos.
Novartis is running with its Hey MS, Take This! campaign for Gilenya, which launched in 2014 and has since won kudos--and made inroads--particularly with its digital and social media work. Besides print and web video, the campaign invites patients to “tell relapsing MS exactly where to go,” and many have, both on the campaign’s website and via social media. They’ve also shared what they do to manage their MS.
Novartis apparently believes that Gilenya DTC and salesforce work, coupled with a steady stream of new data, will keep the brand’s volume growing enough to avoid using price as a driver. The company has “some sensible plans” for growth, without “a big impact ... on price,” Hudson said during the Q3 call. “We are ... looking forward to the energy into Q4,” he said.
Meanwhile, the big leaper of the quarter was Aubagio, Sanofi’s slow-to-start entry in the class. Sales of that drug grew by almost 50% to 334 million euros during the quarter--and that was driven by growth in the U.S. Its 9-month revenue amounted to 928 million euros, a 57% hike. The French drugmaker quickly bragged that Aubagio is the “fastest-growing oral disease modifying therapy” in MS, with a U.S. share of 9%--far far below Tecfidera’s, but rising. This time last year, Sanofi was happy to report it had captured a 6% share.
What’s spurring Aubagio on? The company has been running a campaign with Revenge star Madeleine Stowe since late 2014, for one; the actor has been traveling across the U.S. doing awareness events. The Lights! Camera! Take Action! partnership most recently rolled out a series of “webisodes” featuring Stowe in interviews with MS patients--a common theme in awareness campaigns--but also with nurses, physical therapists and others with advice for MS patients and their caregivers.
The drug's brand website also has a share-your-story channel, and Sanofi has put other promo work under a tagline, "Aubagio quiets MS." The company has set out a goal of €2 billion in sales by 2020 for its entire franchise; if Aubagio and its fellow med Lemtrada keep delivering as they are, the company could actually hit that target sooner. "In MS, we continued to gain share, and sales from the franchise are now approaching €2 billion on an annualized basis," CEO Olivier Brandicourt said during the company's Q3 call.
Biogen’s Vounatsos may have summed it up for the entire oral market when he pledged to fight the good fight on Tecfidera last week. “The base of the market is certainly lower than what we have estimated in our assumptions, but it's not an excuse for not increasing share,” he said.
There’s a confounding factor, however: The group of oral treatments may get some unwanted rivals in a few years. Novartis could face earlier-than-expected Gilenya generics, thanks to some recent patent decisions. As early as 2019, in fact--and that would give these three meds just a few more years to divvy up share just among themselves. Add to that the payer pressure that's increasingly a problem, and the price-increase growth option looks even less likely.
Biogen’s Tecfidera, Amgen’s Enbrel tell a tale of pricing power and weakness
Novartis could snag a blockbuster MS market all for itself, just in time to fight Gilenya generics
Biogen's controversial Tecfidera ad is about to meet its end
Biogen sees new Tecfidera buzz as DTC, marketing push kicks in
Buoyed by rising tide of Aubagio scripts, Sanofi aims for €2B in MS sales
Early Gilenya generics now spell trouble for rival MS drugs