Early Gilenya generics now spell trouble for rival MS drugs

Last week, the U.S. Patent Trial and Appeal Board took a long-term Gilenya patent out of commission, putting the Novartis ($NVS) multiple sclerosis drug in line for early generic competition.

That's not good news for the Swiss drugmaker, of course. But it's not good for rival pharma companies, either. They'll also have to contend with copycat versions of Gilenya, the first oral treatment for MS.

"Without novel IP, Gilenya will go generic in 2019 with multiple entrants," Bernstein analyst Ronny Gal predicted in a Monday investor note. And that means generic erosion across the MS category after 2019, he figures.

Generic Gilenya would join knockoff versions of Teva's ($TEVA) blockbuster MS treatment Copaxone, and together, the two would put pressure on the rest of the treatments for the disease. Though Copaxone is an injectable, it's a mainstay of MS treatment, even in the face of competition from pills like Biogen's ($BIIB) Tecfidera and Sanofi's ($SNY) Aubagio, in addition to Gilenya.

With both Gilenya and Copaxone copies available, those rival meds will be in trouble, Gal says. "[B]y 2019, with both Copaxone and Gilenya generics, I suspect the MS will reasonably lose pricing power and the generics will be used first line," the analyst told FiercePharma.

Gilenya is a big drug for Novartis, with $2.5 billion in 2014 sales and $700 million during the second quarter of 2015. With U.S. payers increasingly aggressive about pushing copycat alternatives to branded meds, Gilenya could see its sales plummet with 2019 generics--particularly when, as Gal notes, several different generics makers put out their own versions.

Likewise for Tecfidera, which delivered $1.7 billion for Biogen so far this year. Prescription growth for the drug has been slowing already, with Tecfidera sales falling short of expectations in both Q1 and Q2; second quarter sales of $883 million were up just 26% year over year. The trend for Q3 doesn't look much better, if at all, analysts say. A generic form of Gilenya would put further pricing pressure on Biogen at best--and could potentially take a big bite out of sales. Aubagio, already a market-share also-ran in the oral MS category, could have an even tougher time.

So, Biogen and Sanofi could well be hoping for Novartis to fight the PTAB's decision in court. The board's ruling--which invalidated Gilenya's 2026 formulation patent--came in response to two separate challenges by generics makers, via a new patent-fighting process known as inter partes review. Novartis could ask for judicial review of that decision, and the company says it's considering its legal options.

Meanwhile, Novartis is in court defending its 2019 Gilenya patent, which was extended by the U.S. Patent and Trademark Office in 2014. Multiple generics makers have challenged that patent, but as Gal sees it, Novartis is likely to prevail in those cases.

There is something of a silver lining to this story for Novartis. The company's Sandoz unit sells a knockoff version of Copaxone, named Glatopa, so that product could benefit from a rush to MS generics. So far, less-than-desirable reimbursement has limited the product's penetration to about 20%, though analysts see the product eventually grabbing 50% of the market.

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