Sanofi's multiple sclerosis pill Aubagio has been an also-ran behind established drugs like Teva's ($TEVA) Copaxone and newer drugs like Biogen's ($BIIB) Tecfidera. But the French drugmaker has not given up on it and today released data that might give it a new opening even as the MS market is shifting.
Sanofi ($SNY) and its biotech subsidiary Genzyme today reported that in a Phase III study, compared with a placebo, the pill significantly slowed brain volume loss over two years in people with relapsing multiple sclerosis (RMS). The slowing is important because the atrophy, which is seen in the earliest stages of the disease, leads to irreversible neurological and cognitive impairment, Sanofi said in a statement.
At the 12-month mark, the drug slowed the effects 36.9% more than placebo with a 14-mg dose and 34.4% with a 7-mg dose. After 24 months, the differences were 30.6% and 27.6% respectively. The company said that adverse effects, including nausea and alopecia, were about the same for those taking the drugs as for those that did not. It said it would present the data Saturday at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Spain.
Aubagio, approved by the FDA in October 2012, was never expected to do as well as Biogen's Tecfidera, which hit the market a bit later. Initial forecasts pegged Aubagio sales at $1.1 billion by 2017. While Tecfidera sales has blown past those of Aubagio, Sanofi has been able to steadily grow Aubagio revenues and might still reach those predictions. It pulled in revenue of €374 million ($420.2 million) in the first half of the year, up 84% from the same period in 2014. That compares to Tecfidera, which reaped $1.7 billion in H1 and Novartis' MS drug Gilenya, which generated $1.3 billion in H1.
Any sales growth is welcome for Sanofi's new CEO Olivier Brandicourt, who is having to deal with weakness in the drugmakers diabetes franchise, and who is working on a new 5-year plan to set up the French drugmaker for renewed growth.
There are some shifting winds in the MS space that might change the standings. Biogen has acknowledged that growth in Tecfidera sales have slowed after the FDA last fall required a label change for the rare brain infection progressive multifocal leukoencephalopathy, or PML. Teva's Copaxone has lost patent protection and now faces a flood of generics. A court ruling this week puts Gilenya at risk of losing patent protection in 2019. Generics for such popular drugs, however, can make it more difficult for competing branded drugs as well.
The MS remains pretty crowded, and a bunch of new drug are in trials that will mix things up some more. A report released today from Global Data predicts a compound annual growth rate of only 1.5% for MS meds in the major markets, which it said should reach $20 billion by 2024 from about $17.2 billion in 2014. It does expect growth to pick up after that as a flood of new drugs from Roche ($RHHBY), Celgene ($CELG) and one from partners AbbVie ($ABBV) and Biogen hit the market. The analysis firm expects many of the new drugs to be popular with patients because they will be oral meds and may not need to be taken as often as some already on the market.
Special Report: The top 10 best-selling multiple sclerosis drugs of 2013 - Aubagio