Novartis MS drug, Gilenya, is the first to be approved in pill form. Further, in clinical trials it reduced relapses by more than 50% compared to Biogen Idec's Avonex. Gilenya (fingolimod) does come with a Risk Evaluation and Management Strategy (REMS), but no "black box" warning. All of this adds up to Gilenya being a very formidable competitor in the MS market to challenge Biogen Idec Avonex and Tysabri.
There are more than 400,000 MS patients in the US and more than 2.1 M worldwide. The Pill is expected to achieve sales of more than $1 B annually - definition of a blockbuster these days - and analysts expect sales greater than $2.4 B by 2019 in 7 major markets. Although, some enthusiastic analysts have forecast peak sales to reach $3.5 B annually.
Meanwhile, back in its Boston headquarters, Biogen, which is in late-stage development of its own MS pill called BG-12, was quick to issue a statement this morning to acknowledge Novartis’s drug approval. Yet the Biogen statement noted that the “long-term safety profile of Gilenya has yet to be established.”
Biogen is expecting to have data from a Phase III trial of its own oral multiple sclerosis drug in the middle of next year. The company now sells the injected MS treatments interferon beta (Avonex) and natalizumab (Tysabri), and those drugs accounted for 70 percent of the firm’s $1.2 billion in revenue for the second quarter of 2010. See Xconomy for more.
We'll also give the final word (for now) on the subject to Fierce Biotech.
Posted by Bruce Lehr September 22nd 2010.