Based on projections, Teva Pharmaceutical's Copaxone (glatiramer acetate) will exceed 30 percent of total sales for MS drugs in 2012. Copaxone sales were $3.6 billion in 2011. At least 80 clinical trials have included Copaxone.
Glatiramir acetate is FDA-approved for reducing the frequency of relapses in patients with relapsing-remitting MS (RRMS). It is also approved for patients that have experienced an initial clinical episode, or clinically isolated syndrome, and whose MRI results are consistent with multiple sclerosis.
Avonex (interferon beta-1a) by Biogen Idec is expected to hold its number two sales slot, owning 20.8 percent of the market. Sales of Avonex reached $2.9 billion in 2011. Avonex has been on the market since 1995 and has been subject to at least 70 clinical trials. It is FDA approved for the treatment of relapsing MS and for people who have experienced a first attack who have lesions consistent with MS but do not currently meet all criteria for an MS diagnosis. Avonex is administered once weekly as an intramuscular injection into the thigh.
Rebif (interferon beta-1a) for relapsing MS is predicted to hold 15.3 percent of the MS drug market in 2012, with sales increasing from its 2011 sales of nearly $2.4 billion. At least 70 clinical trials have included Rebif. Rebif is marketed by EMD Serono and Pfizer. EMD Serono is the biopharmaceutical division of Merck KgaA. Rebif is similar in formulation as Avonex (also interferon beta-1a), but is administered at a higher dose. Rebif is given three times a week. In 1996, Rebif was shown in a head-to-head study to be more efficacious than Avonex in reducing the frequency of MS relapses, and was granted an exception to an exclusivity rule of the Orphan Drug Act by the FDA that had granted Biogen 7-year market exclusivity for Avonex. Rebif is delivered in pre-filled syringes via an automatic injection device (Rebiject II).
Betaseron (interferon beta-1b) by Bayer Healthcare could own 10.1 percent of the MS market in 2012. Betaseron sales were $1.6 billion in 2011, down from $1.7 billion in 2009. Betaseron has been subject to more than 70 clinical trials. Betaseron is for the treatment of relapsing forms of MS and progressive-relapsing MS (PRMS). The FDA also approved Betaseron for patients that have experienced one MS episode, but have not currently meet all criteria for MS. Betaseron was the first disease modifying therapy for MS approved by the FDA and came on the market in 1993.
Tysabri (natalizumab) by Biogen Idec and Elan Pharmaceuticals is predicted to own 6 percent of the 2011 MS market. Tysabri sales in 2011 were about $1.5 billion. At least 50 clinical trials have included Tysabri. Tysabri is approved for the treatment of relapsing MS in patients who do not benefit from or cannot tolerate other treatments. It is administered once a month by infusion, generally in an infusion center, doctors office, or increasingly, in a patient's home through a specialty pharmacy. Tysabri was approved in December 2004, then voluntary pulled from the market by Biogen Idec and Elan in February 2005 after two incidents of serious adverse events. In June 2006, the FDA re-approved Tysabri for use in MS with the requirement that all prescribers, infusion centers, and patients undergo education on safe use of the drug and that patients be closely monitored.