Copaxone is an immunomodulator composed of four amino acids found in myelin basic protein, believed to act by modifying immune processes in the pathogenesis of MS. It was the third disease-modifying MS drug to be available in the US, following its April 1997 launch. Copaxone was subsequently launched across the EU from 2000, where Sanofi shared co-promotion rights with Teva. However, as of February 2012, Teva re-assumed full marketing responsibilities for Copaxone. Takeda possesses marketing rights to Copaxone in Japan, where it has been available commercially from November 2015.
Teva has attempted to extend and improve upon Copaxone through reformulating the drug into a higher 40mg dose, which can be dosed three times weekly, compared to the daily 20mg dose. This formulation was approved by the US Food and Drug Administration in January 2014, and the company has now introduced the higher dose in other markets.
LIST OF FIGURES 8 Figure 1: Copaxone for multiple sclerosis – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary for Copaxone in multiple sclerosis
10 Figure 3: Datamonitor Healthcare’s drug assessment summary for Copaxone in multiple sclerosis
12 Figure 4: Copaxone sales for multiple sclerosis across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES 5 Table 1: Copaxone drug profile
6 Table 2: Copaxone pivotal trial data in multiple sclerosis
13 Table 3: Copaxone sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
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