5 Dec 2002
The EMEA has approved a room temperature formulation of Schering AG's MS drug Betaferon.
EU approval for room temperature Betaferon will provide European patients with a more convenient treatment option. Schering is expected to launch the product, already available in the US, early in 2003. Its launch will increase the opportunity for Betaferon to boost market share, and help defend against rival drugs from Serono and Teva.
Schering AG has announced that the European Medical Evaluation Agency (EMEA) has approved its room temperature injectable formulation of Betaferon (interferon beta-1b) for the treatment of MS.
Betaferon is the first and only MS treatment that can be stored at room temperature (up to 25 degrees Celsius) for up to three months. Approved by the FDA in January 2002 and launched in the US in May, the formulation has proved popular with MS patients - providing them with a convenient option when traveling or not at home. The approval of Betaferon in the EU is expected to provide patients throughout Europe with similar options, improving compliance, retention and length of treatment.
It is estimated that 782,000 people suffer from MS in the seven major markets. In the EU, Betaferon is currently approved for the treatment of relapsing-remitting MS, in addition to secondary progressive MS. It is the only drug to have gained approval for this additional indication.
The global MS market is currently dominated by four drugs: Betaferon, Biogen's Avonex (interferon beta 1a), Serono's Rebif (interferon beta-1a) and Teva's Copaxone (glatiramer acetate). Avonex is currently the market leader, with 2001 sales of $972 million and around 39% of the market share. However, recent head-to-head studies have shown that Rebif and Betaferon both have better efficacy than Avonex, and as consequence this has affected Avonex's growth rate, which is now the lowest of all four drugs.
Betaferon had 2001 sales of $681 million, with 28% market share although
Q3 sales in 2002 have shown relatively low growth compared to Rebif and
Copaxone. The new formulation should help boost market share and sales
growth rates and fight off competition from its rapidly encroaching competitors
in the short term.
© 2002, DataMonitor