Novartis and Multiple Sclerosis: A Major Commitment

Implications: Extavia, Novartis' brand of  interferon beta 1b, has been approved for the  treatment of multiple sclerosis by the European Union.  With FTY72, Fingolimod, Novartis has the eye on filing NDA by the end of 2009.  While essentially identical to Bayer's Betaferon interferon beta 1b, and similar to EMD Serono's Rebif and Biogen's Avonex, Extavia does not offer a new therapy to MS patients, simply a new face.  With this launch, Novartis presumably hopes to work closer to key opinion leaders in multiple sclerosis, allowing an accelerated launch of Fingolimod.     

Analysis: Extavia offers little new for MS patients, as interferon has been in the marketplace for over 14 years, however it marks the key entry of another large pharmaceutical company to the club of companies with an approved MS therapy.  Joining Bayer (Betaseron/Betaferon), EMD Serono (Rebif, Novantrone), Biogen (Avonex, Tysabri) and TEVA (Copaxone), Novartis takes its mark with Extavia, made from acquisition of Ciron's clone used to make the original Betaseron, interferon beta 1b.  Courting key opinion leaders in emerging therapeutic areas has changed since Pharma guidelines have been in place.  With several oral therapies expected to come on line in 2010-2012, additional parenteral monoclonals and biosimilars, I interpret Extavia to be Novartis marking its ground with key opinion leaders, to gain experience in sales in this area, and perhaps more importantly smartly laying groundwork for a successful launch of Fingolimod into an emerging and increasingly competitive multibillion dollar marketplace.