Novartis has been given the green light in Europe to market Extavia, its branded version of Bayer's multiple sclerosis drug Betaseron.

The European Commission has approved Extavia (interferon beta-1b) for the treatment of early and relapsing forms of MS, the first in “a new portfolio of medicines”, says Novartis, that is planned to include “both established treatments and innovative therapies for patients with MS”. Extavia is the same drug as Betaseron/Betaferon, which has been on the market for 13 years and brought in 274 million euros (+12.3%) in the first quarter for the Leverkusen-based group.

The fact that Novartis can market its own version is the result of a deal completed last September between the Basel-based group and Bayer. Betaseron was manufactured first by Chiron through a 1993 agreement signed by Schering (now part of Bayer) and subsequently by Novartis which snapped up Chiron in 2006.

The agreement saw Novartis receive $200 million as a one-off boost to its coffers in return for the Betaseron manufacturing rights, as well as production equipment, stock and buildings leases at a site in California. Bayer also agreed to support the Swiss firm’s bid to get approval for its interferon beta-1b drug.

However Bayer is not overly concerned by the arrival of a new product and Klaus Martens, vice president of the global brand team for Betaferon told PharmaTimes World News that the firm will receive a double-digit royalty from Novartis to supply the drug from 2009. Speaking at Bayer’s recent launch in Copenhagen of a global awareness campaign called Mastering MS, Mr Martens noted that the arrival of Extavia will help grow the market.

Novartis says that marketing approval for Extavia is the first step in getting a foothold in the MS market ahead of its anticipated submission to regulators for its once-daily oral therapy FTY720 (fingolimod). The company noted that results of an ongoing Phase II study extension presented in April show sustained benefits in patients with relapsing MS after three years of treatment with FTY720 and 68-73% of patients in the study remained free from relapses after three years' continuous treatment.

Novartis plans to file for approval of fingolimod by the end of 2009 and says that a number of other compounds for treating MS are in early-stage development.