Merck KGaA: Rebif Reformulation Could Boost Short-Term Sales

The EMEA has issued a positive opinion recommending marketing authorization of a new formulation of Rebif for the treatment of relapsing multiple sclerosis (MS). Although the improved formula is set to strengthen the company’s presence in the MS market in the near term, orally administered pipeline products with novel mechanisms of action represent a long-term threat to sales.

Rebif (interferon beta-1a), a disease modifying MS drug, has been shown to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity. Rebif achieved sales of over $1 billion in 2006 across the US and EU.

Data from a phase III study of the new formulation of Rebif demonstrated an improvement in tolerability and reduction in antibody formation at one year, compared with historical data. In particular, data showed that the incidence of injection-site reactions with the new formulation at 48 weeks was three times lower when compared with Rebif’s pivotal trials. The European Medicines Agency’s (EMEA) recommended approval of the new Rebif formulation will now be considered by the European commission, which will deliver the final decision on the granting of marketing authorization in the EU.

MS is an idiopathic inflammatory disease of the central nervous system, characterized pathologically by demylelination and subsequent axonal degeneration. Over 800,000 individuals across the US, Japan and five EU countries are estimated to suffer from MS. In 2006, the six approved disease-modifying drugs for MS yielded sales of $4.6 billion across the seven major markets.

Key unmet needs in the treatment of MS are improved disease modification and symptomatic efficacy and improved side-effect profile. In addition, according to key opinion leaders interviewed by Datamonitor, patient non-compliance is most likely to be attributed to side-effects that disrupt the course of daily-living such as flu-like symptoms and injection site reactions.

The reduction of injection site reactions and improvement in immunogenicity offered by the new Rebif reformulation will be a key advantage to MS patients and will be responsible for attracting a small number of patients currently on Avonex (interferon beta-1a, Biogen Idec), Betaseron (interferon beta-1b, Bayer Schering) and Copaxone (glatiramer acetate, Teva and Sanofi-Aventis).

As such, the new Rebif reformulation will strengthen Merck KGaA’s presence in the market in the near-term. However, the current MS pipeline contains several orally administered disease-modifying drugs with novel mechanisms of action which pose a long-term threat to Rebif revenues.