Following the announcement of positive Phase III data in June 2012, the FDA has granted approval of Aubagio for the oral treatment of relapsing multiple sclerosis (MS). Sanofi is competitively pricing Aubagio in the face of strong competition, but will nevertheless achieve only modest sales for the drug in the MS market.
Following its approval on September 12, Sanofi's Aubagio (teriflunomide) will represent the second oral therapy to enter the MS market, following the US launch of Gilenya (fingolimod; Novartis/Mitsubishi Tanabe Pharma) in October 2010.
FDA approval was based on the pivotal Phase III TEMSO (Teriflunomide Multiple Sclerosis Oral) trial. Data from the trial demonstrated that treatment with Aubagio 14mg significantly reduced both the annualized relapse rate and time to disability progression at two years versus placebo in patients with relapsing MS. However, the efficacy profile of Aubagio fails to match that of Gilenya, which has demonstrated an annual reduction in relapses of between 55% and 60%. Aubagio also failed to beat the injectable Rebif (interferon beta-1a; Merck & Co.) in a head-to-head study in reducing the rate of treatment failure. In apparent recognition of Aubagio's inability to compete clinically with Gilenya, Sanofi has priced the product at a discount to its rivals Gilenya, Avonex, and Copaxone in order to drive uptake.
Despite Aubagio's label carrying a black box warning regarding hepatotoxic and teratogenic risks, the drug's safety profile appears to be its main advantage over competitors. Gilenya carries the risk of cardiovascular effects for which patients need to be monitored when initiating treatment. Therefore, it will not be necessary for neurologists to monitor patients on Aubagio as thoroughly as they would those on Gilenya or Tysabri (natalizumab; Biogen Idec), thereby conferring Sanofi's drug with an important competitive edge.
On account of the drug's favorable tolerability, Datamonitor expects Sanofi to position Aubagio as an adjunctive therapy. This represents a favorable strategy for Sanofi since a daily oral add-on treatment which further reduces MRI activity will also be well received by patients and will lead to significant revenue.
The French pharma giant is seeking to establish itself as a key player in the MS market. It is currently seeking approval for a second MS treatment, the injectable Lemtrada (alemtuzumab), to which Datamonitor expects Sanofi to position Aubagio as an adjunct.
Although Datamonitor believes that Aubagio will provide an important treatment option for patients due to its convenient oral route of administration and favorable safety profile, the product will face strong competition from Gilenya and BG-12, an oral therapy for MS expected to launch in the US in Q1 2013. As such, Datamonitor forecasts Aubagio to achieve modest sales of $353m across the US and five major EU markets (France, Germany, Italy, Spain, and the UK) by 2020.