Biogen Idec and Sanofi to face contrasting fortunes despite EU MS approvals...
By Daniel Chancellor, Lead Analyst
22 March 2013
I am a Lead Analyst covering the CNS and rare disease markets at Datamonitor Healthcare. I joined in early 2010, having ...
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On March 22, 2013, the EMA’s Committee for Medicinal Products for Human Use (CHMP) provided positive opinions on two new oral treatments for relapsing-remitting multiple sclerosis (RRMS), Tecfidera (dimethyl fumarate; Biogen Idec) and Aubagio (teriflunomide; Sanofi). Both drugs have been recommended for marketing authorization in the EU and can be expected to be commercially available during 2013.
After producing stellar Phase III data, Tecfidera – formerly known as BG-12 – has been hotly anticipated by the multiple sclerosis community. Biogen has demonstrated that Tecfidera can reduce the annualized risk of relapse (ARR) by 49% compared to placebo, surpassing the efficacies of current injectable first-line treatments. Tecfidera also has a robust effect on reducing disability progression and MRI activity. Combined with its benign side-effect profile – treatment can result in gastrointestinal effects and flushing, which typically resolve after 1 month – Tecfidera’s overall clinical profile is extremely encouraging.
Tecfidera’s twice-daily oral dosing makes it a more appealing option to patients than injectable interferon beta and Copaxone (glatiramer acetate; Teva), while it is clearly safer than other high-efficacy treatments such as Gilenya (fingolimod; Novartis) and Tysabri (natalizumab; Biogen Idec). As such, Biogen Idec has an exciting opportunity to grow Tecfidera into a future MS market leader. Its closest rival will be Gilenya, which has already achieved blockbuster status in just its second year on the market. However, Gilenya’s label is for second-line use in the EU; importantly, Biogen Idec will be able to market Tecfidera as a first-line treatment option. Outside of the EU, Tecfidera’s potential will be boosted by launch in the lucrative US market: the FDA is expected to approve the drug on March 28.
The CHMP’s recommendation of Aubagio in RRMS comes 6 months after its US approval. Aubagio treatment also has a significant effect on ARR reduction (31%) and disability progression relative to placebo, albeit less pronounced than that of Tecfidera. Nevertheless, Sanofi is positioning Aubagio as a well-tolerated oral treatment option and, crucially, has undercut the price of its competition in a bid to differentiate.
Sanofi’s attempts to match Aubagio’s encouraging early US sales data in the EU may be hampered by the CHMP’s decision not to consider teriflunomide as a new active substance (NAS). Teriflunomide is the major active metabolite of leflunomide, which is indicated for the treatment of rheumatoid arthritis. If Sanofi is unable to reverse the CHMP’s stance then it may not be entitled to a 10-year market exclusivity period for Aubagio as the product’s originator. This introduces the possibility of early generic competition in the EU market, where Sanofi currently has no patent protection. This worst-case scenario taints Aubagio’s approval and jeopardizes its commercial opportunity. However, Sanofi’s subsidiary Genzyme has already stated its intention to request a re-examination of the NAS designation.