Memorandum

Sanofi’s Toujeo (insulin glargine U300) launched in the US – March 31, 2015

Sanofi has confirmed on its patient and provider web pages for Toujeo (insulin glargine U300) that its new basal insulin has been launched in in the US, around a month after its FDA approval and slightly ahead of the already ambitious previous guidance for a launch in 2Q15. We were extremely pleased to learn that Toujeo will be priced at per-unit parity with Lantus (insulin glargine U100). This is remarkable for a new product launch, although there are a few mitigating factors: (i) in the three phase 3 EDITION studies, type 2 diabetes patients on Toujeo required 11%-15% more insulin units than patients on Lantus needed to achieve comparable A1c reductions; (ii) insulin prices are already quite high, drawing the ire of clinicians we have heard at recent conferences; and (iii) we knew from Sanofi’s forecast for flat diabetes sales in 2015 that Sanofi is choosing, relatively, to preserve access over pricing (despite all the foregoing factors, it would not have been surprising to see the new insulin priced higher on a per unit basis). The Toujeo product page contains a detailed injection guide for using the next-gen SoloStar pen for Toujeo. Notably, there is a new program involving Toujeo COACH patient support program, available free to any patient holding a Toujeo prescription, that provides live one-on-one phone calls with a COACH guide, online resources, tips via text message, and even CDE-led in-person sessions (!). We see this as a valuable way to leverage educators looking to play a greater role in the increasingly value-focused US healthcare system, as well as a great way to differentiate a product that some see as having meaningful but likely not, for most patients, game-changing clinical benefits vs. Lantus. A Savings Card allows patients with commercial insurance (but not Medicare/Medicaid/VA patients) to pay no more than $15 per prescription for the next 12 months. Toujeo is likely to receive a positive EU regulatory decision in the next month or two; BI/Lilly’s biosimilar insulin glargine will launch in Europe in mid-2015; Novo Nordisk recently resubmitted Tresiba (insulin degludec) to the FDA. This is a complicated market for sure and we look forward to watching this roll-out; though some pundits have proclaimed the new insulin won’t do well commercially, we see no reason why a patient new to basal insulin wouldn’t go on it right at the present time, versus Lantus – longer term when cheaper insulin (by how much?) is available, it will be interesting to see how the new one is perceived. We continue to await, of course, the real product of note, Lixi-Lan – we mean, of course, Lixi-Toujeo, which doesn’t have the same ring, but which may well turn out to be patients’ first injectable some years out, along with IDegLira. Exciting times – we hear, of course, the concern about insulin pricing by the way although point out that were insulin approved today and sold for $200+/vial – the pricing would be seen as comical given its life-saving benefits (especially compared to Hep C and cancer drugs). While we care a lot about access, we also care about R&D dollars and making sure there are commercial markets that thrive that ensure new products can be created and launched and that eventually become generic.