ADA 2013: Sanofi will maintain dominance with U300.
By Sebastian Heinzmann, Analyst
3 July 2013
I am an Analyst for cardiovascular and metabolic diseases at Datamonitor Healthcare, focusing primarily on the diabetes ...
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Sanofi’s Lantus has changed the insulin antidiabetics landscape dramatically, and the French big pharma now has an estimated 80% share of the long-acting basal analogs market. However, threats loom on the horizon. Lantus’s product patent is due to expire in 2014–15, opening up the market for biosimilar competition, and newer analogs such as Novo Nordisk’s Tresiba (insulin degludec) and Lilly’s LY2605541 will threaten Lantus’s pole position. Against this backdrop, the results presented for Sanofi’s new insulin glargine U300 will restore confidence in the company’s pipeline and indicate that it is equipped to face its competition head on.
Glargine U300 represents an improvement over Lantus
At this year’s American Diabetes Association meeting (ADA 2013), Sanofi presented positive Phase III results for its insulin glargine U300. While U300 contains the same active ingredient as Lantus, it has different pharmacokinetic (PK) and pharmacodynamic (PD) properties, giving U300 a flatter profile and a prolonged duration of action. This is an essential improvement, as an estimated 15–20% of type 1 diabetic patients are currently not well controlled on Lantus. Lantus has a relatively short half-life of around 12 hours, which can also be a problem for some type 2 diabetic patients who have to inject twice a day or use supplemental insulin to manage their blood glucose. In these cases, a prolonged duration of action would be highly desirable.
The results of the pivotal EDITION I study showed that U300 was non-inferior to Lantus. While both formulations showed similar reductions in glycated hemoglobin levels, U300 reduced nocturnal hypoglycemic episodes by 21%. This reduction is a significant feature, as Novo Nordisk’s competitor product Tresiba has lower nocturnal hypoglycemia rates compared to Lantus, and Novo Nordisk’s marketing for Tresiba focuses heavily on this advantage.
The answer to Tresiba
A basal insulin with a flatter profile and improved PK/PD properties is reminiscent of Novo Nordisk’s Tresiba, which has shown non-inferiority to Lantus, demonstrated lower nocturnal hypoglycemia rates, and can be dosed flexibly. ADA conference attendees picked up on the drugs’ similarities and questions arose as to whether Sanofi is also exploring a flexible dosing regimen with U300, something which Sanofi later confirmed. Indeed, Datamonitor Healthcare believes that Sanofi is exploring all possible avenues in order to demonstrate that U300 is a serious contender to ultra-long acting Tresiba.
In order to be able to challenge Tresiba – and to stay ahead of biosimilar competition – Sanofi needed to come up with a new, improved basal insulin product. Lacking a suitable pipeline candidate and wishing to shorten development times, Sanofi concentrated its efforts on reformulating insulin glargine. The new glargine derives its name from its concentration of 300 units of insulin per milliliter, compared to 100 units for Lantus, which also means that pen injection devices for the new insulin will be able to hold more insulin units in the same volume and thus last longer. Sanofi could also leverage U300’s higher insulin concentration and develop a slimmer, slicker version of its SoloStar pen injector.
Novo’s pain is Sanofi’s gain
The company will profit massively from the fact that Novo Nordisk’s ultra-long-acting Tresiba was rebuffed by the FDA earlier this year. The requirement for additional safety studies will delay Tresiba’s US market launch until 2018, giving Sanofi ample time to drive sales for U300. In addition to better PK/PD characteristics, Lantus brand familiarity and Sanofi’s strong marketing channels will boost U300 uptake. Furthermore, a large number of patients inadequately controlled on Lantus may be able to successfully manage their blood sugar levels with U300, and this will impact Tresiba’s commercial potential. The largest impact will be in the US, where Tresiba is predicted to launch nearly three years after U300.
Commenting on its pricing strategy for U300, Sanofi announced that although there would be a premium over Lantus, the new formulation should be accessible to a large patient population. Datamonitor Healthcare believes this to be an indicator that Sanofi will undercut Tresiba’s price significantly. Novo’s drug is currently sold at a 70% premium over Lantus in the UK. Such a large premium will severely hinder uptake and many EU reimbursement bodies will not look favorably upon such a high price. Sanofi’s pricing strategy therefore appears more suited to the current economic climate.
Datamonitor Healthcare believes that U300 will enable Sanofi to grow its basal insulins revenue. The development of U300 was crucial for Sanofi, given that Lantus’s patent expiry is imminent in 2014–15. The launch of U300 will also have a major impact on Novo Nordisk’s Tresiba. Sanofi’s U300 may ultimately not offer flexible dosing or possess as long a half-life as Tresiba, but it offers a prolonged duration of action and reduced nocturnal hypoglycemia rates. Most importantly, perhaps, with Tresiba’s launch in the US stalled, U300 will be a well-established treatment option before Tresiba can even reach this market.