Insulin 300 performs well in phase III trials
- Sanofi presented data from Phase III trials at the American Diabetes Association annual meeting, highlighting insulin U300 insulin glargine 300 U/mL) as a “next-generation” basal insulin.
- Data showed fewer lower blood sugar events at any time of day, including nocturnal events, compared with Lantus. There were also fewer hypoglycemic events during the initial titration period.
- Lantus, also a Sanofi product, is facing product expiry in 2015 and is trying to introduce U300 ahead of generic competitors and companies with branded competitor products.
Lantus is a big winner for Sanofi, earning around $7 billion a year. Because it addresses type 1 and type 2 diabetes and can be used for adults and children, this basal insulin has been a go-to insulin for many diabetes clinicians. Although U300 is a reformulation of Lantus, it offers improved pharmacodynamic and pharmacokinetic properties, with an overall flatter profile. In phase III studies, U300 reduced hypoglycemic events at night by 21%.
Sanofi is trying to stay ahead of generic competitors, as well as branded competitors. Tresiba (degludec) from Novo Nordisk is in phase III trials and may compete with U300. It also boasts a flatter profile, with fewer hypoglycemic events. It also offers flexible dosing. However, in early 2013, the FDA requested additional safety data on Tresiba, which could delay its launch until possibly 2017 or later.
Sanofi is planning to incorporate a flexible dosing feature into U300, but it has another distinct advantage. It is possible for the company to design a more streamlined, slimmer version of its injection pen, because it has 300 units of insulin per milliliter (instead of 100). This increases the convenience factor, making U300 a solid contender to replace Lantus as a go-to favorite.
- Data Healthcare Monitor ADA 2013: Sanofi will maintain dominance with U300
- http://wallstcheatsheet.com/stocks/merck-aims-to-be-first-to-the-finish-line-with-generic-of-lantus. Merck aims to be first to the finish line with generic Lantus