A SoloStar pen incorporating the French company's 24-hour basal insulin Lantus (insulin glargine) will make its worldwide debut in Germany next month, with an ease of use that will make it a potent competitor against rival products, according to Sanofi.
SoloStar pens for administering Lantus and Sanofi-Aventis' fast-acting prandial insulin Apidra (insulin glulisine) were approved by the European Commission last September.
With Germany as a springboard, the company plans to launch SoloStar into the French market in May and across Europe within 12 months.
The US Food and Drug Administration's review of an approval application for Apidra SoloStar is "ongoing" and launches in international markets will follow, said Anna Radjanova, spokesperson for Sanofi.
The new product's heightened sensitivity to a combination of user needs should differentiate it from other disposable insulin devices such as Eli Lilly's Humulin/Humalog pen and Novo Nordisk's FlexPen, Sanofi believes.
The strategy for SoloStar, which was developed in-house and will be manufactured at a dedicated facility on the Hoechst industrial park in Frankfurt, was to retain the best features of existing pen devices while addressing unmet or unsatisfied needs.
These included simplicity of use, injection force (the amount of pressure needed to inject insulin with a pen), the dial extension (how far the pen extends when a dose is dialled), robustness, the maximum dose deliverable in one injection, and the patient's ability to distinguish between different types of insulin carried in the same pen.
With input from people with diabetes, doctors and nurses, ergonomic tests were run to establish which features would best improve usability.
In particular, Sanofi is highlighting the efficiency of SoloStar's drive mechanism, which in comparative tests reduced the necessary injection force by anything from 30% to 50% against FlexPen and the Humulin/Humalog pen.
In the latter case, this compensated for the markedly shorter dial extension of the Lilly product (11.2mm for a 60-unit dose versus 25.5mm for SoloStar and 33mm for FlexPen).
The injection force and dial extension are important considerations given that up to 58% of people with diabetes have limited joint mobility of the hand and significantly weakened grip strength, often as a result of connective tissue disorders or diabetic neuropathy, Sanofi.
Other key SoloStar features include a dose range of up to 80 units, adjustable in single-unit steps - the highest of any disposable insulin pen, its manufacturer says.
SoloStar is also the only disposable insulin pen whose body colour identifies the specific insulin used (grey for Lantus, blue for Apidra).
This should aid compliance for, say, patients with Type I diabetes or Type II diabetes with a significant beta-cell deficit who are managed through intensive therapy with a basal insulin plus pre-meal rapid-acting insulin.
Many of these patients will need to inject insulin five to seven times a day, Sanofi pointed out.
The company believes SoloStar will be an attractive proposition for first-time insulin users who are making the often difficult transition from oral therapy.
Radjanova would not be drawn on pricing strategy, saying it would depend on the market.
But the competitive positioning, she commented, would be "easy to use, easy to inject and easy to teach."
As Sanofi observed, pens now account for some 56% of all insulin units delivered worldwide, with a volume share of 94% in Japan and 86% in Europe.
The exception is the US, where the vial and syringe method predominates and pens account for only around 14% of all units delivered.
Within that relatively small segment, however, disposable pens hold a volume share of roughly 73%, while in Europe they make up a more modest 46% of all pen deliveries.