Sanofi-aventis announced that ClikSTAR, a new reusable insulin pen, for administration of the 24-hour insulin analog Lantus (insulin glargine [rDNA] injection) or/and the rapid acting insulin analog Apidra (insulin glulisine [rDNA origin] injection), will be available in Europe and Canada in October 2009. ClikSTAR recently received regulatory approval in EU and Canada.

ClikSTAR was designed to provide the state-of-the-art performances of the SoloSTAR pen, in a reusable form.

"Easy-to-use pens such as ClikSTAR bring high degree of flexibility and comfort to patients and may offer an opportunity for earlier initiation of insulin therapy. This may contribute to better glycaemic control," said Professor Alfred Penfornis, Head of the Endocrinology and Diabetology Service, Besançon, "ClikSTAR is the result of over four years of intensive development and testing of pens, designed in close collaboration with patients and conceived to fulfil patients' needs," explained Jean-Philippe Santoni, senior vice president, Industrial Development and Innovation, sanofi-aventis. "The ClikSTAR delivery system is precise, easy to use and reliable, addressing both patients' expectations and medical Sanofi-aventis, the developer, manufacturer and marketer of ClikSTAR, is currently building a significant manufacturing capability to support the worldwide launch.

ClikSTAR will be launched in Canada, Greece, the Netherlands, and Switzerland, in October 2009. With the introduction of ClikSTAR in addition to SoloSTAR, sanofi-aventis offers now a full range of devices to simplify usage of insulin for patients, by better addressing their different needs and lifestyles.

ClikSTAR is currently being reviewed by the US Food and Drug Administration (FDA).

ClikSTAR is the new easy to use reusable pen for administration of Lantus and Apidra and all other sanofi-aventis insulins. ClikSTAR has been designed with the help of nearly 2,000 patients and 500 healthcare professionals and comes in two colours. Its usage is easy to learn for patients of all ages with an easy cartridge changing and a low injection force.

ClikSTAR allows to administer doses from 1 up to 80 units, in one injection, in one unit increments, with the possibility to dial back at any time.

The results of a study comparing ClikSTAR to other pens will be presented during the 2009 Wold Diabetes Congress in Montreal.

SoloSTAR is an easy-to-use disposable pen for administration of Lantus and Apidra. SoloSTAR allows to administer doses from 1 up to 80 units, in one unit increments, in one injection. SoloSTAR offers a 33 per cent greater maximum capacity than other disposable insulin pens, up to 80 units of insulin in one injection.

Lantus is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia and for adult and paediatric patients (6 years and older) with type 1 diabetes mellitus. Lantus demonstrates a peakless and sustained concentration/time profile over 24h thus reducing the risk of hypoglycemia and allowing a constant and high efficacy over 24h with one single daily injection. Lantus is the number one prescribed insulin worldwide. Once prandial insulin is required, Apidra is the logical partner to Lantus.

Apidra is rapid-acting insulin analog with a unique zinc-free molecular structure that maintains a rapid onset and a short duration of action, indicated for adults, adolescents and children with diabetes. Apidra offers patients mealtime dosing flexibility - it can be taken shortly (0-15 min) before or soon after the meal. Apidra is also flexible for use in a wide range of patients from lean to obese.