Companies plan to develop drug-device combinations and deliver care management services to people with the condition


Sanofi and Medtronic have entered into a diabetes-focused global alliance to develop drug-device combinations and deliver services designed to improve adherence, simplify insulin treatment, and help people with the condition better manage their health.

The value of the alliance was not disclosed, with the companies saying the alliance remains subject to negotiation and execution of a definitive agreement.

Sanofi and Medtronic did say that the alliance will combine Medtronic’s expertise in insulin pumps and continuous glucose monitoring with Sanofi’s extensive insulin portfolio and drug development expertise.

Sanofi’s products include the blockbuster Lantus®, among the world’s best-selling drugs with 2013 sales of about $7.75 billion (€5.715 billion), but which is set to lose patent protection next year.

One of the priorities of the alliance will be to deliver new drug-device combinations, including new form factors that the companies said will be affordable, convenient and easy to-use, in order to increase therapy adherence and deliver better outcomes. These efforts will focus on improving the management of Type 2 diabetes, especially for people who cannot achieve glucose control even with multiple daily injections of insulin.

The other collaboration priority will be care management services, to be delivered through a program designed to guide people with Type 2 diabetes who are failing to achieve disease control on oral therapies through the initiation phase of insulin treatment.

Based on the success of the two initial priorities, Sanofi and Medtronic said, they may explore other areas for potential collaboration. The alliance will be structured as an open-innovation model, designed to draw upon the capabilities, as well as the human and financial resources, of both companies.

Sanofi and Medtronic have already agreed to serve specific Type 1 diabetes patients in Europe with an implantable insulin delivery system. The companies said they intend to add this project and additional innovative projects to the alliance.

“Through this important collaboration, Sanofi will tap into technology advances that aim to create holistic treatment solutions which take into account the individual patient’s needs,” Pascale Witz, Sanofi’s evp of global divisions & strategic development, said in a statement.

Omar Ishrak, Medtronic’s chairman and CEO, Medtronic, said the medical device giant was committed to “expanding beyond our core strength in Type 1 diabetes, to co-develop an array of technologies and patient services that will deliver superior clinical outcomes at an affordable price.

With Lantus set to lose patent protection, Sanofi and rival biopharmas are scrambling to bring new diabetes drugs to market.

Yesterday at the 74th American Diabetes Association (ADA) Scientific Sessions in San Francisco, Sanofi trumpeted positive results from three Phase III trials for a potential successor to Lantus, its insulin candidate Toujeo. Sanofi said the rate ratio (per participant-year) of night-time low blood sugar events in patients with type 2 diabetes was reduced by 31% for Toujeo compared with Lantus over the 6-month study period, according to a post-hoc pooled analysis of results from the EDITION I, II, and III trials.

Also at ADA on Saturday, Eli Lilly and Boehringer Ingelheim (BI) presented positive Phase I and Phase III results for their biosimilar version of Lantus Lilly and BI said that LY2963016 was found to be as safe and as effective as its reference product in six clinical trials.

However, Sanofi has alleged that four Lantus® patents were infringed by Lilly in the biosimilar. In January, Sanofi sued Lilly in U.S. District Court for the District of Delaware, an action that effectively scuttled Lilly’s plan to market the biosimilar next year, and delayed its entry to market until at least 2016.