Facing generic rivals, Ipsen starts $66M Somatuline autoinjector project

Ipsen is investing 60 million euros ($66 million) in an electronic autoinjector for its blockbuster cancer drug Somatuline. Facing generic competition, the French drugmaker has partnered with Phillips-Medisize on a delivery device it expects to enable patients to administer the drug independently at home.

The threat of generic competition for Somatuline has loomed over Ipsen for years. European countries granted marketing authorizations to generics last year, although the initial impact was minimal and sales grew to 1.2 billion euros. Even so, with Cipla receiving FDA approval late last year, Ipsen expects a “gradual erosion” of sales of a product that has been a cornerstone of its business. 

Ipsen is seeking to differentiate its product from new generic rivals through drug delivery. Working with Phillips-Medisize, Ipsen is developing a motorized device that pairs a reusable electronic injector and disposable cartridge with a thinner injection needle. The goal is to enable controlled, sustained injection and empower caregivers and patients to administer Somatuline Autogel independently at home. 

The device is currently undergoing performance and safety studies, with a view to being in a position to start a site pain and device safety trial in the first half of next year. That planned clinical trial will gather patient-reported outcomes and satisfaction data. Ipsen plans to make details of the study available on ClinicalTrials.gov after finalizing the study centers in the second half of the year.

If everything goes to plan, the device will reach patients in 2024. That timeline gives generic companies a window in which to capture market share from Somatuline, but the limited impact of off-patent rivals so far suggests Ipsen will still be in the game when its new device launches. Ipsen is committing around 60 million euros to develop the device and invest in a manufacturing site.