Roche to Distribute Long-Term CGM System from SenseonicsRoche to Distribute Long-Term CGM System from Senseonics

Senseonics, a relatively new entrant to the diabetes industry, has signed an exclusive distribution deal with Roche for its Eversense Continuous Glucose Monitoring (CGM) System. The agreement gives Roche, a well-known diabetes player, the right to market and sell the Eversense CGM in Germany, Italy, and the Netherlands.

The announcement comes just a couple weeks after Senseonics announced CE Mark approval for Eversense. The system consists of a long-term wear sensor, which is implanted subcutaneously and can be worn for up to 90 days, a transmitter, and a mobile app. 

"We are pleased to have Roche as our partner, and our distribution agreement represents an important step to enable expanded market access to our product," Tim Goodnow, PhD, CEO and president of Senseonics, said in a press release. He added, "Together with Roche's market presence, and extensive sales and support network, we aim to deliver a truly innovative continuous, long-term glucose monitoring solution to millions of people with diabetes."

In a May 25 research note about the distribution agreement, BTIG analyst Sean Lavin wrote, "This is a big win for the company, as Roche has an established diabetes care division and international presence which will make the launch of the recently CE Marked Eversense stronger in our opinion."

When Senseonics announced the CE Mark approval, Goodnow also noted that commercialization would begin in Sweden with a distributor partner, Rubin Medical. Rubin Medical is the system's exclusive distributor for Sweden, Norway, and Denmark.

On the company's May earnings call, the first after going public in March, Goodnow said that the company plans to file an amendment to the CE Mark approval to double the life of the implantable sensor to 180 days. The company will support this request with data from its PRECISE European trial which included 180-day use of the sensor. "Once approved [this] will further enhance the convenience and freedom that our technology offers to patients as they will then only require two sensors per year," he said, according to a transcript of the call.

Senseonics is also aiming to reach the United States market, with an anticipated PMA submission by the end of 2016 with an expected FDA review time of 12 months. The U.S. pivotal trial completed enrollment at the end of March and the 90-day followup should be reached in July, Goodnow explained on the earnings call.

[Images courtesy of XEDOS4/FREEDIGITALPHOTOS.NET and SENSEONICS]