Goal to integrate smart pen attachment (“Mallya”) into Sanofi’s Integrated Diabetes Care platform; Mallya expected to roll out in Europe this fall
France-based Biocorp announced that it has entered an “exclusive negotiation” with Sanofi to bring its Mallya smart pen attachment into Sanofi’s integrated diabetes care platform. According to the press release, Sanofi will give Biocorp an initial payment of €4 million (~$4.5 million) to support “related development activities.”
Biocorp’s Mallya device just received its CE Mark last month as a class IIb device, and is compatible with “all major pens” – more product details here. Mallya is expected to roll out this fall through commercial partners (just AgaMatrix at this point, though it seems that Sanofi may also distribute the devices). FDA submission Mallya is expected at the end of 2019 or in 1Q20.
For Sanofi, the partnership aligns with efforts to expand its digital health platform. We learned at ATTD 2019 that Sanofi is working internally on developing smart insulin pens, both prefilled (disposable) and durable, with connectivity built in to the body of the pen. In a conversation, Mr. Litman told us the pens would be launching “in the very next few years.” Sanofi has also invested in and is involved in a pilot with smart pen cap manufacturer Common Sensing. Sanofi’s intentions for Mallya are not entirely clear. It may be a near-term play until Sanofi’s proprietary devices are up and running, a long-term partnership to give Sanofi additional connectivity form factors for insulin pens, or possibly an acquisition target (Biocorp’s market cap is currently ~$60 million).
We aren’t sure how this “exclusive negotiation” with Sanofi affects Mallya’s marketing and distribution, or whether it will exclude Biocorp from working with the other two “Big Three” insulin companies (Novo Nordisk and Lilly). Results from the Swedish pilot of Novo Nordisk’s NFC-connected pen Novopen 6 were shown at ADA; it has already been CE-marked and was last scheduled for launch in Europe later this year. The company is also working on a reusable, Bluetooth pen attachment for disposable pens, expected to launch “later in 2019.” Lilly is expected to submit a connected pen to the FDA in 2019.
See our competitive landscape for more on smart insulin pen and cap advancements.
--by Albert Cai, Brian Levine, and Kelly Close