Memorandum

Biocorp Receives ~$2.2 Million from Sanofi to Fit SoloStar Insulin Pens with Biocorp’s Mallya Smart Pen Attachment – December 16, 2019

Sanofi acquires non-exclusive worldwide distribution rights to Mallya, starting in 2020; Biocorp will develop an exclusive version of Mallya for SoloStar (Sanofi’s insulin pen)

France-based Biocorp announced a distribution partnership with Sanofi to incorporate Biocorp’s connected pen attachment, “Mallya,” with Sanofi’s insulin pens. As part of the agreement, Sanofi will acquire non-exclusive distribution rights to Mallya worldwide, starting in 2020. Additonally, Biocorp “is committed” to developing a specific and exclusive version of Mallya for Sanofi’s insulin pen (SoloStar).

Biocorp’s Mallya device received its CE Mark in June as a class IIb device and is compatible with “all major pens” – see more product details here. Biocorp was hoping to launch Mallya in fall 2019 (a delay from the 1H19 timeframe provided by reps at ATTD), but today’s press release suggests that has been pushed back again to “2020.” An FDA submission was expected at the end of 2019 or in 1Q20 – it’s unclear whether that has changed. With today’s deal, Mallya now has two distribution partners in Agamatrix and Sanofi.

  • Sanofi will pay Biocorp €2 million ($2.2 million) and another €1.5 million (~$1.7 million) when Mallya is launched on the market (“expected in 2020”). Based on Biocorp’s “additional milestone payments” phrasing, there Sanofi may also make additional payments depending on Biocorp’s progress with the SoloStar-exclusive version of Mallya. Today’s agreement stems from “exclusive negotiations” between Biocorp and Sanofi that began in July. As part of that announcement, Sanofi made an initial payment of €4 million (~$4.5 million).

  • At ATTD, Sanofi announced it was working internally on developing smart insulin pens, both prefilled (disposable) and durable. Of course, just last week, Sanofi announced that it was discontinuing research in the diabetes and cardiovascular field. Today’s partnership with Biocorp could be an easy way for Sanofi to have a play in the connected pen landscape, without needing to invest in internal research and development. Mallya is also much closer to market than any Sanofi-developed offering. Novo Nordisk’s durable connected pens are expected to launch in 2Q20, with a removable pen attachment in 2021. Lilly’s smart pen offering has been submitted to the FDA as of 1Q19, but we haven’t heard anything since.

    • Notably, at EASD 2019, Sanofi announced a partnership with Abbott to share FreeStyle Libre data with Sanofi’s smart pens and titration apps. Sanofi also has invested in and is involved in a pilot with smart pen cap manufacturer Common Sensing. It’s unclear how these partnerships will be affected.

 

--by Albert Cai and Kelly Close