Category Archives: Insulin Delivery

IQVIA/JDRF Partner for T1DM Research; MannKind Hires Former Medtronic Exec as CCO; Insulet Initiates Horizon Preschool Trial; Adocia Q2 ’20 Earnings; Dario Partners for UK Distribution

A series of diabetes-related news items have been observed including: IQVIA and JDRF are collaborating to use real-world data to better understand T1DM, MannKind announced Alejandro Galindo (former head of Medtronic’s automated insulin delivery business) is joining the company as the new CCO, Insulet initiated a new Omnipod Horizon trial in preschool-aged children (view CT.gov record), Adocia released its Q2 ’20 earnings (view press release; a webcast was not held), and Dario Health has partnered with Williams Medical for UK distribution. Below, FENIX provides highlights and insights for the respective news items, including why the IQVIA-JDRF partnership is interesting to manufacturers of CGM systems and insulin products.

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Tandem and Medtronic Enter Into “Non-exclusive Patent Cross-license Agreement”

Tandem and Medtronic announced they have entered into a “non-exclusive patent cross-license agreement” for existing and new products and services relating to each companies’ diabetes portfolio; however, there are certain undisclosed exclusions. According to the press release, no payments are being exchanged, and additional terms of the deal are not being disclosed. Below, FENIX provides thoughts on this curious agreement in the context of Tandem’s recent win with UnitedHealthcare (previous FENIX insight).

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First Libre 3 Clinical Study Initiated

A CT.gov record has been observed for what is believed to be the first Abbott Libre 3 clinical trial. Abbott publicly disclosed the existence of Libre 3 during its Q1 ’19 earnings call (previous FENIX insight). Recall, the Libre 2 CGM was recently approved in the US, but its use with integrated systems is limited due to Vitamin C interference (previous FENIX insight). There is no mention of Vitamin C in the Libre 3 CT.gov record. Below, FENIX provides an overview of the new Libre 3 study as well as potential insight into the timing of its initiation in the context of the Libre 2 US label restrictions.

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Tandem Partners with JDRF for Diabetes Device Education Campaign; Livongo’s myStrength App Available for Free to Priority Health Members

Two diabetes-related news items have been observed: Tandem announced it is partnering with JDRF for a national T1DM educational awareness campaign focusing on diabetes technology and Priority Health is providing Livongo’s myStrength mental health app for free to its members. Below, FENIX provides insights into the respective news items, notably the timing of the Tandem/JDRF collaboration given the recent favorable reimbursement decision by UnitedHealthcare (previous FENIX insight).

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UnitedHealth to Cover Tandem Pumps

Several equity research analyst sources are reporting UnitedHealth Group is now covering Tandem’s insulin pumps (view article here). Although an official policy document from UnitedHealth (UNH) could not be found in a timely manner, FENIX provides brief thoughts on the United coverage in the context of the previous exclusive agreement between United/Medtronic as well as Tandem’s recent FDA pediatric approval for Control IQ.

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Biocorp Partners with Roche in France for Mallya Distribution

Biocorp announced it has signed an agreement with Roche Diabetes Care France for the distribution of Biocorp’s Mallya device in France. Recall, Mallya turns any disposable or reusable insulin pen into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides thoughts on the Biocorp/Roche partnership in the context of Biocorp’s other partnerships, notably Sanofi, WaveForm (formerly AgaMatrix), and DreaMed.

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Abbott/Tandem Finalize AID Partnership; What is Tandem’s Role?

Abbott and Tandem Diabetes Care announced the finalization of an agreement for the two companies to develop and commercialize “integrated diabetes solutions.” Recall, the companies first announced their intention to work together in October 2019 (previous FENIX insight). Below, FENIX provides thoughts on the partnership, including potential insight into how Abbott may be leveraging the Tandem partnership to deal with the Libre 2 Vitamin C interference issue.

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Roche Sues Insulet for Omnipod Royalties

According to court documents (view here), Roche has filed a lawsuit vs. Insulet in the US District Court of Delaware, seeking royalties due to claimed infringement on a Roche patent (7,931,613). The ‘613 patent, titled “Module For A Computer Interface” was issued on April 26, 2011 and relates to the Accu-Chek Combo system. Of note, Roche’s complaint does not request Insulet to remove its products from the market. Below, FENIX provides brief thoughts on the suit.

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Tandem Control-IQ Approved in Peds Down to 6 Years of Age

Tandem Diabetes Care announced the t:slim X2 insulin pump with Control-IQ has been approved by FDA for use in pediatric patients down to six years of age. Previously, the product was indicated for 14 years of age and older. Tandem senior management also presented at the 2020 Raymond James Healthcare Innovation Conference, providing brief commentary on the pediatric indication and market opportunity. Below, FENIX provides thoughts on the expanded indication from Medtronic, Insulet, Bigfoot, and Beta Bionics.

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