A series of cardiometabolic-related news items have been observed from Novo Nordisk, Insulet, MannKind, Gan & Lee, Medtronic, and Akebia. Below, FENIX provides highlights and insights into the respective news items.
Insulet announced it has acquired assets from Automated Glucose Control LLC (AGC) which include patents and IP licensed from the Francis J. Doyle III laboratory at the University of California, Santa Barbara for $25M. Previously, AGC and Insulet entered into a license agreement and partnership in 2016 based on AGC-acquired patents and IP which were used for the development of the Omnipod 5 (view press release). Below, FENIX provides brief thoughts on the acquisition.
A series of diabetes-related news items have been observed: Insulet announced the full market release of its Omnipod 5 hybrid closed-loop system; Arecor is acquiring Tetris Pharma who is partnered with Xeris for UK/EU/CH Ogluo commercialization (view Xeris press release); and Sanofi/Optum have partnered to reduce the cost of insulin to uninsured patients (press release). Below, FENIX provides context and insight on the respective news items.
A series of cardiometabolic-related news items have been observed: Insulet announced FDA has cleared its Omnipod 5 for T1DM patients ≥ 6 years of age; BI/Lilly announced Jardiance (empagliflozin) has received a positive CHMP opinion for extension of indication to add the treatment of patients with HFpEF; Provention hosted a call with investors to provide additional details on the teplizumab BLA resubmission as well as teplizumab LCM initiatives (listen here); and Lilly announced plans to invest over $1.5B in two new manufacturing sites in Concord, North Carolina, and Limerick, Ireland. Below, FENIX provides highlights and insights for the respective new items.
In March 2021, Insulet presented Omnipod 5 pivotal data at the ENDO conference in which Omnipod 5 was shown to reach 68-74% TIR with low rates of hypoglycemia (time spent 54 mg/dL of 0.17% in adults and 0.23% in pediatrics). Below, FENIX provides a tale-of-the-tape comparative analysis between Omnipod 5, Tandem’s Control IQ, and Medtronic’s 780G AHCL, as well as additional thoughts on how Omnipod 5 may effect new entrants to the market.
Today, Insulet presented Omnipod 5 pivotal data at the 2021 ENDO conference (press release), and the company held an associated call with investors (slides). Omnipod 5 was shown to reach 68-74% TIR with low rates of hypoglycemia (time spent 54 mg/dL of 0.17% in adults and 0.23% in pediatrics). Insulet reiterated that the company anticipates an Omnipod soft launch in Q2 ’21 with a full market release in 2022. Below, FENIX provides an overview of the Omnipod 5 pivotal data, a comparative analysis with Tandem’s Control IQ and Medtronic’s 780G AHCL, and thoughts on how Insulet’s T2DM commentary suggests Lilly may be more inclined to use U200 lispro in Lilly’s own AID system.
Yesterday, Insulet announced that the company will host an investor event on Saturday, March 20, 2021 at 12:30PM EST following the presentation of Omnipod 5 pivotal trial data at the virtual ENDO 2021 conference. According to the ENDO program, Insulet Omnipod 5 pivotal trial data for adults and adolescents will be presented from 11:45-11:55AM EST. Recall, during Insulet’s Q4 ’20 earnings call, senior management stated that they continue to anticipate a US Omnipod 5 commercial launch in H2 ’21.
Insulet and Esperion hosted their respective Q4 and full-year 2020 earnings calls and provided updates to their respective businesses. Of note, Insulet disclosed that its Omnipod 5 AID system will be launched in H1 ’21 at price parity to the current Omnipod DASH platform. Below, FENIX provides highlights and insights from the calls.
Insulet (press release), Mannkind (press release), and Lannett (press release) hosted their respective Q3 ’20 earnings calls. Of note, Insulet provided updates to its Omnipod 5 development plans, including the recent initiation of a T2DM feasibility study. Furthermore, following a meeting between Lannett and FDA in June 2020, Lannett said it is finalizing the trial protocol evaluating its bs-glargine in healthy volunteers. Below, FENIX provides highlights and insights from the calls.
On the first day of EASD, five key press releases were observed from Insulet, Nemaura Medical, DarioHealth, Arecor, and Adocia. Below FENIX provides insights and context from each respective announcement.