Tag Archives: Omnipod 5

Insulet Initiates Omnipod 5 US Broad Launch; Arecor Buys Tetris Pharma; Sanofi/Optum Partner for Insulin Affordability

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Insulet Omnipod 5 Receives FDA Clearance; BI/Lilly’s Jardiance HFpEF Indication Receives Positive CHMP Opinion; Provention Hosts Teplizumab BLA Resubmission Call with Investors; Lilly to Invest $1.5B in Two New Manufacturing Sites

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Insulet Omnipod 5 Tale-of-the-tape Analysis

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Omnipod 5 Pivotal Data Meets the Bar and Leaves Room for Further Innovation

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Insulet to Host Investor Event Following Omnipod 5 Pivotal Data Presentation @ ENDO 2021

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Insulet and Esperion Q4 ’20 Earnings Updates

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Insulet, Mannkind, and Lannett Q3 ’20 Earnings Updates

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Insulet Expands DASH Availability in Europe; Nemaura In-Licenses Healthimation Diabetes App; Dario Enters Distribution Agreement with HMC; Arecor uRAI to be Presented Tomorrow; Adocia to Host Business Review; EASD 2020 Key Press Releases (Sept 21)

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.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.