Category Archives: Basal Insulin

Thoughts on Potential Livongo IPO

Yesterday, The Wall Street Journal reported that Livongo is preparing for an IPO in 2019. According to the story, Livongo has already approached Morgan Stanley, Goldman Sachs, and JP Morgan to underwrite the IPO with a company valuation >$1B. Recall, in March 2017, Livongo raised $52.2M in a growth round, and in April 2018, it raised an additional $105M with a total of $240M in private financing (previous FENIX insight). Below, FENIX provides additional thoughts on the Livongo IPO.

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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Thoughts on Biocon Form 483 Observations and Impact to Semglee US Launch

Biocon has reportedly received six Form 483 observations during FDA’s pre-approval inspection of its insulin drug substance manufacturing facility in Bengaluru (Bangalore); however, this Form 483 is not yet listed in FDA’s public database. Interestingly, the Biocon press release states the FDA inspection was “triggered by a New Drug Application submitted by our insulin API customer” which is assumed to be referencing the bs-glargine filing by Mylan. Below, FENIX provides insight on the impact to the Semglee (glargine U100) US commercial launch and thoughts on how a delayed tentative approval could potentially lead to a royalty agreement between Sanofi and Mylan.

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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Soliqua Label Update More Competitive vs. Xultophy and Basaglar

Sanofi announced FDA approval of an updated Soliqua label to expand its indication to patients uncontrolled on OADs. Additionally, Soliqua stability has been extended from 14 days to 28 days (vs. 21 days for Novo’s Xultophy). Below, FENIX provides thoughts on how Sanofi will likely leverage the updated Soliqua indiction to position Soliqua as the first injectable as well as increasing Sanofi’s competitive position vs. Xultophy and Basaglar.

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.

Tandem and Mylan Q4 ’18 Earnings Updates

Tandem Diabetes Care and Mylan both hosted their respective Q4 ’18 earnings calls. Of note, Mylan did not discuss its biosimilar insulin programs (including bs-glargine) or bs-glucagon. Below, FENIX provides highlights and insights from the Tandem earnings call.

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.

Diabetes Takes a Backseat During Part II Drug Pricing Hearing

Today, the Senate Finance Committee held the second drug pricing hearing of 2019 (Drug Pricing in America: A Prescription for Change, Part II). Part I was held on January 29, 2019. While the Part I drug pricing hearing spent much time discussing insulin pricing, diabetes-specifically was hardly mentioned. When a specific drug was mentioned, it was most often AbbVie’s Humira. Below, FENIX provides diabetes-related highlights and insights from the hearing.

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.

Thoughts on New Hygieia d-Nav Mobile App for Insulin Titration; New Data published in The Lancet

Hygieia recently announced it received 510(k) clearance for a mobile app that is part of the company’s d-Nav insulin guidance service. Recall, d-Nav is a T2DM-focused, cloud platform that provides personalized insulin dose recommendations based on the user’s BGM values. Additionally, results were published in The Lancet for a study showing d-Nav plus HCP support led to superior glycemic control than with HCP support alone. Below, FENIX provides thoughts on how Hygieia’s d-Nav and other similar systems could impact the diabetes 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.

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.

Sanofi Discontinues 2 Dual-Agonist Programs; Q4 ’18 Earnings Update

Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.

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.

No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis from the call.

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.

Novo to File Oral Sema with PRV; Q4 ’18 Earnings Update

Novo Nordisk hosted its Q4 ’18 earnings call and disclosed that it will use its priority review voucher (PRV) for the oral semaglutide US filing by the end of Q1 ’18. Of note, Novo is planning to file for Ozempic and oral semaglutide CV indications based on the results from SUSTAIN 6 and PIONEER 6 despite PIONEER 6 not achieving statistical significance for 3P-MACE. Below, FENIX provides highlights from the earnings call, additional insight on the semaglutide regulatory strategy, and thoughts on why Novo likely wants an oral semaglutide adcom.

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.

Lilly Repeatedly Called Out During US Senate Hearing on Drug Pricing

Today, the Senate Finance Committee held the first hearing of 2019 and it highlighted US drug pricing (Drug Pricing in America: A Prescription for Change, Part I). A majority of the 3-hour discussion focused on Medicare Part B and D, Medicaid best pricing, 340B incentives, and diabetes insulin pricing in particular. Of note, when insulin was discussed, it was largely in the context of Lilly and Humalog with no mention of Novo or Sanofi. Below, FENIX provides diabetes-related highlights from the hearing and thoughts on the national discussion on drug pricing.

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.