Category Archives: Uncategorized

Senseonics Receives MRI Approval for Eversense Implantable CGM

Senseonics announced that its Eversense implantable CGM has been approved for MRI-compatibility (i.e. patients can receive an MRI without the sensor having to be extracted). Of note, patients must still remove the external transmitter prior to the MRI procedure. Below, FENIX provides thoughts on how this label update could impact Eversense uptake.

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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Livongo Acquires Behavioral Health Company

Livongo announced its intention to acquire myStrength, a Colorado-based behavioral health company focused on chronic conditions including depression, anxiety, stress, substance use disorder, chronic pain, opioid addiction and recovery, and insomnia. Below, FENIX provides insight into the acquisition including thoughts on how Livongo may be leveraging myStrength to expand Livongo’s core diabetes business.

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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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.

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Purchase Blast$599.00

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

Biocon CY Q4 ’18 (FY Q3 ’19) Earnings Update

Biocon hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and rh-insulin. Below, FENIX provides highlights from the call as well as additional perspective on Mylan’s upcoming bs-glargine commercialization following the 30-month stay (March 2020).

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.

New Semaglutide Retinopathy Study Called FOCUS

A new study evaluating the effect of semaglutide on retinopathy in T2DM, called “FOCUS,” has been posted on CT.gov. Recall, data from Novo’s SUSTAIN 6 study showed an imbalance in retinopathy with a 1.76 hazard ratio (50 events with sema vs. 29 with placebo) which resulted in a label warning. Below, FENIX provides details from the study as well as thoughts on how Novo will leverage the data.

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.

Libre Reaches 1.3M Users; Abbott Q4 ’18 Earnings Update

Abbott hosted its Q4 ’18 earnings call and provided brief updates on its diabetes business. Of note, Abbott disclosed that Libre now has >1.3M global users, +300k from the previous quarter. Below, FENIX provides a summary from the call as well as thoughts on Libre’s growth potential.

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.

Oramed Initiates Ph1 Oral GLP-1RA; Zafgen and vTv Ph2 data

Oramed has initiated its first ORMD-0901 (oral GLP-1RA) Ph1 study under its FDA IND application. Additionally, Zafgen and vTv Therapeutics recently announced data from their respective Ph2 programs for ZGN-1061 (MetAP2 inhibitor) and TTP399 (glucokinase activator). Below, FENIX provides an overview of the Oramed Ph1 study, Zafgen and vTv Ph2 data, and thoughts the viability of each program in the antihyperglycemic market. Oramed Ph1 Oral GLP-1RA initiation Oramed announced the initiation of its first Ph1 study under their FDA IND application. Recall, The IND was granted in September 2018. According to the press release, the Ph1 trial is a randomized, single-blinded crossover……

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

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JNJ Q4 ’18 Earnings Update

JNJ hosted its Q4 ’18 earnings call (press release) and briefly discussed financial results for its Invokana franchise. Of note, the recent Invokana CV indication listed on a single slide, but was not discussed during prepared remarks or Q&A (see previous FENIX insight). Below, FENIX provides financial highlights for Invokana and perspective on the ongoing CV indication launch.

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 Afrezza Direct Purchase Program

MannKind recently announced a new direct purchase program for Afrezza, offering the drug for as little as $4/day for the first 1000 patients who sign up for the program through http://www.insulinsavings.com. Additionally, MannKind said it is launching an enhanced $15 copay card program; however, the copay card website does not appear to have been updated as of yet. Below, FENIX provides thoughts on the Afrezza program, an RAI pricing analysis, and insight how the program may help drive payer coverage. Afrezza direct purchase program details The Afrezza direct purchase program allows the first 1000 patients a $120 introductory price for 90……

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.

Lexicon down ~24%; Post-adcom Call Summary and Thoughts

Following the T1DM sotagliflozin FDA adcom, Lexicon held an investor call (Sanofi and Lexicon press release) to discuss the panel’s 8-8 split vote (previous FENIX insight). Lexicon senior management briefly summarized the panel’s commentary before answering questions from financial analysts. Following the vote, Lexicon’s stock opened ~24% down. Below, FENIX provides an overview of post-adcom Lexicon webcast as well as additional thoughts on how the companies will overcome the split vote.  The -24% market reaction to Lexicon’s stock price (shown in the chart above) is anticipated to rebound, particularly as Lexicon senior management seek to do damage control with institutional investors…….

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.