Category Archives: Basal Insulin

Lilly’s New Diabetes Helpline to Aid Insulin Access

Lilly announced the availability of its new “Lilly Diabetes Solution Center helpline” to assist patients in finding appropriate programs to make insulin treatments more affordable. Below, FENIX provides insights about the new Lilly program in the context of patient need and other savings programs from large insulin manufacturers.

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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Sanofi Q2 ’18 Earnings Update; Pfizer Discontinues Ph1 T1DM Compound

Sanofi and Pfizer hosted their respective Q2 ’18 earnings calls. Sanofi only briefly discussed its diabetes business including continued headwinds for its glargine franchise. Of note, Sanofi has recently updated the name of its efpeglenatide CVOT to “AMPLITUDE-O.” Pfizer did not discuss its Steglatro (ertugliflozin) franchise; however, in the pipeline update, it was noted that PF-06342674 (IL-7 receptor precursor modulator) for the treatment of T1DM has been discontinued. Below are highlights from the respective 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.

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Purchase Blast$599.00

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Biocon/Mylan Glargine CRL; Biocon and Merck Q2 ’18 Earnings

Biocon hosted its CY Q2 ’19 (FY Q1 ’19) earnings call and provided an update on its biosimilar glargine development program including the CRL that was issued in early June 2018. Additionally, Merck hosted its Q2 ’18 earnings call and briefly touched on its diabetes business unit. Below, FENIX provides an overview of the calls and insight on Biocon’s glargine CRL.

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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LLY Dual Agonist Advances to Ph3; Q2 ’18 Earnings Update

Lilly hosted its Q2 ’18 earnings call and provided updates on its marketed and pipeline products. Lilly announced three major pipeline updates including advancement of their QW GIP/GLP-1 agonist to Ph3 after meeting a “high bar” in Ph2 trials, filing of nasal glucagon, and discontinuation of their Ph1 GPR142 agonist. Of further interest, President of Lilly Diabetes, Enrique Conterno, indicated the median follow-up for REWIND would be ~5 years (providing an additional ~1 year for Kaplan-Meier curve separation compared to the 3.8-year median follow-up for LEADER).

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 Sanofi/Verily Connected Care Pre-filled T2DM Pump Partnership

With Sanofi and Verily’s recent Sensile Medical partnership for a connected pre-filled patch pump (Sensile website), FENIX has conducted an analysis of Sanofi’s connected care strategy with market, manufacturing, and payer implications. Below, FENIX provides insight into the diabetes connected care landscape in the context of the large insulin manufacturers (Sanofi, Novo, and Lilly).

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 Novo CVOT strategy; ADA ’18 Analyst Briefing

Novo hosted its annual ADA analyst briefing (presentation slides), predominantly discussing oral semaglutide. Of note, Novo disclosed they are no longer conducting a large-scale CVOT for Ozempic (formerly SOUL), instead leveraging the results of both SUSTAIN 6 and PIONEER 6 between injectable and oral semaglutide. Novo senior management said they believe it will be difficult for PIONEER 6 to demonstrate CV benefit at p < 0.05 given the low number of pre-specified events will require a large reduction in the hazard ratio. Additionally, Novo stated they plan to file oral semaglutide in mid-2019. Below are highlights from the ADA analyst event including three potential scenarios for injectable and oral semaglutide CV indications.

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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Drug ADA ‘18 Key Data Press Releases (June 23)

21 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs, devices, and apps, a major increase from 9 on the first day of ADA ‘17. Below, FENIX has provided context and analysis for 14 drug-related announcements, with analysis of device and app-related announcements to follow in a separate alert.

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.

Voluntis and Monarch Medical Partnership Will Compete with Glytec

Voluntis and Monarch Medical Technologies have announced a strategic collaborationto integrate Voluntis’s personal T2DM diabetes platform (Insulia) with Monarch’s in-patient insulin titration tools (EndoTool IV and EndoTool SubQ). Below, FENIX provides insight into the collaboration including perspective on competition to Glytec who provides a similar product.

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.

FENIX Analysis: Post-AACE 2018 Drug Promotional Material

In advance of ADA 2018 beginning June 21, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at AACE 2018. Notably, this was the first major conference opportunity for Novo to promote both Ozempic and the Tresiba DEVOTE label update.

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.

Beta Bionics to initiate in-home IDE for insulin-only AP system

Beta Bionics announced it received IDE approval from FDA to initiate in-home trials of the iLet insulin-only closed loop system. According to the press release, Beta Bionics plans to initiate pivotal studies in 2019 with launch of the first commercial device in 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.