Category Archives: Topics

Glooko Appoints Mark Clements as CMO

Glooko announced it has appointed Mark Clements as the company’s new CMO. Recall, Clements is a pediatric endocrinologist from Kansas City, MO who has sat on the Glooko board since 2015. He also served as the Pediatric Chair of T1D Exchange. Below, FENIX provides insight into how Clements fits into Glooko’s business needs.

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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Lifescan Enters CGM Market with New Partnership; Ty Lee Returns to Lifescan

Lifescan announced it has entered into an exclusive partnership with Sanvita Medical for the distribution of Sanvita’s CGM. According to the press release, the companies are planning to launch the CGM in North America and select EU countries starting as early as mid-2020. Additionally, Lifescan recently appointed former J&J VP, Ty Lee, as the new Head of Marketing. Below, FENIX provides insight on Lifescan being the last of the Big 4 BGM manufacturers to move into the CGM market and thoughts on Ty Lee re-joining the Lifescan organization.

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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FDA Warns Against DIY Closed-Loop Systems

FDA issued a safety communication regarding the use of unauthorized devices as part of closed-loop systems. Additionally, FDA said it has identified companies who are “illegally marketing components, such as unauthorized continuous glucose monitors that some patients may integrate into unauthorized automated insulin dosing systems.” According to the FDA communication, the warning is based on a report that a patient received too much insulin resulting in the need for medical intervention. Below, FENIX provides insight on the FDA communication including the potential impact on current closed-loop systems in development as well as thoughts on potential systems that are being marketed illegally.

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 Tirzepatide vs. Semaglutide Ph1 T2DM Clamp Study; Ph3 SURPASS-1 Monotherapy Trial Initiated

Lilly recently initiated two new tirzepatide T2DM studies. The first is a Ph1 clamp study comparing tirzepatide to Novo’s QW injectable semaglutide, and the second is the Ph3 SURPASS-1 monotheraphy trial vs. pbo. Interestingly, the Ph1 trial is evaluating the effect of tirzepatide on α and β cell function. Below, FENIX provides thoughts on both studies including Lilly’s potential rationale for the H2H clamp trial as well as insight as to why SURPASS-1 is longer than Novo’s Ph3 semaglutide monotherapy trial.

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: SGLT2i Promotional Materials Post-AACE 2019

In the second installment of our post-AACE 2019 promotional material coverage, FENIX has conducted an analysis of SGLT2i promotional materials covering Jardiance, Farxiga, Invokana, and Steglatro as well as their respective FDCs with DPP-IVi and metformin. Of note, AZ recently updated the Farxiga patient website with a new “Hit Back-Now!” tagline which is further discussed below.

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.

Zealand Q1 ’19 Earnings Update

Zealand hosted its Q1 ’19 earnings call and provided updates to its diabetes business including dasiglucagon (hypoglycemia rescue, congenital hyperinsulinism, and bi-hormonal closed-loop) and its GLP-1/GCG dual agonist with Boehringer Ingelheim. Recall, Zealand recently disclosed that its dasiglucagon hypoglycemia rescue filing has been delayed to early 2020. Below, FENIX provides highlights and insights 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.

JNJ 2019 Pharmaceutical Business Review

JNJ hosted its 2019 Pharmaceutical Business Review and provided updates on the company’s global pharmaceutical strategy including its diabetes and cardiovascular business. Of note, discussion on Invokana was limited with prepared remarks primarily highlighting the recent CREDENCE results. Below, FENIX provides diabetes-related highlights and insights from the presentation.

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 oral dual agonist comments @ BAML

Lilly’s president of diabetes, Enrique Conterno, participated in a fireside chat at the 2019 BAML Conference (webcast link here). For what is believed to be the first time, Conterno commented that Lilly is looking to develop an oral GIP/GLP-1 based on its current understanding from tirzepatide (injectable GIP/GLP-1) and having a non-peptidic oral GLP-1RA (OWL833) licensed from Chugai (Ph1 ready; previous FENIX insight).  Below, FENIX provides thoughts on Lilly’s oral GLP-1 development strategy.

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.

Sign UpFREE

You’ll be able to access the full article from your FENIX Library after signing up.

Zealand’s Dasiglucagon Filing Delayed; Positive Ph3 Dasiglucagon Topline Results

Zealand announced positive topline results for its confirmatory Ph3 hypoglycemia rescue study evaluating dasiglucagon administered via the HypoPal autoinjector. Of note, Zealand also said its FDA filing timeline has been pushed back to early 2020 (previously YE ’19) based on recruitment difficulties with its Ph3 pediatric study. Below, FENIX provides an overview of the Ph3 HypoPal topline results in the context of Zealand’s pursuit of a commercial partner as well as thoughts on the potential impact of the regulatory filing delay.

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.

FDA Issues Final Guidance on Biosimilar Interchangeability

Late last week, FDA issued the final guidance on biosimilar interchangeability titled, “Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry.” Below, FENIX provides thoughts on the FDA interchangeability guidance in the context of the insulin 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.