Tag Archives: Other

New ADA/EASD Guidelines Recommend GLP-1RA Over Insulin and Make Other New H2H Drug Recommendations

ADA and EASD have updated their T2DM consensus guidelines (journal publication) with notable changes to the framework of the treatment algorithm (pictured below). Now, the algorithm takes a patient-centric approach and suggests a stepwise methodology based on the highest priority for the patient (ASCVD, CKD, hypoglycemia minimization, weight loss, and cost). Importantly, the guidelines recommend the use of GLP-1RA over insulin as the first injectable therapy as well as other in-class H2H drug recommendations. Below, FENIX provides a winners-and-losers analysis, highlights of the guideline updates, and how the identified knowledge gaps may be addressed.

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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Tandem to Pioneer iPump Regulatory Pathway; Shares Close to $50

Tandem hosted its 2018 Institutional Investor & Analyst Day as well as announcing an increase to its 2018 sales guidance. Of note, Tandem disclosed plans to create a new pump category called iPump (via the de novo regulatory pathway), interoperable insulin delivery algorithms, and plans to accelerate development of its t:sport pump. Below, FENIX provides highlights from the investor event with insight into the potential market impact of Tandem’s pipeline, including how iPump could work for Medtronic.

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 DCV CMO Leaves

Riccardo Perfetti (pictured below), Sanofi’s VP Medical Affairs and Head of the DCV Global Medical Team, has reportedly left Sanofi to serve as the CMO of Applied Therapeutics. Perfetti had been with Sanofi since October 2007.

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.

Glucagon: New Xeris Market Survey Detailed in Investor PPT

Today at 4:30pm ET, Xeris has an investor presentation at the Canaccord Genuity investor conference. In advance of today’s presentation, Xeris posted slides late yesterday from a new August 2018 investor presentation in an SEC filing. The slides disclose the results of a 2018 Xeris-sponsored IPSOS market research study that details what the market’s unmet need is for novel glucagon rescue for severe hypoglycemia. Below, FENIX highlights some of the key results from the IPSOS study, including a slide on novel glucagon competitors that may raise worries about intranasal delivery.

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.

AZ Drops Lawsuit Over Generic Farxiga

According to court documents, AZ has dismissed its lawsuit against Zydus Pharmaceuticals over Zydus’ generic Farxiga filing in the US. The suit was initially filed with the US District Court, New Jersey on May 3, 2018 and claimed infringement on two AZ patents (6,414,126 and 6,515,117). Interestingly, the suit was dropped even though Zydus did not answer AZ’s complaint or filed a motion for summary judgment. It is unclear as to why AZ decided to withdraw its lawsuit vs. Zydus; however, AZ and Zydus may have come to an agreement outside of the courts. Below, FENIX provides an analysis based on the FDA Orange Book and Paragraph IV filings.

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.

Former Lilly Exec Thane Wettig Joins Intarcia As New Head of Marketing

Intarcia announced it has appointed Thane Wettig (pictured below) as the new Chief Marketing Officer and Metabolic Franchise Head.

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.

MannKind Re-Initiates TV DTC; Hosts Analyst Meeting

MannKind hosted an Institutional Investor and Analyst Meeting that was largely focused on providing an overview of the company with the intention of attracting new investors. Of note, senior management disclosed that they have re-initiated itsAfrezza TV DTC campaign. Below, FENIX provides highlights of the event including Afrezza EASD data presentations and Afrezza LCM roadmap as well as thoughts on the future for the Afrezza brand.

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 Fiasp/Medtronic 670G Study on CT.gov

A CT.gov record for a study evaluating Novo’s Fiasp (faster-acting insulin aspart) in a Medtronic 670G pump has been observed. This Ph4 study is sponsored by Bruce Buckingham’s lab at Stanford, and Medtronic is listed as a collaborator (Novo is not believed to be part of the study). Recall, the Fiasp label does not include designation for use in insulin pumps. Below, FENIX provides insight into the use of ultra-rapid-acting insulin in pumps as well as why a future commercial partnership between Novo and Medtronic could make sense.

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.