Category Archives: Other

New T1DM Teplizumab Pivotal Ph3 trial (PROTECT)

FENIX has observed a new teplizumab pivotal Ph3 trial (PROTECT) on CT.gov. Teplizumab is an anti-CD3 monoclonal antibody being studied for new-onset T1DM. Of note, the initiation of this pivotal trial is earlier than the previous guidance from Provention Bio (previously late 2019). Below, FENIX provides thoughts on this new trial in the context of the failed Ph2/3 PROTÉGÉ study for teplizumab when the compound was under the control of Macrogenics.

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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Fractyl Hires Former Sanofi and Intercept VPs

Fractyl, a Massachusetts-based medical technology company, announced the appointments of former Sanofi diabetes VP Margaret Borys as Chief Commercial Officer and former Intercept SVP Juan Carlos Lopez-Talavera as Chief Medical Officer. Below, FENIX provides thoughts on the appointments.

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.

Adocia Q4 ’18 Earnings Update; No Call Conducted

Adocia released its Q4 ’18 earnings results, but did not have an associated webcast. Below, FENIX provides highlights from the earnings press release including 2019 pipeline activities, and thoughts on how Adocia could enter the US and EU markets.

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.

Zafgen Q4 ’18 Earnings Update; ZGN-1258 Discontinued in PWS

Yesterday, Zafgen hosted its Q4 ’18 earnings call and discussed its pathway to have FDA remove the clinical hold on ZGN-1061, its novel MetAP2 inhibitor for the treatment of T2DM. Additionally, Zafgen disclosed it has discontinued development of ZGN-1258 for the development of Prader-Willi Syndrome due to unforeseen findings in rat toxicity studies. Below are 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.

New Head of AZ CVRM

In AstraZeneca’s press release regarding presentations at ACC 2019, Joris Silon was listed as the company’s new SVP of the CV, renal, and metabolism (CVRM) group. Recall, in October 2018, Novo announced that Ludovic Helfgott, previous head of AZ’s CVRM business, would be joining Novo as of April 3, 2019. According to Silon’s LinkedIn profile, he took the new position as of December 2018. Below, FENIX provides thoughts on Silon’s appointment to head AZ’s CVRM group as well as the headwinds and tailwinds that he faces.

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.

Pfizer Licenses T1DM Immunotherapy From AnTolRx

AnTolRx, a privately held biotech company, announced Pfizer has exercised its option to license AnTolRx’s antigen-specific immunotherapy for T1DM. According to the press release, AnTolRx will receive an up-front payment and is eligible for milestone and royalty payments. The specific financial terms were not disclosed. Below, FENIX provides thoughts on the AnTolRx opportunity in the context of other T1DM immunotherapies in development.

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 Glooko Business Model; Glooko Mobile App to be Given Away for Free

Glooko announced it is removing the subscription fee for its data management platform. Previously, users who did not have coverage through their insurance or employers were required to pay a fee to access the platform. Additionally, the Glooko/Senseonics data integration appears to be complete. Now, users can directly sync Eversense data to the Glooko platform via the Senseonics Cloud. Below, FENIX provides thoughts on Glooko’s new business model as well as insight into how the integration with Eversense likely benefits Senseonics more than Glooko.

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.

Janssen Diabetes VP Moves to Vertex

As of February 2019, Janssen’s VP and Franchise Medical Leader for the metabolism business, Gary Meininger (pictured below), has left Janssen and is now the SVP and Head of Pipeline Development for Vertex Pharmaceuticals. Prior to his ~9 years at Janssen, Meininger spent 8 years at Merck as a director of Merck Research Laboratories. Below, FENIX provides brief thoughts on Meininger’s departure.

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.

Farxiga eGFR Cutoff Lowered; Positive Brilinta T2DM Data

AstraZeneca’s Farxiga franchise labels (Farxiga and Xigduo) have been updated to reduce the eGFR cutoff from 60 to 45 mL/min/1.73m2. Additionally, AZ announced positive topline results from the Brilinta Ph3 THEMIS study in patients with established CAD and T2DM. Below, FENIX provides insight into the lower Farxiga eGFR as well as thoughts on AZ’s strengthening CV protection market position.

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.