Category Archives: Other

Novo partners for hypertriglyceridemia asset

Today, Novo Nordisk announced an exclusive partnership with Staten Biotechnology for the development of novel treatments for hypertriglyceridemia. Of note, this is Novo’s first partnership focused on hypertriglyceridemia. Below, FENIX provides additional thoughts on this partnership in relation to Novo’s strategic priorities and R&D partnerships.

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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ADA 2019 Standards of Care published

Today, the ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Notably, the 2019 ADA Standards of Care are aligned with the recently updated ADA/EASD guidelines. FENIX will conduct an analysis and provide thoughts on the 2019 ADA Standards of Care.

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’s Evidation Health Collaboration Expanded To Discover Novel Digital Health Measures

Today, Lilly and Evidation Health announced the expansion of their collaboration with a multi-year agreement that will provide Lilly with global access to Evidation’s Andromeda data platform. Of note, Evidation Health also has prior partnerships with Tidepool and Sanofi. Below, FENIX provides additional thoughts on this collaboration in the context of Lilly’s connected care strategy in diabetes. According to the press release, Lilly will leverage the Andromeda data platform across different therapeutic portfolios, including diabetes, to support the clinical utility of digital medicine and improve personalized health outcomes. The press release also noted that Andromeda data platform is being used……

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.

Novo partners with e-Therapeutics to target T2DM

Today, e-Therapeutics announced a partnership with Novo Nordisk to discover novel intervention strategies, biological pathways, and target compounds for T2DM. According to the press release, Novo will work with e-Therapeutics for a 12-month period and use its proprietary Network-Driven Drug Discovery (NDD) to identify early targets and novel compounds. Below, FENIX provides thoughts on this collaboration and Novo’s efforts to build its early stage pipeline. With this collaboration agreement, Novo will utilize e-Therapeutics to foster the ongoing research conducted in their recently inaugurated Novo Nordisk Research Center Oxford (previous FENIX insight). Although the financial terms of the collaboration were not……

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 cuts ~670 jobs and adds 250 employees in France

It has been reported in a French article that Sanofi will cut up to 670 support function jobs in France by the end of 2020 on a voluntary basis and create an additional 250 jobs in bioproduction and digital segments. This decision is in line with Sanofi’s comments from September 2018 indicating plans to continue cost-cutting initiatives. Of note, Sanofi has cut ~5,000 of 25,000 jobs in France since 2008 and also laid off its US employees in the DCV BU (~ 20% of its global DCV BU staff) in December 2016. Recall, Sanofi also announced the restructuring of the global business units (GBUs) in September 2018……

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.

Amarin’s REDUCE-IT: Winners, Losers, and Suitors Analysis

Recently, Amarin presented REDUCE-IT results at AHA. Although there has been a large volume of news and interpretation on the potential for REDUCE-IT to be practice-changing in preventive cardiology, there has been even more talk about Amarin as the hottest take-out target in the industry, despite the growing short interest post-results. In this original research report, FENIX provides a winners-losers-and-suitors analysis, including the rationale and context for why Amarin could be bought by top suitors before REDUCE-IT’s FDA approval, why popular choice suitors would NOT be interested, how the current regulatory environment works in Amarin’s favor, and what an updated Vascepa label could look like. This report is the advanced read that separates itself from all the other REDUCE-IT trial-related analyses you’ve already seen, covering the Amarin market opportunity from the perspectives of Amgen, Sanofi, Novartis, Merck, Lilly, BI, Janssen, Novo Nordisk, Pfizer, Gilead, Esperion, and The Medicines Company.

An inside advanced look at the section titles

In this original research report by FENIX, the following section titles provide a glimpse of the authors’ deep cardiometabolic expertise and analysis:

  • The top Amarin suitors
  • Popular choices that don’t quite fit
  • Loser: AstraZeneca
  • Esperion and The Medicines Company could be affected
  • What about…
  • Dark horses
  • Other relevant thoughts
  • The US regulatory environment is highly favorable to reward innovation in cardiometabolic disease

Take action now knowing the full scope of the opportunity and the implications it has on the 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.

This is a 6-page report with hard-hitting, to-the-point insight.

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Thoughts on the Regulatory Environment in Diabetes

The regulatory environment in diabetes has greatly evolved in the last 10 years since the 2008 FDA CV risk guidance. As recently as ADA and now through EASD in 2018, FENIX considers the regulatory environment in the US and Europe to be highly favorable for sponsors developing diabetes drugs, devices, and technological solutions. Below, FENIX provides its perspective in a winners and losers analysis on how the highly favorable regulatory environment could be positively impactful to the key upcoming 2019 market events in diabetes from sponsors like Lexicon, Sanofi, AZ, Janssen, Novo Nordisk, Xeris, Lilly, BI, Dexcom, Senseonics, Abbott/Bigfoot, Tandem, Insulet, and 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.

New Lilly RNAi Drug Development Collaboration

Lilly announced a new collaboration with Dicerna for the development and commercialization of RNAi therapeutics treating cardio-metabolic disease, neurodegeneration, and pain. It remains unclear if or how this collaboration will impact Lilly’s diabetes business unit. Below, FENIX provides general thoughts on RNAi treatments as well as potential diabetes-related targets that Lilly/Dicerna could be pursuing.

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.

J&J Q3 ’18 Earnings Update

J&J hosted its Q3 ’18 earnings call but only briefly discussed the Invokana franchise. Senior management did not comment on the CANVAS/R review which is anticipated this month. Recall, in July 2018, J&J announced FDA extended the CANVAS/R sNDA review by 3 months. Below, FENIX provides thoughts on the CANVAS review as well as potential read-through from Lilly’s Ph2b dual agonist results to J&J’s dual agonist, JNJ-64565111.

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 Stem Cell Manufacturing Facility

Novo Nordisk announced plans to establish a stem cell manufacturing facility in Freemont, California. The GMP-certified facility was previously operated by Asteria Biotherapeutics and Novo has signed an agreement with the company. According to the press release, the plant will be operational in 2019 at which time, it will be used to support Novo’s clinical development programs. Below, FENIX provides thoughts on Novo’s stem cell program.

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.