Category Archives: Topics

Medtronic CY Q3 ’18 (FY Q2 ’19) Earnings Update

Medtronic hosted its CY Q3 ’18 (FY Q2 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities including the ongoing launch of its standalone CGM, Guardian Connect. Below, FENIX provides key highlights of the earnings call as well as perspective on Medtronic’s push into the standalone CGM 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.

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Verily/Novartis Halts Glucose Sensing Contact Lens Development

Verily announced it has placed a hold on the development of its glucose-sensing contact lens that it had been working on in partnership with Novartis (Alcon). The announcement comes as no surprise given comments from Novartis’s Chairman, Joerg Reinhardt, in May 2017 saying “[The glucose-sensing lens is] a long-term project, not something where we were expecting a breakthrough in the first couple of years” and “I personally think it’s a highly risky project.” Below, FENIX provides thoughts on the Verily/Novartis product as well as the future of non-invasive glucose monitoring.

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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Zealand Q3 ’18 Earnings; Xeris Initiates New Ph3 Study vs. GlucaGen

Zealand hosted its Q3 ’18 earnings call and provided updates to its dasiglucagon development program. Additionally, a new Ph3 Xeris glucagon study vs. Novo’s GlucaGen has been observed. Of note, Zealand narrowed its filing timeline for dasiglucagon hypoglycemia from H2 ’19 to Q4 ’19. Below, FENIX provides thoughts on the dasiglucagon hypoglycemia rescue program, Zealand’s ongoing partnership discussions for dasiglucagon commercialization, and Xeris’s new Ph3 study.

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.

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.

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Purchase Blast$599.00

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DECLARE Disappoints, Yet Creates Many Implications

Results from the Farxiga CVOT, DECLARE, were presented at the American Heart Association conference (AstraZeneca press release) along with a simultaneous publication in the NEJM. Below, FENIX provides thoughts on the many market implications. DECLARE Initial Takeaways and Potential Implications  (In no particular order…) The DECLARE 17% RRR in the composite primary endpoint could be viewed as somewhat underwhelming since there was no CV death benefit, unlike EMPA-REG’s 38% RRR in CV death. Perhaps, though, the 27% RRR in hHF in DECLARE is in the ballpark of RRR based on EMPA-REG and CANVAS/R hHF sub-analyses. At first glance, the DECLARE indication……

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.

Senseonics Q3 ’18 Earnings Update; Abbott FreeStyle Link Now Available

Senseonics hosted its Q3 ’18 earnings call and provided updates on the Eversense implantable CGM launch as well as pipeline activities. Additionally, Abbott recently announced the approval of Libre Link, an app that allows users to scan the Libre device with their iPhone. Below, FENIX provides thoughts on the Eversense launch, ongoing negotiations with Roche, and the potential impact of the Libre Link to accelerate Libre adoption.

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.

Xeris to Launch Stable Glucagon in H2 ’19

In Xeris’s Q3 ’18 10-Q SEC filing, the company disclosed plans to launch its stable glucagon pen for hypoglycemia rescue in H2 ’19, which is later than previously projected by FENIX. Recall, Xeris recently stated that the FDA PDUFA date is on June 10, 2019. Below, FENIX explores potential reasons for the later-than-anticipated launch as well as key exhibition opportunities for Xeris.

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 T1DM US Filing in Q4 ’18; AZ Q3 ’18 Earnings Update

AZ hosted their Q3 ’18 earnings call (press release) and briefly discussed their diabetes portfolio. Of note, AZ disclosed it plans to file Farxiga for a T1DM indication in Q4 ’18. Previously, AZ had been quiet regarding the US Farxiga T1DM filing during Q2 ’18 earnings. Furthermore, full results from the Farxiga CVOT, DECLARE, are being presented at the AHA conference on November 10, 2018. Below, FENIX provides thoughts on the potential DECLARE indication, Farxiga T1DM filing timing, and other highlights from the call. Farxiga CVOT (DECLARE) Filing Given the upcoming DECLARE data presentation at AHA, AZ senior management only……

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.

Insulet Partners with Samsung for Smartphone Pump Control

Insulet announced a partnership with Samsung to allow for control of the Omnipod through a Samsung Galaxy smartphone. The specific Samsung device has not been disclosed. Below, FENIX provides thoughts on why a partnership with a single smartphone manufacturer makes sense from a regulatory standpoint.

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.