Category Archives: Topics

Medtronic Acquires Nutrino Health

Medtronic announced plans to acquire Nutrino Health, a company focused on providing nutrition-related data services, analytics, and technologies. Recall, Medtronic has an existing relationship with Nutrino to integrate Nutrino’s FoodPrint app with the iPro2 professional CGM (previous FENIX insight). Below, FENIX provides thoughts on the acquisition and how Medtronic could leverage Nutrino’s capabilities moving forward.  With the launch of Medtronic’s Guardian Connect stand-alone CGM, the company is placing increased focus and resources toward the CGM market. As previously stated by FENIX, Medtronic is looking to create the “smart CGM” category through software-based features like Nutrino. Therefore, it makes sense for Medtronic to acquire……

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Dexcom and Verily Update Agreement, Focus on T2DM Market

Dexcom and Verily recently announced an amendment to their collaboration and license agreement for the development of next-gen CGM systems. The updated agreement and shift in focus toward the second gen “Band-Aid-like” sensor is consistent with Dexcom senior management commentary during the Q3 ’18 earnings call. While the amendment to the agreement appears to suggest an underlying confidence in its product development, Wallstreet did not react as $DXCM has remained flat. Below, FENIX provides thoughts on the potential impact of the updated agreement on Dexcom and its competitors in the CGM market.

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Onduo Free Promotional Program; Insulet Dash Meets ISO Standards

Onduo announced it is giving away subscriptions to its virtual diabetes program to patients in Georgia. Additionally, Insulet announced it received ISO 27001 certification for its Omnipod Dash. Below, FENIX provides insight into how Onduo could be leveraging the giveaway with payers and the impact of digital security to Insulet’s smartphone-controlled pumps. Onduo Virtual Diabetes Care According to the press release, Onduo will giveaway a 12-month subscription to its virtual diabetes care program to the first 1,000 eligible patients in Georgia. Of note, the promotion coincides with National Diabetes Awareness month.  While it remains speculation, Onduo managed care coverage in Georgia could be lagging behind the……

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Livongo Recognized by CDC

Livongo announced the Centers for Disease Control (CDC) granted Livongo “full recognition,” which recognizes diabetes prevention programs that meet a CDC-approved curriculum for duration, intensity, and reporting requirements. “Full recognition” is part of the CDC’s National Diabetes Prevention Program. Below, FENIX provides thoughts on how Livongo will likely leverage the CDC recognition to help aid uptake for its diabetes program.  Despite the advances in diabetes-related medications, the prevalence of T2DM continues to rise, which is why organizations like the CDC have endorsed technological solutions that focus on changing patient behavior. Livongo is clearly looking to leverage the increased CDC focus on diabetes to aid……

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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.

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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.

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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.

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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.

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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.

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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……

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