Tag Archives: NA

Sanofi Restructures GBUs; Stefan Oelrich Moves to Bayer

Less than 3 years after reorganizing the company into 5 Global Business Units (GBUs), Sanofi is once again restructuring the organization. Now, Sanofi is creating Primary Care and China & Emerging Markets GBUs, which will replace the Diabetes and Cardiovascular (DCV) and General Medicines & Emerging Markets (GEM) GBUs. As part of the transition, Stefan Oelrich, head of the DCV business, is leaving Sanofi to join Bayer’s Board of Management and lead its Pharmaceuticals Division. The transition is set to take effect by the beginning of 2019. Below, FENIX provides thoughts Sanofi’s reorganization with insight on the potential impact on its diabetes business.

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One Drop Now Integrates with Apple Watch

One Drop announced its blood glucose management platform now integrates directly with the Apple Watch. Previously, One Drop’s Apple Watch app required users to manually input BG data. Below, FENIX provides thoughts on the One Drop/Apple Watch integration as a source of new patients for One Drop.

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Semaglutide Ph2 NASH Study Completes Enrollment

The CT.gov record for Novo’s Ph2 study evaluating semaglutide in NASH has completed enrollment. Additionally, the full study completion data was moved up 3 months to April 2020 (previously July 2020). Below, FENIX provides thoughts on a projected timeline for Ph2 read out.

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Thoughts on New Non-Invasive CGM Data

Nemaura Medical announced positive results from an interim analysis of its SugarBEAT non-invasive CGM study. According to the press release, Nemaura plans to launch SugarBEAT in the UK “in the coming months” with FDA fling scheduled for Q1 ’19. Below, FENIX provides thoughts on the potential impact of a non-invasive option for CGM.

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DECLARE Confirmed @ AHA on Sat Nov 10

The full results presentation for DECLARE has been confirmed as a late-breaker at AHA. In a recent AHA online planner posting, captured below, DECLARE will be presented on Saturday November 10 at 345pm CST by TIMI’s Stephen Wiviott. Javed Butler, the PI on the Jardiance EMPEROR-HF trials, has been invited as the discussant for DECLARE

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Insulet CEO Succession

Insulet announced that as of January 1, 2019, Shacey Petrovic (pictured below) will succeed Patrick Sullivan as Insulet’s CEO. For the last two years, Petrovic has served as the company’s President and Chief Operating Officer. Below, FENIX provides thoughts on the CEO succession and impact to Insulet moving forward.

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Zealand Lixi Royalty Sale May Indicate BD Challenges

Last week, Zealand sold its rights to Soliqua and Lyxumia future revenue streams to Royalty Pharma for $205M. While Zealand said it will use the funding to continue its pipeline progression, the sale could also indicate Zealand is having difficulty in some of its near-term business development initiatives, including finding a global commercialization partner for dasiglucagon in hypo rescue. Although speculative, it was likely easier for Zealand to sell its future Soliqua/Lyxumia royalty streams than to raise operational proceeds from the public markets. Below, FENIX provides thoughts on the sale and potential read-through to a dasiglucagon partnership.

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Livongo-Abbott Integration with Libre Pro

Livongo announced a partnership with Abbott to integrate the FreeStyle Libre Pro into the Livongo for Diabetes program. The integration with a professional (retrospective) CGM makes sense given Livongo’s focus on patient education and behavior-based treatment. Below, FENIX provides a unique perspective that the Abbott partnership could signal a limitation in Livongo’s diabetes solution.

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MannKind Partners for Pulmonary Hypertension; $MNKD up ~100%

Yesterday, MannKind announced a partnership with United Therapeutics for dry powder delivery of treprostinil (pulmonary hypertension) and another non-disclosed R&D project. MannKind will receive $45M in an upfront payment and is eligible for up to $50M in additional milestones as well as “low double-digit” royalties” for the tresprostinil development and commercialization. Since the partnership announcement, $MNKD is up ~100% (+89% on Sept 4 and an additional +10% in Sept 5 pre-market trading shown below). Interestingly, the news came 21 years after treprostinil first became available through the MiniMed 407c, a pump created in part by Al Mann.

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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.

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