Category Archives: Topics

Poxel Reports Positive Imeglimin Ph3 Japan Topline Results

Poxel announced positive topline results from the Imeglimin Ph3 (TIMES 3) 36-week open-label extension which evaluated the drug in Japanese patients with T2DM. Following the announcement, Poxel hosted a conference call to discuss the results. The company continues to state that it plans to file a Japanese NDA in 2020. Below, FENIX provides an overview of the Imeglimin Ph3 topline results as well as analysis of the market potential for Imeglimin in Japan.

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Dario Expands Retail Presence For Connected BGM

DarioHealth announced it has launched a new “membership-in-a box” retail program for its BGM connected platform. Dario piloted its brick and mortar retail program through a partnership with Best Buy which was first announced in November 2018. Below, FENIX provides insight on Dario’s strategy including thoughts on how why other connected glucose monitoring solutions (e.g. One Drop) are also moving in the same direction.

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Lifescan Wins Patent Dispute vs. Pharma Tech Solutions

The Federal Circuit Court of Appeals ruled to uphold a previous court ruling that Lifescan and J&J did not infringe upon Pharma Tech Solutions’s (Decision Diagnostics Corp parent company) blood glucose patents. Below, FENIX provides brief thoughts on the patent win for Lifescan.

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Sanofi Head of Strategy to Leave End of November

Reuters is reporting that Muzammil Mansuri, Sanofi’s EVP of strategy and business development, is set to leave the company at the end of November 2019. The same report says that Alban de la Sabliere and Laurent Van Lerberghe will assume Mansuri’s responsibilities. Below, FENIX provides brief thoughts on Mansuri’s departure in the context of the larger management and strategy changes within the Sanofi organization.

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Xeris Gvoke Business Update; Xeris @ Jefferies

Xeris presented at the Jefferies London Healthcare Conference (press release) and provided updates to its business including the recent Gvoke launch and EU filing as well as the discontinuation of two other glucagon programs. Below, FENIX provides highlights and insights from the Xeris presentation at Jefferies.

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Lilly to Invest $400M in Diabetes Manufacturing

Lilly announced plans to invest $400M in its Lilly Technology Center campus in Indianapolis. The capital investment is said to include enhancements to existing manufacturing facilities that make Lilly insulin, expanding capacity for other marketed diabetes products, and initial capital investments for future medicines. Below, FENIX provides brief thoughts on Lilly’s investments including insights into which products are likely benefiting.

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Novo 2019 Capital Markets Day Highlights and Analysis

Novo hosted its 2019 Capital Markets Day and provided updates on the strategic direction of the company through 2025 including commercial activities and R&D strategy. Of note, Novo provided clarity on Rybelsus positioning vs. Ozempic and competitor products as well as details on novel drug delivery technologies, including two oral peptide delivery methods being developed at MIT and the semaglutide+AM833 injection device. Below, FENIX provides details and insights from the call.

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Lexicon @ Stifel; First Presentation Since Empa T1DM Adcom

Lexicon participated in the 2019 Stifel Healthcare conference and provided brief updates on the sotagliflozin regulatory situation including commentary regarding the recent BI/Lilly empa T1DM adcom. Recall, the empa T1DM adcom ended in a 2-14 vote not favoring approval. Below, FENIX provides highlights and insights from the Stifel event including potential readthrough to the ongoing sotagliflozin appeal with the Office of New Drugs.

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Sanofi Ends Sensile Medical Partnership; Onduo Parnters with Hidrate; Other Diabetes-Related News

A series of diabetes-related news has been observed today including Sanofi canceling its deal with Sensile Medical, a new Onduo partnership with Hidrate, an update to Oramed’s oral insulin program, and pre-clinical islet replacement data from Kadimastem. Below, FENIX provides highlights and insights for each respective news item.

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Medtronic CY Q3 ’19 (FY Q2 ’20) Earnings Update

Medtronic hosted its CY Q3 ’19 (FY Q2 ’20) earnings call (press release) and provided a brief update to its diabetes business including the development of its 780G advanced hybrid closed-loop system which is projected to launch in FY H2 ’20 (CY late 2020/early 2021). Of note, Medtronic has also initiated a new “Next-Tech Pathway” program for pump upgrades (described below). Below, FENIX provides highlights and insights from the call.

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