Category Archives: Topics

Teplizumab Regulatory Update; Sanofi Partners with Biocorp; Livongo Preferred on ESI; Omnipod Horizon Pivotal Trial Initiated; Glooko Partners with Mellitus Health

A series of diabetes-related new items were observed today including an update on Provention Bio’s teplizumab, a new Sanofi/Biocorp connected pen partnership, Livongo’s preferred status on ESI, Insulet’s Omnipod Horizon pivotal study, and more. Below FENIX provides insights and context from each respective news item.

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Would AZ, Teva, or Mylan/Upjohn Buy Sanofi’s DCV Business?

Earlier this week, Sanofi hosted its 2019 Capital Markets Day and the company disclosed plans to re-structure its diabetes and cardiovascular business. As part of the discussion, senior management entertained the idea that it would consider divesting the business and/or its assets if it found the right suitor. Below, FENIX provides analysis of companies who could potentially be interested in Sanofi’s DCV assets and why AstraZeneca, Teva, or even Viatris (Mylan/Upjohn) could be viable options.

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Xeris Positive Ph2 Data in PBH; Oramed Partnership with Tianhui; Glooko Privacy Shield Certification

Three news items have been observed today across diabetes players including Xeris, Oramed, and Glooko. Xeris announced positive data from their Ph2 trial in post-bariatric hypoglycemia, Oramed has partnered with Tianhui Incubator of Technologies to launch ORMD-0801 in China in 2 years, and Glooko announced Privacy Shield certification from the US Department of Commerce. Below, FENIX provides context and insights on these news items. Xeris Reports Positive Ph2 Data in Post-Bariatric Hypoglycemia Xeris announced positive results from the in-clinic stage of the Ph2 study evaluating their ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery. Participants in the trial were……

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Sanofi To Move Away From Diabetes/CV; Sanofi 2019 Capital Markets Day

Sanofi hosted its 2019 Capital Markets Day and outlined its new strategy including the R&D focus, which does not include diabetes or cardiovascular projects. In a separate press release, Sanofi also announced it is restructuring the deal with Regeneron for Praluent and Kevzara. Below, FENIX provides CV/Met related highlights from the CMD presentation as well as thoughts on the new direction for Sanofi’s business.

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Beta Bionics’s iLet Breakthrough Designation; Roche Receives CE Mark for Novel BG Test; Glooko Receives ISO 13485 Certification

FENIX has observed several announcements across diabetes technology players. First, Beta Bionics has received breakthrough device designation for the iLet Bionic Pancreas System from the FDA. Note, Beta Bionics is the only manufacturer to receive this designation for 3 system configurations (insulin-only as well as dual-hormone and glucagon-only using Zealand’s dasiglucagon), as no other companies have disclosed configurations beyond insulin-only. Additionally, Roche announced it has received CE Mark for the Accu-Chek SugarView, a meter-free BG monitoring system. Further, Glooko has received ISO 13485 certification, meeting requirements for safety and quality of their system. Below, FENIX provides context and insights on these announcements.

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Sanofi Discontinues Efpeg Development

Ahead of Sanofi’s Capital Markets Day on December 10, 2019, the company issued a press release outlining its new commercial strategy and direction. As part of the new strategy, Sanofi disclosed that it is no longer pursuing commercialization of its QW GLP-1RA, efpeglenatide (in partnership with Hanmi). Tomorrow, FENIX will be providing full coverage of Sanofi’s Capital Markets Day.

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High-Dose Trulicity Filed in EU (CHMP Agenda December 9-12)

The CHMP agenda for this month’s meeting (December 9-12) has been released, and it includes two notable items (potential oral semaglutide opinion and high-dose Trulicity was filed). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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Arecor uRAI (AT247) Positive Topline Results

Arecor announced positive topline results for a Ph1 study of its ultra-rapid-acting insulin (AT247). Arecor did not provide any specifics of the Ph1 data, but the company plans to publish and present results from the study in 2020. Below, FENIX provides brief thoughts on AT247 and its market potential.

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Tirzepatide Ph3 Obesity Program Initiated (SURMOUNT-1)

The first tirzepatide Ph3 obesity study (SURMOUNT-1) has been observed on CT.gov. Below, FENIX provides an overview of the trial, thoughts on the tirzepatide obesity program in the context of Novo Nordisk’s ongoing Ph3 semaglutide obesity program (STEP), and a projection of how far behind Lilly could be.

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Positive Lannett Bs-Glargine Ph1 Results; Zealand Initiates 2nd Ph3 CHI Study

Lannett has announced positive results from the Ph1 PK/PD study evaluating their biosimilar insulin glargine vs. Lantus, which initiated in June 2019. In light of meeting all primary endpoints, Lannett indicated they are planning to meet with FDA to discuss the next steps for bs-glargine development. Below, FENIX provides context and insights, particularly related to the FDA’s recent biosimilar insulin draft guidance.

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