Category Archives: Topics

Novo Cuts 400 Jobs in Denmark/China and Confirms Shift in R&D Strategy

Novo Nordisk announced plans to restructure its R&D organization which includes cutting 400 R&D jobs in Denmark and China. Novo is also establishing a new BD unit in Cambridge, MA to help facilitate additional R&D collaborations. This news comes as no surprise and is consistent with FENIX’s previous insight regarding Novo’s shift in R&D strategy as evidenced by 7 external R&D collaborations/acquisitions thus far in 2018. Below, FENIX provides thoughts on Novo’s new R&D strategy.

This content is for Read Less members only.
Register

Already a member? Log in here

Oramed Oral GLP-1RA Receives IND Approval

Oramed announced FDA cleared its IND application for ORMD-0901, an oral GLP-1RA believed to be using exenatide. According to the press release, Oramed is planning to initiate a Ph1 PK study in Q3 ’18 with intentions to move into Ph2 in 2019. The Ph1 study has not yet been posted on CT.gov, but the press release said the Ph1 study will be a 4-way crossover vs. Byetta in 15 healthy subjects. Below, FENIX provides thoughts on ORMD-0901 in the context of Novo’s oral semaglutide.

This content is for Read Less members only.
Register

Already a member? Log in here

ViaCyte and CRISPR Therapeutics Collaborate for T1DM Stem Cell Therapy

ViaCyte and CRISPR Therapeutics announced a strategic collaboration to modify ViaCyte’s stem cell-based therapy to reduce or eliminate the need for immunosuppression. Below, FENIX provides insight on the collaboration including context from the CRISPR patent dispute.

This content is for Read Less members only.
Register

Already a member? Log in here

Beta Bionics Raises $50M, but No Lilly Investment

Beta Bionics announced it has secured $50M thus far in a Series B round. Interestingly, the press release states Novo has participated in the Series B, but there was no mention of Lilly. Recall, Both Novo and Lilly previously invested $5M each in the Series A financing. Zealand also committed $5M to the Series B fresh off its $205M cash injection from the sale of Soliqua/Lyxumia royalties. Below, FENIX provides thoughts on the Beta Bionics financing including Lilly’s apparent decision to refrain from further investment.

This content is for Read Less members only.
Register

Already a member? Log in here

New Lilly Academic Collaboration to Help Compete with Novo/Oxford

Lilly and the Indiana Bioscience Research Institute (in collaboration with Indiana University School of Medicine) have partnered to create the “Lilly Diabetes Center of Excellence” (LDCE). According to the press release, the LDCE will support “cutting-edge research in diabetes, diabetic complications, and related metabolic disorders.” Lilly’s decision to create the LDCE appears to be (at least in part) driven by a need to keep up with Novo’s collaboration with The University of Oxford. Below, FENIX provides thoughts on the LDCE including a comparison with a similar program between Novo and University of Oxford.

This content is for Read Less members only.
Register

Already a member? Log in here

CREDENCE and CANVAS Filing Update & Implications

J&J hosted its pharmaceutical business review and provided a brief update on its diabetes business. J&J disclosed its intention to file CREDENCE in “2019”, which is later than initially projected by FENIX (late Q3 ’18 / early Q4 ’18). There was no discussion in the prepared remarks on the US review of CANVAS/R. Below, FENIX discusses a hypothesis where delaying the CREDENCE filing to 2019 could signal the CANVAS FDA discussions are going well and Invokana is likely to receive a CV protection indication.

This content is for Read Less members only.
Register

Already a member? Log in here

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.

This content is for Read Less members only.
Register

Already a member? Log in here

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.

This content is for Read Less members only.
Register

Already a member? Log in here

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.

This content is for Read Less members only.
Register

Already a member? Log in here

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.

This content is for Read Less members only.
Register

Already a member? Log in here