Category Archives: Topics

DECLARE CHMP Decision This Week; Sanofi BS-Aspart Filed in EU? CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes some notable diabetes decisions including AZ’s DECLARE CVOT label update (Type II variation). Additionally, there is a new application for insulin aspart which is believed to be from Sanofi. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

This content is for Read Less members only.
Register

Already a member? Log in here

Adocia’s Pramlintide + Insulin Combo (ADO09) Ph1b Trial Posted on CT.gov

Consistent with Adocia’s ADA 2019 press release, a clinicaltrials.gov record has recently been observed for the company’s pramlintide + insulin (ADO09) Ph1b study. Below, FENIX provides an overview of the ADO09 Ph1b trial including thoughts on the market potential for ADO09 as a T1DM adjunctive therapy.

This content is for Read Less members only.
Register

Already a member? Log in here

New Semaglutide High-Dose T2DM Ph3 Trial (SUSTAIN FORTE)

Novo Nordisk’s Ph3 T2DM high-dose semaglutide trial (SUSTAIN FORTE) has recently been posted on CT.gov. Recall, Novo first disclosed its plans to study high-dose semaglutide in T2DM patients during its Q3 ’18 earnings call. Below, FENIX provides insight into SUSTAIN FORTE including context from Lilly’s recently initiated SURPASS-2 trial (tirzepatide vs. Ozempic) and the ongoing AWARD-11 high-dose Trulicity trial.

This content is for Read Less members only.
Register

Already a member? Log in here

Sanofi R&D Re-focusing; R&D Layoffs in France and Germany

According to Reuters, Sanofi is set to layoff 466 R&D-related jobs as part of an initiative to prioritize oncology, immunology, rare diseases, and vaccines while at the same time limiting internal CV R&D to its current pipeline. Furthermore, Sanofi is said to maintain the support of its diabetes and CV programs through its partners. Below, FENIX provides thoughts on the Sanofi R&D re-focusing in the context of the company’s CV/Met pipeline and recent senior management changes.

This content is for Read Less members only.
Register

Already a member? Log in here

New Tirzepatide vs. Ozempic H2H Ph3 Trial (SURPASS-2)

Lilly initiated its Ph3 tirzepatide vs. Ozempic H2H study (SURPASS-2) which is the 4th tirzepatide pivotal trial (not including Japan). The final pivotal trial, SURPASS-5 (add-on to basal insulin), is projected to initiate shortly. Below, FENIX provides an overview of SURPASS-2 as well as insight into the curious observation that the trial does not specify which dose of Ozempic is being used (0.5 or 1.0mg).

This content is for Read Less members only.
Register

Already a member? Log in here

Victoza Pediatric Indication Approved in US

Victoza has been approved by FDA for use in pediatric patients down to 10 years of age. Of note, the pediatric indication was approved as a priority review. Results of the ELLIPSE Victoza pediatric study were recently presented at the Pediatric Endocrine Society/PediatricAcademic Societies annual meeting and subsequently published in the NEJM. A Novo press release has not yet been observed. Below, FENIX provides brief thoughts on the approval including the impact to Victoza’s market exclusivity extension.

This content is for Read Less members only.
Register

Already a member? Log in here

Xeris Glucagon Ph3 Top-line Data vs. Novo’s GlucaGen

Xeris announced topline results from the fourth Ph3 trial evaluating its stable glucagon formulation for hypoglycemia rescue. This Ph3 crossover study demonstrated that Xeris’s glucagon was non-inferior to Novo’s NovoGen in terms of achieving a plasma glucose >70mg/dL or a ≥20mg/dL increase in 30 minutes following administration. Recall, Xeris recently announced that FDA requested an additional 3 months to review the company’s NDA submission with a new action date on September 10, 2019. Below, FENIX provides brief thoughts on the Ph3 crossover trial in the context of the ongoing Xeris glucagon regulatory review.

This content is for Read Less members only.
Register

Already a member? Log in here

Pfizer’s Oral GLP-1RA Advances to Ph2

Pfizer initiated the first Ph2 study evaluating its oral, small-molecule GLP-1RA (PF-06882961) in 400 T2DM subjects. Recall, during Pfizer’s Q1 ’19 earnings call, senior management said they intended to “swiftly” bring PF-06882961 into Ph2. Below, FENIX provides potential insight into the Ph2 study as well as context from other oral GLP-1RAs in development.

This content is for Read Less members only.
Register

Already a member? Log in here

Connected Care: Biocorp Receives CE Mark for Mallya

Biocorp announced it received CE Mark for the Mallya, a wraparound pen solution. Mallya turns any disposable or reusable insulin pen into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides insights and context to the impending Mallya launch including thoughts on how Mallya competes with Companion Medical or could be a compliment to Lifescan’s portfolio.

This content is for Read Less members only.
Register

Already a member? Log in here

Oral Sema Market-Shaping; Novo’s ADA 2019 PIONEER Presentation

On the last session of the last day at ADA 2019, there was a dedicated plenary session for the oral semaglutide development program. Despite the timing, the session was very well attended. The session provided an overview of the oral semaglutide molecule, its place in clinical practice (PIONEER 1, 5, and 8), comparison to alternative therapies (PIONEER 2, 3, 4, 7), and CVOT safety and efficacy results (PIONEER 6). Of note, approximately half of the time was dedicated to PIONEER 6. Below, FENIX provides additional thoughts on oral semaglutide including the ongoing regulatory situation, Novo Nordisk’s clear initiation of market-shaping activities, and insight into how oral semaglutide may fuel new patient lead generation of its entire portfolio.

This content is for Read Less members only.
Register

Already a member? Log in here