Category Archives: Topics

REWIND Safety Issue? Lilly Q3 ’18 Earnings Update

Lilly hosted its Q3 ’18 earnings call and provided updates to its diabetes business including commentary on the recent REWIND topline results. Of note, Lilly’s first Ph3 study for its GIP/GLP dual agonist, now called tirzepatide, has been posted on CT.gov. Furthermore, Lilly said it has purchased a priority review voucher (PRV), but did not disclose how it will be used. Below, FENIX provides its new thoughts on REWIND safety, why Lilly’s PRV would be used for REWIND, and other key highlights from the earnings call.

This content is for Read Less members only.

Already a member? Log in here

Mylan Q3 ’18 Earnings Update

Mylan hosted its Q3 ’18 earnings call (press release) and briefly discussed its bs-glargine. In response to an analyst’s question regarding Merck/Samsung discontinuing glargine development, Mylan affirmed they believe they can launch bs-glargine and still maintain adequate margins. Furthermore, Mylan senior management stated that they are continuing to work with FDA to find a path forward for a substitutable product.

This content is for Read Less members only.

Already a member? Log in here

Positive Trulicity CVOT Creates Many Market Implications

Lilly announced positive topline results from the Trulicity CVOT, REWIND, demonstrating a reduction in 3P-MACE in a patient population which included ~70% primary prevention. Of note, Lilly did not provide any Hazard Ratios so the amount of CV protection remains unclear. Below, FENIX provides thoughts on the potential impact to guidelines and the GLP-1RA market if FDA grants a broader CV indication (reduction in 3P-MACE in T2DM patients with CV risk factors) than the Victoza, Jardiance, and Invokana labels.

This content is for Read Less members only.

Already a member? Log in here

New Lilly and Novo Trials: Trulicity vs. Ozempic Pens, Fiasp U200, and QW Insulin

A series of new Lilly and Novo studies have been observed on CT.gov. These include a Ph4 trial comparing the Trulicity auto-injector to the Ozempic FlexTouch, a new Fiasp U200 formulation Ph1 study, and two Ph1 clamp trials for Novo’s QW insulin 287. Below, FENIX provides thoughts on each of the respective studies.

This content is for Read Less members only.

Already a member? Log in here

Novo Q3 ’18 London Earnings Event

Novo Nordisk hosted its post-Q3 ’18 earnings event in London. The session was primarily comprised of Q&A with topics including high dose Ozempic as well as an update on Novo’s priority review voucher. Below are highlights from the call.

This content is for Read Less members only.

Already a member? Log in here

UPDATED: No Approval for Dexcom Verily G1

Yesterday, FENIX observed a J.P. Morgan analyst research publication from earlier in the week that reported Dexcom’s Verily G1 received approval based on an FDA 510(k) posting entitled “Dexcom G6 Glucose Program Continuous Glucose Monitoring System”. The research publication seemed highly credible since it was produced by the award-winning J.P. Morgan healthcare research analyst team and the FDA source was publicly available. Later, J.P. Morgan analyst Robbie Marcus admitted the incorrect reporting of the Verily G1 approval in a subsequent publication. Below are screenshots from each J.P. Morgan publication obtained by FENIX.

This content is for Read Less members only.

Already a member? Log in here

Insulet and Tandem Q3 ’18 Earnings Updates

Insulet and Tandem hosted their Q3 ’18 earnings calls and provided updates to their respective diabetes device portfolios. Of note, Insulet announced that the Omnipod Horizon automated insulin delivery (AID) system will be controlled directly by the user’s smartphone. If approved, Horizon is anticipated to be the first smartphone-controlled insulin pump. Recall, Tandem also plans to utilize smartphone control for its t:sport pump. Below are highlights from the respective earnings calls.

This content is for Read Less members only.

Already a member? Log in here

Lexicon and MannKind Q3 ’18 Earnings Updates

Lexicon and MannKind hosted their Q3 ’18 earnings calls and provided updates for their respective marketed and pipeline products. Lexicon continues to state they are preparing for an early 2019 FDA adcom for Zynquista (sotagliflozin) T1DM indication. Recall, the PDUFA is March 22, 2019. Below are highlights from the respective earnings calls.

This content is for Read Less members only.

Already a member? Log in here

Novo to Pursue High-Dose Ozempic for T2DM; Q3 ’18 Earnings Update

Novo Nordisk hosted its Q3 ’18 earnings call (press release) and provided updates to its diabetes business. Below are highlights from the call including Novo’s disclosure that it is pursuing high-dose Ozempic (2.4 mg) in T2DM to maintain best-in-class status ahead of Lilly’s anticipated GIP/GLP-1 dual agonist launch projected in 2023. Additionally, Novo has discontinued development of its Hypopen-1513, a glucagon rescue product for the treatment of hypoglycemia.

This content is for Read Less members only.

Already a member? Log in here

Dexcom Verily G1 Approved, But Will It Launch?

Dexcom’s Verily Gen 1 CGM has received 510(k) clearance ahead of initial projections. Dexcom has not yet issued a press release announcing the approval, but will likely discuss it during the upcoming Q3 ’18 earnings call on November 6. Below, FENIX provides thoughts on the Verily G1 CGM including whether or not Dexcom will even launch the product. Pictured below is a slide from Irl Hirsch’s 2017 talk at AACE comparing Verily G1 (top) and Verily G2 (bottom). The continued CGM innovation back-and-forth between Dexcom and Abbott is very impressive and exciting for patients. Recall, Abbott’s 14-day Libre product and……

This content is for Read Less members only.

Already a member? Log in here