Novo has initiated a new renal outcomes trial for Ozempic called “FLOW.” Below, FENIX provides thoughts on the trial in the context of LEADER (Victoza) and SUSTAIN 6 (Ozempic) results. Additionally, FENIX constructed a renal outcomes comparison table including the GLP-1RA and SGLTi classes.
Senseonics announced that its Eversense implantable CGM has been approved for MRI-compatibility (i.e. patients can receive an MRI without the sensor having to be extracted). Of note, patients must still remove the external transmitter prior to the MRI procedure. Below, FENIX provides thoughts on how this label update could impact Eversense uptake.
Livongo announced its intention to acquire myStrength, a Colorado-based behavioral health company focused on chronic conditions including depression, anxiety, stress, substance use disorder, chronic pain, opioid addiction and recovery, and insomnia. Below, FENIX provides insight into the acquisition including thoughts on how Livongo may be leveraging myStrength to expand Livongo’s core diabetes business.
Today, the Senate Finance Committee held the first hearing of 2019 and it highlighted US drug pricing (Drug Pricing in America: A Prescription for Change, Part I). A majority of the 3-hour discussion focused on Medicare Part B and D, Medicaid best pricing, 340B incentives, and diabetes insulin pricing in particular. Of note, when insulin was discussed, it was largely in the context of Lilly and Humalog with no mention of Novo or Sanofi. Below, FENIX provides diabetes-related highlights from the hearing and thoughts on the national discussion on drug pricing.
Biocon hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and rh-insulin. Below, FENIX provides highlights from the call as well as additional perspective on Mylan’s upcoming bs-glargine commercialization following the 30-month stay (March 2020).
A new study evaluating the effect of semaglutide on retinopathy in T2DM, called “FOCUS,” has been posted on CT.gov. Recall, data from Novo’s SUSTAIN 6 study showed an imbalance in retinopathy with a 1.76 hazard ratio (50 events with sema vs. 29 with placebo) which resulted in a label warning. Below, FENIX provides details from the study as well as thoughts on how Novo will leverage the data.
Abbott hosted its Q4 ’18 earnings call and provided brief updates on its diabetes business. Of note, Abbott disclosed that Libre now has >1.3M global users, +300k from the previous quarter. Below, FENIX provides a summary from the call as well as thoughts on Libre’s growth potential.
Oramed has initiated its first ORMD-0901 (oral GLP-1RA) Ph1 study under its FDA IND application. Additionally, Zafgen and vTv Therapeutics recently announced data from their respective Ph2 programs for ZGN-1061 (MetAP2 inhibitor) and TTP399 (glucokinase activator). Below, FENIX provides an overview of the Oramed Ph1 study, Zafgen and vTv Ph2 data, and thoughts the viability of each program in the antihyperglycemic market. Oramed Ph1 Oral GLP-1RA initiation Oramed announced the initiation of its first Ph1 study under their FDA IND application. Recall, The IND was granted in September 2018. According to the press release, the Ph1 trial is a randomized, single-blinded crossover……
JNJ hosted its Q4 ’18 earnings call (press release) and briefly discussed financial results for its Invokana franchise. Of note, the recent Invokana CV indication listed on a single slide, but was not discussed during prepared remarks or Q&A (see previous FENIX insight). Below, FENIX provides financial highlights for Invokana and perspective on the ongoing CV indication launch.
MannKind recently announced a new direct purchase program for Afrezza, offering the drug for as little as $4/day for the first 1000 patients who sign up for the program through http://www.insulinsavings.com. Additionally, MannKind said it is launching an enhanced $15 copay card program; however, the copay card website does not appear to have been updated as of yet. Below, FENIX provides thoughts on the Afrezza program, an RAI pricing analysis, and insight how the program may help drive payer coverage. Afrezza direct purchase program details The Afrezza direct purchase program allows the first 1000 patients a $120 introductory price for 90……