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……
Following the T1DM sotagliflozin FDA adcom, Lexicon held an investor call (Sanofi and Lexicon press release) to discuss the panel’s 8-8 split vote (previous FENIX insight). Lexicon senior management briefly summarized the panel’s commentary before answering questions from financial analysts. Following the vote, Lexicon’s stock opened ~24% down. Below, FENIX provides an overview of post-adcom Lexicon webcast as well as additional thoughts on how the companies will overcome the split vote. The -24% market reaction to Lexicon’s stock price (shown in the chart above) is anticipated to rebound, particularly as Lexicon senior management seek to do damage control with institutional investors…….
Today, the FDA advisory committee panel split the vote (8-8) on whether the sotagliflozin benefit in T1DM outweighs the risks. Of note, the clinicians who treat glycemic control and T1DM tended to vote “yes” while the cardiologists and biostatisticians tended to vote “no.” Below, FENIX provides key highlights of the FDA adcom as well as market implications and read-through to the other SGLT inhibitors being developed for T1DM.
The Trulicity label has recently been updated with 3 major changes: 1) lower rates of hypoglycemia based on moving the cutoff from <70mg/dL to <54mg/dL, 2) inclusion of AWARD-10 data (add-on to SGLT2i), and 3) discontinuation of the pre-filled syringes. Below, FENIX provides analysis of the Trulicity label update including a focus on the broader market implications of lowering the hypo cutoff. Trulicity hypo label data improves competitive messaging vs. Ozempic The Trulicity label was updated with new, lower hypo rates using a lower hypo cutoff to match Ozempic and Bydureon. In the old Trulicity label, the cutoff was high……
Lexicon stock trading has been halted ahead of today’s sotagliflozin T1DM FDA adcom. The previous close was $7.70. FENIX will be providing a full analysis of the adcom.
Briefing documents for the Sanofi/Lexicon sotagliflozin in T1DM FDA adcom were posted today in advance of the January 17, 2019 meeting. As anticipated, FDA’s primary concern appears to be the increased risk of DKA with sotagliflozin; however, Sanofi/Lexicon’s mitigation strategy is projected to quell the concerns of the FDA adcom voting panel. Below, FENIX provides further analysis of the briefing documents, and in light of this evidence, FENIX predicts the results of the adcom will be positive for Sanofi/Lexicon. Executive Summary The 16-member panel will be asked to respond to 4 discussion questions (sota benefits for T1DM, concern for risk of DKA, differences between……
The third day of the 2019 J.P. Morgan Healthcare conference included a presentation from Becton Dickinson, which is the final diabetes-related presentation of the conference. BD senior management briefly discussed their T2DM patch pump, called Swatch, which has already been filed with FDA with a limited launch scheduled before YE 2019. Below, FENIX provides key takeaways from the BD presentation and thoughts on the future T2DM pump market including a competitor comparison table. In case you missed it, here are links to FENIX’s Day 1 and Day 2 JPM 2019 insights. Becton Dickinson In response to an analyst’s question, BD management……