Roche hosted its Q2 ‘19 earnings call and provided brief updates to their diabetes business. Of note, Roche’s earnings press release stated that the Accu-Chek Guide Me, a low-cost version of the Accu-Chek Guide, has been launched in the US. Below, FENIX provides highlights from the call.
AZ hosted its Q2 ’19 earnings call and provided updates to its diabetes commercial, clinical, and regulatory activities. Importantly, AZ updated the DECLARE US/EU regulatory decision timelines which are now both anticipated in H2 ’19 (previously said to occur in 2020). AZ also disclosed it has a new Ph1 GLP-1RA compound (MEDI7219). Discussion regarding the Farxiga T1DM CRL was minimal. Below, FENIX provides diabetes-related highlights and insights from the call.
Lilly’s nasal glucagon has been approved by FDA under the brand name “BAQSIMI”. Recall, during Lilly’s Q1 ’19 earnings call, Lilly announced that FDA delayed the approval by 3 months. FENIX will be conducting an in-depth label analysis in the coming days.
Pack Health announced it has formed a partnership with Glooko to allow for the integration of Glooko’s patient data into Pack Health’s coaching platform. Of note, the press release states that the two companies have already completed a live beta test of the integrated systems. Below, FENIX provides thoughts on the partnership including insight as to how Glooko may be looking leverage Pack Health to follow in Livongo’s footsteps for a potential Glooko IPO.
Medtronic announced it has filed a PMA with FDA seeking a non-adjunctive (insulin dosing) claim for the Guardian Sensor 3 as part of the 670G platform. The timing is consistent with Medtronic’s CGM roadmap from its 2019 ADA investor presentation. Below, FENIX provides thoughts on the filing including the curious observation that Medtronic chose to file as part of the SAP system and not the standalone Guardian Connect CGM.
The CHMP agenda for this week’s meeting has been released, and it includes eight notable items of which Lilly’s REWIND is likely the most significant. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.
Abbott hosted its Q2 ’19 earnings call and provided updates to its FreeStyle Libre commercial performance and LCM initiatives. Curiously, Abbott did not provide an update on the number of global Libre users which it had been consistently disclosing over recent quarters. Below, FENIX provides highlights and insights from the call.
Johnson & Johnson hosted their Q2 ’19 earnings call and briefly discussed the Invokana franchise. Of note, management did not comment on the recent decision to return JNJ-64565111 rights back to Hanmi. Below, FENIX provides highlights and diabetes-related insights from the call.
MannKind announced it formed a partnership with GoodRx to “help raise awareness on ways patients can save money on their mealtime insulin.” Recall, GoodRx is a platform designed for patients without insurance or high-deductible plans to help them compare drug prices and identify savings opportunities (e.g. copay cards). Of note, the MannKind press release appears to suggest that the sole purpose of the partnership is to promote the Afrezza copay card. Below, FENIX provides brief thoughts on the MannKind partnership with GoodRx.
Today, AZ announced it received a CRL from FDA for the Farxiga T1DM label expansion. The news comes on the heels of the July 12 NICE recommendation for Forxiga T1DM reimbursement in the UK. Below, FENIX provides thoughts on what the AZ CRL could mean for the SGLTi class in T1DM, including read-through to BI/Lilly and Lexicon/Sanofi.