Tag Archives: Diabetes

Xeris Glucagon to be Branded “Gvoke”; Xeris Issues 5M Additional Shares

Xeris announced a proposed public offering of 5M additional shares; and, in the S-1 document, disclosed the commercial name of its stable glucagon as “Gvoke” believed to be pronounced (gee’-voke), which appears to be a play on the word “evoke.”   Below, FENIX provides key highlights from the S-1 filing, thoughts on the impending Xeris glucagon launch in H2 ’19 (June 10, 2019 PDUFA date), and insight on potential read-through to Xeris from FDA’s upcoming decisions on Sanofi/Lexicon’s sotagliflozin in T1DM (March 22, 2019 PDUFA date) and Lilly’s nasal glucagon (PDUFA believed to be in April 2019).

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New Lilly and Novo uRAI pump trials: URLi ‘PRONTO-Pump-2’ and Fiasp in iLet Bionic Pancreas

Recently, FENIX has observed new Lilly and Novo pump trials on CT.gov. Lilly has posted a Ph3 trial for its ultra-rapid-acting insulin lispro (LY900014; URLi) for pumps in adults with T1DM called ‘PRONTO-Pump-2.’ Additionally, Novo has initiated a new Ph2 trial for Fiasp in an iLet Bionic Pancreas. Below, FENIX provides thoughts on the respective studies.

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Sanofi Discontinues 2 Dual-Agonist Programs; Q4 ’18 Earnings Update

Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.

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No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis from the call.

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Lilly to use PRV for REWIND? Novo Q4 ’18 London earnings update

Novo Nordisk hosted its post-Q4 ’18 earnings event in London. The session included a brief presentation from management followed by Q&A which primarily focused on Novo’s priority review voucher (PRV) for oral semaglutide. Below, FENIX provides highlights and analysis from the call, as well as the scenario that Lilly could use its PRV for REWIND to keep pace with Novo.

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BD CY Q4 ’18 (FY Q1 ’19) Earnings Update

BD held their Q4 ’18 earnings call and provided a brief update on their diabetes business unit. Senior management disclosed they have filed their T2DM patch pump in the US and European and anticipate a launch in late 2019. When asked by an analyst about their market approach for the T2DM patch pump, senior management commented that BD is in the process of defining their channel strategy. Furthermore, management does not anticipate any new clinical data to presented at ADA 2019.

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JDRF Criticizes Medtronic/UHC For Reducing Patient Choice

JDRF has issued a press release criticizing UnitedHealthcare’s decision to extend Medtronic’s exclusive status for supplying insulin pumps to its covered lives. Recall, Medtronic first signed the deal with UHC in May 2016, which applied to patients 18 years of age and older. However, with FDA’s approval of the 670G pump in patients down to 7 years of age, UHC has extended the agreement to this population. Patients on existing pump therapy or patch pumps (e.g. Insulet Omnipod) are not impacted. Below, FENIX provides thoughts on UHC’s decision, the potential impact to Tandem’s pump business, and the potential irony of JDRF’s criticism.

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Senseonics/Roche Renew Distribution Agreement; Acquisition Unlikely

Senseonics announced it has come to an agreement with Roche to extend the existing distribution agreement for the Eversense implantable CGM. Additionally, Senseonics held an investor webcast to discuss the updated agreement. Below, FENIX provides a summary of the webcast as well as thoughts on why it may have made more sense for Roche to extend the partnership than to outright buy Senseonics.

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Dapa T1DM Positive CHMP Opinion for AZ

AZ received a positive CHMP opinion for dapagliflozin in T1DM and confirmed that dapa T1DM is under review by FDA. The company will likely discuss the positive CHMP opinion and US filing during its Q4 ’18 earnings call on February 14. Below, FENIX provides thoughts on a dapa T1DM indication in the context of the recent sotagliflozin FDA adcom.

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