Category Archives: Basal Insulin

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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Novo to File Oral Sema with PRV; Q4 ’18 Earnings Update

Novo Nordisk hosted its Q4 ’18 earnings call and disclosed that it will use its priority review voucher (PRV) for the oral semaglutide US filing by the end of Q1 ’18. Of note, Novo is planning to file for Ozempic and oral semaglutide CV indications based on the results from SUSTAIN 6 and PIONEER 6 despite PIONEER 6 not achieving statistical significance for 3P-MACE. Below, FENIX provides highlights from the earnings call, additional insight on the semaglutide regulatory strategy, and thoughts on why Novo likely wants an oral semaglutide adcom.

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Lilly Repeatedly Called Out During US Senate Hearing on Drug Pricing

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.

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Biocon CY Q4 ’18 (FY Q3 ’19) Earnings Update

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).

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JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced the……

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Thoughts on 2019 ADA Standards of Care

The ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Of note, the ADA has aligned their CVD recommendations with the ACC’s recent T2DM ASCVD recommendations. The ADA also added a new dedicated section titled “Diabetes Technology,” which includes information previously incorporated in the “Glycemic Targets” section. The ADA also provides a cost breakdown of pharmacologic treatment options. Below, FENIX has provided highlights and insights from the updated ADA 2019 Standards of Care.

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Gan and Lee + Sandoz and FDA Biosimilar Insulin BLA List

Today, Sandoz announced it has in-licensed the biosimilar insulin portfolio of Gan & Lee for commercialization of glargine, aspart, and lispro. Last week, FDA published a Q&A document and a list of biologics that will convert from NDA to BLA under the US BPCI Act of 2010, which include insulin products. Below, FENIX briefly provides thoughts on each topic.

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Mylan invalidates two Lantus patents

Today, Mylan announced the US Patent and Trademark Appeal Board (PTAB) has dismissed two of Sanofi’s Lantus patents thereby favoring Mylan/Biocon’s biosimilar glargine. Importantly, Mylan seems to indicate that it has responded to the June 2018 CRL by describing its Lantus 505(b)(2) NDA as “…under active review…” by FDA. Below, FENIX provides additional thoughts on Mylan’s announcement in the context of a tentative approval of Mylan’s bs-glargine pending its 30-month patent litigation stay with Sanofi. Recall, Mylan filed biosimilar glargine with FDA in Q3 ’17 which triggered a 30-month stay as a result of the patent infringement lawsuit filed by Sanofi. As per the PTAB ruling, Sanofi’s……

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Small Lantus Label Update

According to Drugs@FDA, the Lantus SoloStar label has been updated with changes in “Section 2.1 Dosage and Administration.” Below, FENIX provides additional details on the updated dosing instructions in comparison to the other marketed basal insulins. The updated label language (see excerpt below) includes the 1-unit dose dialing increments for the Lantus SoloStar pen. In addition to this change, a warning note has been added regarding audible clicks for visually impaired patients. Source: Lantus Solostar label from Drugs@FDA database The updated dosing instructions for unit dosage dialing and use in visually impaired patients seems to be consistent with other marketed……

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