The CHMP agenda for this week’s meeting (September 16-20) has been released, and it includes two notable items (REWIND and dapa/saxa/met triple FDC opinions). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.
Xeris Pharmaceuticals announced FDA approval of its Gvoke pre-filled syringe (PFS) and auto-injector for hypoglycemia rescue in patients 2 years of age and older. Xeris held an associated call with investors following the approval announcement. The approval comes exactly 3-months after the PDUFA delay imposed by FDA. Below, FENIX provides an in-depth Gvoke label analysis in the context of the recent approval of Lilly’s nasal glucagon, Baqsimi.
Novo Nordisk announced plans to initiate a new US insulin savings program starting on January 2, 2020. Under the new plan, Novo will offer a $99 Cash Card Program for a select volume of any of its insulin analog products as well as the launch of NovoLog and NovoLog Mix Authorized Generics (AG). Below, FENIX provides thoughts on the New Novo insulin program in the context of similar programs by Lilly and Sanofi.
With the historic results of DAPA-HF recently presented at ESC 2019, FENIX provided some initial reaction. Today, FENIX continues to think about additional market possibilities and implications inside and outside SGLT2i dynamics in a winners-and-losers analysis format.
Lilly announced that an arbitration panel ruled in favor of Lilly with regard to a claim filed by Adocia over the former partnership between the two companies. The panel decided that Lilly is not liable to pay damages. Adocia issued its own statement and held a subsequent call with investors in which it disagreed with the findings of the panel. Below, FENIX provides additional commentary from Adocia and insights into the future potential of the Adocia’s BioChaperone franchise.
Lilly has initiated SURPASS-5 (add-on to glargine) which is the 5th and final tirzepatide pivotal Ph3 trial for T2DM. Below, FENIX provides an overview of SURPASS-5 as well as insight into why the study is likely using background glargine U100 and not all basal insulins as well as a high-level comparison between SURPASS-5 and the Trulicity AWARD-9 study.
A new Jardiance TV DTC commercial, called “Audrey is on it,” has been observed. Of note, the commercial is set to the tune of the 1981 hit “Apache (Jump on it)” by the Sugarhill Gang, potentially in response to the success of other T2DM commercials that have also used jingles (Ozempic, Farxiga, and Tresiba). Below, FENIX provides analysis of the Jardiance TV commercial including insight on how the commercial’s football/marching band theme is apropos leading into the NFL and college football seasons.
Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.
A CHMP opinion on Lilly’s REWIND CVOT was anticipated on Friday, July 26; however, there has been no press release from Lilly nor is REWIND listed on the July 2019 CHMP meeting highlights. Below, FENIX provides brief thoughts on the REWIND EU regulatory situation.
Recently, Lilly’s novel nasal glucagon hypo rescue product, Baqsimi [BAK-see-mee], was approved by FDA. Below, FENIX provides an in-depth analysis of the Baqsimi label, pricing strategy, and potential market implications for other novel glucagon rescue products from Xeris, Zealand, and Mylan.