Tag Archives: Ozempic

Novo has a PCSK9i; Novo Q3 ’19 Earnings Update

Novo Nordisk hosted its Q3 ’19 earnings call (press release) and provided updates to its diabetes business, including details on the Ozempic and Rybelsus launches, discontinuation of an oral GLP-1RA (OG2023SC) due to promising new formulations of oral semaglutide, and other pipeline activities. Of note, Novo disclosed that it is developing a PCSK9i compound for potential co-formulation with its other pipeline products. Below, FENIX provides highlights and insights from the call.

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New Semaglutide Formulations in Ph2 Pen Trial

A CT.gov record for a new Ph2 trial has been observed comparing FlexTouch (PDS290) to the DV3396 pen as well as two different formulations of semaglutide (“Semaglutide B” and “Semaglutide D”). Recall, in July 2019, Novo initiated a nearly identical Ph2 study evaluating two formulations of semaglutide in the same injectors. Below, FENIX provides updated insights regarding the trials, DV3396 injection device, and the new semaglutide formulations.

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Oral Semaglutide Approved as “Rybelsus”

Novo Nordisk announced FDA approval of its oral semaglutide which is now branded as “Rybelsus” (view Rybelsus US label here). Rybelsus (pronounced reb-EL-sus) appears to be a play on the word “rebel” alluding to the idea that oral semaglutide is rebelling against injectable GLP-1RA. Recall, Novo filed oral semaglutide on March 20, 2019 with a priority review voucher (PRV) which allowed for a short 6-month review. Below, FENIX provides a Rybelsus label analysis, thoughts on the impending launch, and potential insights into the upcoming CV indication PDUFAs for Ozempic and Rybelsus.

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Novo Semaglutide Pen Story Continues to Evolve

Novo initiated a Ph1 trial evaluating its new semaglutide injection pen (DV3396) as well as “two different forms of semaglutide” in patients who are overweight or obese. Recall, Novo recently initiated a separate Ph2 trial comparing injection site pain with DV3396 and FlexTouch pens. Below, FENIX provides updated insights regarding the DV3396 injection device based on new information from this Ph1 study.

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New Ozempic Pen Ph2 Trial

A CT.gov record has been observed comparing FlexTouch (PDS290) to the DV3396 pen which appears to be a modified version of the previously studied DV3372 pen (previous FENIX insight). Below, FENIX provides additional insight into Novo’s next-gen semaglutide pen platform.

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Novo Initiates Ozempic TV DTC

The first Ozempic TV DTC commercial, called “Oh!,” has been observed. Of note, the commercial is set to the tune of the 1975 hit “Magic” by Pilot, likely in an attempt to build upon the success of the jingle from the “Tresiba Ready” DTC campaign. Interestingly, the commercial primarily uses messaging from the SUSTAIN 2 (vs. Januvia) and SUSTAIN 6 (CVOT) studies. Below, FENIX analyzes the first Ozempic TV commercial and provides an update on the Ozempic launch.

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