A series of cardiometabolic-related news items have been observed from Pfizer, Novo Nordisk, D&D Pharmatech, Skye Bioscience, and Intarcia. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related updates have been observed: Dexcom announced Jake Leach (view LinkedIn) has been promoted to COO; Biocon announced it received more Form 483 observations; Seraxis announced the appointment of Paul Strumph (view LinkedIn) to CMO; and Intarcia Therapeutics received a letter from FDA (view here) denying a hearing for ITCA-650. Below, FENIX provides context and insight on the respective news items.
Three cardiometabolic-related news items have been observed: It has been reported that Intarcia Therapeutics has filed for a Notice of Opportunity for a Hearing with FDA for ITCA-650 (link to WSJ article); Provention Bio announced topline results from preliminary analysis of popPK model; and Zealand announced topline results for Ph1b trial with GLP1-GLP2 dual receptor agonist (dapiglutide). Below, FENIX provides highlights and insights for the respective new items.
The news of Intarcia receiving a second CRL for ITCA-650 (previous FENIX insight) brings about several thoughts and potential market implications. Below, FENIX provides its latest thinking in a favors/disfavors analysis about Intarcia, the GLP-1RA market, and a reminder that others in diabetes have received FDA approval after 2 CRLs.
It has been observed that Intarcia’s March 9 PDUFA date for ITCA-650 has passed. To the best of FENIX’s knowledge, there has been no company announcement from Intarcia and no new NDA database entries seen in an Orange Book search. Recall, after receiving a Sept 2017 CRL, Intarcia re-filed the ITCA-650 NDA on or around September 9, 2019, with a subsequent acceptance announcement on October 8, 2019 (previous FENIX insight). FENIX will provide analysis and market implications once a company announcement is made from Intarcia.
Intarcia announced FDA accepted the ITCA-650 re-filing, nearly 2 years after it received a CRL. Additionally, Dexcom announced it received FDA clearance for a new G6 professional CGM. Below, FENIX provides thoughts and insights on the respective news items.
Intarcia has a new CMO according to their completely redesigned website. Fred Fiedorek has seemingly replaced Michelle Baron, and this is a big deal. Fiedorak assumes the role of Chief Medical Officer and Global Head of Regulatory Affairs at Intarcia, where he leaves Rhythm Pharmaceuticals in Boston after working on relamorelin and setmelanotide.
Intarcia announced it has appointed Thane Wettig (pictured below) as the new Chief Marketing Officer and Metabolic Franchise Head.