Category Archives: Uncategorized

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.

This content is for Read Less members only.
Register

Already a member? Log in here

Intarcia re-filing mid-2019

Yesterday, Intarcia announced a corporate update, where the main news was that it intends to re-submit the ITCA-650 NDA in “mid-2019”. The announcement also quoted its three new senior team members, including Fred Fiedorek as Chief Medical Officer and Head of Regulatory (previous FENIX insight), Thane Wettig as Chief Marketing Officer (previous FENIX insight), and Anders Vinther as Global Head of Quality & Engagement. Intarcia’s 2017 CRL was well-publicized (previous FENIX insight), but Intarcia has seemingly been given a path to re-filing “…after several consultations with the FDA during 2018…”. If Intarcia re-files in June, it should have a PDUFA date……

This content is for Read Less members only.
Register

Already a member? Log in here

Abbott TV DTC for Libre 14-day system

FENIX observed that Abbott is conducting a TV DTC campaign for the Freestyle Libre 14-day system, placing a strong emphasis on the ease of sensor scanning without fingersticks. Below, FENIX summarizes the key messages and imagery from the new Libre commercial and compares it to Dexcom’s TV DTC campaign from earlier in 2018 (previous FENIX insight). Currently on iSpot.tv, there are two 30-second commercials listed for FreeStyle Libre: ‘No Fingersticks: Libre 14-day system’ (30 sec) – Newly observed from November 2018 ‘No more Fingersticks’ (30 sec) – First aired on February 2018 While Abbott has a central theme on the ease of sensor scanning without fingersticks for……

This content is for Read Less members only.
Register

Already a member? Log in here

Novo partners for hypertriglyceridemia asset

Today, Novo Nordisk announced an exclusive partnership with Staten Biotechnology for the development of novel treatments for hypertriglyceridemia. Of note, this is Novo’s first partnership focused on hypertriglyceridemia. Below, FENIX provides additional thoughts on this partnership in relation to Novo’s strategic priorities and R&D partnerships.

This content is for Read Less members only.
Register

Already a member? Log in here

ADA 2019 Standards of Care published

Today, the ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Notably, the 2019 ADA Standards of Care are aligned with the recently updated ADA/EASD guidelines. FENIX will conduct an analysis and provide thoughts on the 2019 ADA Standards of Care.

This content is for Read Less members only.
Register

Already a member? Log in here

Lilly’s Evidation Health Collaboration Expanded To Discover Novel Digital Health Measures

Today, Lilly and Evidation Health announced the expansion of their collaboration with a multi-year agreement that will provide Lilly with global access to Evidation’s Andromeda data platform. Of note, Evidation Health also has prior partnerships with Tidepool and Sanofi. Below, FENIX provides additional thoughts on this collaboration in the context of Lilly’s connected care strategy in diabetes. According to the press release, Lilly will leverage the Andromeda data platform across different therapeutic portfolios, including diabetes, to support the clinical utility of digital medicine and improve personalized health outcomes. The press release also noted that Andromeda data platform is being used……

This content is for Read Less members only.
Register

Already a member? Log in here

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……

This content is for Read Less members only.
Register

Already a member? Log in here

Tidepool Loop funded at $6M

Today, JDRF and Helmsley Charitable Trust announced a collaborative grant agreement by providing $6M of funding to Tidepool for the development of “Tidepool Loop”. Recall, Loop is an open-source, unregulated automated insulin delivery (AID) app for iPhone that connects to an insulin pump and CGM using BLE (see image below). Of note, Tidepool intends on further developing the app by making it an FDA-regulated, hybrid closed-loop AID app for iOS with interoperability across multiple insulin pumps and CGMs. Below, FENIX provides additional thoughts on Tidepool Loop. Source: Tidepool website This news comes as no surprise considering the recent announcement from Tidepool in October 2018, indicating the initiation of the Loop project, which aimed to develop……

This content is for Read Less members only.
Register

Already a member? Log in here

New Sanofi and Dexcom trials: Efpeglenatide add-on to MET+/-SU and G6 vs. Libre FGM

Recently, FENIX has observed new Sanofi and Dexcom trials on CT.gov. Sanofi has posted its Ph3 efpeglenatide trial (AMPLTITUDE-S) as an add-on to metformin (MET) with or without sulfonylurea (SU). Additionally, Dexcom has an investigator-initiated trial comparing the G6 CGM with Libre FGM in T1DM (ALERT-T1). Below, FENIX provides thoughts on the respective studies, as well as a comparison of GLP-1RA trials with MET+/-SU. Sanofi Efpeglenatide Ph3 study as an add-on to MET±SU (AMPLTITUDE-S) Sanofi has initiated AMPLITUDE-S for its QW GLP-1RA, efpeglenatide, as an add-on to MET±SU. Of note, this is the last pivotal study for efpeglenatide regulatory submission, anticipated to……

This content is for Read Less members only.
Register

Already a member? Log in here

Novo partners with e-Therapeutics to target T2DM

Today, e-Therapeutics announced a partnership with Novo Nordisk to discover novel intervention strategies, biological pathways, and target compounds for T2DM. According to the press release, Novo will work with e-Therapeutics for a 12-month period and use its proprietary Network-Driven Drug Discovery (NDD) to identify early targets and novel compounds. Below, FENIX provides thoughts on this collaboration and Novo’s efforts to build its early stage pipeline. With this collaboration agreement, Novo will utilize e-Therapeutics to foster the ongoing research conducted in their recently inaugurated Novo Nordisk Research Center Oxford (previous FENIX insight). Although the financial terms of the collaboration were not……

This content is for Read Less members only.
Register

Already a member? Log in here