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.
With the start of the 2019 EASD conference, a series of diabetes drug and device-related press releases have been observed including connected care partnerships between Novo/Medtronic and Sanofi/Abbott. Additionally, AstraZeneca announced that FDA granted Fast Track designation for dapagliflozin in worsening heart failure. Below FENIX insights and context from each respective announcement.
Dance Biopharm and DarioHealth recently announced a partnership to integrate data from Dance’s smart inhaler into DarioHealth’s digital health management platform. Recall, Dance is developing inhalable insulin and GLP-1RA products. Below, FENIX provides thoughts on the partnership including context from MannKind similar partnership with OneDrop for the Afrezza BluHale platform.
Today, Lexicon announced that Sanofi and Lexicon have amicably settled their differences in the termination of their collaboration for sotagliflozin. The settlement includes Sanofi to pay Lexicon $208M up front with the balance of $52M to be paid within 12 months ($260M total). Below, FENIX provides thoughts and perspective from the press release and the associated investor call.
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.
Lexicon participated in the 2019 Wells Fargo Healthcare conference and provided brief updates on the sotagliflozin development situation following Sanofi’s announcement that it was withdrawing from the partnership. Additionally, Lexicon briefly commented on sota’s potential in CV and CKD T2DM patients, but senior management made no statements regarding the recent Farxiga DAPA-HF results (previous FENIX insight). Below, FENIX provides highlights and insights from the event.
Zafgen announced that it is planning to “strategic options to maximize shareholder value,” including a merger, acquisition, or in-licensing opportunity. Following preliminary data from a new animal study, Zafgen believes that in the short-term, there is a low probability of resolving the clinical hold placed on ZGN-1061. Below, FENIX provides brief thoughts on potential outcomes for Zafgen and ZGN-1061.
A CT.gov record has been observed for a new Sanofi-sponsored T1DM Ph4 Toujeo vs. Tresiba H2H non-inferiority trial utilizing CGM. Of note, the trial, called “inRange,” will evaluate time-in-range (TIR) as the primary outcome. Below, FENIX provides thoughts on this new trial in the context of the ongoing basal insulin saga between Sanofi and Novo Nordisk.
Livongo hosted its first earnings call following its July 2019 IPO. Senior management provided an overview of the company including its client and member growth prospects. Below, FENIX provides highlights and insights from the call including thoughts on why the Livongo stock plummeted following the company’s first earnings release.