Tag Archives: Diabetes

New T1DM Teplizumab Pivotal Ph3 trial (PROTECT)

FENIX has observed a new teplizumab pivotal Ph3 trial (PROTECT) on CT.gov. Teplizumab is an anti-CD3 monoclonal antibody being studied for new-onset T1DM. Of note, the initiation of this pivotal trial is earlier than the previous guidance from Provention Bio (previously late 2019). Below, FENIX provides thoughts on this new trial in the context of the failed Ph2/3 PROTÉGÉ study for teplizumab when the compound was under the control of Macrogenics.

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Fractyl Hires Former Sanofi and Intercept VPs

Fractyl, a Massachusetts-based medical technology company, announced the appointments of former Sanofi diabetes VP Margaret Borys as Chief Commercial Officer and former Intercept SVP Juan Carlos Lopez-Talavera as Chief Medical Officer. Below, FENIX provides thoughts on the appointments.

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Novo-Teva Generic Victoza Settled; Launch Date Rationale Unclear

Novo Nordisk announced it has settled the patent dispute with Teva regarding Teva’s ANDA filing for generic Victoza. Recall, in February 2017, Teva publicly disclosed the generic Victoza filing, and Novo subsequently announced their lawsuit in March 2017. According to the press release, Novo and Teva’s settlement entitles Teva to launch generic Victoza as early as December 22, 2023 (without pediatric exclusivity) unless Novo’s Victoza patents are invalidated or another generic Victoza is launched. Below, FENIX provides thoughts on the settlement with Teva as well as insight into the Victoza pediatric exclusivity extension.

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Potential Sanofi Bs-Aspart US Regulatory Strategy; New Interchangeability Trial

A new trial evaluating Sanofi’s biosimilar aspart (SAR341402) has been observed on CT.gov. The trial, called GEMELLI X, is an open-label, crossover design comparing SAR341402 vs. NovoLog in 184 T1DM adults who are also on glargine U100. The name of Sanofi’s Ph3 program is clever in that Gemelli is a type of pasta derived from the Italian word for “twins.” The “X” in this trial appears to reference the crossover design. Below, FENIX provides thoughts on the trial as well as insight into Sanofi’s potential strategy to delay filing until after March 23, 2020 thereby allowing for regulatory submission via the 351k biosimilar pathway.

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Lexicon Quiet on Sota T1DM Review; Q4 ’18 Earnings Update

Lexicon hosted its Q4 ’18 earnings call and provided brief updates to its Zynquista (sotagliflozin) clinical and regulatory activities across T1DM and T2DM. With the impending March 22, 2019 sota T1DM PDUFA, Lexicon senior management were reluctant to make comments or answer questions on the topic. For the sota T2DM development program, Lexicon said topline Ph3 data will start reading out in Q2 ’19. Below, FENIX provides highlights and insights from the call.

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New Eversense Bridge Program; Senseonics Q4 ’18 Earnings Update

Senseonics hosted its Q4 ’18 earnings call and provided updates to its Eversense clinical and commercial activities. Of note, Senseonics is launching a new bridge program to help drive user adoption. Recall, Senseonics recently renewed its distribution agreement with Roche and hired Fran Kaufman, former Medtronic CMO. Below, FENIX provides highlights and insights from the earnings call including updates to the Senseonics pipeline.

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Adocia Q4 ’18 Earnings Update; No Call Conducted

Adocia released its Q4 ’18 earnings results, but did not have an associated webcast. Below, FENIX provides highlights from the earnings press release including 2019 pipeline activities, and thoughts on how Adocia could enter the US and EU markets.

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Zafgen Q4 ’18 Earnings Update; ZGN-1258 Discontinued in PWS

Yesterday, Zafgen hosted its Q4 ’18 earnings call and discussed its pathway to have FDA remove the clinical hold on ZGN-1061, its novel MetAP2 inhibitor for the treatment of T2DM. Additionally, Zafgen disclosed it has discontinued development of ZGN-1258 for the development of Prader-Willi Syndrome due to unforeseen findings in rat toxicity studies. Below are highlights and insights from the call.

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New Head of AZ CVRM

In AstraZeneca’s press release regarding presentations at ACC 2019, Joris Silon was listed as the company’s new SVP of the CV, renal, and metabolism (CVRM) group. Recall, in October 2018, Novo announced that Ludovic Helfgott, previous head of AZ’s CVRM business, would be joining Novo as of April 3, 2019. According to Silon’s LinkedIn profile, he took the new position as of December 2018. Below, FENIX provides thoughts on Silon’s appointment to head AZ’s CVRM group as well as the headwinds and tailwinds that he faces.

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Thoughts on Potential Livongo IPO

Yesterday, The Wall Street Journal reported that Livongo is preparing for an IPO in 2019. According to the story, Livongo has already approached Morgan Stanley, Goldman Sachs, and JP Morgan to underwrite the IPO with a company valuation >$1B. Recall, in March 2017, Livongo raised $52.2M in a growth round, and in April 2018, it raised an additional $105M with a total of $240M in private financing (previous FENIX insight). Below, FENIX provides additional thoughts on the Livongo IPO.

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