Category Archives: SGLT2i

AZ Drops Lawsuit Over Generic Farxiga

According to court documents, AZ has dismissed its lawsuit against Zydus Pharmaceuticals over Zydus’ generic Farxiga filing in the US. The suit was initially filed with the US District Court, New Jersey on May 3, 2018 and claimed infringement on two AZ patents (6,414,126 and 6,515,117). Interestingly, the suit was dropped even though Zydus did not answer AZ’s complaint or filed a motion for summary judgment. It is unclear as to why AZ decided to withdraw its lawsuit vs. Zydus; however, AZ and Zydus may have come to an agreement outside of the courts. Below, FENIX provides an analysis based on the FDA Orange Book and Paragraph IV filings.

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Lexicon Q2 ’18 Earnings Update

Lexicon hosted its Q2 ’18 earnings call and provided updates on sotagliflozin. Discussion centered on the potential FDA adcom for sotagliflozin in T1DM, DKA consensus guidelines being developed by ATTD, and the benefit of sotagliflozin in reducing hypoglycemia.

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Biocon/Mylan Glargine CRL; Biocon and Merck Q2 ’18 Earnings

Biocon hosted its CY Q2 ’19 (FY Q1 ’19) earnings call and provided an update on its biosimilar glargine development program including the CRL that was issued in early June 2018. Additionally, Merck hosted its Q2 ’18 earnings call and briefly touched on its diabetes business unit. Below, FENIX provides an overview of the calls and insight on Biocon’s glargine CRL.

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AZ Q2 ’18 Earnings Update

AZ hosted their Q2 ’18 earnings call and briefly discussed their diabetes portfolio, with particular focus on Farxiga and the upcoming DECLARE CVOT results.

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LLY Dual Agonist Advances to Ph3; Q2 ’18 Earnings Update

Lilly hosted its Q2 ’18 earnings call and provided updates on its marketed and pipeline products. Lilly announced three major pipeline updates including advancement of their QW GIP/GLP-1 agonist to Ph3 after meeting a “high bar” in Ph2 trials, filing of nasal glucagon, and discontinuation of their Ph1 GPR142 agonist. Of further interest, President of Lilly Diabetes, Enrique Conterno, indicated the median follow-up for REWIND would be ~5 years (providing an additional ~1 year for Kaplan-Meier curve separation compared to the 3.8-year median follow-up for LEADER).

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Novartis Discontinues LIK066 in obesity; Novartis and Abbott Q2 ’18 Earnings Updates

Novartis and Abbott both held their respective earnings calls today and provided updates to their respective commercial and pipeline products. Of note, Novartis disclosed it has discontinued development of LIK066 (dual SGLT1/2 inhibitor) for the treatment of obesity. Abbott believes it will be able to reach 1 million global Libre users by YE ’18. Below are highlights from the respective Q2 ’18 earnings calls.

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Thoughts on CREDENCE

CREDENCE was recently stopped early, bringing a multitude of thoughts and potential implications to the diabetes market. Below, FENIX provides deep, rich analysis on the potential results of CREDENCE, the possibility for CREDENCE to be in a combined FDA review with CANVAS/R, market and label implications, read-through to DECLARE, and how ARB history seems to be repeating itself with SGLT2i.

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J&J Q2 ’18 Earnings Update

J&J hosted its Q2 ’18 earnings call and provided brief updates on its diabetes business. Importantly, senior management did not make any comments regarding the early stopping of the CREDENCE study or the delay in the CANVAS/R CV indication. Below are highlights from the Q2 2018 J&J earnings call.

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Invokana Renal Outcomes Study (CREDENCE) Stopped Early

Janssen announced its Invokana renal outcomes study, CREDENCE, has stopped early for overwhelming efficacy. The trial was stopped early based on the recommendation of the Independent Data Monitoring Committee (IDMC) after a planned interim analysis. The news comes ~3 days after FDA delayed approval of Invokana’s CV safety indication.

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Invokana CV Indication Delayed 3-Months by FDA

Janssen announced FDA has extended the CANVAS/R sNDA review by 3 months with a new action date in October 2018. According to the press release, FDA requested the extension after receiving additional analyses from Janssen. Recall, BI/Lilly had a similar 3-month delay after FDA asked for additional data from the EMPA-REG OUTCOME study.

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