Category Archives: Topics

REWIND Filed; Empa T1DM, Nasal Glucagon Delayed; Lilly Q1 ’19 Earnings Update

Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Victoza Pediatric Trial (ELLIPSE) Results and Regulatory Filings

Yesterday, Novo Nordisk presented results from the Victoza T2DM pediatric trial (ELLIPSE) at the Pediatric Endocrine Society/Pediatric Academic Societies annual meeting. Importantly, the results were published in the NEJM, which may be a testament to the growing attention on childhood T2DM/obesity. Additionally, Novo disclosed that it has submitted the data to US and EU regulators, although it did not specify the timing. Below, FENIX provides an overview of the ELLIPSE results – including the non-significant weight loss findings, and thoughts on the study in the context of Victoza’s impending LOE and recent settlement with Teva.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Biocon CY Q1 ’19 (FY Q4 ’19) Earnings Update

Biocon hosted its CY Q1 ’19 (FY Q4 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and bs-aspart. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Zynquista Approved in EU for T1DM

Sanofi and Lexicon announced they received EU marketing authorization for the commercialization of Zynquista (sotagliflozin) in T1DM (200mg and 400mg doses). Recall, on February 28, 2019, CHMP adopted a positive opinion. Zynquista is now the second SGLTi to be approved by EU regulatory authorities. On March 25, 2019, Forxiga was granted approval. Below, FENIX provides brief thoughts on the approval.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lispro AG Excluded from ESI 2019 Commercial Formulary

Express Scripts has excluded Lilly’s lispro authorized generic (AG) from its 2019 National Preferred Formulary. The exclusion takes effect starting July 1, 2019. Recall, on March 4, 2019, Lilly announced its intention to launch the lispro AG at a 50% WAC discount. Below, FENIX provides brief thoughts on ESI’s exclusion decision.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

No Sotagliflozin CRL Clarity; Sanofi Q1 ’19 Earnings Update

Sanofi hosted its Q1 ’19 earnings call but only briefly discussed its diabetes business including the recent sotagliflozin T1DM CRL. Below, FENIX provides highlights and insights from the call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

DECLARE Filing Accepted; AZ Q1 ’19 Earnings Update

AstraZeneca hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, senior management disclosed that its Farxiga CVOT (DECLARE) filings have been accepted by US and EU regulatory authorities with approvals projected in 2020. Additionally, AZ said its Farxiga HF study (Dapa-HF) is projected to read out ahead of schedule (now in H2 ’19; previously 2020). Below, FENIX provides highlights and insights from the Q1 ’19 earnings call.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

No Lilly Nasal Glucagon Update?

Curiously, there has been no news from Lilly regarding the US regulatory status of its Locemia nasal glucagon product. Recall, during Lilly’s Q2 ’18 earnings, the company disclosed that it filed the nasal glucagon with FDA in Q2 ’18 (and July in EU). Assuming a 10-month review period, approval was projected by the end of April 2019. Below, FENIX provides thoughts on the Lilly nasal glucagon regulatory situation including the possibility that Lilly received a CRL from FDA.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Novo Oral Sema CVOT Initiated (SOUL)

A CT.gov record for Novo’s oral semaglutide CVOT, SOUL, has been observed. Novo recently announced the simultaneous filings for oral semaglutide T2DM glycemic control, oral semaglutide CV risk reduction, and Ozempic CV risk reduction. Below, FENIX provides a comparative GLP-1RA CVOT analysis as well as key considerations for the SOUL trial.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Abbott and Roche Q1 ’19 Earnings Updates

Abbott and Roche hosted their respective Q1 ’19 earnings calls and provided brief updates to their diabetes businesses. Of note, Abbott disclosed its Libre 2 US filing includes a request for iCGM designation. Below, FENIX provides highlights and insights from the calls.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.