Category Archives: SGLT2i

Forxiga DECLARE EU Approval, BTD For Provention Bio’s Teplizumab (PRV-031), And MannKind/One Drop Collaboration

Today, three key news items were observed including the Forxiga DECLARE EU approval, Breakthrough Therapy Designation to Provention Bio’s Teplizumab (PRV-031) and a MannKind/ One Drop collaboration. Below, FENIX provides context and analysis for these announcements. 

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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New Jardiance TV DTC Campaign Observed

A new Jardiance TV DTC commercial, called “Audrey is on it,” has been observed. Of note, the commercial is set to the tune of the 1981 hit “Apache (Jump on it)” by the Sugarhill Gang, potentially in response to the success of other T2DM commercials that have also used jingles (Ozempic, Farxiga, and Tresiba). Below, FENIX provides analysis of the Jardiance TV commercial including insight on how the commercial’s football/marching band theme is apropos leading into the NFL and college football seasons.

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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Purchase Blast$599.00

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Lexicon Comments on Partnership Termination; Lexicon Q2 ’19 Earnings Update

Lexicon hosted its Q2 ’19 earnings call and provided updates to its business including commentary on Sanofi’s recent decision to end the sotagliflozin partnership. 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.

Merck Q2 ’19 Earnings Update

Merck hosted its Q2 ’19 earnings call but did not provide any updates to its diabetes business beyond the Januvia and Steglatro financial performances. Unsurprisingly, the vast majority of the discussion was focused on Merck’s oncology and HIV portfolios. Below, FENIX provides diabetes-related highlights 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.

Empa T1DM Filed with FDA; Oral GLP-1RA Advanced to Ph1; Lilly Q2 ’19 Earnings Update

Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.

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.

Sanofi Q2 ’19 Earnings Update

Sanofi hosted its Q2 ’19 earnings call and provided updates to its diabetes business unit including the recent Ph1 initiation for its GLP/GIP/GCG triple agonist (SAR441255). Unsurprisingly, Sanofi did not discuss its recent decision to terminate the Lexicon partnership for sotagliflozin. Below, FENIX provides diabetes-related 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.

Sanofi Terminates Partnership with Lexicon for Sotagliflozin Development

In a press release announcing topline results from three Ph3 sotagliflozin T2DM trials, Sanofi disclosed that it is “terminating the collaboration to develop, manufacture, and commercialize Zynquista in all ongoing global type 1 and type 2 diabetes programs.” Following Sanofi’s press release, Lexicon issued its own statement declaring Sanofi’s “notice invalid and Sanofi to be in breach of contract.” Below, FENIX provides initial thoughts and insights about the partnership termination including readthrough to AZ and BI/Lilly.

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 Approval Timeline Moved Up; AZ Q2 ’19 Earnings Update

AZ hosted its Q2 ’19 earnings call and provided updates to its diabetes commercial, clinical, and regulatory activities. Importantly, AZ updated the DECLARE US/EU regulatory decision timelines which are now both anticipated in H2 ’19 (previously said to occur in 2020). AZ also disclosed it has a new Ph1 GLP-1RA compound (MEDI7219). Discussion regarding the Farxiga T1DM CRL was minimal. Below, FENIX provides diabetes-related 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.

J&J Q2 ’19 Earnings Update

Johnson & Johnson hosted their Q2 ’19 earnings call and briefly discussed the Invokana franchise. Of note, management did not comment on the recent decision to return JNJ-64565111 rights back to Hanmi. Below, FENIX provides highlights and diabetes-related 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.

Dapa T1DM CRL Received by AZ

Today, AZ announced it received a CRL from FDA for the Farxiga T1DM label expansion. The news comes on the heels of the July 12 NICE recommendation for Forxiga T1DM reimbursement in the UK. Below, FENIX provides thoughts on what the AZ CRL could mean for the SGLTi class in T1DM, including read-through to BI/Lilly and Lexicon/Sanofi.

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.