Category Archives: Dual/triple agonist

OPKO Oxyntomodulin Ph2 Data; Is It Commercially Viable?

Today, OPKO announced positive topline results from the Ph2 dose-escalation trial of OPK88003 in obese T2DM patients. OPK88003 is QW injectable oxyntomodulin analog (GCG/GLP-1 dual agonist). Recall, OPKO gained rights to OPK88003 (previously TT401) when it acquired Transition Therapeutics in June 2016, after Lilly opted out of further developing the drug. Below, FENIX provides thoughts on the commercial viability of OPK88003 in the context of Lilly’s tirzepatide and Novo/Sanofi’s decisions to pursue triple-agonists over dual-agonists.

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 Lilly Tirzepatide vs. Tresiba Ph3 Pivotal Study (SURPASS-3)

A new tirzepatide vs. Tresiba Ph3 T2DM pivotal trial (SURPASS-3) has been observed on CT.gov. This is the second tirzepatide Ph3 T2DM study supporting its global regulatory approvals. Recall, in November 2018, Lilly initiated SURPASS-4 (vs. glargine in T2DM patients with increased CV risk). Lilly has also recently initiated two Ph3 Japanese studies (SURPASS-J-mono and SURPASS-J-combo). Below, FENIX provides thoughts on SURPASS-3 and potential insight into the trial design.

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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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.

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

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

Diabetes Takes a Backseat During Part II Drug Pricing Hearing

Today, the Senate Finance Committee held the second drug pricing hearing of 2019 (Drug Pricing in America: A Prescription for Change, Part II). Part I was held on January 29, 2019. While the Part I drug pricing hearing spent much time discussing insulin pricing, diabetes-specifically was hardly mentioned. When a specific drug was mentioned, it was most often AbbVie’s Humira. Below, FENIX provides diabetes-related highlights and insights from the hearing.

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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Farxiga LCM and Litigation Update; AZ Q4 ’18 Earnings Summary

AstraZeneca hosted its Q4 ’18 earnings call and provided a brief update on its diabetes business including Farxiga LCM initiatives (T2DM CVOT, T1DM, HF, and CKD). Of note, as part of AZ’s business reorganization, MedImmune has been fully integrated including the dissolution of the MedImmune name. Below, FENIX provides highlights and insights from the earnings call including thoughts the generic dapa patent dispute, PDUFA projections for Farxiga T1DM and DERIVE CKD, and AZ’s dual agonist from MedImmune.

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

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

Sanofi Discontinues 2 Dual-Agonist Programs; Q4 ’18 Earnings Update

Today, Sanofi hosted its Q4 ’19 earnings call, provided updates to its diabetes business, and disclosed that it discontinued SAR425899 (GLP-1/GCGR) and SAR438335 (GLP-1/GIP) for the treatment of obesity in T2DM and T2DM, respectively. Of note, Sanofi’s CEO will be testifying at the February 26, 2019 Senate Committee hearing on drug pricing. Below, FENIX provides highlights from the call as well as thoughts on Sanofi’s position in diabetes, obesity, and NASH.

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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No REWIND PRV Mentioned; Lilly Q4 ’18 Earnings Update

Lilly hosted its Q4 ’18 earnings call and provided brief updates to its diabetes business including its REWIND outlook, Jardiance tailwinds, URLi regulatory filing, and CAROLINA topline results. Of note, Lilly discontinued development of the Ph2 DACRA-042 compound from KeyBioscience. Below, FENIX provides highlights and analysis 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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Purchase Blast$599.00

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JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced the……

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

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

Lilly 2019 Guidance Summary

Today, Lilly hosted its 2019 Guidance and Investment Community Meeting and discussed potential key milestones for 2019. Importantly, Lilly announced late stage development plans in obesity and NASH and provided more information on the Ph3 dose titration for its QW injectable GIP/GLP-1 dual agonist tirzepatide. Connected care was also featured, and several comments were made on guidelines updates and new PBM coverage positively affecting Trulicity and Jardiance in 2019. Below, FENIX provides a summary and thoughts on diabetes-related highlights from the event. 

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

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

Thoughts on the Regulatory Environment in Diabetes

The regulatory environment in diabetes has greatly evolved in the last 10 years since the 2008 FDA CV risk guidance. As recently as ADA and now through EASD in 2018, FENIX considers the regulatory environment in the US and Europe to be highly favorable for sponsors developing diabetes drugs, devices, and technological solutions. Below, FENIX provides its perspective in a winners and losers analysis on how the highly favorable regulatory environment could be positively impactful to the key upcoming 2019 market events in diabetes from sponsors like Lexicon, Sanofi, AZ, Janssen, Novo Nordisk, Xeris, Lilly, BI, Dexcom, Senseonics, Abbott/Bigfoot, Tandem, Insulet, and Medtronic.

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.