Category Archives: GLP-1RA + Basal

New ADA/EASD Guidelines Recommend GLP-1RA Over Insulin and Make Other New H2H Drug Recommendations

ADA and EASD have updated their T2DM consensus guidelines (journal publication) with notable changes to the framework of the treatment algorithm (pictured below). Now, the algorithm takes a patient-centric approach and suggests a stepwise methodology based on the highest priority for the patient (ASCVD, CKD, hypoglycemia minimization, weight loss, and cost). Importantly, the guidelines recommend the use of GLP-1RA over insulin as the first injectable therapy as well as other in-class H2H drug recommendations. Below, FENIX provides a winners-and-losers analysis, highlights of the guideline updates, and how the identified knowledge gaps may be addressed.

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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Novo To Layoff 250 US Workers

Novo Nordisk is reportedly cutting 250 US-based jobs. The most recent round of layoffs appears to be part of the June 7 report that Novo was considering cutting 3000 jobs. Recall, on September 18, the company also announced plans to restructure its global R&D organization which included cutting 400 R&D jobs. Below, FENIX provides known details of the US job cuts and an updated headwinds/tailwinds analysis for the ongoing Novo personnel reductions.

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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Novo Cuts 400 Jobs in Denmark/China and Confirms Shift in R&D Strategy

Novo Nordisk announced plans to restructure its R&D organization which includes cutting 400 R&D jobs in Denmark and China. Novo is also establishing a new BD unit in Cambridge, MA to help facilitate additional R&D collaborations. This news comes as no surprise and is consistent with FENIX’s previous insight regarding Novo’s shift in R&D strategy as evidenced by 7 external R&D collaborations/acquisitions thus far in 2018. Below, FENIX provides thoughts on Novo’s new R&D strategy.

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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Oramed Oral GLP-1RA Receives IND Approval

Oramed announced FDA cleared its IND application for ORMD-0901, an oral GLP-1RA believed to be using exenatide. According to the press release, Oramed is planning to initiate a Ph1 PK study in Q3 ’18 with intentions to move into Ph2 in 2019. The Ph1 study has not yet been posted on CT.gov, but the press release said the Ph1 study will be a 4-way crossover vs. Byetta in 15 healthy subjects. Below, FENIX provides thoughts on ORMD-0901 in the context of Novo’s oral semaglutide.

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 Restructures GBUs; Stefan Oelrich Moves to Bayer

Less than 3 years after reorganizing the company into 5 Global Business Units (GBUs), Sanofi is once again restructuring the organization. Now, Sanofi is creating Primary Care and China & Emerging Markets GBUs, which will replace the Diabetes and Cardiovascular (DCV) and General Medicines & Emerging Markets (GEM) GBUs. As part of the transition, Stefan Oelrich, head of the DCV business, is leaving Sanofi to join Bayer’s Board of Management and lead its Pharmaceuticals Division. The transition is set to take effect by the beginning of 2019. Below, FENIX provides thoughts Sanofi’s reorganization with insight on the potential impact on its diabetes business.

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 Q2 ’18 London Earnings Event

Novo Nordisk hosted its post-Q2 ’18 earnings event in London. The format of the event was different than in past quarters. This event started with a short presentation by Novo’s CEO and was followed by a “Meet the Management” session that was not available through webcast. Below are highlights from the available presentation.

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 Q2 ’18 Earnings Update

Novo Nordisk hosted its Q2 ’18 earnings call and provided updates to its diabetes and obesity portfolio. Of note, Novo disclosed it will be launching Ozempic in Europe with 3 pens (0.25mg for titration as well as 0.5 and 1.0mg for treatment) as compared to 2 pens in the US. Below, FENIX provides highlights and key insights form 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 Q2 ’18 Earnings Update; Pfizer Discontinues Ph1 T1DM Compound

Sanofi and Pfizer hosted their respective Q2 ’18 earnings calls. Sanofi only briefly discussed its diabetes business including continued headwinds for its glargine franchise. Of note, Sanofi has recently updated the name of its efpeglenatide CVOT to “AMPLITUDE-O.” Pfizer did not discuss its Steglatro (ertugliflozin) franchise; however, in the pipeline update, it was noted that PF-06342674 (IL-7 receptor precursor modulator) for the treatment of T1DM has been discontinued. Below are highlights from the respective 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.

Drug ADA ‘18 Key Data Press Releases (June 23)

21 major press releases featuring new data presented at ADA ’18 were observed across diabetes drugs, devices, and apps, a major increase from 9 on the first day of ADA ‘17. Below, FENIX has provided context and analysis for 14 drug-related announcements, with analysis of device and app-related announcements to follow in a separate alert.

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.

FENIX Analysis: Post-AACE 2018 Drug Promotional Material

In advance of ADA 2018 beginning June 21, FENIX has conducted a comprehensive analysis of new and recent promotional materials obtained at AACE 2018. Notably, this was the first major conference opportunity for Novo to promote both Ozempic and the Tresiba DEVOTE label update.

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.