Category Archives: Topics

Adocia’s Pramlintide + Insulin Combo (ADO09) Ph1b Trial Posted on CT.gov

Consistent with Adocia’s ADA 2019 press release, a clinicaltrials.gov record has recently been observed for the company’s pramlintide + insulin (ADO09) Ph1b study. Below, FENIX provides an overview of the ADO09 Ph1b trial including thoughts on the market potential for ADO09 as a T1DM adjunctive therapy.

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.

New Semaglutide High-Dose T2DM Ph3 Trial (SUSTAIN FORTE)

Novo Nordisk’s Ph3 T2DM high-dose semaglutide trial (SUSTAIN FORTE) has recently been posted on CT.gov. Recall, Novo first disclosed its plans to study high-dose semaglutide in T2DM patients during its Q3 ’18 earnings call. Below, FENIX provides insight into SUSTAIN FORTE including context from Lilly’s recently initiated SURPASS-2 trial (tirzepatide vs. Ozempic) and the ongoing AWARD-11 high-dose Trulicity 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.

Sanofi R&D Re-focusing; R&D Layoffs in France and Germany

According to Reuters, Sanofi is set to layoff 466 R&D-related jobs as part of an initiative to prioritize oncology, immunology, rare diseases, and vaccines while at the same time limiting internal CV R&D to its current pipeline. Furthermore, Sanofi is said to maintain the support of its diabetes and CV programs through its partners. Below, FENIX provides thoughts on the Sanofi R&D re-focusing in the context of the company’s CV/Met pipeline and recent senior management changes.

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.

New Tirzepatide vs. Ozempic H2H Ph3 Trial (SURPASS-2)

Lilly initiated its Ph3 tirzepatide vs. Ozempic H2H study (SURPASS-2) which is the 4th tirzepatide pivotal trial (not including Japan). The final pivotal trial, SURPASS-5 (add-on to basal insulin), is projected to initiate shortly. Below, FENIX provides an overview of SURPASS-2 as well as insight into the curious observation that the trial does not specify which dose of Ozempic is being used (0.5 or 1.0mg). 

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.

Victoza Pediatric Indication Approved in US

Victoza has been approved by FDA for use in pediatric patients down to 10 years of age. Of note, the pediatric indication was approved as a priority review. Results of the ELLIPSE Victoza pediatric study were recently presented at the Pediatric Endocrine Society/PediatricAcademic Societies annual meeting and subsequently published in the NEJM. A Novo press release has not yet been observed. Below, FENIX provides brief thoughts on the approval including the impact to Victoza’s market exclusivity extension.

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.

Xeris Glucagon Ph3 Top-line Data vs. Novo’s GlucaGen

Xeris announced topline results from the fourth Ph3 trial evaluating its stable glucagon formulation for hypoglycemia rescue. This Ph3 crossover study demonstrated that Xeris’s glucagon was non-inferior to Novo’s NovoGen in terms of achieving a plasma glucose >70mg/dL or a ≥20mg/dL increase in 30 minutes following administration. Recall, Xeris recently announced that FDA requested an additional 3 months to review the company’s NDA submission with a new action date on September 10, 2019. Below, FENIX provides brief thoughts on the Ph3 crossover trial in the context of the ongoing Xeris glucagon regulatory review.

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.

Pfizer’s Oral GLP-1RA Advances to Ph2

Pfizer initiated the first Ph2 study evaluating its oral, small-molecule GLP-1RA (PF-06882961) in 400 T2DM subjects. Recall, during Pfizer’s Q1 ’19 earnings call, senior management said they intended to “swiftly” bring PF-06882961 into Ph2. Below, FENIX provides potential insight into the Ph2 study as well as context from other oral GLP-1RAs in development.

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.

Connected Care: Biocorp Receives CE Mark for Mallya

Biocorp announced it received CE Mark for the Mallya, a wraparound pen solution. Mallya turns any disposable or reusable insulin pen into a connected device that collects dosing information and sends it to a companion app. Below, FENIX provides insights and context to the impending Mallya launch including thoughts on how Mallya competes with Companion Medical or could be a compliment to Lifescan’s portfolio.

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.

Oral Sema Market-Shaping; Novo’s ADA 2019 PIONEER Presentation

On the last session of the last day at ADA 2019, there was a dedicated plenary session for the oral semaglutide development program. Despite the timing, the session was very well attended. The session provided an overview of the oral semaglutide molecule, its place in clinical practice (PIONEER 1, 5, and 8), comparison to alternative therapies (PIONEER 2, 3, 4, 7), and CVOT safety and efficacy results (PIONEER 6). Of note, approximately half of the time was dedicated to PIONEER 6. Below, FENIX provides additional thoughts on oral semaglutide including the ongoing regulatory situation, Novo Nordisk’s clear initiation of market-shaping activities, and insight into how oral semaglutide may fuel new patient lead generation of its entire portfolio.

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.

CAROLINA to Strengthen Anti-SU Guidelines

Today, BI/Lilly presented data from the CAROLINA CVOT (Tradjenta vs Glimepiride) at the ADA 2019 conference. The results demonstrated non-inferiority on 3P-MACE for linagliptin vs. glimepiride (11.8% vs. 12.0%; HR 0.98; p<0.0001) in patients with relatively early T2DM and increased CV risk. Of note, the results signaled no difference in CV safety between both groups, thereby disproving the hypothesis of increased CV risk from glimepiride usage. Recall, in February 2019, BI/Lilly announced that CAROLINA met the primary endpoint of non-inferiority on 3P-MACE. Below, FENIX provides additional thoughts on CAROLINA, potential market dynamics, and implications.

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.