Tag Archives: NVO

HARMONY Superior; REWIND and PIONEER-6 Expectations High

Full results from the albiglutide CVOT, HARMONY Outcomes, have been published in the Lancet and were presented at EASD 2018. As somewhat of a surprise, results demonstrated a 22% RRR in the 3P-MACE primary endpoint (p=0.0006). In a press release, GSK announced the results and disclosed they are “exploring opportunities to divest this medicine to a company with the right expertise and resources to realise its full potential for patients.” Recall, FENIX recently presented a scenario highlighting a strong possibility that HARMONY could show superiority including GSK likely divesting albiglutide for its re-commercialization. Below, FENIX provides perspective on the potential market implications in a winners & losers analysis, as well as who albiglutide suitors are unlikely to be.

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 Novo Stem Cell Manufacturing Facility

Novo Nordisk announced plans to establish a stem cell manufacturing facility in Freemont, California. The GMP-certified facility was previously operated by Asteria Biotherapeutics and Novo has signed an agreement with the company. According to the press release, the plant will be operational in 2019 at which time, it will be used to support Novo’s clinical development programs. Below, FENIX provides thoughts on Novo’s stem cell program.

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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UPDATED: Novo to Launch Connected Pens and New Connected Care Partnerships with Dexcom, Roche, and Glooko

UPDATED: Both Novo connected pens utilize NFC to transmit data. Previously, it was thought that the pens would use Bluetooth since Dexcom and Roche also use Bluetooth.

With the start of the 2018 EASD conference, Novo Nordisk announced upcoming plans to launch two connected reusable pens (NovoPen 6 and NovoPen Echo) in addition to digital health partnerships with Dexcom, Roche, and Glooko. According to the press release, Novo plans to initiate the launch of its connected pens in Q1 2019. Importantly, Novo also disclosed intentions to launch connected disposable pens “later in 2019.” Below, FENIX provides thoughts on Novo’s connected pens and new partnerships.

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 H2H Tresiba vs. “Lantus” CGM Crossover Study (SWITCH PRO)

A CT.gov record for a new Ph4 T2DM basal-only crossover study (SWITCH PRO) comparing Tresiba (U100) to “Lantus” has been observed. The study was likely named SWITCH PRO because of the crossover design and the use of Abbott’s Libre Pro blinded CGM. Below, FENIX provides thoughts on how Novo could leverage the study to augment its results from the previous SWITCH 1 and SWITCH 2 studies as well as context for the use of time-in-range as the primary endpoint to be first such trial included in the Tresiba label.

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.

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

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

New Sanofi Efpeglentatide vs. Trulicity Study Initiated

A new CT.gov record for a superiority study evaluating efpeglentatide vs. Trulicity (AMPLITUDE-D) has been observed. The trial appears to be similar to Novo’s SUSTAIN 7 (Ozempic vs. Trulicity) where Ozempic was shown to be superior to Trulicity in terms of glycemic control and weight loss. Below, FENIX provides thoughts on AMPLITUDE-D and Sanofi’s potential strategy to avoid a H2H study vs. Novo’s Ozempic.

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.

Oral Semaglutide Superior to Trulicity in Japanese Subjects (PIONEER 10)

Novo Nordisk announced positive topline results from the PIONEER 10 study evaluating oral semaglutide vs. Trulicity in Japanese T2DM patients. Below is an updated PIONEER data summary table including available data from PIONEER 1, 2, 3, 4, 5, and now 10. FENIX also provides thoughts on PIONEER 10 including Novo’s potential opportunity to leverage PIONEER 10 data to model a “SUSTAIN 7-like” trial (oral sema vs. Trulicity 1.5mg) for western markets. Furthermore, PIONEER 10 will likely help Novo’s GLP-1RA market position in Japan where Victoza now trails Trulicity (discussed below).

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 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

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

New Lilly Academic Collaboration to Help Compete with Novo/Oxford

Lilly and the Indiana Bioscience Research Institute (in collaboration with Indiana University School of Medicine) have partnered to create the “Lilly Diabetes Center of Excellence” (LDCE). According to the press release, the LDCE will support “cutting-edge research in diabetes, diabetic complications, and related metabolic disorders.” Lilly’s decision to create the LDCE appears to be (at least in part) driven by a need to keep up with Novo’s collaboration with The University of Oxford. Below, FENIX provides thoughts on the LDCE including a comparison with a similar program between Novo and University of Oxford.

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.

Semaglutide Ph2 NASH Study Completes Enrollment

The CT.gov record for Novo’s Ph2 study evaluating semaglutide in NASH has completed enrollment. Additionally, the full study completion data was moved up 3 months to April 2020 (previously July 2020). Below, FENIX provides thoughts on a projected timeline for Ph2 read out.

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.