Category Archives: GLP-1RA

Bydureon EU label to Include All-Cause Mortality Data from EXSCEL

AstraZeneca announced Bydureon received a positive CHMP opinion to include EXSCEL CVOT data in the EU label. Importantly, the CHMP opinion also recommends inclusion of the pre-specified all-cause mortality secondary outcome data, which demonstrated a 14% RRR. Below, FENIX provides thoughts on the CHMP opinion and insight into potential read-through to a US Bydureon 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.

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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.

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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.

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Purchase Blast$599.00

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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.

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Purchase Blast$599.00

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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.

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Purchase Blast$599.00

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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.

Novo Partners for Cross BBB Drug Delivery

Novo Nordisk has entered into an R&D collaboration with Ossianix, a Philadelphia-based R&D company. Ossianix utilizes its single domain VNAR antibody to increase drug absorption across the blood brain barrier (BBB). According to the press release, Ossianix will deliver a predefined number of therapeutic agents to Novo for the treatment of diabetes and other metabolic diseases. Below, FENIX provides context of the R&D agreement as well as thoughts on potential targets that Novo is pursuing.

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 semaglutide shows superiority in renal impairment patients (PIONEER 5)

Novo announced positive top-line results from PIONEER 5 demonstrating superiority in A1C and weight loss at 26-weeks for 14mg oral semaglutide vs. placebo in T2DM patients with moderate renal impairment. Below is a table representing all of the PIONEER data released thus far for oral semaglutide including PIONEER 1, 2, 3, 4, 5 and 7. FENIX also provides insights on the oral semaglutide development program, SGLT2i eGFR comparison, and a new Ph1 oral sema tablet bioequivalence study.

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.