Category Archives: GLP-1RA

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.

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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.

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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.

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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.

New Novo Ph1 Oral Peptide?

A Ph1 CT.gov record for a new Novo drug (NNC0113-2023; NN9023) has been observed. The compound appears to be an oral peptide for multiple reasons including the fact that it uses SNAC, the same gut delivery technology as oral semaglutide. Below, FENIX provides evidence and insight into potential MOAs of the compound.

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 Initiates Ozempic TV DTC

The first Ozempic TV DTC commercial, called “Oh!,” has been observed. Of note, the commercial is set to the tune of the 1975 hit “Magic” by Pilot, likely in an attempt to build upon the success of the jingle from the “Tresiba Ready” DTC campaign. Interestingly, the commercial primarily uses messaging from the SUSTAIN 2 (vs. Januvia) and SUSTAIN 6 (CVOT) studies. Below, FENIX analyzes the first Ozempic TV commercial and provides an update on the Ozempic launch.

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.

New Ozempic Concentrations; Potential Autoinjector in Ph1 Study

A new Ph1 trial comparing different concentrations of semaglutide between FlexTouch, NovoPen4, and a novel injection device (DV3372) has appeared on CT.gov. In the 68-participant study, the current formulation of Ozempic (1.34mg/mL concentration delivered via FlexTouch, a.k.a. PDS290) will be compared to three more concentrated formulations of semaglutide (0.5mg/mL, 1.0mg/mL, and 2.0mg/mL). Below, FENIX analyzes the trial design, including insights regarding a potential Ozempic autoinjector and a reusable injection device, as well as the value of higher concentrations in reducing the amount of pens needed.

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.

AZ Q2 ’18 Earnings Update

AZ hosted their Q2 ’18 earnings call and briefly discussed their diabetes portfolio, with particular focus on Farxiga and the upcoming DECLARE CVOT results.

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.

LLY Dual Agonist Advances to Ph3; Q2 ’18 Earnings Update

Lilly hosted its Q2 ’18 earnings call and provided updates on its marketed and pipeline products. Lilly announced three major pipeline updates including advancement of their QW GIP/GLP-1 agonist to Ph3 after meeting a “high bar” in Ph2 trials, filing of nasal glucagon, and discontinuation of their Ph1 GPR142 agonist. Of further interest, President of Lilly Diabetes, Enrique Conterno, indicated the median follow-up for REWIND would be ~5 years (providing an additional ~1 year for Kaplan-Meier curve separation compared to the 3.8-year median follow-up for LEADER).

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.