Tag Archives: LLY

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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UPDATED: Lilly Oral GLP-1RA with Chugai

UPDATED: FENIX has included abstract text and the associated poster (download PDF here) that was presented at ADA 2018

Lilly announced it has in-licensed the global development and commercialization rights to Chugai’s non-peptidic GLP-1RA, which is ready to enter Ph1. Below, FENIX provides more details and insight on the deal, especially in the context of Novo’s oral semaglutide. According to the press release, Chugai will receive $50M in an upfront payment and is eligible for undisclosed milestone payments as well as royalties if OWL833 is commercialized.

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.

Zealand Initiates Ph3 Dasiglucagon Pediatric Hypoglycemia Study

Zealand announced it has initiated a Ph3 pediatric dasiglucagon hypoglycemia study, which is consistent with timing previously provided by Zealand (September 2018). Recall, Zealand recently released positive topline results for its Ph3 pivotal study in adults. Below, FENIX provides an overview the of pediatric dasiglucagon study as well as thoughts on the pediatric glucagon rescue market.

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.

Lilly Oral GLP-1RA with Chugai

Lilly announced it has in-licensed the global development and commercialization rights to Chugai’s non-peptidic GLP-1RA, which is ready to enter Ph1. Below, FENIX provides more details and insight on the deal, especially 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.

HARMONY @ EASD: Why You, AZ, and LLY, Should Care

With the upcoming Tanzeum CVOT (HARMONY Outcomes) presentation at EASD 2018 (Tues Oct 2 at 1200pm CET) and in the context of the DECLARE topline results and EXSCEL EU label update for Bydureon (previous FENIX insight), FENIX has conducted an analysis that describes the rationale where by HARMONY Outcomes could act as a potential catalyst for AZ to conduct their next large T2DM CVOT, either as GLP-1RA+SGLT2i or GLP-1/GCG dual-agonist on SGLT2i background therapy. In conjunction, FENIX has conducted a pieces-of-the-puzzle analysis that balances the likelihood HARMONY reads out positive for superiority at EASD.

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.

DECLARE Hits on HF Endpoint but Not 3P-MACE; Bad News for CANVAS Review?

AstraZeneca announced that results from the Farxiga CVOT, DECLARE, demonstrated superiority for the “CV death or hospitalization for heart failure (hHF)” composite endpoint, but did not meet statistical significance for 3-point MACE. Full results from the study will be presented at the American Heart Association conference on November 10 at 345pm CST by TIMI’s Stephen Wiviott. Below, FENIX provides thoughts on the topline results as well as insight into potential negative read-through to the CANVAS/R review for Invokana.

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.

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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.

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Purchase Blast$599.00

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

FENIX Analysis: Triplet SGLT2i+DPP-IVi+MET FDCs

A Ph1 CT.gov record evaluating a new triplet FDC of empa+lina+met XR has been observed. Below, FENIX provides further details on potential triplet FDC filings and analysis, including pricing, based on read-through from the SGLT2i+DPP-IVi FDC market.

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 FDA SGLT2i Warning For Rare Genital Infections

FDA issued a warning for the risk of a rare genital infection (necrotizing fasciitis of the perineum aka Fournier’s gangrene) with the use of SGLT2 inhibitors. FDA is also requiring label updates for the class. According to the FDA’s warning letter, there have been 12 cases (7 males and 5 females) of Fournier’s gangrene from March 2013 to May 2018.

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.