Category Archives: Uncategorized

Lilly Dual Agonist Ph3 Analysis; EASD Investor Presentation

Following Lilly’s Ph2b data presentation for its GIP/GLP-1RA dual agonist (LY3298176), the company hosted an analyst call (slides here) to discuss the data. Of note, Lilly outlined its Ph3 development program called “SURPASS” (pictured below) which includes a H2H study vs. semaglutide. Lilly is planning to initiate Ph3 in late 2018 or early 2019 and is projecting global submissions in 2022. Additionally, Lilly disclosed that it will bring the 5, 10, and 15mg doses into Ph3 and will use an auto-injector device. Earlier today, FENIX outlined the LY Ph2b results and provided the potential impact to Novo Nordisk and Sanofi. Below, FENIX conducted a comparative analysis on contemporary Ph3 GLP-1RA pivotal programs, potential rationales behind Lilly’s Ph3 study choices, and how the LY dual agonist is a pipeline-in-a-product similar to Novo’s 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.

CARMELINA Neutral on CV and Renal Outcomes; No Increased hHF Risk

BI/Lilly presented data from CARMELINA, the Tradjenta CV and renal outcomes study (press release). Unsurprisingly, the trial failed to demonstrate superiority for either CV or renal composite endpoints. Of note, there was no increased risk of hospitalization for heart failure with Tradjenta. Below, FENIX provides thoughts on the neutral CARMELINA result.

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.

Lilly Dual-Agonist Shows Impressive A1C and Weight Control, High Rate of GI AEs

Lilly presented results from a Ph2b study evaluating its GIP/GLP-1 dual-agonist (LY3298176) vs. 1.5mg Trulicity, both dosed QW. The results were also published in The Lancet. The trial demonstrated at 26 weeks up to -2.4% reductions in A1C and -11.3 kg weight loss on the highest dose of the LY dual-agonist. Of note, Lilly disclosed plans to initiate Ph3 for LY3298176 “no later than early 2019” with trial completion in 2021. The T2DM Ph3 program will be called “SURPASS,” which seems like it could be a subtle dig at Novo’s injectable semaglutide Ph3 program called SUSTAIN, since Lilly will attempt to surpass semaglutide with its dual-agonist. Additionally, Lilly said it is planning to evaluate the GIP/GLP-1RA in obesity and “…other conditions” (likely NASH). Below, FENIX provides an overview of the LY Ph2b results and their potential impact to Novo Nordisk and Sanofi.

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.

CORRECTING AND REPLACING: Empa T1DM 2.5mg Safe; 1 Death at High Dose; Paul Strumph no longer with Lexicon

Today at the EASD 2018 conference, BI/Lilly presented data from the Ph3 EASE-2 and EASE-3 empagliflozin T1DM studies along with simultaneous publication in Diabetes Care. Results demonstrated slightly greater reductions in A1C compared to the sotagliflozin and dapagliflozin Ph3 studies; however, there was one death from DKA in a patient on 25mg empagliflozin. Details about the death are described in the EASE Ph3 publication supplementary appendix. Below, FENIX provides a curious press release observation, a winners & losers analysis, and a comparative DKA SGLTi analysis and overview of the EASE-2 and EASE-3 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.

New Intarcia CMO Fred Fiedorek

Intarcia has a new CMO according to their completely redesigned website. Fred Fiedorek has seemingly replaced Michelle Baron, and this is a big deal. Fiedorak assumes the role of Chief Medical Officer and Global Head of Regulatory Affairs at Intarcia, where he leaves Rhythm Pharmaceuticals in Boston after working on relamorelin and setmelanotide.

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.

Positive LLY URLi Ph3 Topline Results

Lilly announced positive topline results from two Ph3 studies (PRONTO-T1D and PRONTO-T2D) for its ultra rapid-acting insulin lispro (URLi). According to the press release, URLi demonstrated non-inferiority in A1C to Humalog along with significant improvements in PPG. Below, FENIX provides thoughts on URLi implications to the overall ultra rapid-acting insulin 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.

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.

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.

Libre 2 With Real-Time Alerts/Alarms Approved in EU

Abbott announced it received CE Mark for the FreeStyle Libre 2, which now includes optional real-time alerts/alarms. Abbott said it will price Libre 2 at parity to the original Libre System and the company is planning an EU launch in the coming weeks. Abbott did not disclose its regulatory/commercial plans for the US; however, this remains a large market opportunity for the company and is anticipated in the coming months. Importantly, during Abbott’s EASD symposium, it was shown that the Libre 2 CE Mark approval includes the updated algorithm for overall 14-day accuracy at 9.5% MARD (US is 9.4%). Below, FENIX provides the key highlights and potential implications to the CGM 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 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.

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.

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.

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.