Category Archives: Topics

Thoughts on OneDrop/Apple BGM Distribution

One Drop recently announced that its BGM platform is now available in select US Apple stores. The One Drop BGM platform, which includes a mobile app, integrates with Apple HealthKit and is able to send data directly to an iPhone or Apple Watch. This is One Drop’s second large distribution agreement in 2019. In March, One Drop announced a partnership with Amazon to be part of Amazon’s Choice. Below, FENIX provides thoughts on why the distribution agreement makes sense for both One Drop and Apple.

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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Farxiga DECLARE Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the DECLARE CVOT. AZ is anticipated to comment on the US and EU DECLARE regulatory activities during its upcoming Q2 ’19 earnings call on July 25. Below, FENIX provides brief thoughts on the impending EMA approval in the context of the ongoing FDA review.

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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Livongo Files for IPO

Livongo has filed for its IPO under the proposed ticker “LVGO”; however, the number of shares and price has not yet been decided. Recall, on March 7, 2019, it was reported by WSJ that Livongo was preparing for a 2019 IPO with a valuation >$1B. Below, FENIX provides a brief overview of key information from the S-1 filing as well as insight into the Livongo IPO including thoughts on how Livongo is under increasing pressure to drive adoption.

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.

Xeris/Insulet Partnership Discontinued? Ph2 Xeris Glucagon Bariatric Surgery Trial

Xeris Pharmaceuticals announced the first patient has been dosed in the Ph2 trial evaluating its ready to use glucagon in patients who experience hypoglycemia after undergoing bariatric surgery (PBH). Xeris previously discussed intentions to initiate this Ph2 trial in a press release from December 2018. Curiously, neither of the press releases nor the CT.gov record makes any reference to delivery via the Insulet Omnipod which had been used in previous Xeris clinical trials with published clinical results. Below, FENIX provides insight into potential reasons why this trial is not using Omnipod.

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.

HF Trial Draft Guidance Issued by FDA; Public Hearing in July 2019

FDA announced it has issued draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry” (download HF draft guidance here). Additionally, FDA will be hosting a public workshop on Friday, July 26, 2019, from 9am to 4pm ET at the White Oak Campus.

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.

High-dose Trulicity Topline Results; Jardiance Fast Track Designation for HF

Lilly announced positive topline results from its AWARD-11 study evaluating high-dose Trulicity (3.0 and 4.5mg). Separately, Boehringer Ingelheim and Lilly announced they have received Fast Track designation for the Jardiance heart failure indication based on the ongoing EMPEROR clinical trials. Of note, Lilly did not provide details on the A1C or weight reduction observed in AWARD-11. Below, FENIX provides insight and context on the Jardiance HF Fast Track designation as well as thoughts on AWARD-11 and the potential magnitude of effect with Trulicity 3.0 and 4.5mg doses.

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.

DECLARE CHMP Decision This Week; Sanofi BS-Aspart Filed in EU? CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes some notable diabetes decisions including AZ’s DECLARE CVOT label update (Type II variation). Additionally, there is a new application for insulin aspart which is believed to be from Sanofi. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.

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.

Adocia’s Pramlintide + Insulin Combo (ADO09) Ph1b Trial Posted on CT.gov

Consistent with Adocia’s ADA 2019 press release, a clinicaltrials.gov record has recently been observed for the company’s pramlintide + insulin (ADO09) Ph1b study. Below, FENIX provides an overview of the ADO09 Ph1b trial including thoughts on the market potential for ADO09 as a T1DM adjunctive therapy.

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 Semaglutide High-Dose T2DM Ph3 Trial (SUSTAIN FORTE)

Novo Nordisk’s Ph3 T2DM high-dose semaglutide trial (SUSTAIN FORTE) has recently been posted on CT.gov. Recall, Novo first disclosed its plans to study high-dose semaglutide in T2DM patients during its Q3 ’18 earnings call. Below, FENIX provides insight into SUSTAIN FORTE including context from Lilly’s recently initiated SURPASS-2 trial (tirzepatide vs. Ozempic) and the ongoing AWARD-11 high-dose Trulicity trial.

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 R&D Re-focusing; R&D Layoffs in France and Germany

According to Reuters, Sanofi is set to layoff 466 R&D-related jobs as part of an initiative to prioritize oncology, immunology, rare diseases, and vaccines while at the same time limiting internal CV R&D to its current pipeline. Furthermore, Sanofi is said to maintain the support of its diabetes and CV programs through its partners. Below, FENIX provides thoughts on the Sanofi R&D re-focusing in the context of the company’s CV/Met pipeline and recent senior management changes.

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.