Category Archives: Glucagon

Xeris Home Delivery via Amazon; Oramed End-of-Ph2 FDA Feedback

Two diabetes news items were observed today. First, Xeris made Gvoke PFS available for home delivery via Amazon Pharmacy and grounded its field force (press release). Of note, Gvoke PFS is now available for home delivery to commercially insured patients through PillPack by Amazon Pharmacy and Xeris has grounded its field force. Additionally, Oramed announced positive feedback from its oral insulin ORMD-0801 End-of-Phase2 (EoP2) CMC meeting with the FDA (press release). Below, FENIX provides highlights and thoughts surrounding these updates, including how the home delivery option could present an opportunity for Xeris and Zealand amid the COVID-19 pandemic.

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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Zealand Q4 ’19 Earnings Update

Zealand hosted its Q4 ’19 earnings call (press release) and provided updates to its diabetes business, including dasiglucagon and other pipeline assets. Of note, Zealand indicated that the dasiglucagon HypoPal NDA is on track for submission by the end of March 2020. Below, FENIX provides highlights and thoughts surrounding these updates.

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 Q4 ’19 Earnings Update

Xeris hosted its Q4 ’19 earnings call (press release) and provided updates on its newly launched hypoglycemia rescue product Gvoke and other pipeline assets. To the best of our memory, this is believed to be the first time that Xeris hosted an earnings conference call to accompany its earnings release. Of note, Xeris also posted an updated corporate presentation from March 2020 to its IR website (presentation slides). Below, FENIX provides highlights and thoughts surrounding these updates, including how the coronavirus disruption could present an opportunity to Xeris.

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.

Positive Topline Novo QW Insulin Results; Novo Q4 ’19 Earnings Update

Novo Nordisk hosted its Q4 and FY 2019 earnings call and provided updates to its diabetes business, including a Rybelsus launch update as well as Ph2 topline results for its QW insulin LAI287 (now called insulin “icodec”). Below, FENIX provides highlights and insights from 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.

Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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 and URLi CHMP Opinions Anticipated; Forxiga Lower-limb Warning?; Xeris Gvoke Filed (CHMP Agenda January 27-30)

The CHMP agenda for this month’s meeting (January 27-30) has been released, and it includes four notable items (oral semaglutide opinion, URLi opinion, potential Forxiga lower limb amputation warning, and Xeris’s Gvoke initial filing) as well as some other items. Below, FENIX provides diabetes-related highlights and insights from the January 2020 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.

Xeris RTU Glucagon Ph2 Results for Exercise-Induced Hypoglycemia

Xeris has announced positive topline results from the in-clinic stage of its Ph2 study of ready-to-use (RTU) glucagon for the prevention of exercise-induced hypoglycemia (EIH) in patients with T1DM. Below, FENIX provides context and insights on the 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.

Thoughts on ADA 2020 Standards of Care

ADA recently updated its Standards of Medical Care in Diabetes for 2020, which includes key additions across multiple drug classes. Of note, the standards now include a recommendation for initiating SGLT2i or GLP-1RA therapy in patients with ASCVD, HF, or CKD (SGLT2i only) who are already at their A1C goal. Interestingly, while the guidelines were updated to include discussion of the CANVAS/R, CREDENCE, DECLARE, REWIND, and CARMELINA trials, CAROLINA and DAPA-HF trials were not addressed. Below, FENIX provides thoughts and market implications for selected guideline updates.

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.

Xeris Positive Ph2 Data in PBH; Oramed Partnership with Tianhui; Glooko Privacy Shield Certification

Three news items have been observed today across diabetes players including Xeris, Oramed, and Glooko. Xeris announced positive data from their Ph2 trial in post-bariatric hypoglycemia, Oramed has partnered with Tianhui Incubator of Technologies to launch ORMD-0801 in China in 2 years, and Glooko announced Privacy Shield certification from the US Department of Commerce. Below, FENIX provides context and insights on these news items. Xeris Reports Positive Ph2 Data in Post-Bariatric Hypoglycemia Xeris announced positive results from the in-clinic stage of the Ph2 study evaluating their ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery. Participants in the trial were……

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.

Beta Bionics’s iLet Breakthrough Designation; Roche Receives CE Mark for Novel BG Test; Glooko Receives ISO 13485 Certification

FENIX has observed several announcements across diabetes technology players. First, Beta Bionics has received breakthrough device designation for the iLet Bionic Pancreas System from the FDA. Note, Beta Bionics is the only manufacturer to receive this designation for 3 system configurations (insulin-only as well as dual-hormone and glucagon-only using Zealand’s dasiglucagon), as no other companies have disclosed configurations beyond insulin-only. Additionally, Roche announced it has received CE Mark for the Accu-Chek SugarView, a meter-free BG monitoring system. Further, Glooko has received ISO 13485 certification, meeting requirements for safety and quality of their system. Below, FENIX provides context and insights on these announcements.

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.