Category Archives: Uncategorized

Connected Pens: Novo Expanded Capability with Glooko; Biocorp/AgaMatrix Partnership

Prior to the start of the 2019 ATTD conference, two diabetes technology-related press releases have been observed. First, Glooko announced that its cloud-storage platform will integrate with Novo Nordisk’s connected pens and Dexcom’s G6 CGM. Second, Biocorp and AgaMatrix entered into a partnership for the distribution of Biocorp’s wraparound connected pen device now called “Mallya” (formerly Easylog). Below, FENIX provides insight into the respective news including thoughts on why the remote upload feature is critical for Novo.

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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Medtronic Receives Breakthrough Device Designation; CY Q4 ’18 (FY Q3 ’19) Earnings Update

Medtronic hosted its CY Q4 ’18 (FY Q3 ’19) earnings call and provided brief updates to its diabetes device pipeline and commercial activities. Of note, Medtronic also announced that FDA granted Breakthrough Device Designation for its Personalized Closed Loop (PCL) insulin pump system (Breakthrough Devices Program Guidance was finalized in December 2018). Below, FENIX provides highlights from the earnings call as well as perspective why Medtronic chose to pursue Breakthrough Device Designation.

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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Merck Files 12 Lawsuits Over Generic Januvia/Janumet Filings

On February 13, 2019, Merck filed 12 lawsuits in the Wilmington, Delaware Federal Court claiming patent infringement on Merck’s Januvia franchise. Defendants include Teva, Sandoz, Mylan, Watson, Zydus, Sun, Wockhardt, Macleods, Apotex, Torrent, Anchen, and Alvogen Pine Brook. Below, FENIX provides thoughts on the lawsuits and potential insight into when generic Januvia could enter the US 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.

Thoughts on iPump Special Controls

Yesterday, FDA approved the first interoperable pump through the de novo pathway and created a new pump category called “alternate controller enabled” (ACE) infusion pump. With the approval of the new class, FDA established “special controls” that must be met in order to qualify as an ACE pump, similar to Dexcom’s G6 iCGM approval in March 2018. Below, FENIX provides analysis and summary of these controls as well as thoughts on how achievable the ACE special controls are compared to the iCGM special controls.

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 iPump Pathway: Tandem t:slim X2 Approved as First Interoperable Pump

Today, FDA approved an interoperable version of Tandem’s t:slim X2 pump under the de novo pathway for a new insulin pump class called “alternate controller enabled” or ACE. Tandem has not yet issued a press release. This designation allows for the pump to be used with different components of an integrated insulin delivery system (e.g. CGM) with future iterations using the streamlined 510(k) process. As part of the approval, FDA has created special controls to meet the standard for ACE designation (similar to how FDA approved iCGM with special controls). Below, FENIX provides thoughts on the ACE category and implications to pump, CGM, and algorithm companies.

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.

CAROLINA CVOT Neutral; No Impact to OAD Market

BI/Lilly announced that the CAROLINA CVOT met the primary endpoint of non-inferiority on 3P-MACE vs. glimepiride. Full results from the study are scheduled to be presented on June 10 at the ADA conference. Below, FENIX provides thoughts on CAROLINA and how OAD market dynamics are unlikely to be affected, continuing the slow decline of SU volume share.

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.

Farxiga LCM and Litigation Update; AZ Q4 ’18 Earnings Summary

AstraZeneca hosted its Q4 ’18 earnings call and provided a brief update on its diabetes business including Farxiga LCM initiatives (T2DM CVOT, T1DM, HF, and CKD). Of note, as part of AZ’s business reorganization, MedImmune has been fully integrated including the dissolution of the MedImmune name. Below, FENIX provides highlights and insights from the earnings call including thoughts the generic dapa patent dispute, PDUFA projections for Farxiga T1DM and DERIVE CKD, and AZ’s dual agonist from MedImmune.

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 Glucagon to be Branded “Gvoke”; Xeris Issues 5M Additional Shares

Xeris announced a proposed public offering of 5M additional shares; and, in the S-1 document, disclosed the commercial name of its stable glucagon as “Gvoke” believed to be pronounced (gee’-voke), which appears to be a play on the word “evoke.”   Below, FENIX provides key highlights from the S-1 filing, thoughts on the impending Xeris glucagon launch in H2 ’19 (June 10, 2019 PDUFA date), and insight on potential read-through to Xeris from FDA’s upcoming decisions on Sanofi/Lexicon’s sotagliflozin in T1DM (March 22, 2019 PDUFA date) and Lilly’s nasal glucagon (PDUFA believed to be in April 2019).

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 Lilly and Novo uRAI pump trials: URLi ‘PRONTO-Pump-2’ and Fiasp in iLet Bionic Pancreas

Recently, FENIX has observed new Lilly and Novo pump trials on CT.gov. Lilly has posted a Ph3 trial for its ultra-rapid-acting insulin lispro (LY900014; URLi) for pumps in adults with T1DM called ‘PRONTO-Pump-2.’ Additionally, Novo has initiated a new Ph2 trial for Fiasp in an iLet Bionic Pancreas. Below, FENIX provides thoughts on the respective studies.

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.

Could Teva Generic Dapa Be Para III? Teva Receives Tentative FDA Approval

Earlier this week, FDA tentatively approved Teva’s generic version of Farxiga. Below, FENIX provides evidence suggesting Teva filed its generic dapa via Paragraph III as well as thoughts on potential generic dapa launch timings, particularly Zydus.

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.