Category Archives: Basal Insulin

Gan and Lee + Sandoz and FDA Biosimilar Insulin BLA List

Today, Sandoz announced it has in-licensed the biosimilar insulin portfolio of Gan & Lee for commercialization of glargine, aspart, and lispro. Last week, FDA published a Q&A document and a list of biologics that will convert from NDA to BLA under the US BPCI Act of 2010, which include insulin products. Below, FENIX briefly provides thoughts on each topic.

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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Mylan invalidates two Lantus patents

Today, Mylan announced the US Patent and Trademark Appeal Board (PTAB) has dismissed two of Sanofi’s Lantus patents thereby favoring Mylan/Biocon’s biosimilar glargine. Importantly, Mylan seems to indicate that it has responded to the June 2018 CRL by describing its Lantus 505(b)(2) NDA as “…under active review…” by FDA. Below, FENIX provides additional thoughts on Mylan’s announcement in the context of a tentative approval of Mylan’s bs-glargine pending its 30-month patent litigation stay with Sanofi. Recall, Mylan filed biosimilar glargine with FDA in Q3 ’17 which triggered a 30-month stay as a result of the patent infringement lawsuit filed by Sanofi. As per the PTAB ruling, Sanofi’s……

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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Small Lantus Label Update

According to Drugs@FDA, the Lantus SoloStar label has been updated with changes in “Section 2.1 Dosage and Administration.” Below, FENIX provides additional details on the updated dosing instructions in comparison to the other marketed basal insulins. The updated label language (see excerpt below) includes the 1-unit dose dialing increments for the Lantus SoloStar pen. In addition to this change, a warning note has been added regarding audible clicks for visually impaired patients. Source: Lantus Solostar label from Drugs@FDA database The updated dosing instructions for unit dosage dialing and use in visually impaired patients seems to be consistent with other marketed……

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 Novo Ph2 study for QW Insulin 287 in T2DM

Last week, Novo initiated a Ph2 trial for the company’s QW basal insulin analog, “Insulin 287” (NN1436), in T2DM patients. This new trial is in line with previous guidance from Novo’s Q1 ’18 earnings call, indicating the Ph2 initiation of Insulin 287 by YE 2018 (see presentation slide below). FENIX provides thoughts on this new Ph2 T2DM trial for Insulin 287 including the use of CGM, observations about dose titration, and the potential for a Ph2 T1DM trial. Source: Novo Q1 ’18 earnings presentation Although Novo previously indicated the completion of Ph1 Insulin 287 trials, additional Ph1 studies have been observed (previous FENIX insight)…….

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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Tresiba U-100 10mL vial FDA approved

According to Drugs@FDA, Novo Nordisk has received US approval for the commercialization of a 10mL vial of Tresiba U-100. Of note, Novo has not received approval for a U-200 vial. Below FENIX provides additional details on the new vial, specifically as it pertains to pediatric use.

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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Thoughts on the Regulatory Environment in Diabetes

The regulatory environment in diabetes has greatly evolved in the last 10 years since the 2008 FDA CV risk guidance. As recently as ADA and now through EASD in 2018, FENIX considers the regulatory environment in the US and Europe to be highly favorable for sponsors developing diabetes drugs, devices, and technological solutions. Below, FENIX provides its perspective in a winners and losers analysis on how the highly favorable regulatory environment could be positively impactful to the key upcoming 2019 market events in diabetes from sponsors like Lexicon, Sanofi, AZ, Janssen, Novo Nordisk, Xeris, Lilly, BI, Dexcom, Senseonics, Abbott/Bigfoot, Tandem, Insulet, and Medtronic.

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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REWIND Safety Issue? Lilly Q3 ’18 Earnings Update

Lilly hosted its Q3 ’18 earnings call and provided updates to its diabetes business including commentary on the recent REWIND topline results. Of note, Lilly’s first Ph3 study for its GIP/GLP dual agonist, now called tirzepatide, has been posted on CT.gov. Furthermore, Lilly said it has purchased a priority review voucher (PRV), but did not disclose how it will be used. Below, FENIX provides its new thoughts on REWIND safety, why Lilly’s PRV would be used for REWIND, and other key highlights from the earnings 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.

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Purchase Blast$599.00

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Mylan Q3 ’18 Earnings Update

Mylan hosted its Q3 ’18 earnings call (press release) and briefly discussed its bs-glargine. In response to an analyst’s question regarding Merck/Samsung discontinuing glargine development, Mylan affirmed they believe they can launch bs-glargine and still maintain adequate margins. Furthermore, Mylan senior management stated that they are continuing to work with FDA to find a path forward for a substitutable product.

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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New Lilly and Novo Trials: Trulicity vs. Ozempic Pens, Fiasp U200, and QW Insulin

A series of new Lilly and Novo studies have been observed on CT.gov. These include a Ph4 trial comparing the Trulicity auto-injector to the Ozempic FlexTouch, a new Fiasp U200 formulation Ph1 study, and two Ph1 clamp trials for Novo’s QW insulin 287. Below, FENIX provides thoughts on each of 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

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Novo Q3 ’18 London Earnings Event

Novo Nordisk hosted its post-Q3 ’18 earnings event in London. The session was primarily comprised of Q&A with topics including high dose Ozempic as well as an update on Novo’s priority review voucher. Below are highlights 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.