Category Archives: Bolus Insulin

Biocon CY Q1 ’19 (FY Q4 ’19) Earnings Update

Biocon hosted its CY Q1 ’19 (FY Q4 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and bs-aspart. 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.

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Lispro AG Excluded from ESI 2019 Commercial Formulary

Express Scripts has excluded Lilly’s lispro authorized generic (AG) from its 2019 National Preferred Formulary. The exclusion takes effect starting July 1, 2019. Recall, on March 4, 2019, Lilly announced its intention to launch the lispro AG at a 50% WAC discount. Below, FENIX provides brief thoughts on ESI’s exclusion decision.

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.

No Sotagliflozin CRL Clarity; Sanofi Q1 ’19 Earnings Update

Sanofi hosted its Q1 ’19 earnings call but only briefly discussed its diabetes business including the recent sotagliflozin T1DM CRL. 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.

New Sanofi Insulin Savings Program

Sanofi announced that it has increased the benefits to its Valyou insulin savings program to now offer up to 10 boxes of SoloStar insulin pens and/or 10 vials of 10mL insulin for $99 per month. Previously each 10 mL vial was $99 and each box of SoloStar pens was $149. According to the press release, the program covers all Sanofi insulins (Lantus, Toujeo, Admelog, and Apidra) but not Soliqua. The program will become available starting in June 2019. Below, FENIX provides brief thoughts on the program in the context of the ongoing drug pricing debate.

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.

PBMs Take Center Stage at Third Senate Drug Pricing Hearing

Today, the Senate Finance Committee held its third hearing on drug pricing titled “Drug Pricing in America: A Prescription for Change, Part III” which focused particularly on the role of PBMs. As predicted, the PBMs largely tried to deflect attention back onto pharmaceutical manufacturers. Key themes from the hearing include: 1) PBMs blame outdated MPD legislation, PBMs do not set list prices, and PBMs do not want to provide as much transparency as manufacturers do. Below, FENIX provides highlights and insights from the hearing.

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 Pursuing U200 Lispro; New Ph1 Study

Sanofi has initiated a new Ph1 trial evaluating a U200 concentration of its bs-lispro. Below, FENIX provides thoughts on why Sanofi is pursuing U200 Admelog including its likely use in the pre-filled patch pump that is being developed in partnership with Verily and Sensile Medical.

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 To Layoff Diabetes Sales Reps; Details Remain Scarce

Sanofi is reportedly set to lay off an undisclosed number of diabetes US sales reps starting in June 2019. Below, FENIX provides thoughts on the new layoffs in the context of increasing US pricing pressures on Sanofi’s insulin franchise as well as the recent sotagliflozin CRL.

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 Cigna/ESI Insulin Savings Program Introduced Ahead of Congressional Hearing

Cigna and Express Scripts announced a new insulin “Patient Assurance Program” that will cap the out-of-pocket cost for a 30-day insulin supply to $25 for eligible patients on participating plans (Cigna purchased ESI in December 2018). Of note, the new savings program was announced ~1 week ahead of the third Senate Finance Committee hearing on drug pricing which is scheduled for April 9, 2019, at 10:15 AM ET. The third installment, titled “Drug Pricing in America: A Prescription for Change, Part III,” will focus specifically on the role of PBMs. Below, FENIX provides thoughts on the Cigna/ESI insulin savings program as an obvious strategy to redirect the focus away from themselves and back onto insulin manufacturers.

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 Lilly Drug Pricing Transparency

With the ongoing national discussion on drug pricing and increasing scrutiny particularly focused on insulin, Lilly released its 2018 Annual Transparency Report which included detailed information on Humalog pricing. Recall, Lilly recently announced the creation of a Humalog authorized generic with a list price 50% lower than Humalog. Below, FENIX provides an overview and insights on Lilly’s drug pricing transparency including Lilly’s apparent strategy to direct legislative pressure onto PBMs.

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.

Potential Sanofi Bs-Aspart US Regulatory Strategy; New Interchangeability Trial

A new trial evaluating Sanofi’s biosimilar aspart (SAR341402) has been observed on CT.gov. The trial, called GEMELLI X, is an open-label, crossover design comparing SAR341402 vs. NovoLog in 184 T1DM adults who are also on glargine U100. The name of Sanofi’s Ph3 program is clever in that Gemelli is a type of pasta derived from the Italian word for “twins.” The “X” in this trial appears to reference the crossover design. Below, FENIX provides thoughts on the trial as well as insight into Sanofi’s potential strategy to delay filing until after March 23, 2020 thereby allowing for regulatory submission via the 351k biosimilar pathway.

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.