Category Archives: Topics

OPKO Oxyntomodulin Ph2 Data; Is It Commercially Viable?

Today, OPKO announced positive topline results from the Ph2 dose-escalation trial of OPK88003 in obese T2DM patients. OPK88003 is QW injectable oxyntomodulin analog (GCG/GLP-1 dual agonist). Recall, OPKO gained rights to OPK88003 (previously TT401) when it acquired Transition Therapeutics in June 2016, after Lilly opted out of further developing the drug. Below, FENIX provides thoughts on the commercial viability of OPK88003 in the context of Lilly’s tirzepatide and Novo/Sanofi’s decisions to pursue triple-agonists over dual-agonists.

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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New Lilly Tirzepatide vs. Tresiba Ph3 Pivotal Study (SURPASS-3)

A new tirzepatide vs. Tresiba Ph3 T2DM pivotal trial (SURPASS-3) has been observed on CT.gov. This is the second tirzepatide Ph3 T2DM study supporting its global regulatory approvals. Recall, in November 2018, Lilly initiated SURPASS-4 (vs. glargine in T2DM patients with increased CV risk). Lilly has also recently initiated two Ph3 Japanese studies (SURPASS-J-mono and SURPASS-J-combo). Below, FENIX provides thoughts on SURPASS-3 and potential insight into the trial design.

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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Thoughts on Oral Sema and Ozempic Filings; 3 NDAs to De-risk Regulatory Uncertainty

In what is believed to be a first, Novo Nordisk simultaneously filed three NDAs for oral semaglutide T2DM glycemic control, oral semaglutide CV risk reduction, and Ozempic CV risk reduction. The timings for the filings, including the use of the priority review voucher (PRV) for oral semaglutide, are in line with Novo’s previous guidance (by the end of Q1 ’19). Novo’s decision to simultaneously file oral semaglutide and the Ozempic CV indication ahead of REWIND data at ADA confirms FENIX’s previous insight. Below, FENIX provides thoughts and insights into Novo’s probable reasoning behind three separate filings as a means to de-risk the submissions, insight into potential approval timings for all 3 products, and an updated REWIND filing scenario that could result in a Q4 2019 2-day FDA adcom discussing GLP-1RA CVOTs.

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 T1DM Teplizumab Pivotal Ph3 trial (PROTECT)

FENIX has observed a new teplizumab pivotal Ph3 trial (PROTECT) on CT.gov. Teplizumab is an anti-CD3 monoclonal antibody being studied for new-onset T1DM. Of note, the initiation of this pivotal trial is earlier than the previous guidance from Provention Bio (previously late 2019). Below, FENIX provides thoughts on this new trial in the context of the failed Ph2/3 PROTÉGÉ study for teplizumab when the compound was under the control of Macrogenics.

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.

Fractyl Hires Former Sanofi and Intercept VPs

Fractyl, a Massachusetts-based medical technology company, announced the appointments of former Sanofi diabetes VP Margaret Borys as Chief Commercial Officer and former Intercept SVP Juan Carlos Lopez-Talavera as Chief Medical Officer. Below, FENIX provides thoughts on the appointments.

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.

Novo-Teva Generic Victoza Settled; Launch Date Rationale Unclear

Novo Nordisk announced it has settled the patent dispute with Teva regarding Teva’s ANDA filing for generic Victoza. Recall, in February 2017, Teva publicly disclosed the generic Victoza filing, and Novo subsequently announced their lawsuit in March 2017. According to the press release, Novo and Teva’s settlement entitles Teva to launch generic Victoza as early as December 22, 2023 (without pediatric exclusivity) unless Novo’s Victoza patents are invalidated or another generic Victoza is launched. Below, FENIX provides thoughts on the settlement with Teva as well as insight into the Victoza pediatric exclusivity extension.

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.

Lexicon Quiet on Sota T1DM Review; Q4 ’18 Earnings Update

Lexicon hosted its Q4 ’18 earnings call and provided brief updates to its Zynquista (sotagliflozin) clinical and regulatory activities across T1DM and T2DM. With the impending March 22, 2019 sota T1DM PDUFA, Lexicon senior management were reluctant to make comments or answer questions on the topic. For the sota T2DM development program, Lexicon said topline Ph3 data will start reading out in Q2 ’19. 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 Eversense Bridge Program; Senseonics Q4 ’18 Earnings Update

Senseonics hosted its Q4 ’18 earnings call and provided updates to its Eversense clinical and commercial activities. Of note, Senseonics is launching a new bridge program to help drive user adoption. Recall, Senseonics recently renewed its distribution agreement with Roche and hired Fran Kaufman, former Medtronic CMO. Below, FENIX provides highlights and insights from the earnings call including updates to the Senseonics pipeline.

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 Q4 ’18 Earnings Update; No Call Conducted

Adocia released its Q4 ’18 earnings results, but did not have an associated webcast. Below, FENIX provides highlights from the earnings press release including 2019 pipeline activities, and thoughts on how Adocia could enter the US and EU markets.

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.