Tag Archives: Diabetes

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.

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CREDENCE sNDA Filed; Priority Review Unclear

Janssen announced it has filed an sNDA for the Invokana renal outcomes study, CREDENCE. Full results from CREDENCE are scheduled to be presented on April 14 at the World Congress of Nephrology meeting. Recall, on July 16, 2018, Janssen announced that CREDENCE stopped early for positive efficacy findings. Of note, Janssen’s press release did not state whether the company requested a priority review by FDA. Below, FENIX provides thoughts on the CREDENCE filing and potential approval timelines based on whether or not FDA grants priority review.

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Glytec Partners with Dario For Outpatient Insulin Titration

DarioHealth announced a joint marketing agreement with Glytec to allow Dario’s connected BGM to integrate into Glytec’s Glucommander Outpatient insulin titration solution. Below, FENIX provides thoughts on why the partnership between Glytec and Dario makes sense for both companies.

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Cellnovo to Close Operations?

Cellnovo announced that it does not have sufficient capital to support a broader launch of its Gen 3 tubed patch pump which is negatively impacting the company’s overall operations. According to the press release, Cellnovo “[intends] to continue contacts initiated with strategic partners and investors in order to protect the value of the assets.” Given the financial situation, Cellnovo initiated collective proceedings in the UK and conciliation proceedings in France. Below, FENIX provides thoughts on Cellnovo’s market position and the potential closure of its operations.

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Diamyd T1DM Vaccine Development Update

Diamyd Medical, the developer of the Diamyd T1DM vaccine, announced its 2019 and 2020 development and regulatory strategy. The company believes it can file for Conditional Marketing Authorization in Europe by the end of 2020 followed by the initiation of a global Ph3 study in the US and EU. Below, FENIX provides thoughts and insight into the Diamyd platform.

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Forxiga T1DM Approved in Europe; Sota EU T1DM Approval Imminent

AstraZeneca announced the European Commission (EC) approved Forxiga in T1DM. The news follows the positive CHMP opinion on February 1, 2019. Recall, Lexicon/Sanofi’s sotagliflozin also received a positive CHMP opinion on March 1, 2019 followed by a CRL from FDA on March 22, 2019. Below, FENIX provides thoughts on the Forxiga EU approval and readthrough to sotagliflozin and Jardiance.

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Sotagliflozin T1DM Receives CRL From FDA

Sanofi and Lexicon announced that FDA issued a CRL for the sotagliflozin T1DM review. Lexicon subsequently hosted a call with investors but did not provide any additional insight into the content of the CRL letter. Below, FENIX provides thoughts on the sota T1DM CRL and impact to the T1DM market including a winners & losers analysis.

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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.

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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.

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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.

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