Sanofi details big plans for Dupixent, sees €10B peak sales

Sanofi (NASDAQ:SNY) announces development plans for Dupixent (dupilumab), an IL-4 and IL-13 antagonist that it is co-developing and co-commercializing with Regeneron Pharmaceuticals (NASDAQ:REGN), which it expects to be one of its top growth drivers with expected peak sales of €10B. Management will provide additional details during a virtual investor event today at 9:00 am ET.

Five potential new indications:

Eosinophilic esophagitis: First part of an ongoing Phase 3 study was successful. If the second part follows suit, regulatory applications will be filed by the end of 2022.

Chronic obstructive pulmonary disease: A Phase 3 trial is underway with a second confirmatory study being initiated. If successful, regulatory applications will be filed in 2024.

Prurigo nodularis: Two Phase 3s underway with top line results expected in 2021. If positive, marketing applications will be filed by the end of that year.

Chronic spontaneous urticaria: Registrational study initiated. If the outcome is positive, marketing applications will be filed in 2022.

Bullous pemphigoid: Phase 3 study initiated. If results are positive, marketing applications will be filed in 2023 and beyond.

Dupixent is currently approved in the U.S. for eczema, asthma, atopic dermatitis and rhinosinusitis with nasal polyposis.

https://seekingalpha.com/news/3582184-sanofi-details-big-plans-for-dupixent-sees-10b-peak-sales

Regeneron initiates study of antibody cocktail for COVID-19

Regeneron Pharmaceuticals (NASDAQ:REGN) launches the first clinical trial evaluating REGN-COV2 (REGN10933 + REGN10987), its dual antibody cocktail, for the prevention and treatment of COVID-19.

The clinical program will involve four populations: hospitalized patients, non-hospitalized symptomatic patients, uninfected people in groups at high risk of exposure and uninfected people with close exposure to a COVID-19 patient.

The first two adaptive Phase 1/2/3 trials will involve hospitalized and non-hospitalized patients with COVID-19. Results from the Phase 1 & 2 portions will inform the endpoints and size of the Phase 3s.

The company says the two antibodies bind non-competitively to the critical receptor-binding domain of the SARS-CoV-2 spike protein.

https://seekingalpha.com/news/3582201-regeneron-initiates-study-of-antibody-cocktail-for-covidminus-19

CVS Health opens 10 drive-thru COVID-19 test sites in Kansas

CVS Health (NYSE:CVS) to open 10 new COVID-19 test sites at select CVS Pharmacy drive-thru locations across Kansas, on Friday, June 12.

These new sites will utilize self-swab tests and deliver on the company’s promise to establish 1,000 locations across the country and help enable a goal of processing up to 1.5M tests per month, contingent on availability of supplies and lab capacity.

https://seekingalpha.com/news/3582233-cvs-health-opens-10-drive-thru-covidminus-19-test-sites-in-kansas

FDA OKs Pfizer’s Neulasta biosimilar

The FDA approves Pfizer’s (NYSE:PFE) Nyvepria (pegfilgrastim-apgf), a bisimilar to Amgen’s (NASDAQ:AMGN) Neulasta, its sixth biosimilar approved in the U.S.
https://seekingalpha.com/news/3582254-fda-oks-pfizers-neulasta-biosimilar

ThermoGenesis files patent applications for detection of COVID-19 antibodies

ThermoGenesis Holdings (NASDAQ:THMO) has filed patent applications for a point-of-care device which improves the speed and accuracy of lateral flow immunoassays (LFIA) to detect COVID-19 IgM and IgG antibodies from a single drop of blood.

The applications have been filed in the U.S. in accordance with the USPTO COVID-19 prioritized examination Pilot Program.

COVID-19 LFIA reader will enable the user to simply slide the test cartridge into a portable reader, providing an instant readout which can be recorded into a database, and/or a cloud-based web portal.

https://seekingalpha.com/news/3582264-thermogenesis-files-patent-applications-for-detection-of-covidminus-19-antibodies

Lannett advances insulin glargine biosimilar

Based on FDA feedback, Lannett Company (NYSE:LCI) expects to file its U.S. marketing application for biosimilar insulin glargine (Sanofi’s Lantus) in calendar year 2022.
https://seekingalpha.com/news/3582256-lannett-advances-insulin-glargine-biosimilar

Anthem debuts decision support tools to aid in COVID-19 reopenings

Aimed at helping public health officials and business leaders’ plan to the reopening U.S. workplaces shuttered during the pandemic, Anthem (NYSE:ANTM) will make its C19 Explorer and C19 Navigator decision support tools available through its new portal.

C19 Explorer is an interactive dashboard on COVID-19 infection rates and community risk scores, including analysis and visualization that authorities and business leaders can use to assess a community’s readiness to reopen.

C19 Navigator is designed for Anthem employer customers to provide clinical insight and predictions to support the identification and clarification of next steps in the reopening process.

Anthem has released other tools over the past weeks to help stakeholders during the pandemic.

https://seekingalpha.com/news/3582261-anthem-debuts-decision-support-tools-to-aid-in-covidminus-19-reopenings