Pharma COVID Roundup: News from Lilly, Pfizer, AstraZeneca, GileadBy
The latest on manufacturing and potential treatments for COVID-19 with news from Lilly, AbbVie, BI, Gilead Sciences, Pfizer, AstraZeneca, CSL, Takeda and others.
Lilly Comments on COVID Trial Enrollment Pause for Bamlanivimab
Eli Lilly and Company issued a statement on October 14, 2020 to comment on a recommendation from an independent data safety monitoring board (DSMB) to pause enrollment in a clinical trial (ACTIV-3) evaluating Lilly’s investigational neutralizing antibody, bamlanivimab, as a treatment for COVID-19 in hospitalized patients. The trial is being sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).
“At this time, only the DSMB has reviewed the data from the trial, and NIH leadership and Lilly remain blinded to the ongoing trial results,” Lilly said in its statement. “Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study.”
Lilly says its other trials of bamlanivimab are not affected by the enrollment pause in the NIH-sponsored trial of hospitalized patients. This includes BLAZE-2, a Phase III study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities, and the NIH-led ACTIV-2 study in recently diagnosed mild-to-moderate COVID-19 patients.
Lilly says it will await additional data to understand whether neutralizing antibodies could play a role in helping hospitalized patients and says it remains “confident in the potential benefits of neutralizing antibodies in patients earlier in the disease course of COVID-19.”
Lilly, Incyte Report Positive Data for Baricitinib for COVID-19
Eli Lilly and Company and Incyte, a Wilmington, Delaware-based biopharmaceutical company, have reported additional data showing Olumiant (baricitinib) in combination with remdesivir, Gilead Sciences’ COVID-19 treatment, reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir alone. Olumiant is approved for treating moderately to severely active rheumatoid arthritis and is licensed to Lilly from Incyte.
Lilly says it is continuing conversations with the US Food and Drug Administration (FDA) around the potential for emergency use authorization of baricitinib to treat hospitalized patients with COVID-19.
Source: Eli Lilly and Company and Incyte
NIH To Evaluate AbbVie’s and BI’s mAb for Treating COVID-19
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), has launched a study designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and merit advancement into larger clinical trials. The ACTIV-5 Big Effect Trial, which will enroll adult volunteers hospitalized with COVID-19 at as many as 40 US sites, is being conducted in collaboration with the NIH’s public-private partnership, Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program.
A Phase II trial will test Skyrizi (risankizumab), a monoclonal antibody developed by Boehringer Ingelheim and AbbVie, in conjunction with Gilead Sciences’ antiviral drug, remdesivir, compared to a placebo plus remdesivir. Skyrizi is now approved to treat moderate-to-severe plaque psoriasis. The trial will also test the investigational monoclonal antibody lenzilumab, developed by Humanigen a Burlingame, California-based biopharmaceutical company, with remdesivir, compared to placebo and remdesivir.
Source: National Institutes of Health
Pfizer, BioNTech in Rolling Submission in Canada for COVID Vaccine
Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have initiated a rolling submission to Health Canada, the pharmaceutical regulatory body of Canada, for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19.
The rolling submission has been accepted under the Minister of Health’s Interim Order that allows companies to submit safety and efficacy data and information as they become available. Health Canada will not make a decision on whether to authorize any vaccine being considered under rolling review until it has received the necessary evidence to support its safety, efficacy, and quality. Following the authorization of any vaccine submission, Health Canada will publish the evidence it reviewed in making its decision for transparency purposes.
BNT162b2 is based on BioNTech’s proprietary mRNA technology and is supported by Pfizer’s global vaccine development and manufacturing capabilities. The vaccine candidate is currently being evaluated in a global Phase III study ongoing at more than 120 clinical sites worldwide, including the US, Brazil, South Africa, and Argentina.
Source: Pfizer Canada and BioNTech
Gilead Reports More Results for Remdesivir for COVID; Updates Supply
Gilead Sciences reported positive results from a Phase III trial evaluating its antiviral drug, remdesivir, for treating adults hospitalized with mild-moderate or severe COVID-19 and updated its plans for supplying the drug.
The results, published in The New England Journal of Medicine, showed that treatment with Veklury resulted in a faster time to recovery (five days faster), reduced disease progression, and showed superior efficacy compared with placebo and reduced mortality (by 70% at Day 29 in patients on low-flow oxygen at baseline) in a post-hoc analysis.
Veklury is being evaluated in multiple international Phase III trials for treating COVID-19 in different patient populations and formulations and in combination with other therapies. It has been approved or authorized in approximately 50 countries globally, including in the US through emergency use authorization.
As the company announced on October 1, 2020, Gilead is now meeting real-time demand for Veklury in the US and anticipates meeting global demand for Veklury this month (October 2020), even in the event of potential future surges of COVID-19. Also, Gilead announced an agreement earlier this month (October 2020) with the European Commission that enables 37 participating countries in the European Union and the European Economic Area as well as the UK to purchase remdesivir for real-time demand and stockpiling needs, coordinated by the European Commission. The agreement covers purchases of remdesivir over the next six months with the option to extend further. In addition, Gilead’s voluntary licensing partners are currently supplying generic remdesivir in more than 40 countries.
Source: Gilead Sciences (results) and Gilead Sciences (Open letter from Gilead’s Chairman and CEO)
AstraZeneca’s COVID Vaccine Advances in Australia
Australia’s Therapeutic Goods Administration (TGA), the national pharmaceutical regulatory agency in Australia, has granted a provisional determination to AstraZeneca’s COVID-19 candidate.
The granting of a provisional determination means that the TGA has made a decision that AstraZeneca is now eligible to apply for provisional registration for the vaccine in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process and does not mean that an application has or will be made, or that the vaccine will be provisionally approved for inclusion in the ARTG.
Source: Australia’s Therapeutic Goods Administration
AstraZeneca Plans Supply of COVID-19 Vaccine in Thailand
AstraZeneca has signed a letter of intent for the manufacture and supply in Thailand for its COVID-19 vaccine candidate, AZD1222. If the vaccine is successful, Thailand will receive doses with the aim of beginning vaccination in the first half of 2021.
AstraZeneca signed the letter of intent with the Thai Ministry of Public Health (MOPH), Siam Bioscience, a Bangkok, Thailand-based biopharmaceutical company, and the Siam Cement Group (SCG), a business conglomerate in Asia.
Siam Bioscience will provide large-scale manufacturing to provide access to the potential vaccine in Southeast Asia. AstraZeneca is providing the potential vaccine at no profit during the pandemic and will work with Siam Bioscience to set up manufacturing facilities through technology transfer.
MOPH will be receiving AZD1222 doses for distribution in the Thai healthcare system and will facilitate regulatory review.
Source: Thai Ministry of Public Health and the UK government
CSL, Takeda Supply Product for COVID Hyperimmune Medicine Trial
The CoVIg-19 Plasma Alliance, a collaboration founded by CSL Behring and Takeda and supported by other global organizations, reports that the first patients are being enrolled in a Phase III clinical trial to evaluate an investigational anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine for treating hospitalized adults at risk for complications of COVID-19.
The trial, which is sponsored by the US National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health, will enroll 500 adult patients at up to 58 sites in the US, Mexico, and 16 other countries. The study will evaluate the safety and efficacy of H-Ig when given with remdesivir.
Four companies are collaborating to provide anti-coronavirus hIVIG for the trial: Emergent BioSolutions, Grifols, CSL Behring, and Takeda.
Source: CSL Behring and the National Institutes of Health
Roche To Launch SARS-CoV-2 Antigen Test
Roche reports it intends to launch a high-volume SARS-CoV-2 antigen test as an aid in the diagnosis of SARS-CoV-2 infection.
The test, the Elecsys SARS-CoV-2 Antigen test, is a laboratory immunoassay for the in vitro qualitative detection of the nucleocapsid antigen of SARS-CoV-2. The test is performed by healthcare professionals and uses nasopharyngeal or oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.
The test is planned to be made available at the end of 2020 for markets accepting the CE Mark, which is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. Roche also says it intends to file for emergency use authorization with the US Food and Drug Administration.