The pandemic outbreak of a novel coronavirus (COVID-19) is spreading rapidly worldwide, which has had a tremendous impact on all of our lives. As of March 31, 2020, the outbreak affected more than 202 countries, areas and territories around the world with over 754,948 cases and 36,571 deaths according to the World Health Organization (WHO) (1). Alongside its human impact and the economic downfall caused by its spread, COVID-19 is  having a growing impact on the global  pharmaceutical industry.

Given the worldwide COVID-19 pandemic, a unifying voice has been heard from small and big pharma alike.  Pharma and biotech companies from across the globe have all laid focus on both therapeutic and preventative medicines to combat the COVID-19. Many companies aggressively searching for a vaccine are testing their own active pharmaceutical ingredients (API) in an attempt to fast track through to clinical trials.  The efforts of the world pharmaceutical response fall into two broad categories: therapeutic medicines to treat those already affected by COVID-19 and preventative vaccines to halt the transmission and susceptibility to the virus.

Therapeutics

Currently, two medicines are approved for emergency treatment of COVID-19: Chloroquine and Favilavir. (2) While the overall response and long-term benefits of these drugs are not known, the initial results appear promising for those who are already infected and in need of urgent intervention.  Initial inquiries into the use of Remdesivir (Gilead Sciences) and several anti-viral /HIV drugs are looking promising.  To date, there are at least 29 companies are working on COVID-19 medication, ranging from Pfizer, Johnson & Johnson, Roche, Gilead, Eli Lilly and Co., and AbbVie to small biotechs and even some universities (2-3). The soonest any trial might see significant result would be China’s study of Actmetra (Roche) which is expected to provide results by the middle of May 2020. (4)

While the majority of these therapeutics are already established anti-viral APIs, the most promising appear to be Remdesivir (anti-Ebola) and Chloroquine (anti-Malaria) in the United States as trials are set to be underway on these medications.  On March 30, 2020 Novartis committed to deliver 20,000 doses of hydroxychloroquine to the University of Washington to aid in a 2,000 patient COVID-19 study. (3) Furthermore, 30 million doses have been supplied to the U.S. Department of Health and Human Services (DHHS) for controlled clinical studies and 130 million doses worldwide. Johnson & Johnson recently worked out a $1 billion deal with BARDA to produce a vaccine suggesting clinical trials will begin September of 2020. The US Food and Drug Administration (FDA)  has also greenlighted plasma therapy for the treatment of COVID-19.  Meanwhile, Japan is preparing mass quantities of Fujifilm’s Avigan (Flu) drug after the Japanese government expressed support for its use as a potential treatment in one China’s clinical trials.  Along with Roche’s Actmetra drug which is currently slated for a 188-person study ending around May 10, 2020. (4)

Preventative

While many companies are searching for a cure for those already infected, at least 25 companies are working on vaccines to prevent the transmission of the virus. (2)  While not immediate, many of these developing APIs are already being fast-tracked for clinical trials with the hope that a viable vaccine could be supplied to the general public within the next 18 months.  Some of these compounds includes:

• Fusogenix DNA vaccine (Entos Pharmaceuticals)

• Gimsilumab (Roivant Sciences)

• ChAdOx1 nCoV-19 (University of Oxford)

• AdCOVID (Altimmune along with the University of Alabama Birmingham-UAB)

• Coronavirus vaccine (Medicago)

and many more. (2)

From universities to large hospital medical supply companies, all of the research comes down to a collaborative effort for basic science and pharmaceutical information.

From universities to large pharma, all of the research comes down to a collaboration for scientific and pharmaceutical information. For example, the COVID-19 mRNA sequence is being mapped as it progresses and this information is vital to the continued research and formulation of new vaccine candidates.  Some companies have even begun modifying parts of the virus to aid in R&D efforts. With about 50 COVID-19 vaccines in development, we may see some ready to use in 12 to 18 months. (3) These vaccines will range from intramuscular injections to nasal sprays for inoculation paths.

Hurdles

Given the current conditions as the world has essentially gone under lockdown to try and flatten the curve of COVID-19 infection rates, drug developers are faced with several hurdles. As with all medical sectors currently, proper  personal protective equipment (PPE) is difficult to obtain, leading to potential exposure to researchers and clinical trial administrators.  Panic buying and hoarding PPE affects highly regulated environments, this could lead to clinical trials being delayed.

For those conducting therapeutic testing, supply could become an issue.  In the US, we have seen chloroquine shortages after an initial press conference from the President which caused a panic buy of prescription chloroquine.  Drugs in the early stages of the pipeline tend to exist in small quantities (<1 Kg).  It isn&rsquo;t until scale-up occurs in the pilot plant stage that mass production can effectively be assessed. Though an API can perform amazingly, however, if it can&rsquo;t be scaled up then it cannot be a viable candidate for world disbursement as time and cost would be prohibitive.

Conclusion

In the seemingly search for both a preventative and therapeutic cure during the COVID-19 pandemic, the collective power of the world&rsquo;s Biopharmaceutical scientists has focused on a singular goal. Large or small companies are utilizing genetic sequencing to fast track APIs through R&D, scale-up and viability testing to provide compounds ready for clinical trials which are likely to start in Q3 2020.  Certainly, we will see therapeutic medicines emerge first as many candidates are already developed and have been approved for the treatment of other conditions.  Although there exists a high level of urgency and desire to shorten approval timelines as much as possible, clinical trials will move forward at a pace that provide for the best statistics which will keep more patients, in the long term, safe and reduce the potential risks and side effects.

References

1. WHO: https://experience.arcgis.com/experience/685d0ace521648f8a5beeeee1b9125cd. March 31, 2020

2. Clinical Trials Arena. https://www.clinicaltrialsarena.com/analysis/coronavirus-mers-cov-drugs/. March 31, 2020

3. FiercePharma. https://www.fiercepharma.com/pharma/coronavirus-outbreak-climbs-to-more-than-6-000-cases-track-pharma-response-here. March 31, 2020

4. https://clinicaltrials.gov 

Keywords:

COVID-19,

Pharmaceutical

Clinical Trials

Author: Lin Zhang

Date: April 1, 2020

About the Author:

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.