Test kit for COVID-19 detection (Yonhap)
With experts suggesting that it will take one to five years for a vaccine for the new coronavirus to be developed from scratch, researchers are redirecting existing drugs and pipelines in an effort to control the outbreak.
On Tuesday, Gilead Sciences’ Ebola treatment remdesivir was approved for a phase 3 clinical trial in South Korea by the Ministry of Food and Drug Safety.
According to the clinical trial designed by Gilead Sciences, the efficacy of remdesivir on COVID-19 patients will be tested here on a total of 195 Korean patients scattered across the Seoul Medical Center, the National Medical Center and Kyungpook National University Hospital.
The former two institutes are in Seoul and the third is in Daegu, the city suffering the toughest blow from the COVID-19 outbreak in Korea.
Gilead Sciences Korea told The Korea Herald that to carry out a successful clinical trial, it is important to make sure a partner hospital has the systems in place to provide reliable data.
Considering the severity of the situation in Daegu, conducting even part of the remdesivir study there was risking the success of the trial, but the company did so in a rare move, a Gilead Sciences Korea official said.
The Drug Ministry also approved Korean local biotech ImmuneMed’s Virus Suppressing Factor injection HzVSFv13 on Feb. 21 for use on COVID-19 patients.
The drug has yet to be commercialized, but temporary permission was granted following a request from the Seoul National University Hospital, the Drug Ministry explained.
With around 5,000 confirmed patients nationwide, Korea is the second-most-affected country after China, which has over 80,000 confirmed patients.
To find other treatment options specific to this outbreak, the Korea Centers for Disease Control and Prevention is recruiting by March 9 a biotech that will research and develop monoclonal antibody drug candidates for a COVID-19 vaccine. The budget for this state-sponsored R&D project is 488 million won ($408,000). Biologics company Celltrion is among the bidders.
Around the world, there are some 30 antiviral drugs still in the clinical trial phase that are being tested for their efficacy against COVID-19.
Johnson & Johnson, Regeneron and CSL are some of the big players actively pursuing treatments, but the most prominent is inarguably Gilead Sciences, whose remdesivir was mentioned by the World Health Organization’s assistant director general as the most promising COVID-19 treatment. The drug is still in the experimental phase, and has yet to be commercialized. Gilead Sciences is carrying out two phase 3 clinical trials of remdesivir in China on COVID-19 patients there.
Other than these experimental drugs, there are currently 35 medicines acknowledged by Korea’s Health Insurance Review and Assessment Service that can be used to treat the virus.
They include ribavirin, Kaletra, zanamivir, immunoglobulin G, interferon and hydroxychloroquin sulphate.
Under normal circumstances ribavirin is used to treat hepatitis C, Kaletra to treat the human immunodeficiency virus, and zanamivir to treat influenza A and B. Immunoglobulin G is a plasma-derived antibody, interferon is an antiviral defense system booster and hydroxychloroquin sulphate is used to treat malaria.
Korean companies GC Pharma and SK Plasma provide the immunoglobulin drugs, while most of the ribavirin and hydroxychloroquin sulphate drugs are produced here.
For the rest of the key drugs, Korea depends on global pharmas that are members of the Korean Research-based Pharma Industry Association.
Kaletra, a lopinavir and ritonavir combinant, is made by Abbvie, and zanamivir is by GlaxoSmithKline. Roche, Merck and Bayer all produce interferon drugs. KRPIA represented the firms in saying that it is the global pharmas’ first priority to supply these drugs to Korea without a snag.
As of Feb. 26, there were enough Kaletra supplies for 6,489 patients to take the drug twice daily for 10 days, according to the Ministry of Food and Drug Safety.
The ministry said it is also considering adding Japanese flu treatment Avigan, or favipiravir, by Toyama, under Fujifilm, as a treatment option for confirmed patients here.
Meanwhile, an increasing number of companies are announcing involvement in COVID-19 vaccine studies and seeing spurts in their stock prices that may not be entirely justified.
Chinese firm BrightGene, which claims to have successfully copied Gilead Sciences’ redesivir, has been censured by the government for manipulating its stocks when in fact it had not gained the necessary license from Gilead.
Likewise, in Korea, stocks of pharmas claiming to have taken the first steps toward vaccine development have soared despite any proof of efficacy.
In order for a pharma firm to carry out drug tests on people, they must have their clinical trial designs approved by the Drug Ministry.
The Drug Ministry makes the information public once it approves a test design, but some companies have rushed ahead before the official announcement to say they have applied for a review, prompting flurried investor reactions.
The ministry has advised concerned individuals to check the official announcements to verify claims about clinical test approval.
Several pharma firms have decided to take the COVID-19 outbreak as an occasion to build a protocol for a repeat outbreak.
Celltrion said it has begun research on a potential drug candidate for coronaviruses and SK Bioscience said it will form a system that will enable it to quickly carry out research and development in future situations.
Meanwhile, the market for over-the-counter drugs and health supplements is experiencing a surge in demand.
Mundipharma’s Betadine sore throat spray, for example, has grown popular because COVID-19’s initial symptoms include sore throat.
Functional food and supplements said to strengthen the immune system are also expected to see 5 to 9 percent growth this year on the back of the COVID-19 outbreak, according to market research group Kantar.
The Korea Health Supplements Association said the market grew 3.5 percent on-year in 2019 to 4.6 trillion won ($3.8 billion), and that if the pace this year lives up to Kantar’s prediction, the market may reach 4.9 trillion won.
By Lim Jeong-yeo (email@example.com)