The COVID-19 pandemic has prompted worldwide interest in the repurposing of drugs such as remdesivir and dexamethasone. Repurposing can be crucial for delivering new treatments to patients, but also raises a number of IP-related questions.
The repurposing of known drugs offers many clinical opportunities in developing new, safe and low-cost treatments. For example, Aspirin (acetylsalicylic acid), developed by Bayer in 1899 for pain and fever relief, has since proven to be effective against heart attacks, strokes and blood clots and may also prove effective in treating colon and other cancers. (Photo: amriphoto / iStock / Getty Images Plus)
In May 2020, the US Food and Drug Administration (USFDA) authorized emergency use of the anti-viral drug remdesivir for the treatment of COVID-19 after research suggested that patients who received it recovered four days faster than those receiving a placebo. The drug has not yet been approved, and further clinical trials are taking place to assess its effectiveness against COVID-19, including in combination with the anti-inflammatory drug baricitinib (sold under the brand name Olumiant). In June 2020, in a breakthrough in treating seriously-ill COVID patients on ventilators or oxygen, the low-cost anti-inflammatory steroid dexamethasone, which has been shown to significantly improve survival rates, became the “standard of care” in the UK.
With COVID-19 now affecting the entire world, and no vaccine or treatment approved, researchers are looking at the potential of many existing drugs, and particularly those that have been effective against similar viruses such as MERS and SARS.
Remdesivir was originally developed to treat Ebola, though it has not yet been approved for any condition. It is one of four treatments that are part of the WHO’s Solidarity trial for treatments, the others being chloroquine or hydroxychloroquine, lopinavir with ritonavir and lopinavir with ritonavir plus Interferon beta-1a. These treatments have previously shown results against diseases such as malaria, SARS, HIV and multiple sclerosis. The Solidarity trial will involve tests on thousands of patients in more than 100 countries.
The repurposing of known drugs is vital to developing new, safe and cost-effective treatments for a wide range of conditions.
Dexamethsone, on the other hand, is a low-cost, on-the-shelf, anti-inflammatory steroid, that has been around for some 60 years. Widely used in treating arthritis, asthma and various skin conditions, dexamethasone has been shown to reduce deaths by up to one-third among seriously-ill patients with COVID-19. The findings emerged from the RECOVERY (Randomised Evaluation of COVid-19 Therapy) clinical trial led by researchers from Oxford University in the UK.
“COVID-19 is a global disease – it is fantastic that the first treatment demonstrated to reduce mortality is one that is instantly available and affordable worldwide,” said Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health at Oxford University, one of the trial’s lead researchers.
The importance of repurposing
The repurposing of known drugs is vital to developing new, safe and cost-effective treatments for a wide range of conditions. For example, Aspirin (acetylsalicylic acid) was developed by German company Bayer back in 1899 as a treatment for pain and fever, and has since been proved to be effective against heart attacks, strokes and blood clots. And today it is in phase 3 clinical trials for treating colon and other cancers.
But Aspirin is not the only example of a drug that has an afterlife. For example, thalidomide, originally developed for treating morning sickness, has since been used against leprosy and is now also approved for treating multiple myeloma. And several drugs have been found to be effective against different types of cancer: examples include Merck’s Keytruda (pembrolizumab), which was developed for advanced melanoma but is now approved for 14 cancer types, and Bristol-Myers Squibb’s Opdivo (nivolumab) which is approved for 10 cancers and is being tested for more. In December 2019, AstraZeneca and Merck announced that Lynparza (olaparib) had been approved for treating pancreatic cancer in the US in addition to ovarian and breast cancer.
Clinical opportunities and...