Competition intensifies over oral medicine for novel coronavirus

The Yomiuri Shimbun

November 22, 2021

The commercialization of oral medicines for the novel coronavirus is advancing around the world, and expectations are high for such medicines that are easy to take and store. This has kicked off a scramble by countries eager to procure a large amount of the drugs from pharmaceutical companies.

There are also moves to support developing countries by exempting them from patent royalty payments in an effort to avoid a repeat of the disparity between developed and developing countries highlighted in the supply of vaccines.

Substantial risk reduction

U.S. major pharmaceutical firm Pfizer Inc. said Tuesday it has submitted an application for emergency use authorization of Paxlovid, an oral drug to help combat COVID-19, to the U.S. Food and Drug Administration.

This is the second application for approval of an oral drug to treat the coronavirus in the United States, following that of U.S. pharma giant Merck & Co., Inc.’s COVID-19 pill Molnupiravir. On Nov. 4, Britain became the first country to approve the use of Molnupiravir on Nov. 4.

Molnupiravir is said to halve the risk of hospitalization and death in patients with mild or moderate symptoms.

Paxlovid was confirmed to have reduced patients’ risk of developing serious symptoms by 89%.

An advisory panel to the FDA plans to examine the efficacy and safety of Molnupiravir at the end of this month.

Pfizer Chief Executive Officer Albert Bourla said the oral medicine could be critical in bringing the pandemic under control and has the potential to save lives and reduce hospitalizations.

20 million doses

Merck plans to produce 10 million doses of the oral drug by the end of this year and expand production to at least 20 million doses next year.

In Japan, the government clarified that it plans to commercialize an oral drug for COVID-19 by the end of this year in its comprehensive measures to prepare for a possible “sixth wave” of infections, which was mapped out on Nov. 12.

The government agreed with Tokyo-based MSD K.K., a subsidiary of Merck, to receive a supply of 1.6 million doses on condition that the drug is approved at an early stage. Of the total, 200,000 doses are expected to be supplied by the end of the year to be available for COVID-19 patients.

As international competition ramps up, it will also be important to secure domestically made COVID-19 medicines.

Having entered the final stage of clinical trials for its oral COVID-19 medicine, Shionogi & Co. is seeking approval for the drug by the end of the year. The company plans to conduct clinical trials in South Korea and Singapore, too, as cases have subsided in Japan.

The government has decided to provide financial support up to ¥2 billion for each pharmaceutical product to encourage further development.

Concerns over supply gaps

Expectations are high in each country for oral medicines to beat the coronavirus. On the other hand, there is a growing sense of crisis among medical professionals that the supply disparity between developed and developing countries, which was highlighted in the case of vaccines, could also occur with therapeutics.

As for the supply of vaccines, some developed countries put priority on stopping the spread of infections within their own borders. As the so-called hoarding of vaccines continued, vaccines were not sufficiently distributed in developing countries. According to the World Health Organization, only 6% of the population in African countries has completed vaccinations. Experts warned that lessons learned through the supply of vaccines must be applied.

Merck and Pfizer have signed an agreement for the licensed production of oral medicines with the Geneva-based Medicines Patent Pool, a U.N.-backed public health organization. Under the contract, generic drug makers and others who are aiming to spread their drugs to low- and middle-income countries are not required to pay patent royalties as a way to boost the production of inexpensive drugs and expand their supply to a wider range of areas.

On Oct. 19, the Bill & Melinda Gates Foundation of the United States announced that it would contribute up to $120 million (about ¥14 billion) to promote the distribution of Merck’s oral medicine. The foundation said everyone must have access to products that can save their lives, regardless of where they live.

Short development period

However, even countries that have been able to secure such medications cannot be free from worries.

The novel coronavirus is said to progress the most in the body in about two to five days after the onset of symptoms. By taking an oral medicine during this period, patients can suppress the growth of the virus and prevent themselves from becoming seriously ill or developing pneumonia. Therefore, it is important to visit a medical institution at an early stage to check for infection.

Many experts agree that, as long as an oral drug is meant to prevent patients from becoming seriously ill, it is necessary, for the time being, to continue taking basic infection control measures, such as maintaining the inspection system and wearing masks.

Since new coronavirus treatment drugs are deemed urgent, the development period for them is as short as one year, instead of the usual 10 years.

The new drugs have undergone clinical trials to confirm their safety, but some of their mid- to long-term side effects remain unknown. It is necessary to make a careful decision on which patients should be treated effectively with these COVID-19 agents.

“The fact that the development of oral drugs for the infection is progressing very quickly leads to a sense of security in society and is a welcome relief,” said Katsumi Maenaka, a professor of drug discovery chemistry at Hokkaido University. “Even after commercialization, it is important to collect data internationally and carefully examine the drugs’ long-term safety and effectiveness.”