US drugmaker Merck & Co on October 27 announced a deal that could see generic versions of its Covid-19 medication widely distributed in poorer countries, in a first during the pandemic.
The global Medicines Patent Pool (MPP) said it had signed a voluntary licensing agreement with Merck to facilitate affordable worldwide access for its investigational oral antiviral medicine molnupiravir.
Subject to regulatory approval, the deal will help create broad access to molnupiravir in 105 low- and middle-income countries.
The US and EU medicines regulators are reviewing the drug.
Antivirals like molnupiravir work by decreasing the ability of a virus to replicate, thereby slowing down the disease.
Given to patients within days of a positive test, the treatment halves the risk of hospitalisation, according to a clinical trial conducted by Merck, also called MSD outside the US.
Merck’s deal with MPP is “a positive step towards creating broader access to treatment as quickly as possible”, the World Health Organisation (WHO) said in a statement.
But it urged the drugmaker to “provide data of clinical trials to WHO as soon as possible so the agency can evaluate the medicine for global use”.
It also pressed Merck to “include other key countries in the scope of the agreement in the near future”.
The Geneva-based MPP is a UN-backed international organisation that works to facilitate the development of medicines for low- and middle-income nations.
Under the deal, Merck grants a licence to the MPP, under which the organisation can then sub-licence to makers of generic drugs.
The deal means the drug’s developers will not receive sales royalties while Covid-19 remains classified as a public health emergency of international concern (PHEIC) by the WHO.
A PHEIC is the highest alarm the WHO can sound and its emergency committee last week reconfirmed the pandemic’s top-alert status.
“The interim results for molnupiravir are compelling and we see this oral treatment candidate as a potentially important tool to help address the current health crisis,” said MPP executive director Charles Gore.
Merck is jointly developing molnupiravir with Ridgeback Biotherapeutics.
The Miami-based company’s CEO Wendy Holman said the deal meant “quality-assured generic versions of molnupiravir can be developed and distributed quickly following regulatory authorisation”.
The MPP was founded by Unitaid, which works on innovations to prevent, diagnose and treat major diseases in poorer countries.
Molnupiravir prices have not yet been determined, but its simplicity, plus competition among generic manufacturers should mean low prices in the 105 poorer countries, said Unitaid spokesman Herve Verhoosel.
He said in countries with low vaccination rates, millions would need the drug to prevent progression to serious illness.
“We also need to see this licence followed by others as soon as possible for other key promising products expected to come out of the pipeline soon, for which we also need to ensure broad supply and affordability,” Verhoosel added.
While the search for vaccines has resulted in multiple products being approved for emergency use in the pandemic, the hunt for treatments for those who have already caught the disease has not been as fruitful.
The medical charity Doctors Without Borders (MSF) welcomed the announcement but said it did not go far enough.
“The licence excludes key upper-middle-income countries like Brazil and China from its territory, where there is strong, established capacity to produce and supply antiviral medicines,” MSF senior policy adviser Yuanqiong Hu said.
“Furthermore, the licence contains an unacceptable clause undermining the rights to challenge patents on molnupiravir.”
Hu said the agreement underlined the urgent need for a temporary waiver of intellectual property rights for all Covid-19 medicines, vaccines and tests.
In the Philippines, about 300,000 Covid-19 patients who have exhibited mild symptoms will be able to avail themselves of molnupiravir by next month.
The medication will be available in hospitals and medical associations that were granted a compassionate special permit (CSP) early this month by the Food and Drug Administration (FDA), officials of pharmaceutical company MedEthix, the local importer of molnupiravir, told a press briefing.
As of October 25, there were 30 hospitals nationwide that had been given CSPs to use the pill.
The list of hospitals would not be disclosed to the public for the patients’ privacy, FDA director-general Eric Domingo told Philippine Daily Inquirer.
Only Covid-19 patients with a doctor’s prescription can avail of the first shipment of the antiviral pills arriving next month, said MedEthix president and CEO Monaliza Salian, stressing that her company is bound by the limitations set in the CSP.
An emergency use authorisation (EUA) for molnupiravir was recently filed with the local FDA, which has yet to act on it, she said.
The market price of molnupiravir in the Philippines has yet to be determined, but is “definitely not as expensive” as the ones sold in the US, said Meneleo Hernandez Jr of Jackpharma Inc, the local distributor of the antiviral pill to the medical institutions. A five-day course of molnupiravir treatment reportedly costs about $700 in the US.
AFP, PHILIPPINE DAILY INQUIRER/ASIA NEWS NETWORK