Covid-19 roundup: Gilead aims remdesivir toward helping India outbreak; Merck pairs with 5 Indian generics manufacturers for molnupiravir
As the number of Covid-19 cases in India dramatically increases, Gilead will donate 450,000 vials of its remdesivir drug to the government.
The company announced the move in a release on Monday. Gilead is offering technical assistance support for new local manufacturing facilities and donations of APIs to scale up the production of the drug — commercially named Veklury — to help cut down on the recent surge.
Gilead has seven licensees based in India, and they all have scaled up batch size to increase supply of the drug. The California biotech has focused on reaching low and middle-income countries with its drug. Remdesivir has been authorized for temporary use as a Covid-19 treatment in 50 countries, including the US.
On April 13, Gilead stopped its study of the drug in high-risk, non-hospitalized Covid-19 patients, and cited a lack of need, not safety or efficacy concerns. India banned exports of the drug as it saw case numbers continue to rise. Veklury is used in more than half of hospitalized patients with Covid-19, the company said.
Merck pairs with 5 Indian generics manufacturers for molnupiravir
In an effort to keep up with the devastating Covid-19 situation in India, Merck has entered voluntary licensing agreements with five Indian generics manufacturers to produce molnupiravir.
The investigational oral antiviral is in Phase III to treat patients who are not hospitalized. Production of the drug, developed with Ridgeback Biotherapeutics, is being upped to increase access and supply.
Cipla, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical Industries are the five generic manufacturers, and all are equipped with WHO prequalified facilities.
Phase II/III trial data provided some mixed results for the team at Merck. Though molnupiravir did not indicate any success preventing deaths or shortening stays in hospitalized patients, the community is hopeful that the pill can work as a preventative measure, keeping at-risk, newly diagnosed Covid-19 patients from ending up in the hospital. The company received positive signs from early trials, and it has moved into Phase III.
Merck has already scrapped 2 Covid-19 vaccines and one drug. The latest drug, known as MK-7110 or CD24Fc, was canned after it was acquired from OncoImmune. The drug faced manufacturing and regulatory delays, and Merck said in a statement that the drug wouldn’t be available until 2022.
US trade representative meets with vaccine makers to talk intellectual property
As the pandemic rages on in some parts of the world, a US trade representative has met with drugmakers Pfizer and AstraZeneca to talk about a potential intellectual property rights waiver, Reuters has reported.
Katherine Tai met virtually with executives of the two companies. Members of the World Trade Organization are set to talk about a proposal from India and South Africa to waive the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The US, among other countries, has blocked the move, according to Reuters.
If it happens, the move could help close the gap between developed and developing countries’ access to medicine. In early April, Tai criticized that gap, and called for sacrifices “in times of crisis.”
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