Highlights:

  • On October 11, Merck approached for U.S. emergency clearance of the first pill for COVID-19
  • In 2021, Merck proposes to produce 10 million treatment courses of the pill
  • Its licensing deals with eight Indian drug makers will enable cheaper generic versions for 109 low- and middle- income countries

International Health group voiced that the plan to roll out Merck & Co’s promising antiviral pill to treat COVID-19 risks repeating the inequities of vaccine distribution, leaving the nations with the greatest need once again at the back of the line.

It cited only around 5% of Africa’s population is immunized, developing an urgent need for therapeutics that could keep people out of hospitals. That compares with over a 70% inoculation rate in most wealthy nations.

On October 11, Merck approached for U.S. emergency clearance of the first pill for COVID-19 after it minimized hospitalizations and death by 50% in a large clinical trial. Reportedly, the medicine composed of Ridgeback Biotherapeutics could achieve authorization as soon as in December.

According to reports, the U.S. drugmaker has performed the unusual pandemic step of licensing several generics of antiviral molnupiravir before its branded version was even authorized for marketing. However, international health officials opined, even that is not enough for medicines to arrive in low- and middle-income countries in large enough numbers. It noted that shortcomings and red tape among global organizations could slow distribution.

In 2021, Merck proposes to produce 10 million treatment courses of the pill, which is required to be taken twice a day for five days. It further aims to produce 20 million in the following year. Moreover, its licensing deals with eight Indian drug makers will enable cheaper generic versions for 109 low- and middle-income countries involving Africa. This is a move taken by international groups in a positive concession.

On the other hand, wealthy nations steps to allocate molnupiravir supply deals. The United States has already secured 1.7 million courses together with an option for 3.5 million more by January of 2023 at around $700 per course, concerns heighten over who might be left out.

Merck asserted that it has worked on the technology transfer required to commence generic manufacturing, in contrast to vaccine makers who carry on to resist calls to waive patents or allow for the generic version to strengthen supplies.

In addition, a recent report formulated for the United Nations Access to COVID-19 Tools Accelerator program tasked with buying COVID-19 therapeutics for poor countries noted concern that U.N. agencies were not progressing quickly enough to enable an adequate amount of potential new treatments ahead of time, including Merck’s drug.

A United Nations-backed public health organization, Medicines Patent Pool (MPP), has 24 companies signed up and are eager to take the drug if Merck expands the licenses. Peter Maybarduk who sits on the MPP governance board voiced, “If you are not in license, you are relying on Merck, and it looks to us that could mean a potential supply shortfall as well as overpricing.” He added that this could lead to wealthy countries outbidding poor nations of medicines.

The licensed Indian manufacturers namely Aurobindo Pharma, Cipla Ltd, Dr. Reddy’s Labs, Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceuticals and Torrent Pharmaceuticals denied disclosing details on production plans.

Merck pledged that it is committed to facilitating timely access to its drug globally with plans for tiered pricing aligned with a country’s ability to pay. A spokesperson affirmed it is in a discussion about expanding licenses for generic molnupiravir “to build sufficient global supply of quality assured product to meet orders globally”.

According to reports, the government of Australia, South Korea, Thailand, Taiwan, Singapore and Malaysia reported that they already had deals or were negotiating supply contracts with Merck. The EU is in view of buying the pill after Merck applies for authorization in Europe.

The Eight generic manufacturers selected by Merck have WHO pre-qualified facilities to permit them to supply buyers such as the Global Fund, as per Paul Schaper, Merck executive director of global public policy. Schaper added, “What we are anticipating and hoping for is that they will compete with each other on pricing.”

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