Boston, Massachusetts 2021-10-20 00:01:17 –
NSDue to growing concerns about access to Covid-19 treatments, the Bill & Melinda Gates Foundation has pledged up to $ 120 million to accelerate the production of generic versions of experimental Merck (MRK) Tablets for treating Covid-19, available in dozens of low-income countries. However, the effort was greeted by various reactions by patient advocates.
The Gates Foundation will offer different types of incentives so that eight generic manufacturers that have already signed a voluntary license agreement with Merck can produce a sufficient amount of a drug called molnupiravir as soon as possible. .. The goal is to convince generic companies to prepare their facilities, rather than waiting to measure demand for pills — What early data suggests Hospitalization and mortality can be reduced before it increases.
“They are capable. They can do this,” said Trevor Mundel, President of Global Health at the Gates Foundation. “This is an incentive to do it early, rather than waiting for what the market looks like … they want to see enough (if any). They (maybe) You’ll want to see who pays at the end of the day. I don’t want them to wait. “
In particular, the Gates Foundation provides volume guarantees over a specified period of time, so generic manufacturers are confident that their production investment will return an acceptable rate of return. So far, the Foundation has also awarded a $ 2.4 million grant to help generic companies quickly apply for pre-qualifications for manufacturing to the World Health Organization.
Currently, the Gates Foundation has agreed to provide up to approximately $ 1.9 billion to undertake various efforts to combat Covid-19. These include the WHO-supervised COVAX vaccine distribution program, which is guaranteed to support the risky production of monoclonal antibody therapies for low- and middle-income countries.
Merck’s Cipla and Dr are the latest moves. It took place after signing contracts with major generic manufacturers such as Reddy’s Laboratories and Sun Pharmaceuticals to supply tablets to more than 100 low- and middle-income countries. However, at this time, it is not clear how many tablets each company will manufacture, the manufacturing costs the company will bear, or the pricing.
Merck tablets caused excitement Top-line research results It showed a 50% reduction in both hospitalization and mortality compared to placebo. In the placebo group, 53 patients (14.1%) were hospitalized or died. For those who received the drug, 28, or 7.3%, were hospitalized or died. The data for this study have been published in a press release and have not yet been peer-reviewed.
However, the findings have created another wave of anxiety over unfair access to Covid-19 medical products. Last year, wealthy countries soon signed contracts with vaccine makers, and low- and middle-income countries became heavily dependent on the World Health Organization to organize programs for the purchase and distribution of vaccines.So far, the effort has been not enough..
As a result, there is consistent pressure on vaccine manufacturers to share their intellectual property and other know-how so that generic manufacturers can make Covid-19 vaccines more easily and make them available to poorer countries at lower cost. ..For example, Pope Francis Prompted to vaccine makers Do so in a statement earlier this week.
Merck wants to avoid a similar fate by signing a voluntary license agreement. However, the company that developed the pill with Ridgeback Biotherapeutics has shown no plans to share its intellectual property. However, Merck said it is in talks with a UN-sponsored organization, the drug patent pool, to explore the possibility of additional licensing.
As a result, unfair access concerns have surfaced.
“Although initiatives to accelerate production and access, especially in the African Continent and low-income countries, are welcome, investment in the Gates Foundation is incomplete. Vaccines and treatments Aparthate are today due to intellectual property barriers. It affects all low- and middle-income countries, “said Rohit Malpani, a former director of policy and analysis for Doctors Without Borders and now a board member of UNITAID, which supports the drug patent pool. ..
“We also need to address these patent barriers to ensure access to these medicines. The Gates Foundation has cast considerable power and influence behind the abandonment of intellectual property rules at the World Trade Organization. , We need to pressure Merck to expand its voluntary licenses to include all countries. “
Pricing uncertainties have heightened concerns. The US government has signed a $ 1.2 billion contract to purchase 1.7 million batches. According to this, it costs $ 712 for a 5-day treatment course. That contract.. The company has indicated that it plans to administer 10 million doses by the end of this year and 20 million doses in 2022.
So far, other wealthy countries such as Singapore, Australia and South Korea have contracts with Merck to buy their pills, urging more countries to sign the agreement. The conditions have not been announced, but it is unclear what measures Merck will take to meet the growing demand, especially if the pill is later approved for a larger patient population.
in the meantime, Actual manufacturing cost It is estimated at $ 20 for a 5-day treatment course. This suggests that Merck will benefit significantly from selling to wealthy countries, but of Northeastern University, a senior health gap policy analyst who specializes in access to medicine and intellectual property. According to Professor Brookbaker, the license agreement does not guarantee sufficient access.
“There are three advantages here: more efficient manufacturing leading to cheaper prices, faster regulatory approval processes in each country, WHO pre-qualification, and quantity guarantees to encourage production.” He said. “The wording of the contract may encourage companies to start taking risks, that is, before regulatory approval is obtained.”
However, he also said the license agreement excludes more than 30 middle-income and low-middle-income countries, including Turkey, Malaysia, Mexico and Ukraine. .. He added that the company is in a position to benefit from vulnerable governments unless Merck pursues gradual pricing and raises prices slightly.
A Merck spokesperson said: [the pill] Must be approved by the regulatory agency. In addition to what Merck has announced, several governments have recently issued statements regarding ongoing discussions or agreements signed. “
However, Baker estimated that middle-income countries excluded from the license agreement would account for 30 million infections in the first half of 2021, accounting for 50% of all infections in low- and middle-income countries. According to his calculations, eight generic editions will be available, and even if this demand is met in licensed regions, Merck will not be able to meet the remaining 70% of the world’s needs.
“Basically, what this announcement says is that intellectual property remains sacred. The Gates Foundation is ready to prime the market-it takes care of the poorest countries, but Merck It doesn’t matter what you want to keep for itself, “Baker said. “The majority of the world’s poor live in high- and middle-income countries, and they will not yet have a guaranteed supply of life-saving treatments.”
However, if a WHO program called Access to COVID-19 Tools Accelerator successfully obtains Merck tablets, these concerns may be alleviated. The program, known as ACT-A, will purchase “new” pills for mild to moderate (Covid-19) patients for $ 10 by November and offer 28 million treatment courses the following year. Is reportedly negotiating.
It is not yet known if such a deal will occur and how much it will help countries excluded from Merck’s deal. Meanwhile, Jenny Ottenhoff, Senior Policy Director for Global Health at One Campaign, a non-profit organization dedicated to global poverty, agreed that incentives could be useful, but more needed. (By the way, the nonprofit is funded by the Gates Foundation and Merck.)
“To scale up production faster and easier, we’ll probably need more access to intellectual property,” she told us. “I don’t know if this is the amount of investment needed to make this happen.”
Gates Foundation commits $120 million for generics of Merck Covid-19 pill Source link Gates Foundation commits $120 million for generics of Merck Covid-19 pill