April 6, 2020

USA: Israeli GENERIC Drug Giant Announced It Will DONATE Ten Million Doses Of Hydroxychloroquine To US Hospitals FREE OF CHARGE. India Decided To Allow Export Of Hydroxychloroquine To The USA.

Times of Israel
written by TOI staff and AFP staff
Friday March 20, 2020

Hydroxychloroquine one of several drugs cited in recent days as being possibly effective against coronavirus; Israeli firm says it will provide as many as possible at no cost.

Israeli generic drug giant Teva announced Friday that it will provide ten million doses of its anti-malarial drug hydroxychloroquine, which could potentially prove effective in fighting the coronavirus pandemic, to US hospitals free of charge.

The company said six million doses will be delivered to US hospitals by March 31, and more than ten million in a month.

“We are committed to helping to supply as many tablets as possible as demand for this treatment accelerates at no cost,” Teva executive vice president Brendan O’Grady said.

US President Donald Trump touted the potential use of chloroquine on Thursday after encouraging results in China and France, although many experts warn of caution.

In France, the Sanofi laboratory said it was ready Tuesday to offer millions of doses of hydroxychloroquine to potentially treat 300,000 patients.

The hydroxychloroquine molecule, also used for decades in autoimmune diseases like lupus or rheumatoid arthritis, could indeed have an effect on the elimination of the virus, said Professor Didier Raoult, director of France’s Institut Hospitalo Universitaire (IHU) for the study of infectious diseases.

According to the study carried out by Prof. Raoult on 24 patients with coronavirus, six days after the start of taking hydroxychloroquine, the virus had disappeared in three-quarters of people treated.

The Food and Drug Administration (FDA), the federal agency that oversees the marketing of drugs in the United States, somewhat tempered President Trump’s enthusiasm by pointing out that the treatment, authorized for certain diseases, had not been approved for coronavirus.

But it will set up “an extended clinical trial,” said Stephen Hahn, its leader.

On the strength of these medical advances, Teva also indicated that it will do everything to accelerate its production of hydroxychloroquine and also conduct research to see if in its large catalog of 3,500 drugs, others can be used to fight COVID-19.

Also this week Chinese authorities said a drug produced in Japan could be effective for treating coronavirus patients. China’s ministry of science and technology said late Tuesday that some clinical trials have been completed on favipiravir — the main ingredient in the influenza drug Avigan.

The trials using the drug as a treatment for COVID-19, the disease caused by the virus, showed “very good clinical results,” an official said.

A trial involving 80 cases conducted by a hospital in Shenzhen and a study of 120 cases led by Wuhan University’s Zhongnan Hospital both showed the drug shortened the recovery time for patients. Clinical tests using Avigan as a treatment for the virus have also started in Japan.

Another drug cited as possibly helping patients is remdesivir, an experimental antiviral from Gilead Sciences.

No drug is specifically approved now for treating COVID-19.
Live Mint News
written by Elizabeth Roche
Sunday April 5, 2020

NEW DELHI: US President Donald Trump said he has requested Prime Minister Narendra Modi to supply hydroxychloroquine tablets that can be used to treat covid-19 patients in his country, which now has the highest number of cases in the world.

According to people familiar with the development in New Delhi, the request is under consideration with India expected to take a call after assessing its own domestic requirement of the drug.

Trump late Saturday had said he urged Prime Minister Narendra Modi to supply hydroxychloroquine tablets to his country, which now has the highest number of coronavirus cases in the world.

Hydroxychloroquine tablets are recognised as prophylactic for those on the frontline of the fight against covid-19--doctors, nurses, paramedics and first responders--and can be used to treat patients infected with the deadly virus.

Analysts say that the request from the US could be seen as an opportunity in multiple ways. It signifies a recognition of India’s contribution and potential in the pharmaceutical sector and will provide a possible opening for India and the US to negotiate their differences to cap prices of drugs and medical devices.

At his White House coronavirus task force briefing late Saturday, Trump said he had reached out to India for supply of hydroxychloroquine. The US recorded the highest number of deaths on the same day, more than 1,300, due to covid-19.

“After the call today (Saturday) with Indian Prime Minister Narendra Modi, India is giving serious consideration to releasing the hold it put on a US order for hydroxychloroquine," Trump was quoted as saying by news agency ANI.

“India makes a lot of it. They need a lot too for their billion-plus people. The hydroxychloroquine, the anti-malaria drug, will be released through the Strategic National Stockpile for treatment," he said.

“I said I would appreciate it if they would release the amounts that we ordered," he added.

In his comments, Trump also said he too may take hydroxychloroquine, though on doctors’ orders.

The president also warned that the next two weeks were going to be “very, very deadly." “Unfortunately, but we are going to make it so that we lose as few lives as possible and I think we are going to be successful," he added.

In a Twitter post on Saturday following his conversation with Trump, Modi had said,“Had an extensive telephone conversation with President @realDonaldTrump. We had a good discussion, and agreed to deploy the full strength of the India-US partnership to fight COVID-19".

India’s foreign ministry readout on Saturday on the conversation made no mention of Trump’s request.

“Stressing on the special relationship between the two countries, the Prime Minister reiterated India’s solidarity with the US in overcoming this global crisis together. The two leaders agreed to deploy the full strength of the India–US partnership to resolutely and effectively combat COVID-19," the Indian statement had said.

Earlier last week, the Indian foreign ministry had said US Secretary of State Michael Pompeo had discussions with Indian foreign minister S Jaishankar on the phone about the importance of continued close cooperation between the two nations to combat the virus by strengthening global pharmaceutical supply chains.

India had announced a ban on the export of hydroxychloroquine and formulations made from hydroxychloroquine on 26 March though the Indian commerce ministry had said exports would be allowed from special economic zones (SEZs) and to fulfil prior obligations or for humanitarian efforts by the government.

Last month India had also banned exports of sanitizers and extended a ban on ventilators to artificial respiratory apparatus, oxygen therapy apparatus and any other breathing appliance to ensure the availability of these critical healthcare items.

On Saturday, India announced a ban on the export of diagnostic kits and laboratory reagents as the number of covid-19 cases in the country soared past the 3,000 mark, with death toll nearing 80.

As of Sunday, there were more than 312,000 covid-19 cases in the US, with 8,503 deaths, according to the US-based Johns Hopkins University & Medicine. The worst affected was New York with over 2,600 deaths.

Former Indian ambassador to the US Lalit Mansingh said given the importance of the request--that had come directly from Trump--India should look at providing some drugs to the US.

“It is a recognition of the potential of the Indian pharmaceutical sector. The US’ need for the drug is more than ours given the alarming numbers of those infected. It is more than our need at present though India has much larger number of people and our graph is also going up...I think the prime minister will respond to President Trump’s request," Mansingh said.

Looking ahead, Mansingh said this may provide India and the US with an opportunity to sort out issues related to India’s capping of prices of drugs and medical equipment like stents that have figured prominently in trade disputes between the two countries.
Live Mint News
written by Elizabeth Roche, Leroy Leo
Monday April 6, 2020

NEW DELHI: Paying heed to US President Donald Trump’s call, India on Monday decided to allow export of hydroxychloroquine -- a drug seen as key in the treatment of the covid-19 pandemic -- on a “case by case" basis. It also allowed the export of paracetamol, a popular antipyretic, as well as some more drugs.

The decision follows a telephone conversation between Trump and Prime Minister Narendra Modi on Saturday. Besides the US, a number of other countries also have approached India to export hydroxychloroquine. Nearly half of US's supply of the drug, which as such is prescribed against malaria, comes from India.

At his White House briefing on covid-19 in the US, Trump said, “After the call today (Saturday) with Indian Prime Minister Narendra Modi, India is giving serious consideration to releasing the hold it put on a US order for hydroxychloroquine."

“India makes a lot of it. They need a lot too for their billion-plus people. The hydroxychloroquine, the anti-malaria drug, will be released through the strategic national stockpile for treatment," he had said.

“I said I would appreciate it if they would release the amounts that we ordered," he added, warning that the next two weeks would be “very, very deadly."

Two government officials familiar with the matter said that the Committee of Secretaries headed by Cabinet secretary Rajiv Gauba gave its green signal to the lifting of the ban – albeit with certain conditions attached. These were domestic availability and sufficient stocks of the drugs for people at home, the situation in the covid-19-affected country and India’s ties with countries to which the drugs will be exported to, one of two officials cited above said.

The second official said that this decision had received the “all clear" and could be implemented soon.

The export of some other drugs, restricted by India’s Directorate General of Foreign Trade (DGFT) last month, had also been cleared, the official said.

DGFT had last month tightened controls over the exports of 13 active pharmaceutical ingredients (APIs), including paracetamol, certain vitamins and antibiotics, and formulations made by them as the covid-19 epidemic in China was seen affecting their supply. This meant that companies planning to export these products would have had to secure a no-objection certificate from the government.

Separately, the government had also banned the export of hydroxychloroquine, an anti-malarial drug which has been repurposed for treatment of covid-19. Drug regulators across the world have been approving the use of hydroxychloroquine as prophylaxis based on anecdotal evidence despite concerns of its adverse impact on cardiac patients. The treatment has been approved due to the health emergency caused by the novel virus, which has no known cure.

The number of infections due to covid-19 worldwide is inching towards the 1.3 million mark with more than 70,000 deaths. In the US, the worst affected currently by covid-19, infection numbers are headed towards the 340,000 mark with the death toll at over 9,600, according to the US-based Johns Hopkins University’s live tracker of the disease. New York is the epicenter of the outbreak in the US with more than 3,000 deaths. In India, the number of active cases is at 3,851 with 111 deaths.

An Indian readout of the telephone conversation between Modi and Trump said: “Stressing on the special relationship between the two countries, the Prime Minister reiterated India’s solidarity with the US in overcoming this global crisis together. The two leaders agreed to deploy the full strength of the India–US partnership to resolutely and effectively combat COVID-19."

Ties between India and the US have warmed rapidly over the past two decades with an increasing congruence of strategic interests from terrorism emanating from Pakistan to peace in the Indo-Pacific region. In February, India hosted President Trump for a three-city 36-hour visit, laying out the red carpet for the occasion.
written by Reuters staff
Friday March 20, 2020

Novartis will donate enough doses of malaria drug hydroxychloroquine to treat several million patients in the fight against the coronavirus, if it wins approval, the Swiss company said on Friday.

There are no vaccines or treatments approved for the disease, but there is currently a 1,500-person trial, led by the University of Minnesota, to see whether hydroxychloroquine can prevent or reduce the severity of COVID-19. Two other trials are studying blood pressure drug losartan as a possible treatment.

Novartis makes the malaria drug, which is also used to treat lupus and rheumatoid arthritis, at its Sandoz unit in the United States. It plans to DONATE 130 MILLION doses of the drug and is in talks with U.S. Food and Drug Administration regulators over expanding its use for coronavirus.

“Novartis is supporting ongoing clinical trial efforts, and will evaluate needs for additional clinical trials,” it said in a statement.

In Washington, U.S. President Donald Trump said during a news conference on Friday he is optimistic about the malaria treatment’s use against COVID-19.

Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, did not take issue with Trump’s optimism, but said the drug’s promise is based so far on anecdotal evidence in France and that more data is needed.

“What I’m saying is that it might - it might - be effective. I’m not saying that it isn’t,” Fauci said.

Fauci also said that while toxic reactions to the drugs are rare based on decades of patient use and can be reversible in many cases, that is not known for COVID-19.

“What we don’t know is when you put it in the context of another disease whether it’s safe. Fundamentally, I think it probably is going to be safe, but I like to prove things first,” Fauci said.

Novartis has 50 million doses in stock, and hopes to produce another 80 million by the end of May for donation. The donations may be sufficient to treat several million patients, depending on the dosing regimen, Novartis said.

The American Society of Health-System Pharmacists (ASHP), added hydroxychloroquine to its list of drugs in short supply this week. Four out of eight manufacturers of the drug are in short supply, it said.

Bayer AG has donated three million tablets of the malaria drug Resochin, which is similar to hydroxychloroquine, to the U.S. government for potential use against coronavirus.

Mylan NV is ramping up production and expects to begin supplying it more broadly in mid-April. It said with the raw materials on hand it can make 50 million tablets to potentially treat more than 1.5 million patients.

Teva Pharmaceuticals Industries Ltd said it would donate more than six million doses of hydroxychloroquine sulfate tablets.

UPDATE 4/7/20 at 1:04am: Added info below.
UPDATE 4/7/20 at 3:33am: Added info below.

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