These are the obstacles before Norwegians can get Trump’s “corona cocktail” – E24

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The biotech company Regeneron is developing the drug that was used to treat Donald Trump. The USA has secured hundreds of thousands of doses, but what does it take before it becomes available in Norway?

GOT “CORONA COCKTAIL”: US President Donald Trump takes off the bandage on the balcony of the White House after being treated for corona with, among other things, Regeneron’s drug REGN-COV2.

KEN CEDENO / POOL / POLARIS POOL

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When Donald Trump received the corona, he received, among other things, an experimental cocktail of various antibodies.

The cocktail is called REGN-COV2 and is developed by the American company Regeneron.

Regeneron’s drug is considered one of the more promising in the fight against corona, but it is still being tested through several clinical studies.

The United States has nevertheless secured around 300,000 doses through a deal worth 450 million dollars or around 4.2 billion kroner, according to Regeneron CEO Leonard Schleifer.

So what about Norway?

TRUMPS ‘DOCTORS: Donald Trump’s medical team meets the press outside Walter Reed Medical Center in Bethesda, Maryland, where the president was treated with Regeneron’s drug REGN-COV2.

Saul Loeb / AFP

Distributed by Roche outside the United States

Outside the US, the pharmaceutical giant Roche will distribute REGN-COV2 if the cocktail proves to be safe and effective – and the relevant authorities approve it.

Regeneron is responsible for the actual testing of REGN-COV2, explains Karsten Bruins Slot, medical director at Roche Norway.

Roche will be responsible for distribution outside the United States, he confirms.

The collaboration between Roche and Regeneron is expected to increase the offer of REGN-COV2 to at least three and a half times the current capacity, with the potential for further upscaling.

Expect answers from studies «soon»

All biotech companies have to go through a risky journey with many obstacles before they can start marketing and selling their medicines.

First comes a preclinical phase without humans. Then at least three clinical phases with humans before the drug can conquer the market.

Regeneron is conducting three clinical trials of REGN-COV2 in the later stages.

– There are currently three clinical studies on this drug and we expect results from these soon, says Bruins Slot in Roche Norway.

NOT FOR SALE: Regeneron’s scientists are still working on the coronavirus.

Regeneron / AP

Is it relevant to try experimental treatment with REGN-COV2 on covid-sick Norwegians in the clinical phase of the drug?

– This medicine is currently only available through three clinical studies, and none of these studies take place in Norway. Furthermore, the drug has not been approved by any drug authority. Thus, the drug is currently not available to Norwegian patients.

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Must be approved by the authorities

Bruins Slot emphasizes that medicines for use against corona must go through the same approval systems as all other medicines.

This means that it must first be approved by the European Medicines Agency and then the Norwegian authorities make a national decision on whether the drug should be introduced or not at Norwegian hospitals, he says.

We can update the Norwegian authorities on the results of the clinical studies when these are available.

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Healthy skepticism

Regeneron’s promising drug is made by extracting antibodies from infected people, and then reproducing them synthetically. The antibodies are intended to mimic the antibodies that the body itself produces to fight the disease.

Trump has described RAIN-COV2 as a cure, but there are good reasons to be skeptical.

AMERICAN COMPANY: The Regeneron logo pictured at one of the company’s offices in New York.

BRENDAN MCDERMID / X90143

Regeneron chief Leonard Schleifer, who is an acquaintance of the US president, has said that Trump’s successful treatment is “the weakest proof you can get” that it is a cure, according to Axios.

The Norwegian superior Arne Broch Brantsæter has told VG that the drug does not have an established place in the treatment of corona.

Former hedge fund manager Jim Cramer, who is currently the TV host of the program Mad Money on the American channel CNBC, warned investors last week from buying Regeneron shares only because Donald Trump boasted about the drug.

Regeneron shares have risen around 56 percent on the Nasdaq stock exchange this year, but fall back just over two percent on a heavy trading day on Wall Street on Thursday night Norwegian time.

CORONA WINNER: Regeneron has risen on the Nasdaq stock exchange in the US during the corona crisis. The picture shows the share in 2020.

InFront

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