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"These guys have the cutting-edge technology to develop antibodies. Nobody else has been able to do what they have done."

"This is not a product that is going to generate perpetual cash flow, not least because companies are going to get negative press if they try to make a lot of money out of it."

"What this does most is help them [Regeneron] build their reputation in D.C., which right now is invaluable."

Yatin Suneja, analyst, Guggenheim

 

"We have seen promising early data and we will see what future studies show."

"We think this is a promising treatment."

Regeneron spokesperson

 

"Somebody down there [the White House medical staff] knows what is at the cutting edge of science."

Barry Bloom, professor of public health, Harvard University

Donald Trump has described the antibody cocktail made by Regeneron as a miracle © AP

Regeneron has been in business for three decades as a pharmaceutical company. The first two decades of its business were distinguished by unremarkable findings. Its founder and chairman was professionally trained as a neurosurgeon who founded the company in 1998, setting up headquarters in Tarrytown on the banks of the Hudson River, New York. It had not one single successful drug in production for its first 20 years of existence.

 

And then came a breakthrough with the discovery of a platform no other pharmaceutical company had. Researchers at the company discovered a way to inject human DNA into mice which then resulted in their immune systems excreting human antibodies on exposure to a virus. This represented the sole reason that Regeneron was in a position to move ahead of all other pharmaceutical companies in the advent of COVID-19. Its laboratories injected mice with the virus and the result was antibodies that could be tested in humans.

 

Its most famous test recently took place when its product was 'tested' on the President of the United States.  Who now enthuses that the product cured his bout with the coronavirus, and will perform the same life-saving feat for all others infected with SARS-CoV-2. Donald Trump had the inside track, as it were. One of his physicians clearly understood that the drug, useful only with people infected with the virus so recently that their immune system hadn't had the opportunity to react, could do the trick for the president.

 

 

The novel antibody cocktail Regeneron was able to produce by taking antibodies from a human and a mouse was shown in early trials to cut recovery time from 13 days to six;rt only, however, for patients whose systems had not yet mounted their own antibody response. People infected with the coronavirus whose immune system was triggered to fight the virus failed to benefit from the anti-virus cocktail. Which identifies it as a 'treatment', not a 'cure' for the disease.

Dr.Len Schleifer, known as "Lenny" to his friends was once an occasional golf buddy of Trump's. And Dr.Schleifer and his company, Regeneron are set to prosper enormously on the basis of President Trump's release of a video where he describes Regeneron's antibody treatment a a "miracle". The company's shares rose 60 percent since January, partially on hopes for its COVID-19 drug, and leaped forward again on the coveted testimonial from the world's most powerful politician.

The downside of course, is that Regeneron's antibody cocktail has not yet been fully tested in clinical trials, and there is no guarantee that it will work for everyone infected. Though it has shown great promise for those newly infected with the disease, it will be available only to a few hundred thousand patients by year's end. "This is not a cure, this is a treatment. Nothing is likely to be a cure for everybody", cautioned an individual knowledgeable about the drug.

Len Schleifer, who trained as a neurosurgeon, founded Regeneron in 1988, setting up its headquarters not in New York City where he was born, but instead in Tarrytown, farther north on the banks of the Hudson River. Photo by Reuters/Erin Scott

This is by no means the only success story for Regeneron in the past decade, where previously it developed two important drugs: Eylea, to treat macular degeneration, and Dupixent, an injection used for the treatment of eczema and asthma. In the last year alone, the company profited by selling $4.6 billion worth of Eyelea and $2.3 billion worth of Dupixent. Another success would go down just fine for the company's reputation and bottom line. A 'miracle' drug would do it.

This week Regeneron applied to the U.S. Food and Drug Administration for emergency authorization for the antibody cocktail and should the drug be authorized, the company is prepared to produce 50,000 doses right off, with another 300,000 doses by January. Impressive, but hardly enough to treat everyone in the U.S., much less further abroad. About 50,000 cases a day of the  COVID  disease is showing up in the United States. 

 

The Trump administration has purchased an initial 300,000 doses, costing $450 million with plans to offer the shots for free  to patients, following which the company has no idea how much it will charge. Guesses can range pretty high, since the cost to produce each shot can be up to several thousand dollars. Eli Lilly produces a similar treatment much less expensively, and it is in the position to manufacture more speedily reflecting that its antibodies are derived from a single source. Lilly expects to produce 100,000 doses this month alone. 

 

An associate professor in medicine at the University of Pittsburgh, Walid Gellad, responds: "We don't all live in the White House ... there are going to be major inequities in who gets the therapy." Was it not ever thus? 

U.S. President Donald Trump pulls off his protective face mask as he poses atop the Truman Balcony of the White House after returning from being hospitalized for coronavirus disease treatment this past week. Photo by Reuters/Erin Scott