President Donald Trump has called Regeneron Pharmaceuticals' antibody "cocktail," which he took while being treated for COVID-19, nothing less than a "cure" for the disease.
That remains to be seen, with the treatment yet to undergo a peer-reviewed drug trial. Mr. Trump's doctors also say he took a variety of medicines, making it unclear which ones may have helped in his recovery. Regeneron, which applied on Wednesday for emergency approval for the drug from the Food and Drug Administration, is also just starting to manufacture the treatment.
The company said in its FDA application that it will initially have enough doses for only 50,000 patients, but Regeneron expects to have enough medicine for as many as 300,000 people in the next few months. According to data from the World Health Organization, about 300,000 new cases of COVID-19 are being detected a day worldwide.
So what exactly is the treatment that Mr. Trump is calling "incredible"?
What is the name of the treatment?
The treatment is officially known as REGN-COV2. But it's not clear if that is the name Regeneron has settled on in bringing the product to market if it receives a green light from the FDA. For now, many people are simply calling it Regeneron, even though that is the name of the Tarrytown, New York-based pharmaceutical company that makes the medicine — not the drug itself.
Is the drug available, and how much will it cost?
REGN-COV2 is not available to anyone outside of Regeneron's experimental trials. It's not clear how much Regeneron would charge if the treatment were to become commercially available. In July, the company signed a contract with the government for $450 million to supply the treatment.
At the time, Regeneron said that under the contract it would produce enough doses to treat anywhere from 70,000 to 1.3 million cases of COVID-19, with a more exact number of patients to be treated based on the severity of their symptoms.
Regeneron has since said that it plans to supply enough doses to treat roughly 300,000 patients under its government contract. That comes out to a cost of about $1,500 per treatment. But if Regeneron's doses only end up treating 70,000 patients, that translates into $6,500 per treatment.
Still, the company said in a statement that if emergency authorization for REGN-COV2 is granted, under the terms of its contract with the U.S. "the government has committed to making these doses available to the American people at no cost, and [the government] would be responsible for their distribution."
A spokesperson for Regeneron told CBS MoneyWatch the company has not determined when it might start charging for the treatment or what it might eventually cost. The company also declined to comment on how much money it had spent to develop the treatment.
"We don't break our programs out this way, but worth noting that the medicine is predicated on decades of investment and effort spent building [other] antibody discovery and development technologies," the spokesperson said.
Investors clearly think REGN-COV2 could be highly lucrative for Regeneron. Shares of the company rose $40 on Monday, and were up another $20 on Wednesday and Thursday. In all, Regeneron's stock is up more than 60% this year, to just over $600 a share.
Who are the people behind the company?
Regeneron was founded by in 1998 by Leonard Schleifer, a physician and former assistant professor at the Weill Cornell Graduate School of Medical Sciences, according to FactSet.
In 2003, Martin Shkreli, the now-jailed pharmaceutical executive, bet against Regeneron by shorting the company's shares. At the time, Shkreli was working for a hedge fund founded by CNBC personality Jim Cramer. Shkreli questioned the value of a weight-loss drug Regeneron was working on, and his bet turned out right: The drug failed and Regeneron's shares plunged.
But that same year Regeneron also inked a development partnership with French drug company Sanofi. The partnership resulted in the development of five drugs, including a treatment for severe asthma attacks that has been a blockbuster. Other drugs have proved successful as well, including treatments for rheumatoid arthritis and macular degeneration.
Sanofi sold nearly its entire stake in the company earlier this year for roughly $13 billion. Regeneron's market value now tops $63 billion, and its largest investors are mutual fund giants Fidelity and Vanguard.
That soaring stock market valuation has made founder Schleifer a billionaire. At the same time, Schleifer, who was paid $21 million last year, has been an outspoken critic of the drug pricing schemes that have made many other executives in his industry rich.
"It's ridiculous. I hate us also when I see all this stuff," Schleifer said while speaking on a panel with other drug company executives at an industry conference in 2016. "As an industry, we have to innovate and innovate. We all have a great story to tell, but it's not a sustainable business model to have double-digit price increases twice a year."
Schleifer is also a member of Mr. Trump's golf club in New York's Westchester County. The president's 2016 and 2017 financial disclosures showed that he own shares of Regeneron. Schleifer, through a spokesperson, said he knows Mr. Trump from living in Westchester, but only as an acquaintance.
How does Regeneron's therapy work?
REN-COV2 is described as a drug cocktail because it consists of two antibodies designed to be particularly attractive to the coronavirus. The idea is that the antibodies will bind to the surface of the virus, stopping it from attaching to other healthy cells in the body. One of the antibodies comes from people who have contracted COVID-19 and recovered; the other comes from mice that have been injected with COVID-19.
Dr. Jon LaPook, CBS News' chief medical correspondent, has said the antibody cocktail makes "scientific sense," while noting that it hasn't yet been proven safe and effective.
Is it an effective treatment for COVID-19?
We don't know yet. Clinical trials for the treatment are ongoing and have yet to be peer reviewed. In late September, Regeneron said the early results showed its treatment reduced the amount of virus in patients taking the drug and accelerated their recovery.
Notably, according to the company, the treatment also seemed to help patients who hadn't been hospitalized and had only had mild cases of COVID-19. That raised hopes that Regeneron could work as a general treatment for the disease.
However, those early results are based on a study of only 275 patients — a small sample for a drug trial. David Nunan, a senior research fellow at Oxford University, called that sample size "pitiful."
Were fetal stem cells used to develop the treatment given to Mr. Trump?
Yes. According to a Regeneron spokesperson, theusing HEK 293T cells. That cell line was originally derived from the kidney tissue of a fetus aborted in the Netherlands in the 1970s.
The cells "were used in testing the antibody candidates' ability to neutralize the virus" and helped researchers "determine the 'best' two antibodies, which now make up the REGN-COV2 cocktail," the spokesperson said.
But there is no fetal tissue in the final product, and fetal tissue isn't used in manufacturing Regeneron's COVID-19 treatment. Other treatments, including potential vaccines from Moderna and AstraZeneca, are also tested on fetal tissue. But the fact that the president is praising Regeneron's therapy, and that at least a portion of its development involved fetal tissue, is notable. Last year, the Trump administration suspended federal funding for most new scientific research involving stem cells derived from abortions.
Earlier this year, a group that advocates for using stem cells in research lobbied the government's National Institutes of Health for permission to use fetal tissue in the development of COVID-19 treatments. The NIH, though, generally declined to relax its previous rules on stem cell research.
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