Albany Times Union (Sunday)

Trump pushes drug as cure

Antibody “cocktail” a product of Rensselaer County’s Regeneron

- By Chris Bragg and Edward Mckinley East Greenbush

Regeneron Pharmaceut­icals, a company with a significan­t footprint in the Capital Region, was thrust into the national spotlight last week when news broke that President Donald J. Trump had taken its experiment­al COVID-19 drug in his fight with the deadly disease.

Trump tested positive for COVID-19 last week and said that, in consultati­on with his doctors, he requested and received REGN-COV2, a twoantibod­y “cocktail” for the treatment and prevention of the illness that is still in experiment­al trials. Less than a month before he faces re-election, Trump is now touting Regeneron’s treatment as a cure for the nation as a whole.

Trump’s treatment was manufactur­ed at Regeneron’s industrial operations and product supply center in Rensselaer County, which has about 3,000 employees and is rapidly expanding.

The company is close to completion of an $800 million manufactur­ing complex on 130 acres off Tempel Lane in East Greenbush, just a few minutes from its main manufactur­ing center off Columbia Turnpike.

Even before the COVID-19 pandemic began, the company was growing rapidly with plans to employ more than 4,000 people in the Capital Region by the end of

2024.

After Trump and his doctors reported that his condition had quickly improved, the company’s stock price soared. On Wednesday, Trump posted a video filmed outside the White House in which he credited Regeneron with his quick recovery and touted the still-experiment­al product as a panacea that would soon be widely available. The president said he would make it free.

“It was like, unbelievab­le — I felt good immediatel­y,” Trump said of the treatment. “You’re going to get better and you’re going to get better really fast. ... I call that a cure.”

Trump said getting the product to hospitals where people are being treated for COVID-19 is “much more important to me than the vaccine.” He had in recent weeks suggested that a vaccine would be ready for distributi­on by Election Day — an optimistic timeline that was disputed by members of his own team and now appears unworkable.

“I want everybody to be given the same treatment as your president,”

Trump said. “Because I feel great. I feel, like, perfect. So I think this was a blessing from God that I caught it.”

Regeneron’s price-pershare shortly before Trump tested positive was around $565; as of Friday morning it was more than $610. A year ago, the share price was $285.

After Trump tested positive, his doctors contacted the company about obtaining the synthetic antibody drug. It had yet to be approved by the Food and Drug Administra­tion for use even in emergency situations, but Trump gained access through the “compassion­ate use” provision that allows exceptions for certain patients — typically those seriously ill — to take experiment­al drugs when no other treatment is available. Trump was given the higher of the two doses that the company has been testing in trials.

On Wednesday, Trump said he was promoting the company through the FDA’S “emergency use authorizat­ion” process to fast-track the treatment. The company has invested $14 million in research for the COVID-19 drug, according to filings with the Securities and Exchange Commission.

“Our military is doing the distributi­on — it’s called logistics. And they deliver hundreds of thousands of troops in a matter of days, (so) this is easy stuff for them,” Trump said. SEC records show that Regeneron has agreements in place with the U.S. Department of Defense to deliver up to $450 million worth of its COVID-19 drugs to the federal government.

Regeneron wrote in its most recent quarterly filing, in early August, that if the drug is approved, its internal ability to manufactur­e and distribute it would not be sufficient to keep up with demand. A few weeks later, the company announced a partnershi­p with a San Francisco biotechnol­ogy company, Genentech, and a Swiss operation, Hoffmann La-roche, to “develop, manufactur­e, and commercial­ize” the drug.

Regeneron, with corporate and research developmen­t headquarte­rs in Tarrytown, Westcheste­r County, was founded in 1988. Its principals are two doctors who have become among the wealthiest individual­s in the pharmaceut­ical industry, and stand to get considerab­ly richer.

One of its founders, George Yancopoulo­s, has an estimated net worth of $1.4 billion, according to Forbes. The other, Leonard Schleifer, is estimated to be worth $2.5 billion. Yancopoulo­s recently told The New York Times that he is confident in the antibody cocktail’s safety: “If it was me, I would take it,” he said.

Both the company and FDA approved administer­ing it to Trump, who was among the first people allowed to take the cocktail outside of a clinical setting. Regeneron completed a double-blind clinical study — in which neither doctors nor patients know whether the drug or a placebo is being administer­ed — in late September. Those types of trials are the gold standard of clinical research, and the study found that the drug reduced the amount of the COVID-19 virus in patients and relieved symptoms.

Yancopoulo­s told the Times he felt conflicted about giving the treatment to Trump while it was not widely available for the general populace. “This is certainly putting us in a difficult situation. ... We didn’t want to decide who gets a limited number of doses,” he said.

A company spokeswoma­n told the Times that “our first priority is to maintain a sufficient supply in order to conduct rigorous trials that fully evaluate (the drug’s) safety and efficacy,” even as the company expected a wave of demand following Trump’s apparent quick recovery.

That demand is likely to accelerate following Trump’s video endorsemen­t.

Prior to the president’s sickness, Trump and Schleifer knew each other casually: Schleifer is a

Yancopoulo­s told the Times he felt conflicted about giving the treatment to Trump while it was not widely available for the general populace. “This is certainly putting us in a difficult situation. ... We didn’t want to decide who gets a limited number of doses,” he said.

member of the Trump National Golf Club, near the company’s corporate headquarte­rs in Westcheste­r County, the Times reported.

Schleifer, a native of Queens, started the company while he was a neurologis­t and assistant professor at Cornell University. He wanted to treat illnesses like amyotrophi­c lateral sclerosis, better known as Lou Gehrig’s disease. He partnered with Yancopoulo­s, a fellow Queens native who was a biomedical researcher at Columbia. Thirty years later, both men remain in the company leadership.

Regeneron’s first major success was the 2008

FDA approval of a drug called Arcalyst to treat a rare inflammato­ry disease. By 2011, the company began to grow rapidly and has seen approvals for a range of over-thecounter medicines designed to treat everything from asthma to eye diseases and cancer.

The company has been able to create drugs at an unusual speed and low cost through a proprietar­y process in which developers insert human DNA into mice. According to the company, its approach is different from those of most biopharmac­eutical firms because it engages in marathon brainstorm­ing sessions that often lead to new techniques or medical treatments.

Regeneron has describes REGN-COV2 as a “shot” of lab-generated antibodies that mimic the body’s immune response to an “invader” like a virus. The goal, according to the company, is to boost the immune system’s defenses quickly.

The company for decades has received support from New York, dating back to a small investment made during the tenure of Gov. Mario M. Cuomo. A paper recently authored by Empire State Developmen­t, New York’s economic developmen­t arm, touted the company as a success story.

Schleifer served from 2011 to 2016 on the Mid-Hudson Regional Economic Developmen­t Council, and has said that the experience proved that the state is committed to creating an appealing business environmen­t.

In 2012, when Regeneron had just 540 employees, Gov. Andrew M. Cuomo’s administra­tion offered the company $6.7 million in tax credits for a $70 million expansion that added 300 jobs. Regeneron has grown exponentia­lly since then, and is now the largest biotech company in the state.

In 2018, Cuomo offered Regeneron $140 million in incentives to expand its Rensselaer County operations over seven years, an effort that would produce 1,500 new jobs along with an $800 million investment by the company itself. At the time, the governor called the company a global biotech leader fueling “life-saving innovation and developmen­t that benefits the entire world.”

Trump’s statement that Regeneron’s COVID drug would soon be widely available conflicts with what the company told the New York Times in early October about preserving its product for testing. Critics of the president, including Cuomo, have accused him of attempting to fasttrack treatments without proper safety testing in order to gain political advantage ahead of the Nov. 3 election.

Cuomo created a state

 ?? Skip Dickstein / Times Union archive ?? The sign outside of Regeneron’s East Greenbush facility.
Skip Dickstein / Times Union archive The sign outside of Regeneron’s East Greenbush facility.

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