Capital Region

Experimental drug given to President made locally

Antibody production work underway recently at Regeneron's East Greenbush production facility. PHOTO PROVIDED

Antibody production work underway recently at Regeneron's East Greenbush production facility. PHOTO PROVIDED

Categories: -The Daily Gazette, Business, News

The promising experimental anti-viral drug cocktail given to President Donald Trump on Friday to treat his COVID-19 was manufactured at Regeneron’s pharmeutical manufacturing complex in Rensselaer County.

Word that the president, who is being treated at Walter Reed National Military Medical Center in Maryland, received a single, 8-gram dose of REGN-COV2 was an unexpected shot of publicity for Regeneron, one of the stars in the constellation of companies that have earned the Capital Region the nickname “Tech Valley.”

A Regeneron spokeswoman on Saturday confirmed that the drug combination that they are developing was the same one administered to Trump — a combination of two monoclonal antibodies — and is made at the sprawling Rensselaer facility, where about 3,000 people work. Rensselaer is the company’s primary U.S. manufacturing location, though it is headquartered in Tarrytown, in Westchester County.

The White House physician announced Friday evening that Trump had been given REGN-COV2 after his diagnosis with COVID, which the president himself announced on Twitter in the Friday early-morning hours.

While Regeneron’s antibody drug is still experimental and has not received approval or even emergency use approval from the Food and Drug Administration, early last week the company announced that the first two phases of clinical trials had been extremely promising.

The company said it provided a dose for Trump at the request of the White House under its “compassionate use” policy, but it will not be available to the general public until clinical trials are completed and FDA approval is granted.

Last Tuesday, Regeneron said that in initial clinical trials, the treatment improved symptoms and reduced viral loads in non-hospitalized patients who have mild to moderate COVID-19. That was based on results for the first 275 trial patients. There is a separate study underway of hospitalized patients, which has also shown promise for the drug.

The product Regeneron is developing is a treatment for patients with COVID, which makes it different from a vaccine, which would prevent people exposed to the novel coronavirus from becoming sick. Trump has pushed aggressively for rapid development of a vaccine.

Regeneron said REGN-COV2 is a shot of lab-generated antibodies that mimics the body’s immune response to an invader like a virus. The goal is to boost the immune system’s defenses. Nearly two-thirds of those participating in the trial had risk factors for COVID complications, according to the company.

The company said at least 1,300 patients will be recruited for the upcoming Phase 2/3 portion of the outpatient trial. The drug must successfully pass those trials to receive FDA approval for public use.

Individuals interested in participating in one of Regeneron’s COVID-19 clinical trials may complete a brief online screener at ClinLife.com/COVID to see if they qualify, the company said.

“The company’s current priority is to maintain a sufficient supply of REGN-COV2 in order to conduct rigorous clinical trials that fully evaluate its safety and efficacy,” Regeneron said in a statement Friday evening. “In addition to the clinical trial supply and product being manufactured under an agreement with the U.S. government, there is limited product available for compassionate use requests that have been approved under rare, exceptional circumstances on a case-by-case basis.”

It has been clear for several months that REGN-COV2 looked promising as a treatment. In July, Regeneron landed a $450 million contract from the federal government to develop and produce REGN-COV2; in August, the company announced a partnership in which Swiss pharmaceutical giant Roche would co-produce the cocktail and distribute it outside the United States.

 

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