Regeneron and Roche's COVID drug wins WHO backing, but agency calls for lower prices and better access

While the debate swirls in Washington about how to lower drug prices, the World Health Organization has made a direct and urgent appeal for lower costs on a critical COVID-19 medicine.

In endorsing Regeneron and Roche’s antibody cocktail for COVID patients, the WHO also has requested that the companies offer the treatment at a discount and to distribute it equitably. In addition, the organization has asked Regeneron to release patents so that other manufacturers can make biosimilars. 

While Regeneron developed the drug, the company last August tapped Swiss pharma giant Roche to help scale up manufacturing and handle distribution outside of the U.S. 

The antibody combo has posted data showing it's effective for those who have contracted the virus and are at a high risk of progressing to a severe form of the disease. It's also used in those who have severe illness and have not developed a natural antibody response.  The WHO’s recommendation limits REGEN-COV's use to these two groups. 

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Complicating the endorsement, however, is the cost. REGEN-COV—or Ronapreve outside the United States—is priced at $2,100 per dose in the U.S., $2,000 per dose in Germany and $820 per dose in India.

“We have utilised international differential pricing to address affordability challenges in low- and middle-income countries,” Roche said in a statement.

Meanwhile, Roche is in discussion with the Access to COVID-19 Tools (ACT) initiative to donate the drug in poorer countries, the company said. The company is also working on an alternative pricing program for those nations. 

The limited supply of the drug is another problem. Roche's largest production facility is “dedicated entirely” to drugs—both authorized and investigational—for patients with COVID-19, the company said.

Regeneron and Roche have increased the global supply of the cocktail by more than 3.5 times from their original capacity, Roche said.  

RELATED: Amid COVID’s latest surge, Regeneron and Eli Lilly score new antibody supply deals with the U.S.

Regeneron gained emergency use approval for the cocktail late last year. After a slow uptake, the treatment has gained steam as it has proven effective against variants. Earlier this month, the U.S. revealed the purchase of an additional 1.4 million doses of REGEN-COV to be delivered by the end of January of next year.

The deal will generate $2.94 billion for the company on top of the $2.59 billion it reported for sales of COVID antibodies in the second quarter of this year—a massive figure for a drugmaker that generated $2.53 billion altogether during the first quarter of 2021.