Roche Holding AG RHHBY 0.51% has agreed to help manufacture and distribute a promising investigational drug for Covid-19 being developed by Regeneron Pharmaceuticals Inc., REGN -0.34% a pairing of rivals that could more than triple supplies of the medicine if it is authorized by regulators, the companies said Wednesday.
Regeneron’s drug, code named REGN-COV2, is among the more promising options for Covid-19 under study in clinical trials as a treatment for sick patients and to temporarily prevent new infections in people at high risk of catching the virus.
Initial study results are expected by the end of September and Regeneron could seek an approval or emergency authorization before the end of the year.
Regeneron made the pact with Roche because it doesn’t expect to be able to manufacture enough of the drug on its own to meet global demand, Regeneron Chief Executive Leonard Schleifer said in an interview.
Roche, a Swiss pharmaceutical company that owns U.S.-based Genentech, is among the world’s largest and most experienced makers of the specialized type of antibody drugs that Regeneron is making, Dr. Schleifer said.
“We know we’re going to be limited in capacity and there are very few people in the world who have as much manufacturing capacity as Roche-Genentech,” said Dr. Schleifer.
A Roche spokesman confirmed details of the arrangement, in response to a request for comment.
Regeneron’s drug combines two monoclonal antibodies that mimic the natural antibodies that the body uses to fight off viruses.
Making such therapies is more complicated, lengthy and expensive than manufacturing traditional medicines because monoclonal antibodies are made from living cells in high-tech, sterilized facilities.
The deal brings together two companies that are usually competitors. Regeneron’s blockbuster vision-loss drug Eylea competes for market share with Genentech’s Lucentis.
The companies also sell competing similar-acting rheumatoid arthritis drugs, both of which were tested this year as treatments for Covid-19, but so far have failed to show benefits.
“We’re letting out our technology and sharing it with a competitor so that we can bring the most amount of doses to people in the U.S.,” Dr. Schleifer said.
Under the terms, Regeneron would be responsible for distributing the drug in the U.S., and Roche would handle international distribution and regulatory approvals, Regeneron said in a press release.
Each company will cover its own manufacturing and distribution expenses, and gross profit will be split according to a formula in which Regeneron is expected to receive a share of 50% to 60%, Regeneron said.
The companies will jointly fund a continuing Phase 3 prevention study and any additional global trials that are needed, Regeneron said.
Roche is setting up its manufacturing facilities to make the drug, and should be ready to start production in the coming months, Dr. Schleifer said.
Once Roche begins manufacturing the drug, supplies should be 3.5 times greater than what Regeneron can produce alone, but will likely still fall short of U.S. demand, Dr. Schleifer said.
The U.S. price of the drug will be set by Regeneron, and Roche will decide the price internationally, said Dr. Schleifer.
Regeneron hasn’t thought about how it will price the drug, Dr. Schleifer said, but he thinks that developed countries should pay one price, while poorer countries should be charged a lower price or receive the drug free via donations from the companies.
Regeneron, based in Tarrytown, N.Y., began preparing months ago to manufacture its drug in large quantities, including the transfer of production of its currently approved drugs to its facility in Ireland so that it can devote its main U.S. plant to REGN-COV2.
How many doses Regeneron will be able to make will depend on what dosage strength proves most effective in trials, and how much is used for treating sick patients versus prevention.
If all its supply goes to treatment, Regeneron should be able to manufacture tens of thousands of doses a month, the company said. If all the supply went to prevention, which requires a much smaller dosage, its capacity should be hundreds of thousands of doses a month.
Combined, the two companies expect to manufacture between 650,000 and two million treatment doses annually, or between four million and eight million preventive, or prophylactic, doses each year, a Regeneron spokeswoman said.
Write to Joseph Walker at [email protected]
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