By Joseph Walker
Roche Holding AG has agreed to help manufacture and distribute a
promising investigational drug for Covid-19 being developed by
Regeneron Pharmaceuticals Inc., 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 joseph.walker@wsj.com
(END) Dow Jones Newswires
August 19, 2020 01:14 ET (05:14 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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