NEW YORK, March 27 (Reuters) - Merck & Co ( MRK ) said
on Thursday that it plans to launch a subcutaneously injected
version of its blockbuster cancer immunotherapy Keytruda in the
U.S. on October 1, and expects to hit peak adoption rates of the
new version within two years.
The subcutaneous version of the drug is not yet approved by
the U.S. Food and Drug Administration, which has a target of
September 23 to decide. By injecting Keytruda under the skin
rather than intravenous delivery, it will reduce the time it
takes for patients to receive the medicine, the drugmaker said.
"We'll be shipping product immediately following approval,
in the first week or two following approval is the expectation,
and we'll have more than enough supply to meet the market
demand," Joanne Monahan, a senior vice president in Merck's ( MRK )
oncology division, said in an interview.
The company expects peak adoption of the drug to be at least
30% to 40% of patients on Keytruda, she added.
"We expect the greatest uptake, at least initially, in
patients who take monotherapy, oral combinations, and those who
have early-stage cancers," Monahan said.
Keytruda, which is approved to treat many types of cancer,
is the world's top-selling prescription medicine, with nearly
$30 billion in sales in 2024.
In data the company is presenting at the European Lung
Cancer Congress, it said the median injection time per
subcutaneous dose was two minutes, down from around 30 minutes
for a Keytruda infusion.
Merck ( MRK ) has relied on Keytruda to fuel its growth for years. It
hopes the intellectual property protection from the subcutaneous
version can help protect against copies of the drug as key
Keytruda patents begin to expire in 2028.
The company hopes to start selling the subcutaneous version
of Keytruda in Europe in early 2026, Monahan said.
South Korea-based drugmaker Alteogen is
developing and manufacturing an enzyme used with the
subcutaneous formulation of Keytruda.
While Merck ( MRK ) and Alteogen could face a potential patent challenge
from biotech Halozyme Therapeutics ( HALO ) over the enzyme,
Merck ( MRK ) said it will not delay the launch of the drug.
"We believe we have a very strong position relative to the
claims from Halozyme," Merck's ( MRK ) Monahan said.