Merck could keep patent edge by shifting Keytruda cancer drug to simple shot

 U.S. drugmaker Merck & Co hopes to patent a new formulation of its $20 billion cancer immunotherapy Keytruda that can be injected under the skin, allowing it to protect its best-selling drug from competition expected as soon as 2028.

For years Merck has relied on Keytruda to fuel its growth. The treatment, approved in 2014, harnesses the body's own immune system to fight cancers with dramatic results. Against advanced lung cancer, it has led to a five-year survival rate in about one-quarter of people compared to 5% of people historically.

But the key patents on Keytruda will begin to expire in 2028, opening the door to biosimilars - near copies of expensive biologic drugs whose complex molecules cultivated inside living cells make it impossible to manufacture exact copies.

Merck is testing in clinical trials two versions of the drug that can be injected subcutaneously, a quick alternative to infusions, the current delivery method in which patients receive an intravenous drip in a health office once every three or six weeks. The company reported early data from one of those trials last year.

While Merck has disclosed that it is developing subcutaneous versions of Keytruda, it has not previously said that it expects the new formulation to become the most widely used version of the drug after it is rolled out and an engine for growth toward the end of the decade.

If successful, Merck could begin marketing the new formulation within a few years, a top Merck executive told Reuters. It expects it to fuel Keytruda's growth as it gains approvals in earlier stage cancers. Keytruda now accounts for more than one-third of Merck’s sales.

"We believe that subcutaneous formulation has the potential to be novel, non-obvious and useful, which means we would get a new patent for it," Merck CFO Caroline Litchfield said in an interview, using the terminology for the criteria under U.S. law to determine what technologies merit a patent.

https://www.yahoo.com/now/merck-could-keep-patent-edge-111346733.html