Merck’s Injectable Keytruda Plans Create Authorized Dispute With Halozyme: WSJ

An investigational injectable formulation of Merck’s blockbuster most cancers drug Keytruda is creating authorized complications for the corporate as Halozyme Therapeutics contends the subcutaneous model infringes on its patents for a selected enzyme, in response to The Wall Avenue Journal. Public dialogue of the dispute between the 2 firms is anticipated Wednesday at an investor convention.

Keytruda was the highest promoting drug worldwide final yr, raking in almost $30 billion in gross sales. With patent protections set to run out in 2028, Merck’s strikes to tweak its formulation may goose gross sales whereas the protections maintain and doubtlessly prolong the patent runway.

Merck started collaborating with the South Korean firm Alteogen in 2020 to include its hyaluronidase enzymes into an injectable Keytruda formulation. Final yr, Merck alleged to the U.S. Patent and Trademark Workplace that seven patents for Halozyme’s personal hyaluronidase enzyme Mdase are too broad and subsequently shouldn’t have been granted, in response to the WSJ.

Halozyme countered Merck’s claims, saying {that a} new Keytruda formulation that makes use of the hyaluronidase enzyme infringes on these patents, and that Merck must signal a licensing settlement.

These petitions recommend the corporate is “tipping their hand that the Halozyme patents could be an issue for them,” Zachary Silbersher, co-founder of patent consulting agency Markman Advisors, instructed the WSJ.

The standing of Alteogen’s enzymes within the U.S. is unclear.

In November 2024, Merck’s Section III trial confirmed that the subcutaneous injection carried out equally in addition to the extra invasive infusion supply of Keytruda. Merck has estimated that if the injectable model is accredited, as much as 40% of sufferers taking Keytruda will swap inside two years, in response to the WSJ. The FDA is presently reviewing the applying for the brand new formulation and Merck CEO Robert Davis mentioned on the J.P. Morgan Convention in January that he expects to launch it this yr, in response to In search of Alpha.

Mdase is a follow-up product to Halozyme’s Enhanze, which the corporate says can allow 4-6 hour intravenous therapies to be given in minutes as a substitute. Halozyme has standing partnerships to include Enhanze into Bristol Myers Squibb’s most cancers drug Opdivo and Roche’s a number of sclerosis drug Ocrevus.