© Reuters. FILE PHOTO: The Merck brand is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid
By Michael Erman
(Reuters) – U.S. drugmaker Merck & Co hopes to patent a brand new formulation of its $20 billion most cancers immunotherapy Keytruda that may be injected beneath the pores and skin, permitting it to guard its best-selling drug from competitors anticipated as quickly as 2028.
For years Merck has relied on Keytruda to gas its development. The therapy, authorized in 2014, harnesses the physique’s personal immune system to battle cancers with dramatic outcomes. Towards superior lung most cancers, it has led to a five-year survival price in about one-quarter of individuals in comparison with 5% of individuals traditionally.
However the important thing patents on Keytruda will start to run out in 2028, opening the door to biosimilars – close to copies of costly biologic medication whose advanced molecules cultivated inside dwelling cells make it inconceivable to fabricate precise copies.
Merck is testing in scientific trials two variations of the drug that may be injected subcutaneously, a fast different to infusions, the present supply methodology through which sufferers obtain an intravenous drip in a well being workplace as soon as each three or six weeks. The corporate reported early knowledge from a kind of trials final 12 months.
Whereas Merck has disclosed that it’s growing subcutaneous variations of Keytruda, it has not beforehand stated that it expects the brand new formulation to turn into probably the most extensively used model of the drug after it’s rolled out and an engine for development towards the tip of the last decade.
If profitable, Merck might start advertising the brand new formulation inside a number of years, a high Merck govt instructed Reuters. It expects it to gas Keytruda’s development because it beneficial properties approvals in earlier stage cancers. Keytruda now accounts for greater than one-third of Merck’s gross sales.
“We consider that subcutaneous formulation has the potential to be novel, non-obvious and helpful, which suggests we might get a brand new patent for it,” Merck CFO Caroline Litchfield stated in an interview, utilizing the terminology for the factors beneath U.S. legislation to find out what applied sciences benefit a patent.
“The clock for that patent would begin ticking from the time we might get that patent authorized.”
Whereas some sufferers would seemingly nonetheless obtain the unique formulation whether it is being administered together with chemotherapy or different intravenous medication, the subcutaneous formulation might substitute the IV model for many sufferers, Merck Chief Medical Officer Eliav Barr instructed Reuters.
“In concept it might substitute in all places that Keytruda at the moment is used,” Barr stated.
Drug patents have a assured time period of exclusivity for 20 years after receiving a patent beneath U.S. legislation, however generally the businesses are in a position so as to add further patents that reach their exclusivity.
For instance, the first patent on Abbvie’s arthritis drug Humira expired in 2016 however the drug won’t face U.S. competitors till 2023, partially as a result of the corporate ultimately acquired greater than 130 patents that shield the drug.
Merck’s patents on the subcutaneous model of Keytruda might shield that formulation till at the least 2040, in accordance with Tahir Amin, co-founder of drug patents watchdog group Initiative for Medicines, Entry & Data (I-MAK).
“It is the best way the pharmaceutical corporations now use that system — it is all about taking on as a lot area as potential, making it troublesome for anyone to enter,” Amin stated. “Keytruda goes to be the subsequent Humira by all accounts.”
Requested whether or not it was motivated extra by patent points than medical want, Merck stated it was repeatedly centered on enhancing Keytruda and getting it to extra sufferers.
Merck stated it might search patents for improvements in how the drug is used, its formulation, the dimensions and schedule of doses and combos with different medication.
“These patent functions, if granted, might present various levels of safety past 2028. Nevertheless, we might proceed to level to late 2028 because the most certainly timeframe for biosimilar entry into the market,” Merck stated in a press release.
DO PATIENTS PREFER SHOTS?
Getting docs and hospitals to undertake the brand new formulation earlier than biosimilar competitors arrives might assist Merck shield extra of its Keytruda income for longer however shouldn’t be sure, analysts stated. On common, they anticipate Keytruda revenues to high $30 billion in 2026 and $35 billion by 2028, in accordance with Refinitiv knowledge.
“Theoretically, within the US, they may transition all the market,” Mizuho analyst Mara Goldstein stated, “relying on how shortly they’ll get it to market.”
Nevertheless, BMO Capital’s Evan Seigerman stated that non-public insurers within the U.S. would possibly balk at paying for the costlier branded product and like a biosimilar infusion model. Nonetheless, he believes the brand new formulation might enable the corporate to carry onto as a lot as 20 p.c of its Keytruda income into the 2030s.
Two docs interviewed by Reuters stated they weren’t satisfied that the brand new route of administration represents a major sufficient scientific enchancment over IV infusions to justify the extra system-wide healthcare prices that is likely to be a product of Merck receiving a brand new patent.
“I do not suppose it is going to enhance the security or the effectiveness of the drug,” stated Dr. Shailender Bhatia, an oncologist on the Fred Hutchinson Most cancers Middle in Seattle.
Merck’s Barr stated the easier-to-use formulation of the drug might assist sufferers’ well being by protecting them on Keytruda and on schedule, and will hold high-risk most cancers sufferers from spending lengthy occasions in hospital settings the place they might be uncovered to different illnesses.
“From a top quality of life and affected person perspective, it is for positive going to be useful,” Barr stated.
That view is backed by scientific research which have discovered that sufferers desire subcutaneous injections to intravenous administration which may be time-consuming and invasive.
How a lot hospitals and docs embrace the tactic might mirror how they are going to be impacted by the change financially.
Hospitals are sometimes paid much less to manage an injection than an extended infusion. That might be offset considerably if the drug’s worth is greater, since suppliers obtain a proportion charge for physician-administered medication, in accordance with Lisa Mulloy, chief pharmacy officer for New York’s Northwell Well being hospital system.
Merck stated it could not speculate on the anticipated worth of pipeline merchandise. The infusion’s listing worth is about $185,000 per 12 months, although the drug might value much less with firm reductions.
Northwell’s Mulloy stated transferring sufferers to subcutaneous variations of medication additionally opens up spots in infusion facilities for extra sufferers.
