© 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, accredited in 2014, harnesses the physique’s personal immune system to combat cancers with dramatic outcomes. Towards superior lung most cancers, it has led to a five-year survival charge 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 high-priced biologic medication whose advanced molecules cultivated inside dwelling cells make it inconceivable to fabricate precise copies.
Merck is testing in medical trials two variations of the drug that may be injected subcutaneously, a fast various to infusions, the present supply technique wherein 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 type of trials final yr.
Whereas Merck has disclosed that it’s creating subcutaneous variations of Keytruda, it has not beforehand mentioned that it expects the brand new formulation to change into probably the most extensively used model of the drug after it’s rolled out and an engine for development towards the top of the last decade.
If profitable, Merck might start advertising the brand new formulation inside a couple of years, a high Merck government informed Reuters. It expects it to gas Keytruda’s development because it good points 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’d get a brand new patent for it,” Merck CFO Caroline Litchfield mentioned 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’d get that patent accredited.”
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 change the IV model for many sufferers, Merck Chief Medical Officer Eliav Barr informed Reuters.
“In idea it might change in every single place that Keytruda at present is used,” Barr mentioned.
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 ready so as to add extra patents that reach their exclusivity.
For instance, the first patent on Abbvie’s arthritis drug Humira expired in 2016 however the drug is not going to face U.S. competitors till 2023, partially as a result of the corporate finally obtained greater than 130 patents that defend the drug.
Merck’s patents on the subcutaneous model of Keytruda might defend that formulation till at the least 2040, in line with Tahir Amin, co-founder of drug patents watchdog group Initiative for Medicines, Entry & Data (I-MAK).
“It is the way in which the pharmaceutical corporations now use that system — it is all about taking over as a lot area as attainable, making it troublesome for anyone to enter,” Amin mentioned. “Keytruda goes to be the following Humira by all accounts.”
Requested whether or not it was motivated extra by patent points than medical want, Merck mentioned it was constantly centered on bettering Keytruda and getting it to extra sufferers.
Merck mentioned it could 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 purposes, if granted, might present various levels of safety past 2028. Nonetheless, we’d proceed to level to late 2028 because the most probably timeframe for biosimilar entry into the market,” Merck mentioned in a press release.
DO PATIENTS PREFER SHOTS?
Getting medical doctors and hospitals to undertake the brand new formulation earlier than biosimilar competitors arrives might assist Merck defend extra of its Keytruda income for longer however isn’t sure, analysts mentioned. On common, they anticipate Keytruda revenues to high $30 billion in 2026 and $35 billion by 2028, in line with Refinitiv knowledge.
“Theoretically, within the US, they might transition all the market,” Mizuho analyst Mara Goldstein mentioned, “relying on how rapidly they’ll get it to market.”
Nonetheless, BMO Capital’s Evan Seigerman mentioned that personal insurers within the U.S. would possibly balk at paying for the dearer branded product and like a biosimilar infusion model. Nonetheless, he believes the brand new formulation might permit the corporate to carry onto as a lot as 20 % of its Keytruda income into the 2030s.
Two medical doctors interviewed by Reuters mentioned they weren’t satisfied that the brand new route of administration represents a major sufficient medical enchancment over IV infusions to justify the extra system-wide healthcare prices that is perhaps a product of Merck receiving a brand new patent.
“I do not suppose it will enhance the security or the effectiveness of the drug,” mentioned Dr. Shailender Bhatia, an oncologist on the Fred Hutchinson Most cancers Middle in Seattle.
Merck’s Barr mentioned the easier-to-use formulation of the drug might assist sufferers’ well being by protecting them on Keytruda and on schedule, and will maintain high-risk most cancers sufferers from spending lengthy instances in hospital settings the place they could possibly be uncovered to different ailments.
“From a high quality of life and affected person perspective, it is for positive going to be useful,” Barr mentioned.
That view is backed by medical research which have discovered that sufferers desire subcutaneous injections to intravenous administration which will be time-consuming and invasive.
How a lot hospitals and medical doctors embrace the tactic might mirror how they are going to be impacted by the change financially.
Hospitals are usually paid much less to manage an injection than an extended infusion. That could possibly be offset considerably if the drug’s value is greater, since suppliers obtain a proportion charge for physician-administered medication, in line with Lisa Mulloy, chief pharmacy officer for New York’s Northwell Well being hospital system.
Merck mentioned it will not speculate on the anticipated value of pipeline merchandise. The infusion’s listing value is about $185,000 per yr, although the drug might value much less with firm reductions.
Northwell’s Mulloy mentioned shifting sufferers to subcutaneous variations of medication additionally opens up spots in infusion facilities for added sufferers.