Merck patents new cancer drug Keytruda
2022.12.02 06:35
Merck patents new cancer drug Keytruda
Budrigannews.com – Merck Corp., a pharmaceutical company based in the United States, plans to create a new form of Keytrud cancer immunotherapy, worth $20 billion, which can be used under the skin. This will help protect its best-selling drug from competition, which is expected to begin in 2028.
Keytruda has been supporting MERCK’s expansion for many years. The treatment, approved in 2014, uses the body’s own immunity in the fight against cancer. The results are amazing. This gave five years of life to about a quarter of patients with advanced lung cancer, not 5 patients in the previous year.
However, in 2028, the key patent for Cytruda will expire, which will open the way for bioalcoholic drugs close to expensive biological drugs, complex molecules of which can be grown in a living cell and it is impossible to produce precision. In clinical trials, Merck will test two versions of the drug that can be injected under the skin. This is a rapid alternative infusion, when patients receive intravenous drops every three to six weeks in the clinic. Last year, the company released preliminary information about one of these tests.
Although Merck has realized that it is working on the release of subcutaneous versions of Keytrud, it has not yet announced that the new recipe will be the most widely used version of drugs and growth engine by the end of the decade, expecting that the new recipe will become the most widely used drug and growth engine in the coming decade.
The senior executive director of Merck believes that if the new recipe is successful, then it can be sold in a few years.
Perhaps the expansion of Keytruda contributes to its approval for the treatment of early-stage cancer. To date, Keytrud ranks more than third in MERCK sales. Merck Chief financial Officer Keroline Lixfield said in an interview: “We think that subcutaneous injection of the drug could potentially be new, non-obvious and useful,” given the criteria used in US law to determine which technologies deserve a patent. “From the moment the patent is approved, the clock will start poking at this patent.”
“While some patients will still have the first plan suggesting that it is regulated together with chemotherapy or other internal drugs, the introduction of subcutaneous injection can replace the introduction of an intravenous option to most patients,” Merck Boss Elias Barr told Reuters.”Barr said: “Theoretically, this could replace everything that is currently used in Keytrude.”
According to American law, a patent for medicinal products is guaranteed to be exclusive for 20 years after issuance, but sometimes companies can additionally add patents, which expands their uniqueness.
For example, Abbvie’s main patent for Humira ended in 2016, but the drug does not compete in the United States until 2023, in particular, due to the fact that the company eventually received more than 130 patents to protect the drug.
According to Tahir Amin, co-founder of the I-MAK Initiative Group for Drug Supervision, Access and Knowledge, Merck’s patent for the subcutaneous version of KeyTruda can protect the drug for at least 2040 years.
Amin said that “This is how pharmaceutical companies use the system now – it all depends on how much space it takes and does not make it difficult to access someone.” Everything indicates that Kaytruda is the successor of Humira. Merck replied that it is constantly paying attention to improving Keytrud and making it available to a large number of patients, asking if this motivates patent problems rather than medical necessity.
Merck said that it can request patents for the latest drugs, the formulation of the drug, the size and schedule of dosing and combinations of drugs. “With the approval of these patent applications, various protections can be provided after 2028. “However, we will still consider the end of the 20th century as the most likely time for biosimilars to enter the markets,” Mercks said in a statement.
Do THE PATIENTS want MORE INJECTIONS? Analysts believe that Merck could retain most of the income from Kitrud for a longer period if doctors, hospitals and pharmacies adopted new formulations before competition with biologically active drugs arose. But this is not guaranteed.
According to Refinitiv data, they assume that in 2026 the revenue of Kitrud will be more than $ 30 billion, and in 2028 — more than $ 35 billion. Mizugo analyst Mara Goldstein stated: “Theoretically, the US can transfer all the markets, how quickly they can bring them to the markets.”
However, as Evan Seigerman of BMO Capital says, a private insurer in the United States may not want to pay for more expensive branded products and will prefer to purchase a similar infusion option. However, he believes that a completely new formula will allow businesses to save up to 20% of Kitrud’s revenue in 2030.
According to two doctors from Reuters, Merck’s new patents did not suggest that additional system-wide medical costs would be associated with the new method of administration, since the new method of administration did not allow for a sufficiently significant clinical improvement than intravenous infusions.
Dr. Shailender Bhatia, an oncologist at the Fred Hutchinson Cancer Center in Seattle, said: “I don’t think this will increase the safety and effectiveness of the drug.” Merck’s Barr believes that simpler prescriptions of the drug may be useful for the health of patients while continuing to take Keytrud as prescribed. It can also prevent high-risk cancer patients from staying in hospitals for a long time, where other diseases may occur.
Barr said, “It will definitely be good for the patient as well as for the quality of life.” Clinical studies have shown that patients prefer subcutaneous tissue injections by more complex and invasive intravenous injection. The degree of implementation of the method by doctors and hospitals may indicate the financial consequences of the change. Injection, as a rule, costs less in hospitals than long-term infusion.
According to Lisa Mallo, chief medical officer of Northwell Health (New York), health care providers receive interest payments for medications prescribed by a doctor, so they can be partially compensated when drug prices rise. Merck said it was not going to speculate on the prices of pipeline products.
The cost of inflation according to the price list is approximately 185 thousand dollars per year, but the discounts offered by the company can reduce the price. According to Malloy from New Jersey, the transfer of patients to drugs that are administered intradermally also frees up space in infusion centers for an additional patient.
