Here's an edited version of the article, from "The Lever"
Research universities, many of them public, have joined forces with pharmaceutical companies and Wall Street firms to fight new government efforts to curtail out-of-control drug prices, saying the regulations could stifle innovation.
But these universities are also likely concerned that drug-price reforms would hamper their profits. Case in point: the University of California, Los Angeles (UCLA) has quietly reaped more than a billion dollars in payouts from Xtandi, a lifesaving cancer drug that it developed with the help of government funding and now costs U.S. patients $200,000 a year. The university is among those working to block the government from lowering the cost of prescription drugs like Xtandi that have been developed with taxpayer money.
Since this first-of-its-kind prostate cancer drug was approved for use in 2012, UCLA has received $1.6 billion in royalty fees, patent income, and reimbursement payments thanks to its development of Xtandi, according to information obtained through the California Public Records Act by The Lever.
As the price of Xtandi increases and demands mount to lower its cost, the public institution — which exists because of federal land grants and is supported by government funding — has seen its royalty fees grow substantially, increasing by $11.6 million from 2021 to 2022.
These payouts are on top of the $520 million UCLA received in 2016 after selling some of its royalty rights — and suggest that UCLA has a vested interest in stopping new drug pricing reforms, thus allowing Xtandi’s price to reach ever higher.
“For UCLA, this has been the gift that keeps on giving,” said Robert Sachs, who was prescribed Xtandi after being diagnosed with advanced prostate cancer and petitioned government agencies to reduce the drug’s price.
While researchers deserve compensation for developing breakthrough medicines, experts say the opposition against even limited drug pricing reforms hurts patients and their access to lifesaving medications.
Last December, the Biden administration announced plans to use a long-standing federal law to lower the price of prescription drugs developed with taxpayer funds. The Bayh-Dole Act of 1980 allows government agencies to “march in” and license brand-name drug patents to generic manufacturers to sell the medication at a more reasonable price.
In response, the University of California system — along with pharmaceutical giants, generic drugmakers, and venture capital firms — argued that march-in rights were not meant to address high drug prices and that doing so would stifle innovation.
The research that laid the groundwork for Xtandi came about in the early 2000s, thanks to grants from the National Institutes of Health (NIH) and the U.S. Army. UCLA chemist Michael Jung designed a molecule called enzalutamide, known commercially as Xtandi. With the help of then-UCLA professor of medicine Charles Sawyers, the two discovered that the molecule can block cell absorption of androgens — a group of hormones that includes testosterone and fuel prostate cancer cell growth.
In 2005, UCLA licensed three Xtandi patents to the biopharmaceutical company Medivation, which later entered into a global agreement with Japan-based Astellas Pharma to develop and commercialize the drug. In 2012, the U.S. Food and Drug Administration approved the drug, and the pill, which is very effective at slowing prostate cancer growth, is now taken by hundreds of thousands of patients worldwide. In 2016, the pharmaceutical behemoth Pfizer spent $14 billion to acquire Medivation, adding Xtandi to its ever-growing cancer-drug roster.
Now, global sales of Xtandi by Pfizer and Astellas Pharma are $5 billion each year. The U.S. market, where Xtandi costs $136.50 per 40-milligram pill, accounts for roughly half of those sales. In 2022, Medicare and Medicaid spent $2.6 billion on the drug.
Regardless of the public funding that contributed to Xtandi’s creation — and the fact that all three of the drug patents currently licensed to Pfizer and Astellas Pharma state that “The Government has certain rights in this invention” — the medication has an average wholesale price of $199,290 per year as of 2023, making it unaffordable for many patients. The price has increased by almost $10,000 since January 2022. In Japan, where Astellas Pharma is based, the drug costs less than a fifth of the U.S. wholesale price.
As the first medication of its kind on the market, Xtandi’s exorbitantly high price set a precedent for other androgen-blocking prostate cancer drugs, said Sachs. For example, darolutamide, made by the Finnish pharmaceutical company Orion Corporation and drug giant Bayer, costs $14,303 for 120 tablets.
On April 9, Knowledge Ecology International and other groups sent a letter to CMS demanding the Biden administration leverage their authority provided under patent law to “authorize qualified companies to make and sell generic versions of” Xtandi.
The authors noted that nine drug manufacturers, many of which are based in India, are currently making generic versions of Xtandi, and some of these drugmakers have tentative approval from the FDA to sell their medication in the U.S.
Good News Story from Australia: Apalutamide to become available on PBS for men living with mHSPC
Cancer drugs: dosing debates, cost conflicts
'CARAVAN' OF AMERICANS IS CROSSING THE CANADIAN BORDER TO GET AFFORDABLE MEDICAL CARE
Zytiga generics
