US govt faces calls to green-light prostate cancer drug generics
Annual global sales of Pfizer and Astella blockbuster drug reach roughly $5 billion | Nonprofits argue the drug is sold at a price three to six times higher in the US than it’s priced in other similar high-income countries | Move to curb drug prices follows controversial march-in rights plan.
The US government is being urged to back generic manufacturers in producing lower cost versions of Astellas and Pfizer prostate cancer drug Xtandi (enzalutamide).
Nonprofits including Knowledge Ecology International, Universities Allied for Essential Medicines, and the Union for Affordable Cancer Treatment outlined this request in a letter sent today, April 9, to the US Department of Health and Human Services.
Controversial plan
The move comes after the administration announced a controversial plan in December for ‘march-in’ rights, that would allow it to take control of certain drug patents and offer licensing deals to generic drug makers.
According to this week’s letter, patent law—or more specifically sections 35 U.S.C. § 202(c)(4) and 28 U.S.C. 1498—permits the Biden administration to authorise qualified companies to make and sell generic versions of enzalutamide.
Xtandi, it continues, is sold by Astellas and Pfizer at a price three to six times higher in the US than it is priced in other similar high-income countries.
“Prostate cancer is among the three most common forms of cancer. It is not a rare disease, yet Astellas is charging very high prices for the drug,” says the letter.
The capsule with a 2023 price of $136.50 in the US sells for just $22 in Japan and $20.75 in Australia.
“Prices are lower in every high-income country than in the US, despite the fact that Xtandi was invented at University of California-Los Angeles (UCLA) on grants from the US Army and the National Institutes of Health,” it adds.
Global sales of Xtandi are roughly $5 billion per year, of which the US market accounts for roughly half. In 2022, the spend of health insurers Medicare Part D and Medicaid on Xtandi reached nearly $2.6 billion.
Currently, there are four patents on Xtandi listed in the FDA Orange Book. Three of the patents (numbers 7,709,517, 8,183,274 and 9,126,941) disclose federal rights based upon grants from the US Army and the NIH, according to the letter.
A world-exclusive licensing opportunity
It argues that this means the US government has a “worldwide nonexclusive, non-transferable, irrevocable, paid-up licence to practise or have practised for or on behalf of the US any subject invention throughout the world”.
This worldwide paid-up licence, argues the nonprofits, can be used at any time by the government, including to acquire generic versions of enzalutamide for federal programs such as Medicare, Medicaid or health care provided to federal employees or veterans.
The letter requests that the government provide any qualified drug company with contracts to supply generic enzalutamide to patients in any federal program, including but not limited to Medicare, Medicaid and other drug purchase or reimbursement programs for federal employees and veterans.
Under its contract with UCLA, the federal government is immune to the threat of patent owners obtaining injunctions against the generic manufacturers to make, register and sell their versions of the drug.
Further, the letter says that because the federal government already has a paid-up licence to use the inventions, it would not be obliged to pay any royalties.
The letter goes on to provide a list of prospective generic drug makers.
Teva subsidiary Actavis and Apotex have each received tentative FDA approval to sell generic enzalutamide, while Biolyse Pharma has previously expressed a willingness to supply a generic version of enzalutamide to patients in the US and the developing world.
Meanwhile, BDR Pharma, Allieva Pharma, Glenmark, Aprazer, Dr Reddy's Laboratories and Zydus Cadila all currently produce generic enzalutamide in India.
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