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More than 50 advocacy organizations are urging the federal government to allow a small Canadian company to make a generic version of a cancer medicine and sell it to poor countries.

In a Oct. 17 letter to the US Department of Health and Human Services, the groups argue that the company, Biolyse, should be allowed to sell a version of the Xtandi prostate cancer treatment to low- and middle-income countries because federally funded research was used to create the drug. In their view, the government holds a royalty-free license and can allow a third party to then market a generic.

At issue is the cost of Xtandi, which is sold by Astellas Pharma and has an average wholesale price in the United States of more than $129,000, which is about two to four times more than what other high-income countries are paying. Although advocacy groups did not offer specific price comparisons, they noted a generic version would be sold in countries with less than one-third of the per capita income of the US.


“If the US ignores or rejects the request, and no agreement is forthcoming, access to the prostate cancer (treatment) will be restricted, and unequal. It is appalling to have restrictions on access to a publicly funded cancer drug, and it is morally repugnant to deliberately sanction unequal access,” the groups wrote in their letter.

The drug was developed at the University of California, Los Angeles, with help from National Institutes of Health and US Department of Defense grants. The university later licensed the drug to Medivation, a biotech that struck a marketing deal with Astellas and, more recently, was acquired by Pfizer, which paid $14 billion deal in order to bolster its own pipeline of cancer drugs.


Biolyse, which last month wrote its own letter to HHS seeking such a license, was solicited to get involved by Knowledge Ecology International, one of the 55 groups that signed the letter. The other groups included NAACP; Oxfam International; Treatment Action Campaign, South Africa; Union for Affordable Cancer Treatment; Kenya Network of Cancer Organizations; and the Alliance for Retired Americans.

Whether the HHS will grant the request is uncertain, at best. Earlier this year, Biolyse wrote to the Centers for Medicare and Medicaid seeking a license to sell a generic version in the US for $3 per 40-milligram tablet, compared with the $69.41 that Medicaid paid in 2014. But nothing came of that request. The US government covers much of the cost for Xtandi prescriptions filled by Medicare, Medicaid, and the US Department of Veterans Affairs.

And last June, the National Institutes of Health rejected a request by advocacy groups to override the Xtandi patent so a lower-cost version could be sold in the US. Under federal law, an agency that funds private research can require a drug maker to license its patent to another party in order to alleviate health and safety needs or when the benefits of a drug are not available on “reasonable terms.”

We asked the HHS for comment and will update you accordingly.

An Astellas spokesman sent us a statement saying the company is “focused on delivering innovative medicines that address the unmet medical needs of the patients we serve around the world. We are pleased that the National Institutes of Health has concluded that Xtandi is broadly available to patients, and we are committed to continuing our work with our diverse stakeholders to provide patients with affordable access to our medicines.”

The flap over Xtandi emerged earlier this year as the cost of prescription medicines became a hot-button topic and attracted the attention of several lawmakers, including Bernie Sanders, who expressed interest in holding a hearing on so-called march-in rights. This allows the government to override a patent, although the NIH rejection seems to have stymied plans for such a hearing, at least for now.

Sanders, in fact, later forwarded us a statement saying that “the United States should use every tool available to lower outrageously high prescription drug prices. The government has the power to stop the pharmaceutical industry’s blatant profiteering and make this drug available to patients in poor countries at a more affordable price.”

This story was updated to include a comment from Bernie Sanders and from Astellas.