Xtandi Petition (filed in 2016, appealed in 2017)

On January 14, 2016, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted a request to the National Institutes of Health (NIH) and Department of Defense (DoD) asking that they exercise their authority under the Bayh-Dole Act to authorize the generic production of an expensive prostate cancer drug. See: http://keionline.org/node/2412

KEI and UACT were asking the NIH use either its royalty-free, non-exclusive license or march-in rights.

On April 22, 2016, Biolyse Pharma offered to sell generic versions of enzalutamide to Medicare and other federal programs for $3 per pill, a discount of about 95 percent compared to the Astellas price of Xtandi to Medicare. See: http://www.keionline.org/node/2480

On June 20, 2016, NIH Director Francis Collins rejected the march-in/royalty free request. See: http://keionline.org/node/2603

On April 29, 2017, KEI and UACT appealed the Collins decision HHS Secretary Price. See: http://www.keionline.org/node/2756


Background

Enzalutamide, marketed as Xtandi by the Japanese firm Astellas Pharma, was developed with the support of NIH and DoD grants at the University of California, Los Angeles. Astellas markets Xtandi for over $129,000 per year per patient in the United States, which is over two to four times higher than the price of other high-income, high-GDP countries. The KEI and UACT request asked the NIH to use its march-in or royalty-free rights on Xtandi, citing the comparatively high price of Xtandi in the United States and the failure of Astellas to make the drug available to the public on reasonable terms.

Links to relevant pages on KEI's website on the request are available below, and this page will be updated with new developments.