Xtandi (INN enzalutamide) Timeline

Revised February 14, 2022 Early 2000 UCLA claims work that led to the development of enzalutamide began at UCLA in early 2000. 2005 May 13, 2005.  Priority date for the three patents in the Xtandi Orange Book. Patents 7709517, 8183274… Continue Reading

Robert H. Mermell Letter of Support for Government Use Request on Prostate Cancer Drug Xtandi

The Department of Health and Human Services (HHS) and National Institutes of Health (NIH) is currently reviewing whether to proceed with the request that the government use its rights in the prostate cancer drug Xtandi, in order to enable generic… Continue Reading

Eric Sawyer December 13, 2021 Petition to HHS on Xtandi March-in Case

On December 13, 2021, Eric Sawyer filed this petition with the Department of Health and Human Services, asking to join an outstanding march-in petition on the patents for the prostate cancer drug enzalutamide, sold under the brand name Xtandi by… Continue Reading

HHS Asked to Take Up March-in Request of Prostate Cancer Drug Xtandi

(Update: On December 15, 2021 KEI hosted a press briefing regarding the Xtandi march-in request. Video and details available here: https://www.youtube.com/watch?v=KwqUl7NLMXo) On November 18, 2021, Robert Sachs and Clare Love submitted a petition to the Secretary of Health and Human… Continue Reading

Regeneron COVID-19 Contract Weakens the Government’s Rights in Data

On November 5, 2020, Regeneron Pharmaceuticals published a redacted version of the contract awarding the company $450 million taxpayers’ dollars for the large-scale manufacture of Regeneron’s investigational COVID-19 antibody treatment. The contract uses Other Transactions Authority to weaken the U.S.… Continue Reading

Taxpayers are subsidizing 80 percent of Regeneron’s COVID-19 treatment’s R&D costs

Regeneron Pharmaceutical recently applied for Emergency Use Authorization of its investigational COVID-19 treatment, REGN-COV2, after Donald Trump said that it cured him of COVID-19, suggesting that Regeneron expects to cash in on the treatment. Taxpayers, however, are funding 80 percent… Continue Reading

House Coronavirus Bill Provision Could be Used for COVID-19/Coronavirus-Related R&D without Public-Interest Safeguards

A House coronavirus stimulus bill contains a provision concerning the use of Other Transactions Authority to fund COVID-19 diagnostics. The provision appears to authorize the Department of Homeland Security (DHS) to award $2.2 billion to private sector companies to develop… Continue Reading