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

Harvard academics letter supporting use of US government rights in Xtandi patents to remedy price discrimination against US residents

On February 2, 2022, Drs. Ameet Sarpatwari, Aaron S. Kesselheim, Jerry Avorn, and Benjamin N. Rome of Harvard Medical School and Dr. Michael S. Sinha of Northeastern University and Loyola University sent a letter to HHS Secretary Xavier Becerra in… Continue Reading

Pfizer Agrees to International Reference Pricing in US Government Contract for COVID-19 Therapeutic

Published in an article by Sydney Lupkin of NPR, the Pfizer-US government contract for the COVID-19 therapeutic Paxlovid contains terms of interest in broader drug pricing discussions. The Pfizer contract includes a “Most Favored Nation Clause” (H.7), which provides that… Continue Reading

KEI Comment to the NIH Regarding Exclusive License of Anti-Viral Prevention and Treatment

On Wednesday January 12, 2022, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding a prospective exclusive, sublicensable license to the University of Louisville Research Foundation (ULRF), for “Griffithsin Compositions for Treatment and Prevention of… Continue Reading

December 15th 10AM – Briefing on Xtandi March-in Request

Update: Video recording of the press briefing available here: https://www.youtube.com/watch?v=KwqUl7NLMXo) December 15th 10AM – Briefing on Xtandi March-in Request Supporters of the march-in petition to lower the cost of the prostate cancer drug Xtandi will host a virtual press conference… Continue Reading

KEI letter to Brian Nelson, Office of Terrorism and Financial Intelligence, regarding exceptions to sanctions for medical products

KEI is sending this letter to the Administration today, regarding measures we would like to see undertaken to make the humanitarian exceptions to sanctions work better.  This is a neglected area of policy failure, although there is evidence that the Biden administration… Continue Reading

KEI requests an open compulsory license relating to Paxlovid in the Dominican Republic

On Friday, December 3, 2021, KEI requested an open public interest license to allow the exploitation of PF-07321332 (marketed in combination with ritonavir under the brand Paxlovid) in the Dominican Republic. PF-07321332, being developed by Pfizer, has shown promising results… Continue Reading

WHO member countries agree on a pathway to draft and negotiate a convention, agreement or other international instrument on pandemic prevention, preparedness and response

After two weeks of intense negotiations, member states of the World Health Organization (WHO) have finally agreed to compromise text on a decision (The World Together: Establishment of an intergovernmental negotiating body to strengthen pandemic prevention, preparedness and response, SSA2/CONF./1)… Continue Reading