On Thursday, 27 October 2016, Brazil, China, India and South Africa submitted a communication (IP/C/W/619) to the World Trade Organization (WTO) requesting the WTO Secretariat to “place a dedicated agenda item for consideration at the 8-9 November 2016 session of the TRIPS Council entitled “the United Nations Secretary-General’s High-Level Panel Report on Access to Medicines.” In the WTO submission, Brazil, China, India and South Africa enclosed the entire Final Report of the UN Secretary-General’s High-Level Panel on Access to Continue Reading
According to IMS, the global market for HIV antiviral drugs was $24.4 billion in 2015. Over the past three decades, drug companies have registered an average of one new molecular entity HIV ARV per year. This is a lot of money to spend on HIV drugs to induce just one new drug per year.
Today I took a look at data from the NIH clinicaltrials.gov database, to see what the industry was reporting in terms of trials.
Part 1, and the GPhA report on cost savings from generics, and prices of generics relative to brand in 2015.
The US based Generic Pharmaceutical Association (GPhA) has issued its 8th annual survey of cost savings due to generic medicines. (Copy here). The data they present comes from QuintilesIMS Institute.
The leading shout-out from the report is that generic drugs saved U.S. consumers and third party payers $227 billion in 2015.
The November/December edition of the Washington Monthly cover story (available here) addresses executive actions to lower drug prices in the United States, in particular the use of march-in rights or royalty-free license rights in the Bayh-Dole Act. The story uses the case of Xtandi, a taxpayer-funded prostate cancer drug developed at UCLA with support from the National Institutes of Health and the U.S. Army, to highlight how those rights can be used by the executive branch to the lower the price of the drug. For more on Xtandi, see here: /xtandi. Continue Reading
In a recent exchange with Senator Durbin, NIH Director Francis Collins expressed his concern that the NIH would alienate potential collaborators if the NIH applied the march-in remedy to address excessive prices of drugs. Continue Reading
Attached below are the appointment calendars, with redactions by the USTR FOIA office, for USTR Ambassadors Froman, Holleyman and Punke.
Note: The files containing Ambassador Froman’s calendar are arranged alphabetically by month. Continue Reading
KEI is holding a December 2, 2016 meeting on the delinkage of R&D costs from drug prices.
The venue will be US Senate Hearing Room SD-106, Dirksen Office Building. The meeting will take place from 9:00am to 2:00pm.
A copy of the agenda is available here.
For more information about delinkage, see: http://delinkage.org.
Today, KEI submitted comments to the Notice published in the Federal Register on October 5, 2016, entitled “Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers.” KEI’s comments addressed issues with the NIH’s processes for granting exclusive licenses, and transparency in those licenses, resulting data, trials, pricing, and revenue.
Kite Pharma is a California-based biopharmaceutical company working on various types of cell therapies for the treatment of cancer, in a bid to become the first pharmaceutical firm to gain successful FDA approval for this new class of cancer treatment.
Kite closely collaborates with the National Cancer Institute, which conducted significant early research into the forms of cell therapies that Kite is seeking to commercialize. NCI conducts clinical trials under Cooperative Research and Development Agreements (CRADAs) with Kite, and additionally has granted exclusive licenses on over a dozen patents to Kite on the same technologies.
Kite Pharma, Inc., which is racing Juno Therapeutics and Swiss pharmaceutical giant Novartis to successfully bring the first T-cell receptor (TCR) therapy to market, relies heavily on government support in the course of its research and development.
As noted previously by KEI, in various comments to the National Institutes of Health, the NIH rarely discloses detailed information on its connections with industry, raising concerns about how the NIH licenses out taxpayer-funded technologies without regard for future prices or access for U.S. residents.
For a selected bibliography of news stories on Kite’s relationship with the National Cancer Institute, see here: /node/2644.
T-cell receptor therapy is the latest breakthrough in cancer treatment, and involves modifying a patient’s own cells to better track and destroy cancer proteins, and then reintroducing them into the body. (The NIH has a concise description for non-scientists here.)
|Dr. Steven A. Rosenberg is the Principal Investigator for the National Cancer Institute on Kite’s 2012 CRADA. Dr. Rosenberg mentored Kite CEO and co-Founder Dr. Arie Belldegrun, and is also listed as a “Special Advisor” to Kite on their website. | Partnership for Public Service / Aaron Clamage|
According to Kite’s filings with the Securities and Exchange Commission (SEC), Kite has secured three Cooperative Research and Development Agreements (CRADAs) with the National Cancer Institute (NCI). In exchange for quarterly cash payments, the NCI conducts clinical trials and laboratory work on many of its own patented technologies, with the understanding that Kite will have the rights to commercialize any successful products developed through the CRADA.