2016: Kite Pharma, KEI Comments on NIH Proposed Exclusive License for Cancer Treatment

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.
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Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments

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 Rosenberg
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.
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56 NGOs ask US Government enable export of low cost generic versions Xtandi to developing countries

17 OCTOBER 2016

CONTACT: Zack Struver, zack.struver@keionline.org, +1-202-332-2670, or Paul Davis, pdavis@keionline.org, +1-202-332-2670

Note: Letter from Biolyse to HHS here: /wp-content/uploads/28-sept-2016-biolyse-to-hhs-letter.pdf
Letter from NGOs to HHS here: /wp-content/uploads/17-oct-2016-civil-society-letter-xtandi.pdf

Washington, DC — Today, over 50 patient, senior citizen, global health, development, social justice, and faith groups urged the United States Government to use its rights in a federally funded patented invention, and accept the request by a Canadian generic drug manufacturer (Biolyse Pharma) to enter into an agreement to manufacture and export an affordable version of the taxpayer-funded prostate cancer drug enzalutamide to South Africa and other countries with low per-capita incomes relative to the United States.
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General Assembly 2016 – Opening Statement of Bangladesh on behalf of the LDC Group

On Monday, 3 October 2016, Bangladesh delivered the following opening statement on behalf of the LDC Group at the World Intellectual Property Organization’s (WIPO) General Assembly.

General Statement on behalf of the LDC Group at the 56th Session of the Assemblies of the Member states of WIPO
[3 October 2016]
Delivered by Ambassador H.E. Mr. M Shameem Ahsan,
Permanent Representative of Bangladesh to the United Nations
( Suggested time: 5 minutes)

Mr. President,
Director General,
Distinguished representatives,
Good morning.

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National Association of Manufacturers told USTR the EU position on LDC extension made a mockery of international trading system

On September 10, 2015, the National Association of Manufacturers (NAM), wrote to USTR expressing alarm at the European Union support of an indefinite extension of a WTO waiver of obligations to grant patents on pharmaceuticals for UN defined least developed countries (LDCs). In 2015, there were 954 million persons living in LDCs, with a per capita income of $964, according to the World Bank. The EU had aligned itself with health advocates trying to protect the bottom billion access to life saving medicines.

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Summary of Report of United Nations Secretary-General’s High-Level Panel on Access to Medicines

On September 14, 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its report, in which they had a mandate to “review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”[1]

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