Manon Ress manon.ress at cancerunion.org
Thu Aug 31 10:59:34 PDT 2017



AUGUST 31, 2017

UACT asks CEOs for Transparency on CAR T Treatments

Today, UACT submitted letters to the CEOs of three major pharmaceutical
companies currently developing chimeric antigen receptor T-cell (CAR T)
technologies.  UACT asked the leaders of Novartis, Gilead Sciences, and
Juno Therapeutics to address questions regarding research and development
(R&D) costs, federal-funding received, potential public health impact, and
ensuring equitable and affordable access to CAR T treatments in the US and
around the world.

The first CAR T treatment was approved by the FDA yesterday, a treatment
for leukemia in children and young adults produced by Novartis, and was
quickly announced to carry a $475,000 price tag. As this new area of
cancer-treating technologies emerges, it is important to examine the costs
involved in producing these treatments and to push drug companies to ensure
broad, affordable access to these potentially game-changing treatments. The
public also has a particular interest in these treatments as much of the
initial research was conducted by the NIH and with NIH funding, before the
resulting patents were licensed to the pharmaceutical companies.

The text of the body of the letters follow below .  Here are the links to
the PDF versions of the letters sent to Novartis, Gilead and Juno.

Union for Affordable Cancer Treatment
1621 Connecticut Avenue NW
Suite 500
Washington, DC 20009
Tel.: 202.332.2670

.....  Separately addressed to CEOs of Novartis, Gilead and Juno

The Union for Affordable Cancer Treatment (UACT), created in 2014, is a
union of people affected by cancer, their family members and friends,
people who take care of people with cancer, health care professionals and
cancer researchers committed to increasing access to effective cancer
treatment and care. We are particularly concerned about the rapidly
escalating cost of cancer medication and seek to fight for cancer treatment
and care to be affordable and available, everywhere, for everyone who needs

We are writing to ask questions about the company’s costs of developing
chimeric antigen receptor T-cell (CAR T) treatments for cancer, the number
of people you anticipate will benefit from this treatment, and the steps
that each company will take to ensure equitable and affordable access. The
questions are as follows:

What are the specific costs that your company has incurred or you
anticipate will incur to bring a CAR T treatment to market, including, in
particular, the actual research and development costs, as opposed to and
distinct from the costs of acquiring a company that holds CAR T patents?

What is the expected manufacturing and delivery cost of a CAR T treatment,
including specifically the costs your company will incur to provide the
treatment to a patient? In estimating the manufacturing costs, we ask that
you identify the components of costs that are related to infrastructure
that can have dual uses, or can be reused for other projects.

What will be the expected costs to the patient incurred by related health
care providers, such as the entities receiving and injecting cells into the
patient, and monitoring and caring for the patient during and after
delivery of the cells?

Which patents and patent applications are currently held by and/or licensed
to the company for CAR T, and in which countries are these patents filed or
expected to be filed?

For the patents listed in question 4, which patents have rights by the
United States or any other government?

Which grants, research contracts, CRADAs, tax credits and other subsidies
from governments and nonprofit entities were relevant to the development of
the CAR T treatment?

How many patients will potentially benefit from CAR T treatment in the
United States, in other high income countries, and in developing countries?

What steps will your company take to ensure equitable and affordable access
to CAR T treatments in the United States, in other high income countries,
and in developing countries?

Will your company enter into negotiations with the Medicines Patent Pool to
license CAR T technologies in developing countries?
We look forward to receiving your responses. Thank you.

Manon Ress, Acting Director, UACT

Jordan Donn Jarvis, Member, UACT Board of Directors

Ophira Ginsburg, MD, Member, UACT Expert Advisory Board

Gilberto de Lima Lopes Jr., MD, MBA, FAMS, Member, UACT Expert Advisory

Ruth Lopert, MD, Member, UACT Expert Advisory Board

Ilze Aiszelniece, Member, UACT Organizing Committee

UACT <https://twitter.com/Cancer_Union>@Cancer_Union
+1 571 331 6879

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