[Ip-health] NIH is sued for plans to award exclusive license for CAR-T therapy to Gilead

Claire Cassedy claire.cassedy at keionline.org
Fri Apr 20 08:57:41 PDT 2018


https://www.statnews.com/pharmalot/2018/04/20/nih-sued-license-gilead-car-t/

NIH is sued for plans to award exclusive license for CAR-T therapy to Gilead

By Ed Silverman @Pharmalot

April 20, 2018

A patient advocacy group has filed a lawsuit to block the federal
government from awarding an exclusive license to Gilead Sciences (GILD) for
an experimental cancer therapy, arguing that the potential for a high price
may preclude access to many Americans.

At issue is a CAR-T treatment, which relies on the immune system to attack
cancer cells. Last December, the National Institutes of Health indicated
plans to award a worldwide exclusive license to a CAR-T treatment that is
being developed with taxpayer funds to Kite Pharma, which had recently been
purchased by Gilead.

The advocacy group, Knowledge Ecology International, contended in its
lawsuit filed on Thursday that the federal government should not award a
license to Gilead without securing an agreement that any emerging medicine
is affordable to Americans. The group also believes the NIH should not
consider licenses until development work is done in order to assess the
effectiveness of the medicine and wield greater leverage in any negotiation.

An NIH spokeswoman wrote us that the agency does not comment on pending
litigation.

In arguing its case, the group pointed to prices for two recently approved
CAR-T therapies. One drug, called Kymriah, is sold by Novartis (NVS) for
treating children with advanced leukemia, and the other is called Yescarta
and is sold by Gilead to treat a type of lymphoma in adults. They have a
one-time cost of $475,000 and $373,000, respectively.

The pricing, the group maintained, “bears no relationship” to the cost of
manufacturing, and cited reports that CAR-T researcher Dr. Carl June
estimated costs were as low as $15,000. Novartis has previously disputed
such figures and claimed it spent $1 billion to bring the drug to market,
although never divulged manufacturing costs. We asked Gilead for comment
and will pass along any reply.

The CAR-T therapies have been hailed as breakthrough treatments and
continue to generate considerable hope in the medical community. But at the
same time, they have also contributed to ongoing national controversy over
the cost of prescription medicines. An analysis claimed the Novartis drug
is way overpriced and could cost one-third less, or $160,000, while still
allowing Novartis to pocket historic profit margins. However, a recent
analysis by a nonprofit found both drugs are cost-effective to varying
degrees.

Nonetheless, the advocacy group argued in its lawsuit that the NIH
“mismanaged taxpayer funds at a time when high drug prices are a leading
concern both within the U.S. and abroad, thereby threatening access to this
treatment, imposing unnecessary financial toxicity on patients that have
access, and ignoring the public interest in having affordable cancer
treatments.”

These are the same concerns that led to controversy over a Zika virus
vaccine last year. The U.S. Army was pressed by lawmakers and advocacy
groups not to award an exclusive license to Sanofi, which received taxpayer
funds toward development work. The company refused to agree to a pricing
arrangement and eventually ended work on the project after government
funding was scaled back.

The lawsuit is part of a broader effort by the advocacy group to widen
access to high-priced medicines in the U.S. For instance, four times in
recent weeks, KEI has urged the White House, the Department of Health and
Human Services, or the NIH to either investigate or sidestep drug patents
over a purported failure to disclose government funding.


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