[Ip-health] Gilead is getting government loans, tax credits and grants to set up a CAR T manufacturing facility in Maryland.

James Love james.love at keionline.org
Wed Apr 24 14:41:45 PDT 2019


According to Kyle Bankenship's article in Fierce Pharma, Gilead is getting
government loans, tax credits and grants to set up a CAR T manufacturing
facility in Maryland. I'm wondering if the same is true in other CAR T
facilities in the US or Europe, including also by Novartis or other
companies.

* "Matthew Doyle, a business development specialist with the Frederick
County Office of Economic Development, told FiercePharma the facility broke
ground in Fall 2018 and will include office and lab space. To support the
project, the county gave Kite a $2 million conditional loan, a $200,000
training grant and a suite of state and local tax credits."

Also, interesting that Carl June could manufacture the cells for $15k per
patient, five years ago, and now companies are asserting it is super
expensive.  Apparently governments are not seeking to verify these claims.

Anyway, to sum up, Gilead's technology is licensed from the NIH and other
NIH funded grantees, and this plant is subsidized by the state and country
governments in Maryland, they get the Orphan Drug Tax Credit (even though
it is not a drug and is already profitable), and the cost of the cells is
something like $363,000 to the patient.

Jamie


https://www.fiercepharma.com/pharma/new-maryland-facility-to-boost-kite-s-car-t-manufacturing-ability

Kite's CAR-T manufacturing gets another boost with new Maryland facility
by Kyle Blankenship | Apr 24, 2019 12:48pm

Kite's newest CAR-T manufacturing facility will employ between 400 and 800
employees. (Frederick County Office of Economic Development)

With an FDA approval for its pricey CAR-T therapy Yescarta under its belt
and more treatments in the pipeline, Gilead’s Kite Pharma was on the hunt
for a new manufacturing site to fuel those hopes. The company found it in
Maryland.

Kite said Wednesday that it was building a 279,000-square-foot facility on
20 acres in Frederick County, roughly 20 miles west of Baltimore. The site
will employ 400 and 800 workers and expand Kite’s ability to manufacture
its next-gen oncology treatments, including Yescarta and its prospective
T-cell receptor therapies, the company said.

Tim Moore, Kite’s VP of Technical Operations, said the new facility would
step up the company's ability to turn around CAR-T therapies, which require
personalized manufacturing.

“This new facility in Frederick County builds on our substantial technical
capabilities and rapid progress in making personalized CAR-T and TCR cell
therapies for people with cancer,” Moore said in a release, adding that
"expanding and investing in our manufacturing capabilities is essential” as
Kite works to expand in the nascent field.

Matthew Doyle, a business development specialist with the Frederick County
Office of Economic Development, told FiercePharma the facility broke ground
in Fall 2018 and will include office and lab space. To support the project,
the county gave Kite a $2 million conditional loan, a $200,000 training
grant and a suite of state and local tax credits.

The company didn't say how much it would spend to develop the site or when
it's planning to start production there.

Kite’s new facility will aid a costly CAR-T therapy manufacturing process
that genetically codes a patient’s T cells. Blood must be taken from a
patient, cryopreserved, shipped to a manufacturing facility, reprogrammed
and manufactured in the lab, and then shipped back for infusion into the
patient, all in the shortest time possible.

Kite won FDA approval in October 2017 for Yescarta, a $375,000 one-time
treatment for diffuse large B-cell lymphoma (DLBCL) and primary mediastinal
B-cell lymphoma. Yescarta’s sole challenger in the field, Novartis’
Kymriah, lists for $475,000.

In August, Novartis said it would invest $91.5 million over three years to
build its own CAR-T manufacturing facility in Switzerland that will employ
450 workers. Novartis struggled in 2018 as manufacturing issues led to
doses of Kymriah not meeting specifications and hampered the drug's sales.

That move closely followed Kite’s May announcement that it was building a
separate CAR-T manufacturing facility at an Amsterdam airport, a move that
would help shorten shipping times.

That 117,000-square-foot facility is expected to employ around 300 workers
when it's fully operational in 2020. As with the Frederick County plant,
Gilead did not disclose how much it would spend on that facility.

In May, Kite also said it had acquired a new building in Santa Monica,
California, from Astellas Pharma that it will use for clinical
manufacturing and cell therapy R&D.

The company also picked up a 26,000-square foot facility in Gaithersburg,
Maryland, as part of an agreement with the National Cancer Institute to
develop adaptive cell therapies targeting patient-specific tumor
neoantigens, or mutations found on the surface of cancer cells.


RELATED: With Kymriah nod in EU, Novartis is building a plant with up to
450 jobs
RELATED: Gilead finds CAR-T manufacturing costly but says Kite's is
'superb' and cost-efficient
RELATED: Gilead to build its EU CAR-T manufacturing facility at Amsterdam
airport

-- 
James Love.  Knowledge Ecology International
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U.S. office phone +1.202.332.2670
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