[Ip-health] Gilead is getting government loans, tax credits and grants to set up a CAR T manufacturing facility in Maryland.
Ellen 't Hoen
ellenthoen at medicineslawandpolicy.net
Wed Apr 24 22:23:21 PDT 2019
The facility to prepare the cell treatments in Europe is based in the Netherlands. See here: https://fd.nl/ondernemen/1254367/farmaconcern-gilead-opent-fabriek-in-nederland#
Gilead bought a Dutch biotech company T-Cell-Factory three years ago. Kite/Gilead paid, mostly in cash, 20 million euro (including 3.5 million for shares). T-Cell was established by university researchers from the Netherlands and Germany according this newspaper article:
One of the Dutch researchers involved in T-Cell and working at the Dutch cancer hospital and National Cancer Institute has become the chief scientific officer of the new Gilead/Kite outfit. According to this article he will also remain a director at the National Cancer Institute. He is an expert in immunotherapy.
The newspaper article are in Dutch but Google translate to the rescue.
Ellen ‘t Hoen LLM, PhD | Medicines Law & Policy
E-mail: ellenthoen at medicineslawandpolicy.net
> On 24 Apr 2019, at 23:41, James Love <james.love at keionline.org> wrote:
> 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
> * "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.
> 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
> 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
> James Love. Knowledge Ecology International
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