[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


Dear Jamie,

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:

https://fd.nl/economie-politiek/1097069/amerikaans-beursfonds-slokt-nederlands-biotechbedrijf-op

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

————————————————————
Ellen ‘t Hoen LLM, PhD | Medicines Law & Policy
www.medicineslawandpolicy.org
E-mail: ellenthoen at medicineslawandpolicy.net
Twitter: @ellenthoen


> 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
> 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
> U.S. Mobile +1.202.361.3040
> U.S. office phone +1.202.332.2670
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