Another cell manufacturing facility will be built in the U.S., this one by a transatlantic biotech in which GlaxoSmithKline owns a sizable share.
The U.K.-based Orchard Therapeutics intends to spend some of the proceeds of an IPO to build a cell production facility in the San Francisco area and use the rest to take three gene therapies through the clinic and onto the market, according to a prospectus filed last week.
Orchard could not comment because it is in its IPO’s quiet period.
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Orchard is believed to have one of the broadest clinical-phase gene therapy pipelines after earlier this year buying GlaxoSmithKline’s portfolio, including its “bubble boy” drug Strimvelis, adding to its own pipeline of gene therapy candidates. GSK took a 19% equity stake and a seat on the Orchard board as part of the deal.
The biotech already has close to $200 million in cash following a series C funding and is now planning the $173 million IPO that will put it in a strong position financially. Orchard intends to run pivotal trials of the three gene therapies and file for approvals in both the U.S. and Europe.
The company said in the prospectus that initially it intends to seek approval of its immune system therapies with products and vectors manufactured at contract manufacturers. The process involves using hematopoietic stem cells (HSCs) derived from the patient’s mobilized peripheral blood and drug products manufactured using HSCs derived from the patient’s bone marrow. But it already operates two development laboratory facilities in California and “plans to invest in additional facilities and implement in-house drug product and vector manufacturing capabilities.”
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Orchard’s plan follows other drugmakers that have committed to building gene therapy manufacturing operations in the U.S. Just last week, Sweden’s Novo Nordisk said it had paid $2 million for a facility in Fremont, California, that it has leased from stem cell biotech Asterias Biotherapeutics. Along with the manufacturing intellectual rights it is picking up in the deal, the facility gives Novo a plant that can produce stem cell-based therapies while kick-starting Asterias’ stem cell program.
Pfizer last year said it would invest $100 million to expand an 11,000-square-foot plant in Sanford, North Carolina, that it acquired in 2016 when it bought gene therapy biotech Bamboo Therapeutics in a deal valued at up to $688 million. Bamboo is working on gene therapies for certain rare diseases related to neuromuscular conditions and the central nervous system.
California-based BioMarin last year completed the renovation of a 25,000-square-foot building in Novato, California, for manufacturing the gene therapies for hemophilia A.
