OUTSOURCING
Catalent will enter genetherapy service market
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Planned $1.2 billion acquisition of Paragon is latest in a flood of gene-therapy-focused deals Seeking to enter the business of gene-therapy manufacturing, the drug service firm Catalent Pharma Solutions has agreed to pay $1.2 billion for the custom manufacturer Paragon Bioservices. Paragon will put Catalent in the business of making adeno-associated virus vectors, plasmids, and lentivirus vectors used to deliver gene and cell therapies. Earlier this month, Paragon opened a gene-therapy manufacturing facility in Maryland’s Anne Arundel County, complementing the production capacity at its headquarters at University of Maryland’s BioPark. The new capacity will support customers’ clinical- and commercial-stage programs. After the Catalent deal was unveiled, Paragon announced it will expand its relationship with a key customer, Sarepta Therapeutics. In October, Sarepta enlisted Paragon to help make its experimental Duchenne muscular dystrophy gene therapy; now, Paragon and Sarepta are considering a joint venture to manufacture gene therapies at a new site. The deal for Paragon, which expects to have sales of $200 million this year, is part of a feeding frenzy in the gene-therapy arena. So far, the US Food and Drug Administration has approved just one gene
therapy: Spark Therapeutics’ Luxturna, which treats a rare, inherited form of blindness. But the FDA recently said that by next year it expects to receive more than 200 requests annually for permission to begin clinical studies of cell and gene therapies. By 2025, as many as 20 new such therapies could be approved each year, the agency predicts. Contract manufacturing organizations (CMOs) and drug developers alike are scrambling to figure out how to manage that wave of therapeutics. “There are hundreds, if not thousands, of gene-therapy programs being developed globally, which is creating a huge backlog and long wait times at CMOs that have the capability to manufacture these products,” says Katie W. McCarthy, chief development officer at Halloran Consulting Group. “Competition for manufacturing slots is fierce, and the long lead times can drastically slow down the forward progress of a development program.” As a consequence, CMOs are scrambling to buy or build capacity. The Catalent deal comes just weeks after Thermo Fisher Scientific said it will buy the viral vector contract manufacturer Brammer Bio for $1.7 billion. Other CMOs are sink-
Manufacturing mania Investment in gene-therapy capacity has exploded. ▸ April 2019: Catalent agrees to pay $1.2 billion for Paragon Bioservices. ▸ March 2019: Thermo Fisher agrees to buy Brammer Bio for $1.7 billion. ▸ March 2019: Bluebird Bio opens gene- and cell-therapy manufacturing site in Durham, North Carolina. ▸ October 2018: Novasep opens viral vector production facility in Seneffe, Belgium. ▸ April 2018: Lonza opens industry’s largest dedicated geneand cell-therapy manufacturing plant, outside Houston. ing significant cash into new facilities. While service firms like Catalent and Thermo Fisher snap up specialists in geneand cell-therapy production, drug companies are gobbling up gene-therapy-focused biotech firms. In the past year, some of the industry’s biggest acquisitions have been of gene-therapy companies, including Novartis’s $8.7 billion acquisition of AveXis and Roche’s $4.8 billion deal for Spark. Both deals brought a pipeline of treatments and sizable manufacturing facilities. For firms like Novartis and Roche, acquiring companies with production capacity creates more certainty in development timelines. “If you build it yourself and bring the capability in-house, you won’t need to get in line for slots at external CMOs,” McCarthy says.—LISA M. JARVIS
DRUG DISCOVERY
Kintai launches to drug the gut The life sciences venture capital firm Flagship Pioneering has unveiled its latest start-up, Kintai Therapeutics, which is developing small-molecule therapies for the gut. The biotech company already has about 60 employees and more than 10 drug programs in the works. But Kintai isn’t merely a gastrointestinal company, CEO Paul-Peter Tak insists. Instead, Kintai views the gut as both a portal for delivering drugs and a command center for relaying messages throughout the rest of the body. That command center comprises three main parts, Tak explains. First are our body’s immune cells, about 70% of which
are located in the gut. Since they migrate throughout the body, drugging them in the gut could send them off to fight cancer or dampen autoimmune diseases. The second is the enteric nervous system, the collection of about 500 million neurons woven up and down the length of the gastrointestinal tract. Kintai views gut neurons as portals for changing the brain without having to design a drug that crosses the blood-brain barrier. The third is the microbiome, the trillions of bacteria living throughout our bodies, but mostly in our guts. Other companies are using bacteria themselves as therapies, but Kintai is looking for new
microbial genes and metabolites as inspiration for making small-molecule drugs. “This has been an incredibly rich source of drug discovery,” Tak says. “We want to translate this knowledge into straightforward chemistry.” Kintai isn’t divulging any specific drug targets yet. One of its lead programs is for ulcerative colitis. Another is for a drug to treat hyperlipidemia and promote weight loss in people with obesity. Kintai also has drug programs for autoimmune conditions, cancer, chronic kidney disease, nonalcoholic steatohepatitis, and neurological conditions, including multiple sclerosis.—RYAN CROSS APRIL 22, 2019 | CEN.ACS.ORG | C&EN
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