When Novavax Inc. received $1.6 billion last year from the federal government to speed up testing and production of a coronavirus vaccine, some observers were incredulous. The small biotechnology firm, based in Gaithersburg, Maryland, was largely unknown and had never successfully brought a product to market.
But now that the company nears completion of its Phase 3 trials for its COVID-19 vaccine, which was found to be nearly 90% effective during clinical testing in the United Kingdom, it is grabbing headlines around the world.
Novavax’s newfound fame is casting a light not only on its own unique story, but also — more broadly — on Maryland’s growing biohealth industry. About 40 companies in Maryland are playing some role in the coronavirus response, either by producing a vaccine, medication, therapeutics, diagnostic tests or supplying research, according to Martin Rosendale, the chief executive of Maryland Tech Council, a trade association that supports technology and life science companies.
When the pandemic first surfaced, Maryland Tech Council created what it called the “Maryland COVID Coalition” that pulled together dozens of companies from across the state that were working on, or starting to work on, coronavirus-related products. The group met monthly to share research and resources. “We realized how serious it was going to be and the response was going to be happening here in Maryland,” said Rosendale. “Everybody came together, everybody realized that we needed to work together,” he said.
“We had collaborations everywhere.”
One of the leading companies is Emergent BioSolutions Inc., also headquartered in Gaithersburg, which was founded 22 years ago and is best known for supplying huge amounts of anthrax vaccine to the U.S. government’s emergency medical reserves, which are stockpiled in the event of a terrorist attack. Emergent not only manufacturers its own proprietary vaccines and pharmaceuticals, but also contracts out its manufacturing capabilities to other companies and the federal government.
In the past year, the company has landed nine contracts to manufacture coronavirus-related products for companies, including manufacturing all or part of vaccines for Johnson & Johnson, Novavax and AstraZeneca plc.
The contract with J&J alone calls for Emergent to manufacture 1 billion doses of the COVID vaccine. The U.S. federal government plans this week to purchase an additional 100 million of J&J’s single-shot doses for Americans, on top of an original 100 million doses purchased last summer as part of Operation Warp Speed.
Emergent is one of 10 companies worldwide helping to produce the J&J vaccine, according to J&J’s website. While it’s not unusual for drug companies to contract out some of its manufacturing capabilities, the current pandemic rush has prompted vaccine makers to partner with a larger number of contractors in an effort to scale up quickly. Earlier this month, the White House announced that Merck, a pharmaceutical giant based in New Jersey, will also help produce the J&J vaccine.
The COVID contracts helped to sharply boost Emergent earnings last year. The company reported revenue over $1.6 billion for 2020, up 41% from 2019. Its net income jumped to $305.1 million, up from $54.5 million in 2019.
Each contract varies in scope. Some contracts require Emergent to provide all three stages of a drug’s production, from development to producing substances that go into the drug to the finished vaccine. Other contracts require Emergent to provide just one stage of production.
Emergent has four facilities in Maryland, and about 1,000 of its total 2,400 workforce is employed in the state. The Gaithersburg facility handles development work and the Bayview (Baltimore) facility conducts work on substances. The manufacturing plants in Rockville and Camden Yards are for “fill and finishing” where the product is loaded into vials, labeled and placed in boxes for shipment.
Syed Husain, who heads Emergent’s contract development and manufacturing division, said the company’s Baltimore and Rockville plants are able to manufacture four different vaccines at the same time but in separate suites. “Think of it as four plants within one plant,” he said. “Everything is segregated. So we’re working on one product (and) that’s the only thing that can be in a suite. But given the fact that it’s multi product capable, you can work on one product, and then you can change over and then work on another product.”
Husain said that production has accelerated since October 2020, with plants operating 24 hours a day, seven days a week. “We are manufacturing drug substance to support hundreds of millions of doses on a monthly basis and more than a billion doses annually,” he said.
Meanwhile, Emergent is developing its own products, including two plasma-based therapeutics that could be potential treatments for hospitalized patients with coronavirus disease. The company announced in October that one of the therapeutics entered Phase 3 clinical trials.
Other Maryland companies working on COVID-19 products include Altimmune Inc., which is working on a vaccine and therapy that can be sprayed into the nasal cavity instead of being administered via a shot in the arm; Qiagen NV, which is developing a rapid test that can detect coronavirus within an hour; Amarex Clinical Research LLC., working on a treatment for some COVID-19 symptoms; and Vigene Biosciences Inc., which provides viral vector-based gene delivery services and products for research and clinical applications.
Maryland has a high concentration of biohealth companies in part due its close proximity to the National Institutes of Health and the Food and Drug Administration as well as research institutions including the University of Maryland.
Richard Bendis, president and chief executive of BioHealth Innovation Inc., a nonprofit that networks with companies in Washington, D.C., Maryland and Virginia, said the region ranks fourth in the nation for the number of biohealth companies, after San Francisco, Boston and New York.
“You want to be in a region where there’s other companies that do similar work,” which makes it easier to “attract some of the top scientists, researchers and business people,” said Bendis. He noted that GlaxoSmithKline plc, the large British pharmaceutical company, located its North American headquarters in Maryland partly due to the proximity to NIH and numerous research institutions with which it can collaborate. In 2012, Glaxo purchased Human Genome Sciences Inc. of Rockville for $3.6 billion.
In addition to the human genome business that Glaxo acquired, several other companies in Maryland are doing research that uses the human DNA sequence to develop targeted drugs. That research is important for the development of vaccines.
Dozens of companies
Novavax Inc. and Emergent BioSolutions Inc. are two of the largest companies in Maryland working on remedies to fight COVID-19. But there are dozens of other companies responding to the coronavirus pandemic by producing vaccines, therapeutics and diagnostics. Here’s a quick look at a few of the companies.
Qiagen, Germantown, Maryland, North American headquarters
Employees: 1,328 in America and 5,610 internationally
In March of 2020, Qiagen received FDA emergency authorization for a test that differentiates the novel coronavirus from other respiratory infections in an hour. At the end of January of this year, Qiagen planned to resubmit an antigen test for emergency authorization after withdrawing it from submission in November due to a chemistry issue that the company says has been fixed.
Amarex Clinical Research, Germantown, Maryland
Amarex, a contract research organization, has assisted 16 companies on 32 different coronavirus-related products since last March. Most recently, they reached full enrollment for Phase 3 clinical trials for leronlimab, a potential treatment for severe-to-critical COVID-19 symptoms. Full data analysis results are expected by the end of this month.
Altimmune Inc., Gaithersburg, Maryland
Altimmune is a biopharmaceutical company focused on treating liver diseases and immune modulating therapies. Altimmune is working on a Covid therapy and is working with Vigene Biosciences Inc. on the development of a single-dose intranasal Covid vaccine. The products are in early clinical phases.
Vigene Biosciences Inc., Rockville, Maryland
Vigene is a biotech company focused on offering viral vectors and plasmids to help with vaccine and therapy development. In the fight against COVID-19, Vigene is helping to produce research genomes to help with the development of COVID-19 vaccines.
This article originally published on CNSMaryland.org on Tuesday, March 23, 2021.