Emergent licenses flu vaccine for new federal biodefense center -- Gazette.Net


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Back in June, Emergent BioSolutions, the Rockville biotech that sells the only approved anthrax vaccine to the federal government, won a federal grant worth up to $220 million to establish a new biodefense development and manufacturing center in Maryland.

Late last week, the company announced that it acquired the license to manufacture and sell an experimental pandemic influenza vaccine to help meet its commitment under that grant.

Under its deal with VaxInnate of Cranbury, N.J., Emergent said in a statement, it gains exclusive rights to the candidate, a recombinant vaccine that has the potential to be produced quickly and cost-effectively with high yields.

VaxInnate will continue to develop the candidate under its current contract with the Biomedical Advanced Research and Development Authority, while Emergent will produce it, using flexible manufacturing technology. Emergent also works with the federal authority to develop a second-generation anthrax vaccine.

“Our public-private partnership with [the biomedical authority], which taps into our core manufacturing capabilities and infrastructure, provides a real opportunity to make significant progress to address the nation’s medical countermeasure manufacturing requirements,” Emergent CEO Daniel J. Abdun-Nabi said in a statement.

The project — which also involves the University of Maryland, Michigan State University and Kettering University — will support 1,000 jobs, according to U.S. Sen. Barbara A. Mikulski (D) of Baltimore.

The Emergent grant calls for $163 million for an initial eight-year period, followed by 17 additional one-year optional renewals. The flu vaccine plant will be in Baltimore, with some of the money also earmarked for renovating an Emergent development and manufacturing plant in Gaithersburg.

All told, the Department of Health and Human Services initially is earmarking $400 million for the program, which supports three centers. The other two centers will be led by Novartis in Holly Springs, N.C., with a $60 million investment for the first four years; and by the Texas A&M University System, under a $176 million, five-year contract.

The centers are designed to develop a range of medical countermeasures to biological, radiological and nuclear threats. They also will ensure the capability to produce vaccines for pandemic influenza and provide workforce development programs for federal needs through academic partners, according to federal officials.

Under the program, the private partners will cover about 35 percent of the initial building costs, with the federal agency paying operating and maintenance costs in subsequent years.

In other company news, Emergent reported that the European Commission granted orphan medicinal product designation to its humanized single chain monoclonal antibody against CD37, also called TRU-016, to treat chronic lymphocytic leukemia.

“Receiving orphan medicinal product designation for TRU-016 from the European Commission, following orphan drug designation from the [Food and Drug Administration] in 2011, is an important step in the development of TRU-016 and underscores the medical need in treating B-cell malignancies” such as chronic lymphocytic leukemia, Scott C. Stromatt, senior vice president and chief medical officer of Emergent, said in a statement.

The new designation qualifies the antibody for certain development and commercial incentives, including protocol assistance, access to centralized authorization procedures, reduced fees for regulatory activities and 10 years of market exclusivity after approval, according to Emergent information.

The product is in phase 1b and phase 2 studies, used in combination with other treatments, with data from both studies expected in the second half of the year.

In other Maryland bioscience industry news:

OpGen reported advances using its technology to both map the genome of the domestic goat and track foodborne illnesses.

A study published online in Nature Biotechnology reports the first mapping of the goat genome by Chinese researchers using the Gaithersburg company's Whole Genome Mapping System.

“This independent technology provides not only the validation of the genome sequencing, but also provides the large-scale chromosome structure information that cannot be detected by sequencing,” Xun Xu, deputy director of BGI-Shenzhen, one of the research entities, said in a statement. “The experience in these genome assembly projects shows that the physical whole genome map should be the standard for any reference genome to be assembled in the future.”

The genome mapping is the first for small ruminate animals and could help advance understanding of goats, an important economic resource in many developing nations, according to OpGen.

In the study, OpGen’s system produced 100,000 single molecule restriction maps in three hours, resulting in 30 times the physical coverage of the goat genome.

“While we continue to demonstrate the value of Whole Genome Mapping for assembly, quality control and validation of microbial genomes, we are pleased to expand its applications as a critical, complementary technology enabling investigators to provide complete and accurate long-range genomic information in complex, de novo projects,” said Richard Moore, OpGen’s chief scientific officer and an author of the paper.

Meanwhile, OpGen also entered into a scientific and technical partnership with the University of California, Davis, in cooperation with the 100K Genome Project, to create high-resolution microbial genetic maps.

The project is a collaboration initiated by FDA, the university and Agilent Technologies to sequence the genetic code of at least 100,000 infectious organisms and accelerate the diagnosis of foodborne illnesses.

Data from the project will be used in the surveillance and management of international foodborne microbial outbreaks, according to OpGen.

Such outbreaks include diseases caused by salmonella, listeria and E. coli.

DioGenix, a molecular diagnostics company in Gaithersburg, reported raising $1.5 million in Series B financing. Existing investors, including life sciences fund Nerveda, participated in the round.

The cash will help support a prospective, multisite clinical trial to validate DioGenix’s proprietary next-generation sequencing test for early identification and diagnosis of multiple sclerosis, according to a company statement.

In a recent study, the test, called MS Precise, outperformed the specificity of the current standard of care for cerebral spinal fluid analysis in patients suspected of having multiple sclerosis by a ratio of almost 2 to 1, the company said.

“DioGenix continues to execute its strategy to develop MS Precise as a diagnostic to accurately identify patients in the early stages of multiple sclerosis. The team has a solid track record developing and commercializing products that elevate the standards of diagnosing disease, and I have confidence they can do it again,” Cam Gallagher, DioGenix's chairman and president of Nerveda, said in a statement.

According to the National Multiple Sclerosis Society, at least 400,000 Americans have the disease.