Nearly $800 million in federal contracts awarded over 12 years have helped Los Angeles-area biotechnology firms take a lead on developing medical countermeasures for the government to use against a nuclear or radiological attack.
Now comes commercialization.
“We’re always looking to support products that not only support the U.S. government requirement, but the commercial market,” said Gary Disbrow, deputy director for Biomedical Advanced Research and Development Authority, or BARDA. “There’s a lot of innovation and great technology in the Los Angeles area.”
BARDA is an agency that’s part of the U.S. Department of Health & Human Services, charged with protecting the U.S. against chemical, biological, radiological and nuclear threats. It funds the development of new drugs, devices and tests, while also stockpiling approved treatments in the event of an attack or other event.
A core of local companies and research centers have been putting the federal funds toward the development of diagnostics, medical devices and treatments for radiation.
Several have also made the turn toward the commercial market.
DxTerity Diagnostics Inc. of Rancho Dominguez signed a $150 million contract to develop its REDI-Dx blood test – which estimates radiation doses – and to stockpile some 400,000 of the tests.
“If a bomb has gone off in a major city, and there were survivors, you would need to triage them,” said Robert Terbrueggen, chief executive and founder of the DxTerity, which started. “We think the total world market is about two times the U.S. market, or $300 million.”
But there are often non-national defense uses for these tests, Terbrueggen said, noting that the gene-based test, which was approved in Europe last month and slated for U.S. approval next year, can also help diagnose autoimmune diseases such as lupus, multiple sclerosis and rheumatoid arthritis.
“The auto-immune monitoring market is in the billions,” Terbrueggen said.
The largest BARDA contract in Los Angeles County went to Neumedicines Inc. of Pasadena – a $273
million deal to develop a molecular treatment for radiation sickness that can destroy vital bone marrow cells.
Its HemaMax drug is slated for federal approval for emergency use in two weeks, and full approval could come as soon as 2020, executives said.
The drug also is in a final trial for wound healing, diabetic foot ulcers and age-related macular degeneration.
Neumedicines Chief Executive Lena Basile, who founded the USC spin-off in 2003, said the BARDA funds were integral in developing HemaMax.
“We have benefitted tremendously,” she said.
“The BARDA contribution really enabled us to understand the drug. It’s a cancer drug. Now we’re pursuing a pipeline in immunology and regenerative medicine.”
Among other local companies that have gotten chunks of funding from BARDA are Avita Medical Ltd. of Santa Clarita, which was awarded $79 million to support its ReCell stem cell spray to regenerate the skin of radiation or other burn victims; and Amgen Inc. of Thousand Oaks, which received $196 million to develop its Neupogen and Neulasta drugs to counteract effects of radiation, and chemotherapy.
A study released by the Southern California Biomedical Council last month tallied $799 million in BARDA contracts spread over nine companies. Also in the mix are UCLA and USC, each of which has received $1.6 million from the agency.
The local spending was part of $1.7 billion the agency provided throughout the state, funding a total of 24 companies and three universities.
Research and development supported by the BARDA funds have ranged from antidotes against the toxic effects of radiation to vaccines to gird against a pandemic flu, according to SoCalBio.
The federal agency has spent billions of dollars on such efforts nationwide since 2006, with contracts going to nearly 200 private-sector companies and various universities to speed up biological countermeasures considered vital to national security.
The $799 million that has gone to Los Angeles-area companies is “a significant amount of money,” said Ahmed Enany, chief executive of the Southern California Biomedical Council, author of the report. “This helps the local economy and creates a competence here on radiological countermeasures, which is likely to have a spill-over effect for cancer, wound healing, drug development and delivery.”
The area’s ability to get the attention of BARDA as a biotech center tracks to Dr. William McBride, a UCLA oncologist who in 2005 founded the UCLA Center for Medical Countermeasures Against Radiation, according to Enany and BARDA’s Disbrow.
McBride has since assisted a number of UCLA spinoffs, including BCN Biosciences in Pasadena and Chromologic in Monrovia, develop both biodefense and cross-over technologies. McBride was traveling and unavailable for comment as of press time, but SoCal Bio’s Enany said he was involved with much of the research connected to the BARDA funding.
“He’s a hot shot for radiation technology,” Enany said. “Many who got BARDA grants collaborated with his center.”
There could be additional BARDA money rolling in, but the federal agency might want a cut of whatever profits are made going forward.
BARDA last month rolled out a $35 million initiative to spur business accelerators and investment into countering manmade threats.
Its DRIVe initiative – short for BARDA’s Division of Research Innovation and Ventures – aims to set up a third-party venture fund to directly invest in biodefense firms on behalf of the federal government.
“This will allow the market to drive the technology, instead of the companies trying to meet the U.S. government regulations,” Disbrow said. “We want them to be innovative, to develop the best technology available – and not be limited by the government.”
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