Maryland’s Emergent BioSolutions Inc. is starting another clinical program for its Covid-19 drug candidate — this time to test its ability to protect people who have been in contact with the coronavirus — with New York’s Mount Sinai Health System and millions of dollars in funding from the Department of Defense.
The Gaithersburg company said this week the partners are starting up two phase 1 studies to assess whether the experimental drug can prevent the disease following someone's exposure to the virus. The product is aimed at patients at high risk of such exposure, such as front-line health care workers and military, Emergent said. The first trial will involve healthy adults, while the second will enroll adults with asymptomatic or mild cases of Covid.
The trials kick off following Emergent’s (NYSE: EBS) collaboration with Mount Sinai and Los Angeles biotech ImmunoTek Bio Centers LLC to collect plasma from recovered coronavirus patients. The local company used that to help develop and manufacture its candidate, called COVID-HIG, ahead of clinical trials.
The partners have received $34.6 million in funding for the program from the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. It comes after the Department of Health and Human Services awarded Emergent $14.5 million in April to develop COVID-HIG as a Covid treatment. That iteration of the drug is in a phase 3 study, which started in October, to test whether the product can treat hospitalized patients who tested positive for the virus. That trial, for which Mount Sinai is a study site, is led by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases.
The initiative “should enhance the nation’s rapid response to Covid-19,” Douglas Bryce, the DOD’s joint program executive officer for CBRND, said in a statement. “Working together through public-private partnerships harnesses expertise from government, industry, and academia, increasing our chances of developing safe and effective medical countermeasures for this, and other biological threats.”
Emergent’s share price was down 2% to $90.92 per share Thursday morning, but that reflects a substantial climb over the course of the year. The company’s stock opened 2020 at about $54 per share and reached a high of $137.61 this summer. The company holds a market cap of $4.8 billion.
The needle moved as Emergent’s contract development and manufacturing work exploded, with multiple companies tapping the local biotech to assist with their Covid vaccine programs during 2020. Emergent is juggling manufacturing and other services for candidates for Vaxart Inc. (NASDAQ: VXRT), Johnson & Johnson (NYSE: JNJ), AstraZeneca PLC (NYSE: AZN) and Novavax Inc. (NASDAQ: NVAX), a fellow Gaithersburg biotech whose experimental Covid vaccine just entered phase 3 clinical trials in the U.S.
Alongside that work, Emergent earned a new approval from the Food and Drug Administration for its opioid overdose antidote, Narcan nasal spray, extending its shelf life from two to three years — a factor that could help the biodefense-focused company fight off generic competition within the opioid market. The company also completed a $450 million offering in part to help repay $353 million in debt, announced plans to invest $75 million to expand its manufacturing capacity and footprint beyond Maryland, and won a $628 million contract with the federal Biomedical Advanced Research and Development Authority to manufacture several other vaccine candidates.
Emergent generated $972.4 million in revenue over the first nine months of 2020, up nearly 15% from the $845.7 million the company took in for the first nine months of 2019, fueled partly by the growth of its contract and manufacturing business. The company reported $119.7 million in net income for the first three quarters of the year, a massive jump from the $7.6 million it netted for the same period last year.
