Public health officials around the U.S. are predicting a second wave of the deadly novel coronavirus outbreaks later this year, and local biopharmaceutical company Emergent BioSolutions is optimistic about having coronavirus therapeutics available by then.
Emergent BioSolutions President and CEO Robert G. Kramer Sr. said the company decided to work on combatting COVID-19 because public health threats are its specialty.
“For 22 years, we have been focused solely on providing solutions to very complex public health threats,” Kramer said. “It’s natural because of the focus of this threat, the way we organized our business and our mission of protecting and enhancing lives; this is a perfect example of what we’re made for and how we built the business.”
Although the company is in the process of developing COVID-19 vaccine and therapeutics, the therapeutics are slated to be ready for public use later this year, he said.
The therapeutic treatments are being developed based on Emergent’s decades-long work in the hyperimmune plasma space, Kramer explained. The company has licensed six products with the U.S. Food and Drug Administration using the same technology.
He noted the company will use that technology and apply it to the COVID-19 virus. The company plans to create a treatment that will be made available to health care workers and patients exposed to the virus. The therapeutics will be a rescue therapy to save the lives of those who are sick and dying from the effects of the coronavirus.
Kramer said Emergent expects to be in a phase-two clinical trial with its therapeutics in early summer. This phase will determine whether the therapeutics are safe for humans and if they meet their intended results.
“We expect that to be a fairly short clinical trial because of the long history of safety and efficacy that we have on the technology platform,” Kramer said. “We’ll know very quickly on the therapeutic treatment.
“We are confident that it will demonstrate that it is safe and effective in neutralizing the COVID-19 virus and offering very quick and immediate protections in humans,” he added.
Once the therapeutics prove safe and effective in phase two, Kramer said Emergent will work with the FDA to get its consent and approval to make the treatment available to patients under some type of compassionate-use protocol or an emergency-use authorization protocol.
“This is going to happen pretty quickly on the treatment side,” he said.
He said with a second wave predicted for later this year and a vaccine still up to 18 months away, the therapeutics and testing for COVID-19 will be crucial to the survival of some who fall ill.
“This could be the only thing that saves their lives. So, success means saving lives,” he said.
Although Kramer said the bulk of the work on the COVID-19 therapeutics and vaccine are being done in some of Emergent’s other eight locations, the Lansing operation is crucial to the development of the therapeutics and vaccine. He said the Lansing operation’s work supports critical parts of the process, including the supply chain and making sure raw materials are available to the sites developing the COVID-19 treatments and preventatives.
“As many businesses are shutting down and not having employees come to work every day, we are continuing to operate our business as best we can because we’re serving the needs of our patients and customers with very unique live-saving medical countermeasures and products,” Kramer explained.
“We have now added at least four additional initiatives around COVID-19, so the work that is being done in Lansing every day is critically important,” he said. “I would just like to find a way to thank and recognize our team for their continued contribution under these really difficult times. Our success is a result of their hard work and commitment.”