Grace Holds the Equipment and Expertise to Manufacture a Smallpox Treatment for SIGA Technologies
By Grace's FCMS
Even though smallpox has been eradicated for more than 40 years, the highly contagious and deadly virus is still a matter of significant national security. Smallpox is roughly as contagious as the Delta variant of coronavirus but has a historical 30% mortality rate, far higher than estimates for COVID-19, which fall in the 0.5–1.0% range.
The variola virus, which causes smallpox, is still a high priority for biosecurity experts because of concerns that it could be used as a bioweapon. As part of its bioterrorism preparedness effort, the U.S. government procures medical countermeasures, including the antiviral tecovirimat, for use during public health emergencies. The drug—marketed by SIGA Technologies under the brand name TPOXX®—is the first drug approved by the U.S. Food and Drug Administration that is specifically indicated to treat smallpox.
TPOXX works by blocking the formation of variola’s secondary envelope, which traps the virus inside a cell and prevents its spread in the body. Over the past decade, the federal government has procured about $705 million worth of TPOXX from SIGA Technologies. To produce the drug at the levels required to achieve preparedness goals, the company came to W. R. Grace’s Fine Chemical Manufacturing Services (Grace’s FCMS) to obtain the active small-molecule drug substance in TPOXX.
Team Effort Secures Nation
So how does a company develop an antiviral to treat an eradicated disease? The key for SIGA Technologies was a longstanding relationship with several U.S. government agencies, including the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response. The government partners with the pharmaceutical industry to develop medications for the national response to health security threats.
Over a decade ago, SIGA responded to BARDA’s call to develop a smallpox treatment as a critical medical countermeasure for U.S. public health preparedness, according to Tove’ Bolken, the company’s Senior Vice President of Operations & Chief Supply Chain Officer. During the drug discovery and development process, SIGA began searching for a contract development and manufacturing organization (CDMO) to manufacture the active pharmaceutical ingredient (API).
“When SIGA was looking for a CDMO, we knew we needed a partner with specific equipment to produce TPOXX,” Bolken says. Other considerations included a manufacturer that could work at the necessary scale and that would adhere to the additional requirements of SIGA’s federal contract with BARDA. The company found its ideal match in the fine chemicals division of Albemarle, which Grace acquired last year.
Grace’s FCMS manufacturing site in South Haven, Michigan, is a full-service, current good manufacturing practices (cGMP) facility for the production of APIs. To work on a federally funded project with biosecurity considerations, Grace’s FCMS had to install additional cyber- and physical security at the site, says Mike Helms, the company’s manager of Employee Health & Safety. That kind of accommodation demonstrates the willingness and capacity of Grace’s FCMS to fulfill customer needs as well as help protect the U.S. from bioterrorism threats.