Missouri Gov. Mike Parson participated in a ceremonial bill signing with the API Innovation Center (APIIC) @ Cortex on Thursday for House Bill (HB) 3007.
The bill went into effect on July 1, approving $15 million in grant funding for the advanced manufacturing of active pharmaceutical ingredients (APIs) and semiconductor computer chips. The passing of this bill is evidence of Missouri’s commitment to leading innovation in bioscience, healthcare and advanced manufacturing and fostering job growth and economic development throughout the state.
The grants outlined in HB 3007 from the Missouri Technology Investment Fund will aid in funding the state’s efforts in bolstering domestic semiconductor production and leading the reshoring of APIs. According to the Food and Drug Administration (FDA), approximately 78 percent of active pharmaceutical ingredients (API) manufacturers are located outside of the U.S. This state legislation combats the public health and national security risk caused by the nation’s over-reliance on foreign-sourced manufacturers.
“This investment in the advanced manufacturing of active pharmaceutical ingredients and semiconductor computer chips will help strengthen our domestic supply chains and create quality jobs right here in Missouri,” Governor Mike Parson said. “One of the greatest lessons we learned from the COVID-19 pandemic and subsequent supply chain crisis, is our over-reliance on foreign manufacturing. Missouri is a leader in bioscience, health care, and advanced manufacturing, and when we find ourselves in the next crisis, the last thing we want to do is rely on other countries for goods we can produce – and produce better – right here in Missouri.”
United States Pharmacopeia (USP) identified Missouri as first in the nation with the most API manufacturers producing essential medicines, positioning it as the ideal location to activate the process of reshoring APIs to the U.S. APIIC @ Cortex is a nonprofit organization that is currently working in the API sector in Missouri to strengthen American pharmaceutical manufacturing. Their initiative is to establish Missouri as the nation’s hub for domestic API production, resulting in a secure U.S. essential drug supply chain.
“The APIIC @ Cortex is proud to partner with the Governor and the state of Missouri to strengthen drug API manufacturing in the United States,” said Tony Sardella, CEO and Chair of the APIIC @ Cortex. “The Center’s efforts to foster adoption of innovative and advanced manufacturing capabilities will help build our nation’s health security, reduce drug shortages and production costs while accelerating time to market.”
Cortex President and CEO Sam Fiorello said, “APIIC @ Cortex brings together industry experts to advance new technologies and make the United States more secure by having greater control of our drug manufacturing. Beyond that, APIIC @ Cortex will drive diversity in our bioscience innovation ecosystem by creating quality jobs that are attainable for our region’s residents. We welcome APIIC @ Cortex to the district and look forward to partnering with them towards a growing, diverse and equitable regional economy.”
The initial project of the APIIC @ Cortex is to secure a source of U.S.-produced API for lomustine, a chemotherapy drug used to treat glioblastoma, an aggressive brain cancer. There is currently no U.S. source of lomustine, and recently the sole manufacturer of the drug significantly increased its price, making clinical trials cost-prohibitive. In 2021, the manufacturer also pulled out of the federal discount program for Medicare patients, leaving many patients struggling to pay for treatment. According to the Society for Neuro-Oncology, “the field of neuro-oncology is in the midst of a crisis with lomustine.” This crisis is being resolved by the APIIC @ Cortex in collaboration with Glioblastoma Foundation, a nonprofit that will develop lomustine and make it more affordable and accessible for glioblastoma patients that need it most. Lomustine will be manufactured utilizing continuous flow manufacturing, an advanced drug manufacturing process developed by Continuity Pharma that is more efficient than decades-old batch manufacturing. The continuous flow manufacturing process can significantly improve drug quality, address shortages of essential medicines, accelerate time to market, and strengthen the overall manufacturing competitiveness of the U.S.
“The Glioblastoma Foundation is proud to be a part of this initiative to make Lomustine more accessible and affordable for glioblastoma patients. We’re grateful to our partners at Continuity Pharma for sharing our commitment to getting this drug to the people who need it without excessive pricing as no one should ever have to give up their chance at life due to money,” said Gita Kwatra, PharmD and Chief Executive Officer of the Glioblastoma Foundation.
The APIIC @ Cortex has facilitated stakeholder partnerships with key players, such as the Glioblastoma Foundation, Continuity Pharma, Emerson, Experitec, and Mallinckrodt Specialty Generics, to create a sustainable network for the U.S. production of lomustine and other critical drugs.
Missouri Chamber of Commerce and Industry President and CEO Daniel Mehan stated, “There are strong national security and economic arguments being made right now about the need to onshore high-tech manufacturing. As these industry functions look to expand in the United States, we think Missouri — a leading state for tech manufacturing growth — stands to benefit. Bringing these critical investments to Missouri will benefit every industry and ripple across our economy for decades to come. We greatly appreciate Gov. Mike Parson and the leaders of the Missouri General Assembly for helping position our state for this opportunity.”
Brewer Science, headquartered in Rolla, Missouri, is a global leader in the tech industry, specifically in the development and manufacturing of next-generation materials and processes that foster cutting-edge technology, including semiconductor computer chips.
Brewer Science Executive Vice President Dan Brewer stated, “Brewer Science is living proof that Missouri is more than ready to be a hub for innovation in the semiconductor industry. For over 40 years, our business has helped cultivate Missouri’s growing, diverse high-tech talent pipeline and the significant cost advantages that benefit all industries in our state. With these new critical investments, Missouri is poised and ready to be a national leader in the domestic production of semiconductors. We are grateful for the leadership of Governor Mike Parson and everyone in the Missouri General Assembly who has championed our growing industry.”