The API Innovation Center, (APIIC), the St. Louis-based nonprofit focused on strengthening the U.S. supply chain for pharmaceutical ingredients, has selected a local firm to manufacture a treatment for brain cancer.
Ballwin-based Apertus Pharmaceuticals has been selected by APIIC as the contract manufacturer to make lomustine, which is used in chemotherapy to treat glioblastoma, an aggressive form of brain cancer.
APIIC said it will provide investment for Apertus to build out an “oncology production suite” at Apertus' production facility in Maryland Heights that will be equipped with advanced manufacturing technology to produce generic lomustine. Lomustine is the first treatment being pursued by APIIC in its efforts to boost U.S. drug production.
Launched in 2021 as the Active Pharmaceutical Ingredients Innovation Center, APIIC is a nonprofit organization that seeks to bring together businesses, researchers, academics and experts to find ways in which the U.S. can increase production of pharmaceutical ingredients. It launched through the Cortex Innovation Community.
APIIC has partnered with the Durham, North Carolina-based Glioblastoma Foundation in its effort to establish U.S.-based production of lomustine. The drug currently has no domestic production, according to APIIC.
“Partnership is key to resolving the lomustine crisis in the U.S. and working with the API Innovation Center and Apertus Pharmaceuticals, we now have the ability to provide patients with a safe, affordable U.S.-produced source of generic lomustine," said Gita Kwatra, CEO of the Glioblastoma Foundation.
The partnership has funded development of continuous flow advanced manufacturing technology that Apertus will use to produce lomustine, said APIIC Chief Operating Officer Kevin Webb. The continuous flow technology provides the ability to make drugs more quickly and at a lower cost compared with traditional pharmaceutical manufacturing methods, said Apertus CEO Rick Ryan.
Apertus, founded in 2011, is a contract development and manufacturing organization that makes pharmaceutical products. Apertus has been a member of APIIC since its launch, recognzing the importance of U.S. ingredient production as it has become “familiar with what some of the potential challenges of getting those products from overseas,” Ryan said.
Apertus has about 15 employees. It’s in the early stages of working to implement the continuous flow technology to establish its oncology production suite, Ryan said. He estimated Apertus could have the facility launched within the next nine to 12 months. Ryan said it will be located within its existing Maryland Heights facility, occupying a roughly 12-foot by 15-foot footprint and including the necessary continuous flow technology needed to make lomustine. Investment figures into the new production facility weren’t disclosed.
APIIC in 2023 received a $9.5 million grant from Missouri Technology Corp., the private-public organization that supports innovation and entrepreneurship in Missouri.
As APIIC seeks other projects to increase domestic drug production, Webb said the efforts targeting lomustine have validated its operating model.
“This is an example of how the network is working and how we’re then proceeding to move products through that network, ultimately to patient use,” he said.
