Generic lomustine to be first product of US-based partnership

Amid shortages of cancer drugs in the U.S., the API Innovation Center will use continuous manufacturing technology and a partnership with Apertus Pharmaceuticals and the Glioblastoma Foundation to produce lomustine, which is used to treat brain tumors.

Under the agreement, Apertus will use continuous flow advanced biomanufacturing technology funded by the API Innovation Center and developed by the group’s research members.

The two Missouri-based groups will also invest in an oncology production suite as part of an effort to expand the state’s biomanufacturing infrastructure with an aim to eventually make more cancer drugs, the partners said in an April 9 press release.

Last year, the API Innovation Center was awarded $9.5 million from the Missouri Technology Corporation’s Advanced Manufacturing Resiliency Grant Program.

“When faced with glioblastoma, no one should have to be worried about the cancer drug they need being in shortage or being cost-prohibitive,” Gita Kwatra, the Glioblastoma Foundation’s chief executive, said in the release. “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.”

There has been a push on the industry from both political, patient and other interests to “on-shore” more drug manufacturing in the U.S. after the COVID-19 pandemic spotlighted weak points in the pharma supply chain.

More recently, shortages of key cancer drugs began to hit headlines in early 2023 after the FDA slammed a production facility in India that was a major manufacturer of cisplatin and carboplatin. The regulatory agency officially reported the supply shortfall of platinum-based chemotherapies in February 2023.

Earlier this year, members of the American Society of Clinical Oncology testified before Congress in an effort to push the legislative body to take action to address the crisis of essential cancer medicine supplies in the U.S. The group asked lawmakers to put incentives in place that would boost U.S. manufacturing and encourage more advanced technologies such as continuous manufacturing.

(Source: Fierce Pharma)