The U.S. Food and Drug Administration has given approval to Switzerland-based Novartis to begin commercial manufacturing of a drug developed in Indiana at its new, $100 million plant on the west side of Indianapolis, the company said Friday.
The 70,000-square-foot facility near Indianapolis International Airport will be used to make Pluvicto, which is used to treat advanced-stage prostate cancer who have run out of treatment options.
The facility is only the second location in the U.S. for Novartis to produce radioligand therapies, or RLTs, and the company says there is room for further expansion. RLTs are used to deliver radiation to specifically targeted cancer cells without causing damage to healthy cells.
The company said Indianapolis was chosen for the plant because of its centralized location, making it easier to deliver the therapies in a timely manner; each dose must be provided to the patient within three to five days after being produced.
“The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” Steffen Lang president of operations at Novartis, said in a news release. “Adding a second US RLT facility, our largest and most advanced yet, into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come.
Novartis says it currently has an “unconstrained supply” of Pluvicto to treat patients within two weeks of diagnosis. Commercial production at the Indianapolis site is expected to begin this quarter.
Novartis Head of RLT Jeevan Virk told Inside INdiana Business last month the new facility opens the door to more patients having access to life-saving drugs.
“Our ability to get patients doses that are required to extend their life and improve their life is something that really motivates me and gives me hope that every time we release a product from the Indianapolis facility that we’re actually not just delivering the medicine, but we’re delivering hope within that medicine of longer life and improved quality of life for those patients as well,” Virk said.
Pluvicto was originally developed by Dr. Philip Low, the Presidential Scholar for Drug Discovery at Purdue University, and received FDA approval in April 2022. Novartis received Pluvicto when it acquired Low’s company, Endocyte, in a $2.1 billion deal in 2018, which was the largest-ever acquisition of an Indiana life sciences company.
In addition to providing the therapies for patients in the U.S., Novartis said the facility will supply the growing demand for patients in Canada as well, pending approval.
Novartis also has RLT production facilities in Millburn, New Jersey; Ivrea, Italy; and Zaragoza, Spain. The company is looking to further build out its manufacturing capabilities with planned facilities in Sasayama, Japan and Haiyan, Zhejiang, China.