Current Edition

Novartis plots 2nd U.S. factory to meet demand for Lutathera and future cancer radiotherapies

When Novartis shelled out $3.9 billion for France-based Advanced Accelerator Applications in 2017, it had blockbuster hopes for AAA’s Lutathera, a radiotherapy to treat neuroendocrine tumors (NETs).

Those expectations were not misplaced. In fact, demand for Lutathera is so high that AAA is planning to build a new 50,000-square-foot manufacturing plant in Indianapolis’ Purdue Research Park to make the drug and other radiotherapies, the Novartis unit said Tuesday.

The Indianapolis factory will open in 2023, said AAA, which did not release financial terms or hiring plans. It’s the subsidiary’s second U.S. manufacturing plant.

Lutathera is a “radioligand”—a drug that combines a therapeutic molecule with a radioactive particle that binds to tumor markers. It was approved by the FDA in 2018 based on phase 3 data showing a 79% drop in the risk of disease progression or death when compared to the standard of care in patients with NETs in the midgut region that could not be surgically removed.

Sales of Lutathera hit $441 million in 2019 with a 31% jump in the fourth quarter alone, indicating a strong growth trajectory for the radiotherapy. Analysts have predicted peak sales of the drug will land somewhere between $1 billion and $2 billion.

Mike Rossi, AAA’s general manager in the U.S., said in a statement (PDF) that the Novartis unit is “excited by the response” to Lutathera and that it expects “to follow this success with new treatments for other cancer types.”

AAA’s pipeline includes more than a half-dozen radiotherapies to treat prostate cancer, glioblastoma and multiple solid tumor types. Its most advanced pipeline candidate, Lu-PSMA-617, came from Novartis’ $2.1 billion purchase of Endocyte in 2018. That drug marries the radioisotope lutetium 177—the backbone of Lutathera—with a drug that targets prostate tumor marker PSMA.

Radiotherapies typically don’t generate the same level of excitement as, say, immuno-oncology drugs or targeted antibodies, but that hasn’t dissuaded Novartis from investing heavily in the emerging field. In fact, when CEO Vas Narasimhan named the company’s top 25 blockbuster pipeline candidates at a management event last year, he included Lu-PSMA-617 on the list.

Narasimhan also vowed to stay ahead of competitors in radiotherapy by making sure Novartis invests early in supply chain logistics, distribution and manufacturing.