Novartis' World's Largest Radioligand Therapy Manufacturing Facility Receives FDA Approval for Pluvicto Production

On January 5, according to Novartis' official website, its new radiopharmaceutical production base in Indianapolis has received FDA approval for the commercial production of Pluvicto.

Image Source: Novartis Official Website

A Novartis spokesperson revealed in an interview that the site had been producing Pluvicto for clinical trials even before receiving approval.

The World's Largest and Most Advanced Nuclear Medicine Production Base

The Indianapolis production base is the second Novartis production base in the United States to receive FDA approval for radioligand therapy (RLT). This base will increase RLT production capacity to 250,000 doses per year by 2024 and beyond.

The new RLT production base, covering an area of 70,000 square feet, is the world's largest and most advanced RLT production base. Located in the heart of the United States, it maximizes availability for patients and treatment centers.

Novartis stated that the production base allows for the continued expansion of the production line, with plans to adopt a fully automatic production line for the first time in the radiopharmaceuticals industry.

In addition, Novartis has four active RLT production bases, which can ensure supply volume and fully meet current and future demands.

Novartis' radiopharmaceuticals production network includes a facility in Millburn, New Jersey, which received FDA approval in April 2023 to manufacture Pluvicto for commercial use. A plant located in Ivrea, Italy, has been supplying prostate cancer treatment to patients both within and outside the United States, while a facility in Spain is responsible for meeting demand outside the U.S.

In terms of indications, Novartis is conducting extensive RLT research on advanced cancers such as breast cancer, colon cancer, neuroendocrine cancer, lung cancer, pancreatic cancer, and prostate cancer to continue meeting the needs of patients worldwide.

Expansion is not limited to Europe and the United States

In expanding the radiopharmaceutical production capacity of Lutathera and Pluvicto, Novartis has not limited its efforts to Europe and America but has also taken action in the Asian region.

On December 1, 2023, Novartis announced the construction of a new radiotherapy production base in China, with an investment exceeding RMB 600 million (USD 84.6 million).

The new factory is located in Haiyan County, Zhejiang Province, approximately 110 kilometers from Shanghai. Novartis stated that the factory is expected to begin local production by 2026, pending regulatory approval.

It is worth mentioning that, once completed, this new radiopharmaceutical production base will become Novartis' second innovative drug production base in China. Currently, Novartis’ production base in China is located in Changping, Beijing, which was established in 1987 with a total investment of over 700 million RMB, with a maximum annual production capacity of 3 billion tablets and 400 million packages.

In November 2023, Novartis Japan announced that it would invest 100 million US dollars to establish a production base in Sasayama to support the production of radioligand therapy.

RLT is a core project that Novartis has focused on developing, including multiple drugs such as Pluvicto and Lutathera. Since the launch of the targeted radiopharmaceutical Pluvicto, its sales performance has repeatedly exceeded expectations, with $271 million in sales in 2022 and $451 million in the first half of 2023, expected to surpass $1 billion for the full year. The outstanding performance of Pluvicto has also drawn significant attention to radiopharmaceutical biotechnology companies in the capital markets.

Source:

1. Novartis Official Website

2、https://www.fiercepharma.com/manufacturing/thermo-fisher-cut-lights-california-plastics-plant-lay-74

Editor: Pea Shooter

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