Pharma Focus Asia

POINT Biopharma Receives U.S. Nuclear Regulatory Commission Materials License for Indiana Facility

Wednesday, June 02, 2021

POINT Biopharma Inc., a radiopharmaceutical company dedicated to bringing the many benefits of precision radioligand therapy to cancer patients, announced today that the U.S. Nuclear Regulatory Commission (NRC) has issued a Materials License for its new production facility located in Indianapolis, Indiana.

POINT is currently finishing renovations to its 80,000-square-foot radiopharmaceutical manufacturing center which, when complete, will make it one of the largest, state-of-the-art, Good Manufacturing Practices (GMP) radioligand manufacturing facilities in the world. The NRC Materials License authorizes the handling of nuclear material in chemical and/or physical form, enabling POINT to begin work with a wide variety of radioisotopes on-site and complete testing and qualification of its operations.

“The completion of our Indianapolis facility and scope of this Materials License will enable POINT to quickly bring its drug manufacturing operations online,” said Todd Hockemeyer, EVP, US Manufacturing Operations at POINT Biopharma. “Our mission is to make radioligand therapy applicable to more cancers, available to more people, thereby improving the lives of cancer patients and their families everywhere. This Materials License is an important milestone in our journey to deliver on our mission. ”

“I am proud of the many accomplishments Todd and his team in Indiana have achieved,” added Joe McCann, CEO of POINT Biopharma. “Attaining the NRC Materials License means we can get to work using radioisotopes like Lutetium-177 and Actinium-225 at our facility, which is a key milestone in the path to manufacturing our products in Indianapolis.”

POINT expects the Indianapolis facility will begin to provide supply for its Phase 3 clinical trial targeting metastatic castration resistant prostate cancer later this year. More information about POINT’s Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH) is available at https://www.splashtrial.com.

POINT Biopharma has entered into a definitive merger agreement with Research Alliance Corp. I (Nasdaq: RACA). Upon closing, the combined company is expected to be listed on Nasdaq under the ticker symbol “PNT”. A full description of the terms of the business combination can be found in registration statement on Form S-4 filed with the SEC by RACA.

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