Siemens Molecular Imaging, Inc.

MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced results from a post-hoc analysis from the Phase 3 SPOTLIGHT trial (NCT04186845) that investigated the use of POSLUMA ® (flotufolastat F 18) PET injection (formerly referred to as 18 F-rhPSMA-7.3) in suspected biochemical recurrence of prostate cancer. The analysis examined the detection rate (% positive PET scans) in the pelvis region for SPOTLIGHT patients who had received radical prostatectomy (RP) only (168/389) and with low-very low Prostate Specific Antigen (PSA) levels of < 1 ng/mL (119/168). Results demonstrated 69% and 67% detection rates for POSLUMA in men with PSA < 1 ng/mL (82/119) and < 0.5 ng/mL (57/85), respectively. The findings were discussed in a moderated poster presentation at the 2024 ASTRO Annual Meeting on October 1, 2024, “ 18 F-Flotufolastat Detection Rates in the Pelvis Region for Patients with Prostate Cancer Recurrence after Radical Prostatectomy and PSA Levels <1 ng/mL: Data from the Phase 3 SPOTLIGHT Study , by Bridget F. Koontz,* MD, FASTRO, AdventHealth Cancer Institute, Orlando, FL for the SPOTLIGHT Study Group. (She was affiliated with Duke University Medical Center, Durham, NC, at the time of the study.) Full session details and the abstract are available in the ASTRO online program here . FDA-approved POSLUMA ® (flotufolastat F 18) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. “Physicians need actionable information from PSMA PET scans to guide informed clinical management decisions for men with prostate cancer,” said Bridget F. Koontz, MD, FASTRO. “This is of particular importance in the pelvis region, the most common site of recurrence. This analysis explored the performance of POSLUMA in the pelvis region for post-prostatectomy men who were likely in the early stages of disease recurrence. Approximately one-third of patients had detectable recurrence in the prostate bed, suggesting that POSLUMA may be useful in identifying recurrence next to the bladder, and help to guide curative salvage therapy.” “Findings presented at ASTRO about POSLUMA detection rates in the pelvis region for men with recurrent prostate cancer reinforce important clinical considerations in selecting a precision diagnostic imaging agent for PSMA PET procedures,” said Marco Campione, Chief Executive Officer of Blue Earth Diagnostics. “Activity in the urinary bladder and ureters is a common feature of PSMA PET radiopharmaceuticals, and can potentially obscure tumors and interfere with accurate image interpretation. A post-hoc analysis of POSLUMA clinical trials demonstrated that urinary activity did not impact image assessment for 96% of patients (682/712) by majority read 1 .” POSLUMA represents a newer class of high-affinity PSMA-targeted PET radiopharmaceuticals based on novel radiohybrid technology and leverages the high image quality of 18 F-labeled PSMA PET imaging to help facilitate detection of prostate cancer. It can provide clinically valuable information to guide patient management based on its high-affinity PSMA binding, low urinary uptake and positive performance at very low PSA levels. POSLUMA is included in nationally recognized clinical oncology guidelines for prostate cancer, covered by the vast majority of insurance plans and is readily available for patients across the country through the network of Blue Earth Diagnostics’ commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company. Indication and Important Safety Information About POSLUMA INDICATION POSLUMA ® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or . Full POSLUMA prescribing information is available at . About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . 1 Kuo PH, Hermsen R, Penny R, Postem EJ. Post-hoc analysis of the LIGHTHOUSE and SPOTLIGHT studies to assess the impact of urinary activity on interpretation of 18 F-rhPSMA-7.3 PET/CT. Mol Imaging Biol. 2024 Feb;26(1):53-60. doi: 10.1007/s11307-023-01867-w. POSLUMA is a registered trademark of Blue Earth Diagnostics Ltd. PP-rh-US-0564 For U.S audiences only Contacts For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice President, Corporate Communications (M) (781) 799-7917 priscilla.harlan@blueearthdx.com For Blue Earth Diagnostics (UK) Clare Gidley Associate Director Marketing and Communications Tel: +44 (0) 7917 536939 clare.gidley@blueearthdx.com Media Sam Brown Inc. Mike Beyer (M) (312) 961-2502 mikebeyer@sambrown.com

With a short half-life by design, the imaging agents need to be manufactured as close to their patients as possible. The deal includes 14 cyclotron sites across six European countries. Siemens Healthineers aims to grow its PET imaging business by picking up the radiodiagnostic manufacturing and distribution network of Novartis’ Advanced Accelerator Applications division.First reported by the Financial Times, the transaction will weigh in above 200 million euros, or about $223 million, and will include the production base behind radioactive tracers used in scans for cancer, heart conditions and neurological disorders such as Alzheimer’s disease.The deal will allow Siemens Healthineers to expand the reach of its U.S.-centered PET diagnostic operations further across Europe—where AAA manages the continent’s second-largest network of cyclotrons employed in the production of radioactive medical isotopes.With a short half-life by design, the imaging agents need to be manufactured as close to their patients as possible and are used to determine who may be eligible for future treatments with stronger, punchier radiotherapies.In a statement to Fierce Medtech, Siemens Healthineers described the radiopharmaceutical market as one that’s “at an inflection point” and being pushed by innovations across the industry among new therapies and theranostic applications. “The number of patients suffering from cancer and neurodegeneration is rising rapidly as life expectancies increase,” said Jim Williams, Siemens Healthineers’ head of molecular imaging. “We’re excited to expand our capabilities with the added benefit of Advanced Accelerator Applications’ first-class operations, extensive experience in nuclear medicine, and proven track record.”Today, Siemens Healthineers’ U.S.-based PETNET Solutions arm maintains 47 cyclotron-powered facilities, with locations in the U.K. and Paris, and also operates as a contract radiopharma manufacturer.According to the company, the deal with AAA will add 14 more manufacturing sites for the radioactive isotope fluorine-18 dotted across France, Spain, Portugal, Italy, Germany and Switzerland. The transaction is slated to close by the end of this year, after which Siemens Healthineers will continue as a partner for Novartis’ radioligand therapy business.The Swiss drugmaker first acquired AAA for $3.9 billion in late 2017, with its eyes on the anti-cancer radiopharmaceutical Lutathera. Novartis later nabbed Pluvicto through a $2.1 billion deal for Endocyte and followed up with an FDA approval for its use against prostate tumors; both drugs rely on the isotope lutetium-177 and are combined with specific, targeted ligands to destroy cancer cells.In a statement, Novartis said the transfer “follows a strategic assessment that concluded the growth of the molecular imaging business would be best supported under the ownership of a dedicated diagnostics shareholder” and would allow the company to focus its efforts on a pure-play radiopharmaceutical enterprise.

MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE)-- Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced highlights from clinical studies conducted by its collaborators at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, June 8-11, 2024. They included interim results of a study by Emory University that evaluated POSLUMA® (flotufolastat F 18) injection PET/CT with and without furosemide in men with biochemically recurrent prostate cancer (BCR), as well as results of a retrospective study conducted by the Technical University of Munich (TUM) that evaluated qualitative and quantitative PET parameters in urinary activity and tumor uptake for 18F-flotufolastat and 68Ga-PSMA-11 in primary prostate cancer. The studies build upon a recently published post-hoc analysis of Blue Earth Diagnostics’ clinical studies in which POSLUMA demonstrated low urinary bladder interference that did not impact disease assessment in the vast majority of patients1. Links to the abstracts follow below. POSLUMA is approved and indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. 18F-Flotufolastat produced at TUM is an investigational agent for which the safety and efficacy have not been established by the U.S. Food and Drug Administration. “The ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” said Eugene Teoh, MBBS, MRCP, FRCR, D.Phil., Chief Medical Officer of Blue Earth Diagnostics. “Activity in the urinary tract, especially in the urinary bladder, is a common feature of FDA-approved PSMA-PET radiopharmaceuticals which are excreted via the urine. High urinary activity can potentially obscure tumors in the prostate region and regional lymph nodes in the pelvis, which are common sites of recurrence, and interfere with accurate image interpretation.” Dr. Teoh continued, “These results reported at SNMMI support our previous experience with POSLUMA and are broadly consistent with results from our clinical trials. A post-hoc analysis of our Phase 3 clinical trials demonstrated that 96% of patients (682/712) exhibited either no urinary activity or activity that was easily distinguishable from disease1. Although furosemide usage has been widely described for other PSMA PET imaging agents as a potential means to reduce urinary activity, the POSLUMA Phase 3 trial results were achieved without its use. In cases from this Emory study where furosemide was not used, results also demonstrate the high POSLUMA detection rates in patients with low PSA levels as observed in prior Blue Earth Diagnostics clinical trials.” “These findings from Emory and TUM reinforce important clinical considerations in selecting a precision diagnostic imaging agent for PSMA-PET procedures,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA provides physicians with useful information based on its performance at low PSA levels, PSMA binding and low urinary bladder activity. It is included in nationally recognized clinical oncology guidelines for prostate cancer and covered by the vast majority of insurance plans. Labeled with the radioisotope fluorine-18 (18F) to leverage high image quality, POSLUMA is widely available through the network of our commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company.” Highlights of the Abstracts Impact of forced diuresis with furosemide in the evaluation of biochemical recurrence of prostate cancer with 18F-rhPSMA 7.3 PET/CT: Interim analysis of an ongoing prospective trial Interim results from a prospective study were presented by Ismaheel Lawal, MD, PhD, Resident Physician, Department of Radiology and Imaging Sciences, Emory University, Atlanta Ga. The study investigated the impact of forced diuresis with furosemide during 18F-flotufolastat PET/CT imaging for further improved bladder activity and prostate bed region recurrence detection in BCR. Twelve men had completed both with- and without-furosemide PET/CT scans at the time of the interim analysis. The study assessed bladder activity by SUV, patient-level recurrence and recurrence in the prostate-bed region. The authors concluded that furosemide-augmented bladder activity reduction showed no safety issues and was feasible for 18F-flotufolastat PET/CT imaging. While recognizing detection rates without furosemide remain high and consistent with Phase 3 studies, recurrence detection may be enhanced with the use of furosemide, by further decreasing observed urinary activity, and with no impact on the radiotracer avidity in the recurrent lesion. The full abstract is available here. Evaluation of qualitative and quantitative PET parameters in primary prostate cancer patients: double-match comparison of 18F-flotufolastat- and 68Ga-PSMA-11-PET Results from a retrospective study were presented by Isabel Rauscher, MD, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany. The study evaluated qualitative and quantitative PET parameters in urinary activity and tumor uptake for 18F-flotufolastat and 68Ga-PSMA-11 in a matched cohort of 62 patients staged for primary prostate cancer. Parameters included overall interference from bladder activity, scoring of median semi-quantitative bladder activity, presence of ureteral retention and halo artifacts, and tumor-to-bladder uptake ratio. The authors concluded that interpretation of 68Ga-PSMA-11 PET was significantly more impacted by bladder activity than 18F-flotufolastat PET in the matched populations of primary prostate cancer patients. The full abstract is available here. Indication and Important Safety Information About POSLUMA INDICATION POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or . Full POSLUMA prescribing information is available at . About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: . About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: . 1Kuo PH, Hermsen R, Penny R, Postem EJ. Post-hoc analysis of the LIGHTHOUSE and SPOTLIGHT studies to assess the impact of urinary activity on interpretation of 18F-rhPSMA-7.3 PET/CT. Mol Imaging Biol. 2024 Feb;26(1):53-60. doi: 10.1007/s11307-023-01867-w. POSLUMA is a registered trademark of Blue Earth Diagnostics Ltd. PP-rh-US-0499 This press release is for U.S. audiences only View source version on businesswire.com: Contacts For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice President, Corporate Communications (M) (781) 799-7917 priscilla.harlan@blueearthdx.com For Blue Earth Diagnostics (UK) Clare Gidley Associate Director Marketing and Communications Tel: +44 (0) 7917 536939 clare.gidley@blueearthdx.com Media Mike Beyer (M) (312) 961-2502 mikebeyer@sambrown.com Source: Blue Earth Diagnostics View this news release online at: