FDA Approves Telix’s Prostate Cancer Imaging Product, Illuccix®

MELBOURNE, Australia and INDIANAPOLIS, Dec. 20, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company), a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on molecularly targeted radiation (MTR), today announces that the United States Food and Drug Administration (FDA) has approved Telix’s lead prostate cancer imaging product, Illuccix®.

Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer with:

  • suspected metastasis who are candidates for initial definitive therapy;
  • suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

“The approval of Illuccix will give patients considerably improved access to PSMA-PET imaging, an advanced diagnostic tool that was recently included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)1 for Prostate Cancer,” said Dr. Oliver Sartor, Medical Director at Tulane Cancer Center. “With patient doses able to be prepared on-site or via commercial radiopharmacy networks, either via generator or cyclotron, Illuccix delivers flexible patient scheduling and on-demand access throughout the day.”

Illuccix is the first commercially available FDA-approved product to enable wide accessibility to 68Ga-based PSMA-PET imaging for physicians and eligible patients across the United States. Illuccix can be prepared with 68Ga via either GE’s FASTlab™ cyclotrons or in nuclear pharmacies and healthcare centers across the country using Eckert & Ziegler’s GalliaPharm® generator or IRE ELIT’s Galli Eo® generator. This optionality along with a four-hour shelf life after radiolabeling with 68Ga, enables Illuccix to flexibly extend the reach of advanced PSMA-PET imaging to patients across the country.

“This product offers a level of flexibility and accessibility to healthcare professionals we really haven’t seen before in this class of products and may help us provide better patient experiences as a result,” said Dr. Sartor.

With a distribution network encompassing more than 140 nuclear pharmacies through its agreements with Cardinal Health and PharmaLogic, Telix will be able to provide Illuccix to more than 85% of eligible PET imaging sites throughout the United States.

“This heralds a new era of patient and physician access to gallium-based PSMA-PET imaging and marks an important new stage for Telix as we bring our first commercial product to market in the United States,” said Dr. Christian Behrenbruch, Managing Director and CEO at Telix. “Improved imaging can provide physicians with the insights to determine the most appropriate treatment pathway and give patients in the U.S. access to a specific and sensitive imaging tool for the detection of prostate cancer throughout the body.”

About Illuccix®

Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection. 68Ga gozetotide Injection is used for imaging prostate cancer with positron emission tomography (PET), and targets prostate specific membrane antigen (PSMA), a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix enables gozetotide (PSMA-11) to be labelled with the radionuclide 68Ga directly before injection by medical professionals. After preparing the radiopharmaceutical and injecting it into the patient, PSMA positive lesions are localized by PET imaging.

Illuccix has been approved by the U.S. Food and Drug Administration (FDA), and by the Australian Therapeutic Goods Administration (TGA).2 Telix is also progressing marketing authorization applications for Illuccix in the European Union3, Canada4, and other jurisdictions around the globe.

Important Safety Information

WARNINGS AND PRECAUTIONS

Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide 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 gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Please see full Prescribing Information at http://illuccixhcp.com/s/illuccix-prescribing-information.pdf

About Prostate Cancer in the United States

Prostate cancer is the second leading cancer in men in the United States after skin cancer, with nearly 250,000 cases estimated in 2021, a significantly higher incidence than either lung cancer (119,000 new cases) or bowel cancer (80,000 new cases). Prostate cancer was also the second leading cause of cancer death in U.S. men in 2020, and it is estimated that more than 34,000 men will die from their disease in 2021.5 More than 812,000 U.S. men were estimated to be living with prostate cancer in 2020.6 In 2021 the National Comprehensive Cancer Network Guidelines® for prostate cancer were updated to include PSMA-PET imaging to be considered as an alternative to standard imaging of bone and soft tissue and for detection of unfavorable intermediate, high and very high risk as well as recurrent prostate cancer.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com

Important Information

This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “U.S. Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the U.S. Securities Act or an exemption from the registration requirements of the U.S. Securities Act is available. None of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. This announcement has been authorised for release by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer. The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

1 https://www.nccn.org/guidelines/category_1 – Pg. 24J.
2 ASX disclosure 2 November 2021.
3 ASX disclosure 1 May 2020.
4 ASX disclosure 16 December 2020.
5 American Cancer Society, 2021.
6 Globocan, 2021.

USAID-funded project aims to reduce harm of plastic pollution on public health

The Institute of Strategy and Policy on Natural Resources and Environment (ISPONRE) has recently coordinated with the United States Agency for International Development (USAID) to launch the “Plastic and Health Action Partnership” (PHA) with the aim of reducing impact of plastic wastes on public health.

The PHA is part of progress of the Local Solution for Plastic Pollution (LSPP) sponsored by the USAID and Center for Supporting Green Development (GreenHub).

In Vietnam, it is estimated that there is 25 million tonnes of solid domestic waste each year, and 10-20 percent of it is plastic.

The percentage of plastic waste and single-use nylon bags in the country’s urban areas has rapidly increased, accounting for 10 to 20 percent of domestic solid waste.

Solving plastic pollution problems requires the joint efforts of many parties, such as Governmental bodies, international organisations, NGOs, research institutes, universities and businesses, said Nguyen Trung Thang, ISPONRE deputy director, at the launch ceremony.

“Establishing PHA can be considered as an opportunity to recruit the participation of all related groups to help in reducing the harm of plastic pollution on human health,” he added.

Christine Gandomi, USAID acting director office of Environment and Energy, stated that the partnership would mark the beginning of a new era of collaboration, exchange of knowledge and good practices around plastic pollution challenges.

PHA would be among the first partnerships focusing on plastic and its impacts on human health, she said.

“This exchange and dialogue will help us address pressing development challenges in Vietnam,” she added.

PHA has mobilised 18 organisations in Vietnam. They are partners from international organisations, Government, NGOs, research institutes and universities.

In the future, PHA will support departments and localities all over the country to carry out policy advocacy activities related to plastic and health; build and contribute to a datacentre; boost communication activities; raise awareness on the relationship between plastic and health; and deploy pilot models to reduce plastic pollution across the country.

Source: Vietnam News Agency

Health Ministry proposes suspending large gatherings during Tet

The Ministry of Health has proposed that all non-essential activities, entertainment and festive activities in localities with a high risk of COVID-19 resurgence be suspended during the upcoming Tet (Lunar New Year) holidays.

The ministry sent an official document to the Government regarding strengthening anti-pandemic measures during the country’s Lunar New Year period.

In the document, the ministry said many localities are still recording a large number of COVID-19 cases in the community, especially in localities with high population density, high rates of trade and travel activities.

In addition, the Omicron variant is spreading rapidly, with complicated and unpredictable developments in many countries around the world.

To ensure the effective prevention and control of the COVID-19 pandemic, the Ministry of Health proposed the Government consider stopping unnecessary gatherings of crowds, entertainment activities, festivals and religious activities in localities at risk of an outbreak during the Lunar New Year holiday.

Travel and trade activities during the Lunar New Year holiday must absolutely comply with the 5K message (masks, disinfection, no gatherings, medical declaration and distance) of the National Steering Committee for COVID-19 prevention and control, the document said.

Localities, based on the pandemic situation in their areas, will assess and update the pandemic level on the local portal and to the Ministry of Health to take up the anti-pandemic measures in the area according to Government’s Resolution No. 128 on safe and flexible adaptation with the pandemic and Ministry of Health’s Decision No. 4800 on COVID-19 guidelines.

In a separate move, the Ministry of Health also asked local administrations, Pasteur institutes, and the National Institute for Hygiene and Epidemiology to enhance surveillance for the Omicron variant.

All arrivals into the country since November 28, 2021, who have tested positive for coronavirus through the RT-PCR method or NAAT (Nucleic Acid Amplification Test) within 14 days of entry, will have their samples taken for genomic sequencing.

If the Omicron variant is detected, all close contacts of the infected will also be tested and all positive samples will be further analysed as well.

Health authorities must strengthen the surveillance system for cases with unusual developments and characteristics (number of cases, severe development or hospitalisation, or abnormal increase in mortality over time, geographical area, specific groups of people, etc.), and collect samples for screening and identification, to identify any Omicron transmissions.

All genetic sequencing results must be uploaded onto the Global Science Initiative and Primary Source (GISAID), which is a platform to share genetic data of influenza virus and SARS-CoV-2.

Localities have also been told to immediately administer the COVID-19 vaccines they have been allocated to boost vaccine coverage, with attention on the unvaccinated or partially vaccinated in their jurisdictions, as well as providing booster shots for priority groups (old people, people with chronic health issues, and immunocompromised conditions).

From the beginning of the fourth outbreak to December 17, the country recorded over 1.5 million cases of COVID-19, of which nearly 1.1 million patients were declared all-clear and more than 29,000 died. The number of community cases and deaths continue to increase rapidly in many localities.

Over the past week, Vietna has recorded about 15,000 new COVID-19 cases a day, including 9,000-10,000 community cases.

According to the Ministry of Health, the Omicron variant has appeared on four continents. At least 77 countries and territories have confirmed cases of Omicron.

According to the World Health Organization, Omicron is worrisome because it increases the chance of reinfection, it can evade immunity systems, and it spreads 3.2 times faster than the Delta strain. However, there is no evidence that the Omicron variant reduces the effectiveness of the COVID-19 vaccine, nor is there evidence of increased morbidity and mortality.

Source: Vietnam News Agency

Mother language training course for overseas Vietnamese teachers wraps up

A virtual Vietnamese language training course for Vietnamese teachers in Europe and North America concluded at a ceremony held by the Commission for Overseas Vietnamese Affairs (COVA) under the Ministry of Foreign Affairs in Hanoi on December 19.

In his remarks, Director of the COVA’s Department of Information and Culture Dinh Hoang Linh said the nearly one-month course brought together 142 members from 20 countries, during which they were equipped with teaching skills and relevant documents.

The course formed part of a Vietnamese language training programme for Vietnamese teachers abroad, co-organised by the COVA and the Ministry of Education and Training from October 9 to December 17.

Apart from the course for Vietnamese teachers in Europe and North America, there was another for those in Asia and Australia.

The programme featured two seminars where delegates shared views on measures to remove difficulties to improve the quality of Vietnamese language teaching abroad.

Source: Vietnam News Agency

Da Nang pilots QR code technology for tourist information search

The central city of Da Nang city is piloting the installation of QR code display boards on street name posts across its Son Tra district to serve the need on searching information of residents and visitors.

Accordingly, QR code display boards are being installed on 111 street name posts across 30 major roads in Son Tra district.

Residents and visitors can use their smartphones to scan the QR code and will be directed to a link to access the information.

The galvanised steel QR code display board has a length of 18cm and a width of 12cm, on a blue reflective background with white letters in both Vietnamese and English.

Initially, detailed information about Da Nang tourism will be displayed in Vietnamese. In 2022, Son Tra district will expand the installation of QR code display boards in more roads, and add English in displayed information.

Nguyen Dinh Hung, a resident in Son Tra district, said this is a very good practice and suitable with the trend at present because most people have smartphones to scan QR codes in order to search for information about tourist destinations in a simple and convenient way.

According to the municipal People’s Committee, the work has contributed to implementing the direction of the Standing Committee of the municipal Party Committee on building and developing Son Tra district into a modern urban centre and a key tourist, service and marine economic hub of Da Nang.

Source: Vietnam News Agency

PM demands stronger anti-pandemic actions in face of Omicron

The Prime Minister has requested all ministries, sectors, and localities to ramp up efforts against COVID-19 in the face of the new variant Omicron.

According to the PM’s official dispatch issued on December 19, the COVID-19 pandemic remains highly unpredictable around the world amid the emergence of Omicron, which has been found to spread much faster than the Delta variant.

Though Vietnam hasn’t seen any Omicron cases, the numbers of infections, patients in critical condition, and related deaths have still been on the rise, and the healthcare systems in some localities have become overloaded, it said.

Facing that fact and the high possibility of recording Omicron in the country, the PM asked the Ministry of Health to keep a close watch on the global pandemic situation to make timely guidelines, propose necessary and appropriate measures to the PM, and increase monitoring so as to detect any new variant early.

All ministries, sectors, and provincial-level People’s Committees have to step up the application of COVID-19 prevention and control measures, boost examination, and strictly deal with those who violate anti-pandemic rules.

The Government leader told the Health Ministry and provincial-level administrations to organise as safe and fast as possible vaccination and ensure that no persons subject to vaccination are left without full inoculation, especially the ones in high-risk groups.

They were also requested to increase training in home treatment to avoid overloading at higher-lever hospitals and enhance the capacity of the healthcare system at all levels.

Meanwhile, the Ministry of Information and Communications was demanded to promptly complete IT tools and work with relevant sides to conduct uniform and effective application. This ministry also needs to coordinate with the Party Central Committee’s Information and Education Commission to step up communications to raise public awareness of the pandemic, Omicron, and prevention measures, according to the dispatch.

Source: Vietnam News Agency

Remains of martyrs reburied in Dien Bien

A memorial and reburial service was held in the northern province of Dien Bien on December 19 to rebury the remains of two Vietnamese soldiers who laid down their lives during the Dien Bien Phu campaign in 1954.

The event took place at the Doc Lap martyrs’ cemetery in Dien Bien district.

One of the martyrs was To Kim Chuy, born in 1924 in Thai Binh province. He was posthumously presented the Victory Order, third class.

The remains were discovered in Dien Bien Phu city’s Na Tau commune.

Remains of martyrs reburied in Dien Bien hinh anh 2

At the reburial service (Photo: VNA)

Addressing the ceremony, Colonel Le Tien Dung, Deputy Political Commissar of the provincial Military High Command, affirmed that the Party, State and people are always grateful to the soldiers who sacrificed their lives for the country’s independence and freedom.

Source: Vietnam News Agency