John Lennon Impersonator Javier Parisi Gives Special Invitation to His Fans

Featured Image for MYDIO Tech

Featured Image for MYDIO Tech

BUENOS AIRES, Argentina, Dec. 20, 2021 (GLOBE NEWSWIRE) — Javier Parisi is an Argentinian impersonator of John Lennon, famous among many Beatles fans. He is currently working in collaboration with MYDIO Tech to offer a special program that invites his fans to enjoy the diverse features of MYDIO Sing to have fun. His fans are invited to join his special invitation link on https://home.mydiosing.com/parisi.

I hope this can be a form of appreciation from me to my fans who have been supporting me so far,” Javier Parisi said.

The program is up and running in the Philippines while Mexico, Argentina and Brazil are among many others to follow suit. “We are fans of the Beatles! So we couldn’t be happier to work with Javier Parisi to present this program. We’re very proud if MYDIO Sing can be entertaining to the music community,” said Indra Putra, Founder of MYDIO Technology.

MYDIO Sing is a karaoke application established since 2017 concentrated mostly in Asia and is well received in The Philippines and Indonesia as well.

CONTACT :
Media Relations
Phone : (+65) 6220 2293
Email: marketing@mydiowork.com


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AGC Biologics Receives Transatlantic Award for Investments in Milan Biopharmaceutical Industry

Milan, Dec. 20, 2021 (GLOBE NEWSWIRE) — AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced it has won the 2021 Transatlantic Award from the American Chamber of Commerce in Italy (AmCham). The company was named the 2021 winner for its investments in the Italian biopharmaceutical industry, which includes expansion at its Center of Excellence in Milan to make it a global hub for cell and gene therapy innovation, development and manufacturing.

The annual award honors companies fostering economic development and growth between Italy and the United States. Luca Alberici, AGC Biologics General Manager and Site Head of the Milan facility, received the award on behalf of the company during the XV Transatlantic Award Gala Dinner, held on December 2 at Studio 90 East End Studios in Milan.

The additional guests of honor at the award ceremony included Mariangela Zappia (AmCham Italy Honorary President and Ambassador of Italy to the United States of America), Thomas D. Smitham (Chargé d’Affaires and interim and U.S. Embassy to Italy), On. Giancarlo Giorgetti (Italian Minister of Economic Development) and On. Lorenzo Guerini (Italian Minister of Defense).  AGC Biologics was honored alongside other notable companies such as Apple, Coca-Cola, Diasorin and KKR.

“I am happy and honored to receive this award on behalf of AGC Biologics. This is an important award that showcases the investments our company has made in our Milan site, as well as the growing biopharmaceutical industry in our region,” said AGC Biologics Milan General Manager and Site Head, Luca Alberici. “Our Center of Excellence, one of the best in world and our team of scientists and employees, who work hard every day with responsibility and professionalism, played a crucial role in the successes we’ve achieved over the last two years.”

AGC Biologics acquired the Milan facility when it purchased Molecular Medicine S.p.A. (“MolMed”) in 2020. Since that transaction, AGC Biologics has focused on supporting and developing the teams working at the site, and investing in expanding the site’s services, capabilities and production capacities. These commitments in the Milan facility have helped AGC Biologics become one of the most complete and active biotech CDMOs in the global healthcare market.

The AGC Biologics Milan site was the first GMP facility approved in Europe for ex-vivo gene therapy manufacturing and has industry-unique commercial manufacturing experience, having previously brought three cell & gene therapy products to the market.

To complement the Center of Excellence in Milan, the company recently opened a new facility in Longmont, CO., USA, which will help AGC Biologics expand its global capacity for cell and gene therapy development and manufacturing. Through these two key sites, AGC Biologics can now offer more capacity and services to pharmaceutical companies worldwide developing new life-changing cell and gene therapy products.

About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,000 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.

Nick McDonald
AGC Biologics
(425) 419-3555
nmcdonald@agc.com

Helsinn and Xediton sign exclusive license and distribution agreement for TRUSELTIQ™ (infigratinib) in Canada

Helsinn and Xediton sign exclusive license and distribution agreement for TRUSELTIQ™ (infigratinib) in Canada

Lugano, Switzerland, and Mississauga, Ontario, 20 December 2021  Helsinn Group (Helsinn), a Swiss Biopharmaceutical Group with an innovative R&D pipeline in cancer supportive care and oncology therapeutics, strategically investing in a fully integrated targeted therapy structure to develop, manufacture and commercialize small molecules in precision medicine with higher market potential, and Xediton Pharmaceuticals Inc. (Xediton), a Canadian based specialty pharmaceutical company with a strong presence in products in Oncology, announced today the signing of an exclusive license and distribution agreement in Canada for TRUSELTIQ™ (infigratinib), which was recently approved under Health Canada’s Notice of Compliance with Conditions (NOC/c) policy for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Under the terms of the license and distribution agreement, Helsinn Healthcare SA grants Xediton an exclusive license to distribute, promote, market, and sell TRUSELTIQ in Canada and Helsinn will supply TRUSELTIQ for commercialization in Canada. TRUSELTIQ has been reviewed in Canada under Project Orbis, an initiative of the U.S. Food and Drug Administration’s (FDA’s) Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO commented, “We are very pleased to have signed this agreement with Xediton for the distribution of TRUSELTIQ in Canada. This marks an important step in our TRUSELTIQ commercialization strategy. We look forward to continuing to work closely with Xediton to ensure that this treatment reaches the Canadian patients that could most benefit from it.”

George Gafrey, President of XEDITON Pharmaceuticals Inc., commented: “We are very pleased to partner with Helsinn Group to bring to Canadian patients TRUSELTIQ. We believe TRUSELTIQ and its imminent launch will fill a gap in the much-needed therapy for cancer patients. We look forward to TRUSELTIQ being on the market.”

About TRUSELTIQ™ (infigratinib)

TRUSELTIQ (infigratinib) is a small molecule kinase inhibitor that targets FGFR, which was conditionally approved by Health Canada for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.

Prior to initiation of TRUSELTIQ therapy, FGFR2 fusion or rearrangement should be established using a validated test.

Clinical effectiveness of TRUSELTIQ is based on overall response rate (ORR) and duration of response (DoR) from a single-arm Phase 2 trial in patients with specific FGFR2 fusion or other rearrangements.

Infigratinib is not FDA- or Health Canada-approved for any other indication in the United States and Canada.

About Cholangiocarcinoma (CCA)

CCA (bile duct cancer) represents an aggressive group of malignancies that form in the bile ducts. The incidence of this serious and fatal disease varies considerably worldwide. As the disease is usually asymptomatic at early-stages, CCA typically presents at diagnosis as locally advanced or metastatic disease with a poor prognosis. FGFR2 genetic aberrations are present in approximately 15% to 20% of people who have this disease. Currently, the five-year survival rate is only 9%.1

References

Dhanasekaran, R., Hemming, A. W., Zendejas, I., George, T., Nelson, D. R., Soldevila-Pico, C., Firpi, R. J., Morelli, G., Clark, V., Cabrera, R. “Treatment outcomes and prognostic factors of intrahepatic cholangiocarcinoma”. Oncology Reports 29.4 (2013): 1259-1267.

TRUSELTIQ is a trademark of Helsinn Group.

About the Helsinn Group

Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and innovative pipeline of cancer therapeutics.

Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in over 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners.

Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

To learn more about Helsinn Group please visit www.helsinn.com

About Xediton Pharmaceuticals

Xediton Pharmaceuticals is a privately-held pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. Xediton Pharmaceuticals is committed to developing, partnering and making available new and established medicines to promote the health of Canadians. Located in the Greater Toronto Area, Canada, Xediton Pharmaceuticals has products in Oncology, Anti-Infectives, Pain, GI, Ophthalmology and CV and has built strong strategic alliances with Global and International Healthcare and pharmaceutical companies.

For more information, please visit www.xediton.com.

For more information:

Helsinn Group Media Contact:

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

Email: Info-hhc@helsinn.com

For more information, please visit www.helsinn.com and follow us on Twitter and LinkedIn

Xediton Contact:

George Gafrey

President

Tel: +1 905 286 9111

Email: info@xediton.com

For more information, please visit www.xediton.com and follow us on Twitter and LinkedIn

ISW Holdings Inc. (ISWH) Reports Record Revenue, Forecasts $7M Per Month

NEW YORK, Dec. 20, 2021 (GLOBE NEWSWIRE) — via InvestorWire — ISW Holdings Inc. (OTC: ISWH) today announces its placement in an editorial published by NetworkNewsWire (“NNW”), one of 50+ trusted brands within the InvestorBrandNetwork (“IBN”), a multifaceted financial news and publishing company for private and public entities.

To view the full publication and forward-looking statements, please visit: https://nnw.fm/YrdIL

Developments are translating to revenue and cash flow, resources that will underscore growth in 2022 and beyond with Pod City and other hosting and mining operations. During Q3, ISW Holdings Inc. (OTC: ISWH) reported revenue from operations of $1.075 million (including deferred revenues), up 2,435% on a year-over-year basis. That didn’t include a full three months of 550 new miners acquired from Minerset, 150 of which came as a result of ISWH meeting stock performance milestones. Total assets during Q3 increased 5,263% year to date to $9.56 million, while total liabilities decreased 73%, and total derivative liabilities decreased 98% to under $340,000. …

Looking ahead, revenue at Pod City will be comprised of hosting service fees, which aren’t contingent upon cryptocurrency pricing. Once running at full capacity, the company estimates annual revenue in excess of $7 million per month, a tremendous improvement compared to current capacity with the benefit of being recurring under service contracts.

About ISW Holdings

ISW Holdings, based in Nevada, is a diversified portfolio company comprised of essential business lines that serve consumer product demands. The company’s expertise lies in strategic brand development, early growth facilitation, as well as brand identity through its proprietary procurement process. Together, with its partners, ISW Holdings seeks to provide a structure that meets large scalability demands, as well as anticipated marketplace needs. The company is able to meet these needs through a variety of strategic innovative processes. ISWH is creating and managing brands across a spectrum of disruptive industries. It maneuvers its proprietary companies through critical stages of market development, which includes conceptualization, go-to-market strategies, engineering, product integration, and distribution efficiency. The company has also partnered with a well-known software development and consulting company, Bengala Technologies LLC, which is developing significant enhancements in the supply chain management space; and the partnership has a vitally needed patent now pending.

For more information about the company, visit www.ISWHoldings.com.

NOTE TO INVESTORS: The latest news and updates relating to ISWH are available in the company’s newsroom at http://ibn.fm/ISWH.

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness.

To receive SMS text alerts from NetworkNewsWire, text “STOCKS” to 77948 (U.S. Mobile Phones Only).
For more information please visit https://www.NetworkNewsWire.com.

Please see full terms of use and disclaimers on the NetworkNewsWire website, applicable to all content provided by NNW wherever published or re-published: http://NNW.fm/Disclaimer

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
212.418.1217 Office
Editor@NetworkNewsWire.com

NetworkNewsWire is part of the InvestorBrandNetwork

 

Feedzai’s market leadership endorsed with category recognition by leading analyst firms

Analyst firms Quadrant Knowledge Solutions and Aite-Novarica Group both name Feedzai in their top categories for technology providers and highlight customer experience

SAN MATEO, Calif. and LONDON, Dec. 20, 2021 (GLOBE NEWSWIRE) — Feedzai, the world’s first RiskOps platform, has been named in the top categories of two analyst firms: Technology Leader in Quadrant’s Enterprise Fraud Management survey and Best-in-Class For Fraud and Anti Money Laundering (AML) in Aite-Novarica Group’s latest Aite Matrix Report in a testament to its market presence, vision and customer value proposition.

The Quadrant Knowledge Solutions SPARK Matrix™ analysis of the global Enterprise Fraud Management (EFM) Market highlights how Feedzai offers premium fraud & risk management solutions through its flagship Transaction Fraud for Banking (TFB) solution.

Feedzai’s TFB leverages machine learning and helps banks and financial institutions manage financial crime and digital trust across the entire customer lifecycle with innovative and differentiated capabilities. The solution is based on the world’s first RiskOps platform that encompasses:

  • A single, end-to-end solution to manage multiple forms of risk and compliance with a fully extensible architecture that facilitates instant promotion of models from sandbox to production;
  • Human-Centered AI with individualized risk assessment – not cohort-based;
  • A Collaborative Analytics Suite to further break down the silos between fraud, AML, compliance and risk teams by putting all the data, tools and analytics in one, collaborative space.

According to Pradnya Gugale, Analyst at Quadrant Knowledge Solutions, “Powered by its comprehensive advanced ML-driven EFM capabilities, strong customer value proposition and continued focus on innovation Feedzai’s Transaction Fraud for Banking is a single solution for fraud management and risk scoring. Feedzai has received strong ratings across the parameters of technology excellence and customer impact and hence is recognised in the Leader category.”

Aite-Novarica Group, an advisory firm focused on technology, regulations, strategy, and operations for banking, insurance payments, providers and investment firms, once again places Feedzai as a Best-in-Class vendor for helping banks, merchants and payment processors fight Fraud and AML.

The 2021 Fraud and AML Vendor Report highlights the company’s omnichannel approach that allows clients to “construct single, unified views of customer risk that facilitate elevated monitoring, accelerated detection, and optimized investigation and decisioning. Illustrative in-market use cases for FI’s include AML transaction monitoring and screening as well as transaction monitoring for banking, including payment card and card-not-present fraud, transfer fraud, application fraud, and wholesale transactional fraud.”

Charles Subrt, Analyst at Aite-Novarica Group, said, “Feedzai offers a unique omnichannel financial crime platform that analyzes large data sets in milliseconds, facilitates holistic customer risk profiling and real-time decision making, and elevates fraud and money laundering detection and investigation. Transparent, explainable, and accountable by design, the Feedzai platform supports robust model risk management practices as well as responsible artificial intelligence.”

The same report also highlights the best in class experience from Feedzai’s customers and future proof vision. Clients indicated that “the solution’s accuracy, flexibility, data leverage and ease of adaptation, as well as Feedzai’s strong data science expertise, responsive service and support, and forward-thinking.”

About Feedzai:

Feedzai is the world’s first RiskOps platform, and the market leader in safeguarding global commerce with today’s most advanced cloud-based risk management platform, powered by machine learning and artificial intelligence. Feedzai is securing the transition to a cashless world while enabling digital trust in every transaction and payment type. The world’s largest banks, processors, and retailers trust Feedzai to protect trillions of dollars and manage risk while improving the customer experience for everyday users, without compromising privacy. Feedzai is a Series D company and has raised $282M to date with a current valuation of $1.5B. Its technology protects 800 million people in 190 countries. For more information, visit feedzai.com

Catarina da Fonseca
PR & Communications Manager, Feedzai
catarina.fonseca@feedzai.com

ISW Holdings Inc. (ISWH) รายงานบันทึกรายได้ คาดการณ์ 7 ล้านเหรียญต่อเดือน

นิวยอร์ก, Dec. 20, 2021 (GLOBE NEWSWIRE) — ทาง InvestorWire — ISW Holdings Inc. (OTC: ISWH) วันนี้ได้มีการประกาศสถานะของบริษัทในบทบรรณาธิการที่ตีพิมพ์โดย NetworkNewsWire (“NNW”) ซึ่งเป็นหนึ่งในกว่า 50 แบรนด์ที่เชื่อถือได้ภายใน InvestorBrandNetwork (“IBN”) ซึ่งเป็นบริษัทข่าวและสำนักพิมพ์ด้านการเงินที่หลากหลายสำหรับหน่วยงานภาครัฐและเอกชนหากต้องการดูสิ่งพิมพ์ฉบับเต็มและข้อความคาดการณ์ล่วงหน้า โปรดไปที่: https://nnw.fm/YrdIL

การพัฒนาได้แปรเปลี่ยนเป็นรายได้และกระแสเงินสด ซึ่งเป็นทรัพยากรที่จะเน้นย้ำการเติบโตในปี 2022 และไกลกว่านั้นด้วย Pod City และการโฮสต์ติ้งรวมถึงการทำเหมืองอื่น ๆ ในช่วงไตรมาสที่ 3 ISW Holdings Inc. (OTC: ISWH) รายงานรายได้จากการดำเนินงาน 1.075 ล้านดอลลาร์ (รวมรายรับรอตัดบัญชี) เพิ่มขึ้น 2,435% เมื่อเทียบเป็นรายปี ซึ่งไม่รวมสามเดือนเต็มจาก 550 การขุดใหม่จาก Minerset โดย 150 ครั้งจากจำนวนดังกล่าวนั้นเป็นผลมาจากการประชุม ISWH ที่บรรลุเป้าหมายด้านประสิทธิภาพของหุ้น สินทรัพย์รวมในไตรมาสที่ 3 เพิ่มขึ้น 5,263% เมื่อเทียบเป็นรายปีเป็น 9.56 ล้านดอลลาร์ ในขณะที่หนี้สินรวมลดลง 73% และหนี้สินอนุพันธ์ทั้งหมดลดลง 98% เหลือต่ำกว่า 340,000 ดอลลาร์ …

เมื่อมองไปยังภายภาคหน้าแล้ว รายได้ที่ Pod City จะประกอบด้วยค่าบริการโฮสติ้ง ซึ่งไม่ได้ขึ้นอยู่กับราคาสกุลเงินดิจิทัล เมื่อดำเนินการอย่างเต็มประสิทธิภาพแล้ว บริษัทประมาณการรายรับต่อปีอยู่ที่เกิน 7 ล้านดอลลาร์ต่อเดือน ซึ่งเพิ่มขึ้นอย่างมากเมื่อเทียบกับกำลังการผลิตปัจจุบัน โดยมีประโยชน์ของการอยู่ภายใต้สัญญาบริการที่เกิดขึ้นประจำ

เกี่ยวกับ ISW Holdings

ISW Holdings ตั้งอยู่ในรัฐเนวาดา เป็นบริษัทที่มีผลงานที่หลากหลายซึ่งประกอบด้วยสายธุรกิจที่จำเป็นเพื่อตอบสนองความต้องการด้านผลิตภัณฑ์ของผู้บริโภค ความเชี่ยวชาญของบริษัทอาศัยการพัฒนาแบรนด์เชิงกลยุทธ์ การอำนวยความสะดวกในการเติบโตช่วงแรก รวมถึงเอกลักษณ์ของแบรนด์ผ่านกระบวนการจัดซื้อจัดจ้างที่เป็นกรรมสิทธิ์ของบริษัท ISW Holdings ได้พยายามที่จะจัดเตรียมโครงสร้างที่ตอบสนองความต้องการด้านความสามารถในการปรับขยายขนาดใหญ่ เช่นเดียวกับความต้องการของตลาดที่คาดการณ์ไว้ ด้วยการร่วมมือกับพันธมิตรของบริษัท บริษัทสามารถตอบสนองความต้องการเหล่านี้ผ่านกระบวนการนวัตกรรมทางกลยุทธ์ที่หลากหลาย ISWH กำลังสร้างและจัดการแบรนด์โดยครอบคลุมหลากหลายอุตสาหกรรมที่เปลี่ยนแปลง ซึ่งจะช่วยให้บริษัทที่มีกรรมสิทธิ์ก้าวผ่านขั้นตอนสำคัญในการพัฒนาตลาด ซึ่งรวมถึงการวางแนวความคิด กลยุทธ์การเข้าถึงตลาด วิศวกรรม การผสานรวมผลิตภัณฑ์ และประสิทธิภาพในการจัดจำหน่าย บริษัทยังเป็นพันธมิตรกับบริษัทพัฒนาและให้คำปรึกษาด้านซอฟต์แวร์ที่มีชื่อเสียงอย่าง Bengala Technologies LLC ซึ่งกำลังพัฒนาการเพิ่มประสิทธิภาพในด้านการจัดการซัพพลายเชน และการร่วมมือดังกล่าวอยู่ระหว่างการจดสิทธิบัตรในขณะนี้

ดูข้อมูลเพิ่มเติมเกี่ยวกับบริษัทได้ที่ www.ISWHoldings.com.

หมายเหตุสำหรับนักลงทุน: ข่าวสารล่าสุดและข้อมูลอัปเดตเกี่ยวกับ ISWH มีให้บริการในห้องข่าวของบริษัทที่ http://ibn.fm/ISWH

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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.