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Sat 19 Jun 2021 - 11:07:am (Sydney)

TLX Share Price

TELIX PHARMACEUTICALS LIMITEDTLXPharmaceuticals, Biotechnology & Life Sciences

TLX Company Information

Name:

Telix Pharmaceuticals Limited

Sector:

Healthcare

Industry:

Biotechnology

GIC Industry:

Biotechnology

GIC Sub Industry:

Biotechnology

Address:

55 Flemington Road North Melbourne VIC Australia 3051

Phone:

61 3 3093 3897

Co-Founder, MD, CEO & Exec. Director:

Dr. Christian P. Behrenbruch Ph.D., BEng(Hons), MBA, DPhil(Oxon), J.D., GAICD

Group Chief Financial Officer:

Mr. Douglas Cubbin FCPA, GAICD

Group Chief Operating Officer:

Dr. Gabriel Liberatore B.Sc., M.A.I.C.D., M.B.A., Ph.D.

Director of Corp. Fin.:

Mr. Harry Marfatia

Chief Scientist:

Dr. Michael Wheatcroft Ph.D., Ph.D., (Cantab), BSc(Hons)

Chief Bus. Devel. Officer & Group Gen. Counsel:

Mr. Jonathan Barlow B.Sc., L.L.B.

Communications Mang.:

Ms. Amanda Griffin

VP Sales and Marketing, EMEA:

Mr. Christian Davis

Global Director of People & Culture:

Ms. Margaret Haarhoff B.A.

Chief Operating Officer (APAC):

Dr. Jyoti Arora BappSc(Hons), Ph.D.

Company Overview:

Telix Pharmaceuticals Limited, a radiopharmaceutical company, develops molecularly targeted radiation products for unmet needs in cancer care in Australia, Belgium, Japan, and the United States. The company focuses on developing diagnostic and therapeutic products using molecularly targeted radiation (MTR). Its lead products include TLX250, which is in Phase II clinical trials for the diagnosis and treatment of renal (kidney) cancer; TLX250-CDx that is in Phase III clinical trials for the diagnosis and treatment of renal (kidney) cancer; TLX591, which is in pre-Phase 3 development for the diagnosis and treatment of metastatic castrate-resistant prostate cancer; TLX591-CDx that is in Phase III clinical trials for the diagnosis and treatment of metastatic castrate-resistant prostate cancer; and TLX101, which is in Phase I/II clinical trial for the treatment of glioblastoma (brain cancer). The company has a strategic collaboration with RefleXion Medical for the treatment of high-risk cancers; a strategic license and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited for developing a portfolio of MTR products; and scientific and clinical research collaboration with Mauna Kea Technologies. In addition, it has a collaboration with Kanazawa University to commence a Phase I trial of prostate cancer imaging product TLX591-CDxin Japan. The company was founded in 2015 and is headquartered in North Melbourne, Australia.

TLX Share Price Information

Shares Issued:

281.37M

Market Capitalisation:

$1.71B

Revenue (TTM):

$5.21M

Revenue Per Share (TTM):

$0.02

Earnings per Share:

$-0.089

Operating Margin (TTM):

$-9.45

Return On Assets (TTM):

$-0.24

Return On Equity (TTM):

$-0.60

Quarterly Revenue Growth (YOY):

1.162

Gross Profit(TTM):

$3.19M

Diluted Earnings Per Share (TTM):

$-0.174

TLX CashFlow Statement

CashFlow Date:

2020-12-31

Investments:

$-1,091,000

Change To Liabilities:

$32.42M

Total Cashflow From Investing Activities:

$-1,091,000

Net Borrowings:

$-904,000

Net Income:

$-44,887,000

Total Cash From Operating Activities:

$1.96M

Depreciation:

$4.88M

Other Cashflow From Investing Activities:

$-447,000

Change To Inventory:

$-91,000

Change To Account Receivables:

$-328,000

Sale Purchase Of Stock:

$-130,000

Capital Expenditures:

$322K

TLX Income Statement

Income Date:

2020-12-31

Income Before Tax:

$-47,935,000

Net Income:

$-44,887,000

Gross Profit:

$1.25M

Operating Income:

$-51,188,000

Interest Expense:

$1.18M

Income Tax Expense:

$-3,048,000

Total Revenue:

$3.28M

Total Operating Expenses:

$52.44M

Cost Of Revenue:

$2.02M

TLX Balance Sheet

Balance Sheet Date:

2020-12-31

Intangible Assets:

$54.97M

Total Liabilities:

$78.81M

Total Stockholder Equity:

$79.02M

Other Current Liabilities:

$10.89M

Total Assets:

$157.82M

Common Stock:

$167.06M

Other Current Assets:

$2.65M

Retained Earnings:

$-92,961,000

Other Liabilities:

$57.41M

Good Will:

$4.22M

Other Assets:

$183K

Cash:

$77.95M

Total Current Liabilities:

$19.96M

Short-Term Debt:

$264K

Property - Plant & Equipment:

$4.82M

Net Tangible Assets:

$19.83M

Total Current Assets:

$93.63M

Long-Term Debt:

$95K

Net Receivables:

$12.40M

Short-Term Investments:

$64.19M

Inventory:

$633K

Accounts Payable:

$5.81M

Short-Term Investments:

$64.19

Non Current Liabilities (Other):

$57.41M

Non Current Liabilities Total:

$58.85M

TLX Share Price History

TLX News

14 Jun, 2021
MELBOURNE, Australia & INDIANAPOLIS, Jun 14, 2021--Telix Pharmaceuticals and Applied Radiology launch TelixU Medical Education Platform Focused on Radiopharmaceutical Research
11 Jun, 2021
MELBOURNE, Australia & INDIANAPOLIS, Jun 11, 2021--Telix launches "Gallium Wave" Awareness Website
01 Jun, 2021
MELBOURNE, Australia and NEW YORK, June 01, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that Chief Executive Officer, Dr. Christian Behrenbruch, will present at the Jefferies Virtual Healthcare Conference 2021. The presentation details are as follows: Date:Wednesday, June 2, 2021 Time:8:00 AM Eastern Time Webcast:https://wsw.com/webcast/jeff174/tlx/1728648 The presentation will be webcast live using the link above, and a replay will be available on Telix’s corporate website (www.telixpharma.com) following the event. About Telix Pharmaceuticals Limited Telix is a clinical-stage 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, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs 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’s lead investigational product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,1 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).2 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union3 and Canada.4 None of Telix’s products have received a marketing authorisation in any jurisdiction. Telix Corporate Contact Telix Corporate Communications Dr. Christian Behrenbruch Telix Pharmaceuticals Limited Managing Director and CEO Email: chris.behrenbruch@telixpharma.com Dr. Stewart Holmstrom Telix Pharmaceuticals LimitedDirector of Corporate CommunicationsEmail: stewart.holmstrom@telixpharma.com ___________________1 ASX disclosure 24/11/20.2 ASX disclosure 14/04/21.3 ASX disclosure 1/05/20.4 ASX disclosure 16/12/20.
27 May, 2021
Cardinal Health and Telix launch Gallium Awareness campaign with release of White-Paper: "Moving beyond the Myth"
25 May, 2021
MELBOURNE, Australia and KYOTO, Japan, May 25, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a clinical study in Japan using Telix’s investigational prostate cancer imaging product TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11 injection). The study is an academic collaboration between Telix and Kanazawa University. The study will enroll ten patients with advanced prostate cancer and is the first clinical evaluation of gallium-based PSMA imaging in Japan. The objective is to obtain safety data in a representative Japanese patient population, and to demonstrate that the targeting and biodistribution of TLX591-CDx in Japanese patients is consistent with international experience. Clinical data may facilitate development planning discussions with the PMDA and other Asian regulators. Anri Inaki MD PhD, Principal Investigator of the study, said, “The development of PSMA prostate imaging in Japan has been eagerly awaited by prostate cancer patients and the urology and nuclear medicine community. We are delighted to announce this cornerstone event as a collaborative achievement between Professor Mizokami of Urology, Professor Murayama of the Innovative Clinical Research Center (iCREK), and Professor Kinuya of Nuclear Medicine at Kanazawa University Hospital, along with Kanazawa Advanced Medical Center (KadMedic), ATOX Co. Ltd, IRE ELiT (Belgium) and Telix.” Telix Japan President Dr. Shintaro Nishimura added, “This is the first study in Japan where a gallium based PSMA imaging agent is being systematically evaluated. Dosing the first patient represents a significant first step for the Japanese domestic medicine community to deliver innovative benefits to Japanese prostate cancer patients. We would like to express our appreciation to Dr. Inaki, the study’s principal investigator at Kanazawa University Hospital, the investigators and the study team for their excellent collaboration and, most importantly, the patients who will participate in this study.” About Telix Pharmaceuticals Limited Telix is a clinical-stage 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, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs 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’s lead investigational product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,1 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).2 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union3 and Canada.4 None of Telix’s products have received a marketing authorisation in any jurisdiction. Telix Corporate Contact Telix Media ContactDr. Christian Behrenbruch Dr. Stewart HolmstromTelix Pharmaceuticals Limited Telix Pharmaceuticals LimitedManaging Director and CEO Director of Corporate CommunicationsEmail: chris.behrenbruch@telixpharma.com Email: stewart.holmstrom@telixpharma.com 1 ASX disclosure 24/11/20.2 ASX disclosure 14/04/21.3 ASX disclosure 1/05/20.4 ASX disclosure 16/12/20.
MELBOURNE, Australia and SOUTHAMPTON, United Kingdom, May 25, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Company’s bone marrow conditioning investigational candidate TLX66 (90Y-besilesomab) has met study objectives, demonstrating the initial safety profile in patients with Systemic Amyloid Light Chain Amyloidosis (AL amyloidosis). The TRALA trial (Targeted Radiotherapy for AL Amyloidosis) is a Phase I/IIa trial to evaluate the safety and toxicity of TLX66 as the sole bone marrow conditioning agent prior to autologous hematopoietic stem cell transplantation (HSCT) in patients with AL amyloidosis.1 The TRALA trial was sponsored by University Hospital Southampton in Southampton U.K. and run across four centres: Southampton, University College Hospital London, Royal Free Hospital London, and Queen Elizabeth Hospital Birmingham. All study data were reviewed by the trial’s Independent Data Monitoring Committee (IDMC). In total, nine patients with AL amyloidosis were enrolled into the TRALA trial and received TLX66 as the sole bone marrow conditioning agent prior to undergoing autologous HSCT. TLX66 demonstrated a favourable safety profile and was well tolerated in all nine patients, each of whom completed the trial. All patients (100%) were successfully engrafted following bone marrow conditioning with TLX66 and autologous HSCT without any chemotherapy. Disease response as measured by fall in clonal free light chains (FLC) was seen in seven out of the nine patients, with two complete responses (CR) and five partial responses (PR) within the first 100 days post-transplant. In two of the patients achieving PR, the clonal FLC continued to fall, with one patient achieving CR subsequently with no further treatment. In addition, reduction in the measurable malignant plasma cells in the bone marrow was seen in six of eight evaluable patients. All patients remain alive at a median follow-up of 31 months (range 14 – 57 months). Consultant Hematologist at University Hospital Southampton and TRALA principal investigator Dr. Kim Orchard stated, “We are highly encouraged by the safety and tolerability that 90Y-besilesomab has demonstrated as a single agent bone marrow conditioning approach in patients with AL amyloidosis. Compared to the significant toxicity profile typically experienced with conventional chemotherapy-based regimens, molecularly targeted radiation with 90Y-besilesomab demonstrated a very benign toxicity profile, which may in turn enable a considerably greater proportion of patients with AL amyloidosis to undergo life prolonging stem cell transplantation. The very low toxicity but with demonstrable responses is very encouraging.” Telix Chief Medical Officer Dr. Colin Hayward said, “The results from the TRALA trial indicate that TLX66 may offer a new approach to bone marrow conditioning in patients who could benefit from HSCT such as those with AL amyloidosis, providing new hope to patients with this rare disease and with few effective treatment options. TLX66 was well-tolerated, enabling successful engraftment of the patients’ own transplanted stem cells without the need for toxic chemotherapy. With all patients remaining alive, and most not requiring further therapy, we believe these data support taking TLX66 forward into a pivotal registration program in this rare disease indication.” About Amyloidosis Amyloidosis is a rare disease in which faulty plasma cells in the bone marrow (that normally generate antibodies in response to infection) produce an abnormal protein called ‘amyloid’ which accumulates in the organs of the body. Progressive accumulation of amyloid in organs such as the heart and kidneys eventually lead to organ failure and death. Amyloidosis occurs at the rate of ~12 per 1,000,000 population, per annum, with an estimated prevalence of 30,000 to 45,000 in the United States and European Union, respectively.2 While a rare disease, amyloidosis portends a poor prognosis, with a median survival from diagnosis of approximately 11 months if untreated. Current standard of care typically requires bone marrow conditioning with multi-drug regimens comprising cyclophosphamide, bortezomib, dexamethasone and high dose melphalan, prior to HSCT. While long-term survival is achievable in patients undergoing HSCT, such bone marrow conditioning regimens are typically highly toxic and may be poorly tolerated in a significant proportion of patients and associated with high morbidity and mortality. Consequently, safer, more tolerable conditioning agents represent a significant unmet clinical need. About Telix Pharmaceuticals Limited Telix is a clinical-stage 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, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs 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 Corporate ContactTelix Media ContactDr. Christian BehrenbruchDr. Stewart HolmstromTelix Pharmaceuticals LimitedTelix Pharmaceuticals LimitedManaging Director and CEODirector of Corporate CommunicationsEmail: chris.behrenbruch@telixpharma.comEmail: stewart.holmstrom@telixpharma.com 1 EudraCT Number: 2015-002231-18. 2 Quock TP et al. Blood Advances. 2018.
10 May, 2021
MELBOURNE, Australia and ISTANBUL, Turkey, May 10, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered a global clinical supply agreement with Istanbul-based Eczacıbaşı-Monrol Nuclear Products Co. (Monrol) for no carrier added (NCA) lutetium-177 (177Lu), a key therapeutic isotope used in Telix’s portfolio of Molecularly Targeted Radiation (MTR) products. This new activity expands an existing master services and distribution agreement concluded with Monrol in 2019 to support the ZIRCON Phase III trial of Telix’s TLX250-CDx (89Zr-DFO-girentuximab) investigational product for imaging of renal cell carcinoma with positron emission tomography (PET). Under the terms of the agreement, Monrol will supply 177Lu, for clinical and commercial use, in support of Telix’s drug development programs. Telix CEO Christian Behrenbruch stated, “Monrol is a leading nuclear medicine company in the countries in which it operates and has proven to be a reliable isotope supply, manufacturing, and distribution partner during the course of the ZIRCON study. We are pleased to expand our validated and trusted collaboration to include the supply of lutetium, an important radioisotope with broad utility in the treatment of human cancers.” Monrol General Manager Aydın Küçük added, “Since we started collaborating with Telix in 2019, the Company has continued its rapid growth and is now recognized as a leading global company in the radiopharmaceutical field. We are very pleased to be working with Telix to supply 177Lu in support of Telix’s mission to help patients with cancer live longer, better quality lives.” Telix expects to use Monrol 177Lu, both for the pending STARLITE Phase II (177Lu-DOTA-girentuximab for the treatment of metastatic renal cell carcinoma) and ProstACT Phase III (177Lu-DOTA-rosopatamab for the treatment of metastatic castrate-resistant prostate cancer) studies. Telix and Monrol will also validate the use of Monrol’s 177Lu production to support the commercial roll-out of Telix’s products in Monrol’s commercial territories, subject to completion of clinical studies and the relevant regulatory approvals. About Telix Pharmaceuticals Limited Telix is a clinical-stage 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, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs 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. About Eczacıbaşı-Monrol Eczacıbaşı Monrol Nuclear Products Co. is a leading developer, manufacturer, and distributor of radiopharmaceutical products globally. Headquartered in Istanbul, Turkey, Eczacıbaşı Monrol has 300 employees, and manufacturing facilities in 6 countries. Monrol exports a broad spectrum of high-quality nuclear medicine products to more than 40 countries around the world. For more information visit www.monrol.com Telix Corporate Communications Eczacıbaşı Monrol Contact Dr. Stewart HolmstromMr. Aydın KüçükTelix Pharmaceuticals LimitedEczacıbaşı-Monrol Nuclear Products CoDirector of Corporate CommunicationsGeneral ManagerEmail: stewart.holmstrom@telixpharma.comE: aydin.kucuk@monrol.com
09 May, 2021
MELBOURNE, Australia, May 09, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has been granted Human Research Ethics Committee (HREC) approval and received Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA) to commence a Phase III clinical trial of the Company’s PSMA1 targeted prostate cancer therapy candidate TLX591 (177Lu-DOTA-rosopatamab), in patients with advanced metastatic castrate-resistant prostate cancer (mCRPC). The Phase III “ProstACT” trial is an international, multi-centre, randomised controlled trial (RCT) in patients with PSMA-expressing mCRPC, experiencing disease progression following prior treatment with a novel androgen axis drug (NAAD). The ProstACT trial will enrol approximately 390 patients and incorporates patient selection using 68Ga-PSMA imaging with TLX591-CDx (Illuccix®). The trial will compare standard of care therapy alone versus standard of care therapy plus TLX591, with a primary endpoint of radiographic progression-free survival (rPFS). Trial secondary endpoints will include overall survival and quality-of-life assessment. Telix has commenced the initiation of Australian ProstACT trial sites and will add global sites progressively during the second half of 2021, subject to the requisite approvals. Telix Chief Executive Officer Dr. Christian Behrenbruch stated, “The commencement of the ProstACT Phase III study for TLX591 marks a major corporate milestone for Telix that brings the Company a step closer to delivering on a major unmet medical need for treatment options in this patient population. ProstACT builds on a significant body of clinical data for TLX5912, which to date has been studied in over 200 patients with advanced prostate cancer, across five previous studies. TLX591 has demonstrated promising and competitive clinical potential that we believe warrants further confirmation in this second-line disease setting. It is also noteworthy that Telix’s differentiated approach to integrating molecular imaging with PET alongside therapy, enables a comparatively streamlined study that we believe will support efficient patient enrolment and study execution.” About Prostate Cancer Prostate cancer is the second most common cancer in men after skin cancer and worldwide 1.4 million men were diagnosed with prostate cancer in 2020. Despite advances in treatment, prostate cancer still accounts for a large number of deaths and in 2020 more than 375,000 men died from their disease. Rates of diagnosis are increasing, and the highest incidences of prostate cancer are found in the United States, Europe, Australia and New Zealand.3 About TLX591 TLX591 (177Lu-DOTA-rosopatamab) is an antibody-based radioimmunoconjugate (molecularly-targeted radiotherapy or “MTR”) targeting PSMA, a cancer target highly expressed in men with metastatic prostate cancer. About Telix Pharmaceuticals Limited Telix is a clinical-stage 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, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs 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’s lead investigational product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,4 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).5 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union6 and Canada.7 None of Telix’s products, including TLX591 and TLX591-CDx, have received a marketing authorisation in any jurisdiction. Telix Corporate ContactTelix Corporate Communications Dr. Christian BehrenbruchDr. Stewart HolmstromTelix Pharmaceuticals LimitedTelix Pharmaceuticals LimitedManaging Director and CEODirector of Corporate CommunicationsEmail: chris.behrenbruch@telixpharma.comEmail: stewart.holmstrom@telixpharma.com ___________________________1 Prostate-Specific Membrane Antigen (PSMA)2 Tagawa S et al. Cancer 2019.3 GLOBOCAN 2020.4 ASX disclosure 24/11/20.5 ASX disclosure 14/04/21.6 ASX disclosure 1/05/20.7 ASX disclosure 16/12/20.
02 May, 2021
MELBOURNE, Australia and HERSTAL, Belgium, May 02, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that Mr. Richard Valeix has joined the Telix executive leadership team in the role of President, Europe, Middle East and Africa (EMEA). Richard joins Telix with approximately twenty years of pharmaceutical industry experience, including radiopharmaceuticals, gained in senior executive leadership roles across a broad range of therapeutic product areas. Prior to joining Telix, Richard worked at Advanced Accelerator Applications (AAA), a Novartis Company where he served for seven years in the roles of General Manager for France, Switzerland, Belgium, Netherlands and Luxembourg, and Global Head of Marketing and Sales. Earlier in his career, Richard held senior sales, marketing and strategy roles at Ipsen and Roche, where he gained extensive experience in European market access, reimbursement, regulatory affairs and commercial launch planning for first-in-class products. Richard holds a Pharmacist diploma from the Pharmaceutical University Marseille (France), a Master’s degree in Management gained from the ESC Business School Marseille, and has completed the International Marketing Program from INSEAD, Paris (France). Telix Chief Executive Officer Dr. Christian Behrenbruch stated, “I am delighted to welcome Richard to Telix’s executive leadership team. Richard brings to the Company extensive experience and a proven track record in successfully launching practice-changing radiopharmaceuticals in the diverse EMEA market. Richard’s broad commercial skill-set and his prior experience are uniquely aligned to Telix’s European commercial launch preparation for the prostate cancer imaging product Illuccix®, and the broader product pipeline that will follow.” Mr. Valeix added, “Telix has made rapid progress in only a short period of time to develop an exciting portfolio of radiopharmaceutical assets that address significant unmet needs in oncology. Having joined Telix, I look forward to working with the team to deliver on the promise of nuclear medicine and ultimately improve outcomes for patients living with cancer.” About Telix Pharmaceuticals Limited Telix is a clinical-stage 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, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs 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’s lead investigational product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,1 and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).2 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union3 and Canada.4 None of Telix’s products have received a marketing authorisation in any jurisdiction. __________________________1 ASX disclosure 24/11/20.2 ASX disclosure 14/04/21.3 ASX disclosure 1/05/20.4 ASX disclosure 16/12/20. Telix Corporate ContactTelix Media Contact Dr. Christian BehrenbruchDr. Stewart HolmstromTelix Pharmaceuticals LimitedTelix Pharmaceuticals LimitedManaging Director and CEODirector of Corporate CommunicationsEmail: chris.behrenbruch@telixpharma.comEmail: stewart.holmstrom@telixpharma.com
20 Apr, 2021
BRUSSELS, Belgium and MELBOURNE, Australia, April 20, 2021 (GLOBE NEWSWIRE) -- The Oncidium Foundation, a non-profit organisation created to promote and support the development of radiopharmaceuticals for better patient access, and Telix Pharmaceuticals Limited (‘Telix’), a radiopharmaceutical company developing diagnostic and therapeutic products (‘theranostics’) using Molecularly Targeted Radiation (MTR), are pleased to announce the launch of the NOBLE Registry, an international clinical collaboration for the development of 99mTc-iPSMA SPECT imaging for prostate cancer, and the dosing of the first patient at the University College Hospital, Ibadan, Nigeria. Prostate cancer is the second most frequent cancer diagnosis in men and the fifth leading cause of cancer death worldwide1. Early detection can significantly reduce the mortality rate and in recent years much attention has focused on PSMA2 as a target for imaging and therapy using radionuclides for prostate cancer. PSMA positron emission tomography (PSMA PET) is an emerging standard of care in prostate cancer imaging.3 Unfortunately, globally, not every patient will have access to a PSMA PET scan when indicated. The NOBLE (Nobody Left Behind) Registry aims to demonstrate that PSMA single photon emission computed tomography (PSMA SPECT), a diagnostic imaging technology widely available in healthcare facilities throughout the world,4 is a cost-effective and viable alternative. Enhancing global availability and access to 99mTc-iPSMA SPECT imaging has the potential to provide accurate diagnosis and staging to patients with prostate cancer regardless of where they reside. The NOBLE Registry Committee, made up of globally recognized investigators at eight sites worldwide,5 aims to deliver and publish real-world evidence and clinical practice guidelines related to SPECT imaging and prostate cancer. “The advancement of PSMA directed diagnostics and therapeutics in prostate cancer is helping to extend life and improve treatment outcomes in men with prostate cancer,” said Dr. Batool Albalooshi, Chair of the NOBLE Registry Committee. “However, millions of men do not have access to PET imaging. For this reason, it is our aspiration to develop a powerful, affordable, and widely available alternative imaging tool by using iPSMA SPECT technology.” “Introducing PSMA has been difficult and exciting for the team at Ibadan. When I think of the opportunities for prostate cancer research and management without PET, I am motivated to get past the challenges. I look forward to a better future, with nobody left behind,” said Dr. Akintunde Orunmuyi, Investigator at the University College Hospital, Ibadan, Nigeria, where the first patient is being dosed. The NOBLE Registry has been initiated and is co-supported by the Oncidium Foundation and Telix Pharmaceuticals. “We aim to enable patients with prostate cancer, regardless of origin, technology access or financial situation, to access PSMA SPECT imaging for accurate diagnosis and treatment planning,” said Rebecca Lo bue, General Manager of the Oncidium Foundation. “We are honoured to support the launch of the NOBLE Registry, which represents the very essence of our belief that every patient deserves access to the benefits of nuclear medicine. We wish to thank the Oncidium Foundation for their support and partnership, as well as the expert global clinical leadership team led by Dr. Albalooshi. Above all, we are grateful to the patients that will make this registry study possible and, in doing so, help to deliver an important milestone toward improving access to this important technology.” said Dr. Christian Behrenbruch, Chief Executive Officer of Telix Pharmaceuticals. About the Oncidium FoundationThe Oncidium Foundation was created in 2011 by Dr. Richard Zimmermann. The Foundation's priorities include promoting awareness about radiotherapeutics among patients and physicians, investing in research and scholarships, supporting, and financing the development of new radiopharmaceuticals for therapy, supporting clinical best practice, and improving access to patients. https://www.oncidiumfoundation.org/ About Telix Pharmaceuticals Limited Telix is a clinical-stage radiopharmaceutical 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, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs 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. None of Telix’s products have received a marketing authorisation in any jurisdiction. Oncidium Foundation Contact Telix Media ContactRebecca Lo bueOncidium FoundationGeneral ManagerEmail: rebecca@oncidium-life.org Dr. Stewart HolmstromTelix Pharmaceuticals LimitedDirector of Corporate CommunicationsEmail: Stewart.Holmstrom@Telixpharma.com _______________________ 1 Globocan 2020.2 Prostate-specific membrane antigen - a protein expressed on the surface of prostate cancer cells.3 Hofman M, et al. The Lancet 2020; Trabulsi E, et al. Journal of Clinical Oncology 2020.4 In 2020 there were an estimated 25,500 SPECT and 6,700 PET cameras installed worldwide (Source: MEDraysintell).5 Australia, Egypt, India, Mexico, Nigeria, South Africa, Turkey, United Arab Emirates.
30 Mar, 2021
MELBOURNE, Australia and INDIANAPOLIS, March 30, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today that it has completed an agreement with contract development and manufacturing organisation (CDMO) Grand River Aseptic Manufacturing (‘GRAM’) to perform commercial-scale Good Manufacturing Practice (GMP) manufacturing of Telix’s Illuccix® product (TLX591-CDx, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging. Under the terms of the Agreement, GRAM will perform advanced aseptic fill and finish services for Illuccix® at its facilities in Grand Rapids, (Michigan, U.S.A.) for the U.S., Canada, EU, and Australian markets. Telix Americas President Dr. Bernard Lambert stated, “With commercial distribution agreements in place with major radiopharmacy networks covering over 90% of the U.S. population, we are pleased to have entered this agreement with GRAM, thus delivering a key component of our manufacturing and supply chain strategy for GMP manufacturing of Telix’s first commercial product. As we prepare for the U.S. launch of Illuccix® it is especially reassuring to know that, subject to approval by the FDA, supply will originate from a site in Michigan, providing certainty of access for American men living with prostate cancer.” GRAM President and CEO Tom Ross added, “We wish to congratulate Telix on reaching this incredible milestone. It is a great honor to support pharmaceutical innovators with fill and finish services as they work to deliver novel drug products to market. GRAM’s partnership with Telix is founded on deep technical expertise and shared values that are backed by a strong quality record, world class equipment and passionate team members. I look forward to all we will accomplish together.” About Telix Pharmaceuticals Limited Telix is a clinical-stage biopharmaceutical company developing diagnostic and therapeutic products using Molecularly Targeted Radiation. Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs 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’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA1, and has been granted Priority Review status by the Australian Therapeutic Goods Administration (TGA).2 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union3 and Canada.4 None of Telix’s products have currently received a marketing authorisation in any jurisdiction. About Grand River Aseptic Manufacturing, Inc. Grand River Aseptic Manufacturing, Inc. (‘GRAM’), a leading parenteral contract development and manufacturing organization, delivers customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics as well as controlled substances, GRAM’s advanced technology and staff supports pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing. Telix Corporate Contact Media Contact Dr. Christian Behrenbruch Dr. Stewart HolmstromTelix Pharmaceuticals Limited Telix Pharmaceuticals LimitedCEO Director of Corporate CommunicationsEmail: chris.behrenbruch@telixpharma.com Email: stewart.holmstrom@telixpharma.com 1 ASX disclosure 24/11/2020.2 ASX disclosure 7/12/2020.3 ASX disclosure 1/05/2020.4 ASX disclosure 16/12/2020.
16 Feb, 2021
MELBOURNE, Australia and LIÈGE, Belgium, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today that the Ministry of Health of the Czech Republic is the first European health authority to grant a national authorisation allowing the use of TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET). The national authorisation, which is specific to Telix’s prostate cancer imaging product, enables Czech physicians to use TLX591-CDx under a Specific Therapeutic Programme (STP), which allows medical products intended for the treatment, prevention or diagnosis of conditions severely affecting human health to be used prior to being granted a full European marketing authorisation.1 The value of PSMA imaging in the detection of prostate cancer, and its superior performance compared with conventional imaging has been demonstrated in prospective clinical studies. PSMA imaging is especially effective at detecting prostate cancer in patients with a rising PSA level following radical treatment2, and in the primary staging of newly diagnosed prostate cancer.3 Under the STP authorisation, TLX591-CDx is indicated for the diagnostic imaging of prostate cancer using PET/CT or PET/MRI for the purposes of: Primary staging of high-risk disease with a view to early identification of metastasesLocalisation of prostate cancer in patients with PSA progression following radical treatmentIdentification of patients with extensive generalised prostate cancer for who radical life-saving treatment is not indicated President of the Czech Society of Nuclear Medicine, Dr. David Zogala stated, “The Czech Society of Nuclear Medicine considers this temporary approval of PSMA PET in the Czech Republic to be a very important milestone, with an immense impact on the quality of prostate cancer care. Accessibility to this valuable examination will increase across the Czech Republic, as previously it was limited to one single pioneer hospital in Pilsen. The Society would like to acknowledge all the specialists who have taken part in the preparation of the Programme documentation, the supporting societies, the distributor, and the manufacturer.” Telix CEO, Dr. Christian Behrenbruch, added, “We wish to acknowledge the outstanding leadership of the Czech Society of Nuclear Medicine, the Nuclear Medicine Institute at General University Hospital Prague, and the First Faculty of Medicine at Charles University Prague, in preparing and submitting the application for the Specific Treatment Programme use of TLX591-CDx, to the Czech Ministry of Health. The Czech Republic is the first European country to grant broad patient access to PSMA imaging, and we look forward to working with our distribution partner THP Medical Products to ensure this state-of-the-art imaging modality is available to all men in the Czech Republic living with prostate cancer.” About Prostate Cancer Prostate cancer is the second most common cancer in men following skin cancer, with approximately 1.4 million men diagnosed with prostate cancer annually worldwide.4 While meaningful advances in the treatment of prostate cancer have occurred in recent years, more than 375,000 men still die from their disease each year. The incidence of prostate cancer continues to increase, with the highest rates of the disease occurring in the United States, Canada, Europe and Australia and New Zealand. About Telix Pharmaceuticals Limited Telix is a clinical-stage 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, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow us on Twitter (@TelixPharma) and LinkedIn. Telix’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA5, and has been granted Priority Review status by the Therapeutic Goods Administration (TGA) in Australia.6 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union7 and Canada.8 None of Telix’s products have currently received a marketing authorisation in any jurisdiction. ____________________1 https://www.sukl.eu/pharmaceutical-industry/related-information.2 Clinical indication is also known as biochemical recurrence (BCR).3 Hofman MS et al. Lancet 2020 Apr 11;395(10231):1208-1216.4 GLOBOCAN 2020.5 ASX disclosure 24/11/2020.6 ASX disclosure 07/12/2020.7 ASX disclosure 01/05/2020.8 ASX disclosure 16/12/2020. Telix Corporate ContactDr. Christian BehrenbruchTelix Pharmaceuticals LimitedManaging Director and CEOEmail: Chris.Behrenbruch@Telixpharma.comMedia ContactDr. Stewart HolmstromTelix Pharmaceuticals LimitedDirector of Corporate CommunicationsEmail: Stewart.Holmstrom@Telixpharma.com
24 Jan, 2021
MELBOURNE, Australia and INDIANAPOLIS, Jan. 24, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announces that the first patients have been dosed in the Phase III ZIRCON1 clinical trial of Telix’s renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in the United States. The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth. The ZIRCON trial, which includes twelve participating clinical study sites across the U.S. and Canada, initiated patient recruitment in U.S. on Friday, with the first patients being dosed with TLX250-CDx at University of California, Los Angeles (UCLA), and Seattle Cancer Care Alliance, University of Washington, Seattle (SCCA). The remaining seven U.S. sites2 and three sites3 in Canada are expected to commence patient recruitment progressively over the next month. Telix Chief Medical Officer, Dr. Colin Hayward, stated, “We are pleased to have commenced the Phase III ZIRCON clinical trial in North America and wish to express our gratitude to Prof. Allan Pantuck and Dr. Delphine Chen, principal investigators at UCLA and SCCA, respectively, as well as their clinical research teams and patients, who have made this important milestone possible.” About the ZIRCON Study ZIRCON (“Zirconium Imaging in Renal Cancer Oncology”) is an international multi-centre Phase III study at 36 sites in Europe, Australia, Turkey, Canada, and the United States (subject to regulatory approval in the various jurisdictions). ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, to determine the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “ground truth” determined from surgical resection specimens. About TLX250-CDx TLX250-CDx (89Zr-girentuximab) is being developed by Telix for the purpose of determining whether “indeterminate renal masses”, typically identified based on CT or MRI imaging, are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using Positron Emission Tomography (PET) imaging. Girentuximab is a monoclonal antibody that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancers. In July 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer. About Telix Pharmaceuticals Limited Telix is a clinical-stage 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 and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information, please follow Telix on Twitter @TelixPharma and LinkedIn, and visit www.telixpharma.com. Telix’s lead product, Illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA4, and has been granted Priority Review status by the Therapeutic Goods Administration (TGA) in Australia.5 Telix is also progressing marketing authorisation applications for Illuccix® in the European Union6 and Canada.7 None of Telix’s products have currently received a marketing authorisation in any jurisdiction. Telix Corporate Contact Telix Investor RelationsDr. Christian BehrenbruchDr. David N. CadeTelix Pharmaceuticals LimitedTelix Pharmaceuticals LimitedCEO CBO and Head of Investor RelationsEmail: Christian@telixpharma.comEmail: david.cade@telixpharma.com 1 ClinicalTrials.Gov Identifier: NCT03849118.2 City of Hope, Duarte California; Advanced Molecular Imaging and Therapy, Maryland; Barbara Ann Karmanos Cancer Hospital, Detroit; Emory University, Atlanta Georgia; John Hopkins, Baltimore; Washington University, St Louis; Memorial Sloan Kettering, New York City.3 Sir Mortimer B. Davis Jewish General Hospital, Montreal; CHU de Québec-Université Laval, Quebec City; Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Montreal.4 ASX release 24th November 2020.5 ASX release 7th December 2020.6 ASX release 1st May 2020.7 ASX release 16th December 2020.
12 Jan, 2021
ARTMS Inc. (‘ARTMS’) and Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’) are pleased to announce they have successfully produced Telix’s prostate cancer imaging product, TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11)1, using multi-Curie quantities of cyclotron-produced Gallium-68 (68Ga) via ARTMS’ proprietary Quantum Irradiation System (QIS®) solid target system.
30 Nov, 2020
MELBOURNE, Australia and BAAR, Switzerland, Nov. 29, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into an agreement with Scintec Diagnostics GmbH (‘Scintec’) to acquire TheraPharm GmbH (‘TheraPharm’), a Swiss-German biotechnology company developing innovative diagnostic and therapeutic solutions in the field of hematology. The acquisition of TheraPharm provides Telix with access to a portfolio of patents, technologies, production systems, clinical data and know-how in relation to the use of Molecularly Targeted Radiation (MTR) in hematology and immunology. TheraPharm is developing antibody MTR technology against CD66, a cell surface target highly expressed by neutrophils (a type of white blood cell) and tumor-infiltrating lymphocytes. As such, the technology has potentially very broad applications in the diagnosis and treatment of hematologic diseases (e.g. blood cancers), lymphoproliferative disorders and immune-mediated diseases (e.g. lupus, and multiple sclerosis). Of particular interest is the demonstrated use of the technology to safely and effectively perform bone marrow conditioning (BMC) prior to bone marrow stem cell transplant.Telix CEO, Dr. Christian Behrenbruch stated, “Telix is committed to extending and improving the lives of patients with serious diseases. As such, the acquisition of TheraPharm and its MTR assets are uniquely aligned to Telix’s mission and technical strengths in antibody engineering and radiochemistry. TheraPharm’s technology has a significant role to play in BMC and stem cell transplantation across a broad range of blood cancers and rare diseases. The current approach to BMC employs highly toxic drugs that have a poor morbidity and mortality profile, and for which many patients are ineligible. MTR offers an excellent safety profile that may greatly expand the number of patients able to undergo life prolonging stem cell transplantation while greatly reducing the hospitalisation burden and cost associated with such procedures.”TheraPharm co-founder and Managing Director, Dr. Klaus Bosslet added, “Over the past 5 years, TheraPharm, in collaboration with Dr. Kim Orchard from the University of Southampton (UK), has made excellent progress developing 90Y-besilesomab for the treatment of hematologic cancers and several related conditions including multiple myeloma, leukemia and amyloidosis. This unique asset is a logical addition to Telix’s portfolio, offering a potentially rapid development path to a first commercial indication for the treatment of patients with SALA, while at the same time having potentially broad applications for stem cell transplantation in patients with more common cancers of the blood, including multiple myeloma and leukemia. We look forward to joining the Telix team in order to expedite the development of products for this under-served field.”Full transaction details, including financial terms, can be found via the Telix website and ASX portal here.About Hematopoietic Stem Cell Transplant (HSCT)Bone marrow conditioning (BMC) followed by hematopoietic stem cell transplantation (HSCT) is presently performed to treat patients with hematologic malignancies (blood cancers), with the objective of extending patient survival or achieving cure. HSCT is also performed for a broad range of non-cancer conditions. HSCT is preferentially performed in countries of high income (Europe >30,000, Americas >20,000, worldwide >65,000 p.a., respectively) and is growing at around 5% annually.About Systemic Amyloid Light-Chain Amyloidosis (SALA)SALA is a rare, but serious protein deposition disease, caused by a protein known as ‘amyloid’ that is produced by abnormal plasma cells residing in the bone marrow. As amyloid accumulates in the organs of the body, organ function will eventually deteriorate, ultimately causing organ failure. SALA has an estimated prevalence of 30,000 and 45,000 in United States and Europe, respectively and while a rare disease, SALA portends a very poor prognosis, with a median survival from diagnosis of ~11 months if untreated.The current standard of care comprises of induction therapy (typically cyclophosphamide, bortezomib, dexamethasone) plus high dose melphalan BMC, followed by HSCT. This approach is typically only accessible to a small proportion of patients (
02 Nov, 2020
MELBOURNE, Australia and HONG KONG, Nov. 02, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into a strategic licence and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (‘China Grand Pharma’) for Telix’s portfolio of Molecularly-Targeted Radiation (‘MTR’) products. Telix has appointed China Grand Pharma as its exclusive partner for the Greater China market (‘Territory’)1 and grants China Grand Pharma exclusive development and commercialisation rights to Telix’s portfolio of prostate, renal and brain (glioblastoma) cancer imaging and therapeutic MTR products in the Territory.Leveraging off China Grand Pharma’s capabilities and infrastructure in China, Telix will enter a significant oncology market, and by partnering with Telix, China Grand Pharma will build on its pipeline of innovative products for Greater China, as well as its strategy in Nuclear Medicine.   The material terms of the partnership include:Therapeutic Products * US$25M (~AU$35M) up-front non-refundable prepayment to Telix, to be credited against future regulatory and commercial milestone payments. * Up to US$225M (~AU$315M) in regulatory and commercial milestone payments to Telix, across Telix’s existing therapeutic products portfolio. * Program-related investment estimated at up to US$65M (~AU$90M) for clinical costs associated with the development of the therapeutic products in the Territory, to align with Telix’s global clinical development programs. * Royalties on therapeutic product sales in the Territory, in addition to milestone payments. Imaging Products * Exclusive commercial partnership (sales, marketing, distribution) for Telix’s core imaging product portfolio: * TLX250-CDx (89Zr-Girentuximab) for renal cancer, and; * TLX591-CDx (68Ga-PSMA), TLX599-CDx (99Tc-PSMA) for prostate cancer. * Includes minimum annual purchase obligations to maintain Territory exclusivity. Strategic Equity InvestmentAdditionally, China Grand Pharma will make a simultaneous one-time strategic equity investment of US$25M (~AU$35M) in Telix. The investment is in the form of a private placement to China Grand Pharma of 20,947,181 fully paid ordinary Telix shares representing a post-issue holding by China Grand Pharma of 7.62%. Shares will be issued at a price of AU$1.69, based on the 10-day volume-weighted average price (‘VWAP’) for Telix shares up to and including 28th October 2020. Shares will be issued no later than November 06 2020, following receipt of the placement proceeds. Shares issued to China Grand Pharma are subject to a holding lock and will not be able to be traded for a period of 12 months from the date of issue. In addition, China Grand Pharma is subject to a standstill provision and is unable to trade in Telix shares for a period of 12 months.Telix Pharmaceuticals CEO, Dr. Chris Behrenbruch stated, “Telix’s mission is to be a leading global oncology company and China is an important future market for our products. We are pleased to be working with China Grand Pharma to deliver our diagnostic imaging and therapeutic products to cancer patients in China. Considering the successful acquisition of Sirtex Medical Limited with joint venture private equity partner CDH Genetech Limited2 and subsequent approval of a New Drug Application filing for SIR-Spheres® by the National Medical Products Administration (‘NMPA’) of the People’s Republic of China3, we believe that China Grand Pharma possesses the technical experience and execution infrastructure to be an ideal clinical and commercial partner for Telix in China.”China Grand Pharmaceutical and Healthcare Holdings Executive Deputy Officer, Mr. Frank Zhou added, “China Grand Pharma has a strong commitment to oncology, including radioactive products, in China and around the globe. Grand Pharma sees nuclear medicine as the future and has a strategy to build a suite of the world's best products to service the Greater China Region, which includes mainland China, Hong Kong SAR, Macau SAR and Taiwan. We firmly believe in the potential of Telix’s product portfolio to have a significant clinical impact in China. It is an honour for us to have the right to bring Telix's unique product range to our doctors and patients with major unmet medical needs. At the same time, our close clinical involvement will help bring strength to Telix's product development and reach. We are very excited about this long-term partnership.” About the China Opportunity  In China, an estimated 100,000, 70,000 and 35,000 new diagnoses of prostate cancer, renal cancer and glioblastoma, respectively were made in 2018.4 * Prostate cancer: The prevalence of prostate cancer in China is heavily weighted to urban versus rural areas (14/100,000 versus 5/100,000, respectively) and men are first diagnosed with more advanced stage disease compared to their Western counterparts (localised; locally advanced; metastatic: 40%; 30%; 30% versus 84%; 12%; 4% in Chinese versus Western men, respectively).5 Consequently, there is a significant unmet need for effective prostate cancer imaging for the improved diagnosis and staging of prostate cancer in China, as well as more effective systemic therapies to address the high rate of advanced forms of the disease. * Renal cancer: Renal cancer is the third most common urologic cancer, after prostate and bladder cancers in China, and most patients are diagnosed as incidental findings from abdominal imaging.6 Similar to Western countries, there are major unmet needs in China for improvement in diagnosis of renal cell carcinoma (typically the most common and aggressive form of kidney cancer) from otherwise indeterminate renal masses using PET imaging, as well as effective treatments for advanced (metastatic) forms of this disease. * Glioblastoma: The diagnosis of glioblastoma, the most common type of primary brain cancer is typically considered incurable in China. While surgical resection plus radiation therapy are the mainstays of treatment, the vast majority of patients experience disease recurrence. Thus, there remains a major need for therapies targeted towards glioblastoma in patients in both the front-line treatment setting, as well as for patients experiencing disease recurrence following surgical intervention.7  About Telix Pharmaceuticals LimitedTelix is a clinical-stage 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 and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.About China Grand Pharmaceutical and Healthcare HoldingsChina Grand Pharmaceutical and Healthcare Holdings Limited (512.HK) is a diversified global pharmaceutical enterprise, principally engaged in research, development, manufacturing and sales of pharmaceutical products, advanced medical devices, specialized pharmaceutical ingredients, biotechnology products and nutritional products. CGP’s core product portfolio covers several major therapeutic areas including respiratory and ENT, cardiovascular emergency products and advanced medical devices, bio-technology products and nutritional products. The business is structured into four major segments: innovative medicines and medical devices with high barriers of entry; branded drugs; pharmaceutical ingredients and products; and nutritional products. For more information visit www.chinagrandpharm.com.Telix Corporate ContactCGP Corporate Contact    Dr. David N. CadeMr. Chao (Frank) Zhou Telix Pharmaceuticals LimitedChina Grand Pharmaceutical CBO and Head of Investor RelationsExecutive Deputy Officer Email: david.cade@telixpharma.com Email: zhouc@chinagrandinc.com  _________________________________ 1 Territory includes mainland China, Hong Kong SAR, Macau SAR, Taiwan. 2 Source: http://chinagrandpharm.com/history/ 3 Source: http://www.sirtex.com/au/media/news/news-item?id=38760 4 Globocan 2018 http://gco.iarc.fr/today/data/factsheets/populations 5 Chinese guidelines for diagnosis and treatment of prostate cancer 2018 (English version) National Health Commission of the People’s Republic of China. 6 Globocan 2018 http://gco.iarc.fr/today/data/factsheets/populations 7 Chang L, et al. Treating malignant glioma in Chinese patients: update on temozolomide. OncoTargets and Therapy 2014:7 235–244.
22 Oct, 2020
MELBOURNE, Australia and ISTANBUL, Turkey, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) and Eczacıbaşı-Monrol Nuclear Products Co. (‘Eczacıbaşı Monrol’) are pleased to announce that the first patients have been dosed in Telix’s Phase III ZIRCON clinical trial of Telix’s renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Turkey. The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth. Under a contract manufacturing agreement, Eczacıbaşı Monrol will supply 89Zr-labelled TLX250-CDx for the Turkish clinical sites.The ZIRCON trial includes four participating clinical study sites in Turkey, comprising Istanbul Training and Research Hospital, Istanbul University-Cerrahpasa, Ankara Hacettepe University and Ankara University.1Telix Chief Medical Officer, Dr Colin Hayward stated, “We are pleased to have commenced the Phase III ZIRCON clinical trial in Turkey and wish to acknowledge the team at Eczacıbaşı Monrol, as well as the principal investigators and study teams at each of the four institutions participating in the study, who have made this important milestone possible.”Aydın Küçük, General Manager of Eczacıbaşı Monrol added, “As one of our missions is to contribute to the human health, we are very honoured to be part of this significant achievement of the ZIRCON clinical trial initiation in Turkey with the first patients’ doses manufactured at our Istanbul facility, and we are thankful to the Telix team for this great collaboration.”About the ZIRCON Study ZIRCON (“Zirconium Imaging in Renal Cancer Oncology”) is an international multi-centre Phase III study at 33 sites in Europe, Australia, Turkey, Canada and the United States (subject to regulatory approval in the various jurisdictions). ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, to determine the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “ground truth” determined from surgical resection specimens.About TLX250 / TLX250-CDx TLX250 (Girentuximab) is being developed by Telix Pharmaceuticals Limited both as a diagnostic PET imaging agent, 89Zr-Girentuximab (Phase III) and a therapeutic radiopharmaceutical, 177Lu-Girentuximab (Phase II). TLX250 is an antibody-based platform that targets carbonic anhydrase IX (CAIX), a cell surface target that is highly expressed in several human cancers including renal, lung and oesophageal cancer. High CAIX tumour expression is generally correlated with poor prognosis. Telix has prioritised the development of TLX250 for metastatic renal cell carcinoma (RCC), particularly the clear cell variant (ccRCC), which typically over-expresses CAIX.About Telix Pharmaceuticals Limited Telix is a clinical-stage 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 and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, renal and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.About Eczacıbaşı MonrolEczacıbaşı Monrol Nuclear Products Co. is a leading developer, manufacturer and distributor of radiopharmaceutical products in the Balkans, Middle East, North Africa, Central and Eastern Europe. Eczacıbaşı Monrol exports to more than 40 countries worldwide and also has manufacturing sites and operational projects in different regions. The company produces radiopharmaceuticals used for diagnosis and treatment in its seven world-class production facilities with a total of 12 cyclotrons and two SPECT production lines, one SPECT EU release site employing modern and environmentally friendly technologies. Eczacıbaşı Monrol’s facilities are GMP certified, and the Gebze-Turkey, Romania, Bulgaria facilities also have EU GMP certificates. The company also has been operating cyclotrons in Kuwait, Iraq, Libya, Pakistan and has long term operational agreements with two centres in Turkey and one centre in Dubai. Eczacıbaşı Monrol is headquartered in Kavacık (a district of Istanbul, Turkey) and services regional nuclear medicine needs through 300 employees and more than 20 distributors, delivering high quality and customer-oriented service to nuclear medicine centres. For more information visit www.monrol.comTelix Pharmaceuticals ContactEczacıbaşı Monrol Contact Dr. Colin HaywardMr. Aydın Küçük Chief Medical OfficerGeneral Manager Telix PharmaceuticalsEczacıbaşı-Monrol Nuclear Products Co. E: colin.hayward@telixpharma.comE: aydin.kucuk@monrol.com W: www.telixpharma.comW : www.monrol.com.tr     Mrs. Banu Evliyazade Kaptan  Business Development and Projects Director  Eczacıbaşı-Monrol Nuclear Products Co.  E: banu.evliyazade@monrol.com  W : www.monrol.com.tr ______________________ 1 ClinicalTrials.gov Identifier: NCT03849118
24 Sep, 2020
MELBOURNE, Australia and INDIANAPOLIS, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announces it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET).1 Telix’s NDA submission for TLX591-CDx includes clinical data from over 600 patients obtained from both prospective and retrospective clinical studies performed by Telix or in collaboration. The submission also builds on definitive peer-reviewed clinical research conducted at leading academic centres including the University of California, Los Angeles (USA), the Peter MacCallum Cancer Centre (Australia) and Heidelberg University Hospital (Germany).Telix USA President Dr Bernard Lambert stated, “We are pleased to have achieved this significant milestone with the submission of the first commercial NDA for PSMA imaging in the United States. Telix has engaged with the FDA since July 2019, with valuable guidance resulting in what we believe to be a comprehensive submission. Subject to FDA approval, we look forward to bringing this product to market with our commercial partners to serve the needs of men living with prostate cancer.”Telix CEO Dr Christian Behrenbruch added, “Submitting an NDA to the US Food and Drug Administration for our first product is a major commercial inflection point for the Company and follows our European submission earlier this year. The Telix team and our advisors have done an outstanding job of preparing this submission, which we believe is founded on compelling clinical evidence that supports broad diagnostic utility in the management of prostate cancer. I’d like to acknowledge the commitment of our investigators, study teams and the independent physician readers who contributed to our clinical data package.”Telix would like to gratefully acknowledge Eckert & Ziegler AG, IRE ELiT and GE Healthcare, who collaborated closely with Telix to validate both 68Ge/68Ga generator and cyclotron-based 68Ga production systems with TLX591-CDx for the NDA submission. The Company wishes to particularly acknowledge and thank Memorial Sloan Kettering Cancer Center (MSKCC) and Advanced Accelerator Applications (a Novartis Company) for their significant contribution to the NDA submission and their commitment to men’s health.About TLX591-CDx TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11) is a proprietary formulation of PSMA-HBED-CC (PSMA-11), a novel imaging agent targeting prostate-specific membrane antigen (PSMA), originally developed by the Heidelberg group of the Deutsches Krebsforschungszentrum (German Cancer Research Centre, DKFZ).2 The ‘cold kit’ format of TLX591-CDx enables rapid radiolabelling at room temperature with high radiochemical purity and production consistency, optimised for the radiopharmacy setting.About Telix Pharmaceuticals LimitedTelix is a clinical-stage 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 and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.Telix Corporate ContactTelix Investor Relations    Dr Christian BehrenbruchDr David N. Cade Telix Pharmaceuticals LimitedTelix Pharmaceuticals Limited CEOCBO and Head of Investor Relations Email: chris@telixpharma.com Email: david.cade@telixpharma.com 1 TLX591-CDx is not currently approved in any jurisdiction including the United States and European Union. 2 Eder, et al. Bioconjugate Chem Apr 18, 2012; 23(4): 688-97.
03 Sep, 2020
MELBOURNE, Australia and PALO ALTO, Calif., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) today announced it has entered into a strategic collaboration agreement with Palo Alto-based Varian Medical Systems, to evaluate the use of advanced prostate cancer imaging within Varian’s radiation treatment planning platform. Under the terms of the agreement, the parties will leverage Telix’s extensive clinical data for imaging prostate-specific membrane antigen (PSMA) with positron emission tomography (PET) to potentially develop new image-guided treatment planning functions, automated analysis and artificial intelligence capabilities within Varian’s radiation treatment planning technology platforms. The goal of the collaboration is to ensure that the latest standard of care in prostate imaging is able to be an integral part of radiation treatment planning.Telix CEO Dr Christian Behrenbruch said “Advanced prostate imaging techniques using PET/CT have evolved as a new standard of care for imaging patients across the prostate cancer continuum, from early through to the advanced stages of disease.1 Given that radiation therapy is a mainstay of treatment for patients with prostate cancer, we believe it is vitally important that we work with Varian, the radiation oncology market leader, to ensure all men with prostate cancer are offered radiation therapy for maximum clinical benefit.”Dr Corey Zankowski, Senior Vice President of Varian’s Oncology Software Solutions said “The additional diagnostic and cancer staging information provided by PSMA PET/CT imaging may offer important insights that impact clinical care decisions for prostate cancer patients. This collaboration with Telix will investigate the potential to incorporate this rich diagnostic information into Varian’s bioinformatics and radiation treatment planning platforms to generate highly personalized and targeted radiation therapy for men with prostate cancer.”About Prostate CancerProstate cancer is the most common cancer in men, with an estimated 192,000 new cases and 33,000 deaths from prostate cancer in the United States expected in 2020.2 Prostate cancer is more common in older men, with approximately 60% of cases diagnosed in men over 65 years of age. Due to high rates of screening, over 90% of prostate cancers are diagnosed early, when the disease is localised to the prostate or nearby tissues. Both surgery and radiation therapy are effective treatment options for men with localised prostate cancer, offering 5-year survival rates over 95%. More than 60,000 men in the United States undergo radiation therapy for prostate cancer annually,3 with advances in medical imaging and radiation treatment planning continuing to increase the effectiveness and reduce the side effects of radiation therapy.4_____________ 1 Trabulsi EJ, et al. Optimum Imaging Strategies for Advanced Prostate Cancer; ASCO Guideline. J Clin Oncol 38: 1963 – 1996 (published online January 15, 2020). 2 American Cancer Society: https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. 3 Prostate Cancer Foundation: https://www.pcf.org/c/treatment-for-prostate-cancer-external-beam-radiation-therapy/. 4 Garibaldi c, et al. Recent advances in radiation oncology. Ecancermedicalscience. 2017; 11: 85.About Telix Pharmaceuticals Limited Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.About Varian Medical Systems Inc.At Varian, we envision a world without fear of cancer. For more than 70 years, we have developed, built and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year. With an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning and data analytics to enhance cancer treatment and expand access to care. Our 10,000 employees across 70 countries keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com and follow @VarianMedSys on Twitter.Telix Corporate Contact Dr Christian Behrenbruch Telix Pharmaceuticals Limited CEO Email: chris@telixpharma.comTelix Investor Relations Dr David N. Cade Telix Pharmaceuticals Limited CBO and Head of Investor Relations Email: david.cade@telixpharma.com
18 Aug, 2020
TOKYO, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Japan K.K., a wholly-owned subsidiary of Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) is pleased to announce that the first patient has been dosed in a Phase I/II study of Telix’s renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Japan. The objective of the study, termed the “ZIRDAC-JP” (Zirconium Dosing and Comparison in Japan) study is to confirm the safety and tolerability, as well as sensitivity and specificity of positron emission tomography (PET) imaging with TLX250-CDx to detect clear cell renal cell cancer (ccRCC) in Japanese patients. The patient population for the ZIRDAC-JP trial has been selected to be identical to the global Phase III ZIRCON trial, with comparison to surgical resection (histology) as standard of truth. The study has been carefully designed in consultation with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to collect the necessary data to potentially bridge to the ZIRCON study by confirming that dosing and pharmacology in Japanese patients is consistent with the rest-of-world experience.Telix Pharmaceuticals Japan K.K. President, Dr. Shintaro Nishimura stated, “The ZIRDAC-JP study is the first commercially sponsored clinical trial in Japan in which a zirconium-based diagnostic agent has been studied. Dosing the first patient in the ZIRDAC-JP study represents a significant first step for the Japanese nuclear medicine community to deliver benefit to Japanese cancer patients and to pave the way for the future use of theranostics in Japan. We’d like to express our appreciation to Dr Nakaigawa, the study’s principal investigator at Yokohama City University Hospital, the investigators and the study team for their excellent collaboration, and most importantly the patients who will participate in this trial.”Mr. Masahiro Tanaka, Director of the Medical Division of JFE Engineering Corporation stated, “We are very pleased to have contributed to the successful initiation of the ZIRDAC-JP study with the investigational drug manufactured by JFE Engineering at our Yokohama cyclotron facility. Our centralized manufacturing capabilities will provide the patients and medical community with flexible and convenient access to this novel radiopharmaceutical and will provide the pharmaceutical industry with a significant commercial opportunity.”About the ZIRDAC-JP Study ZIRDAC-JP (Zirconium Dosing and Comparison in Japan, NCT04496089) is a Japanese multi-centre Phase I/II study that will recruit approximately 40 patients in total. The objectives of the study are to determine the safety, tolerability, radiation dosimetry and pharmacokinetics / pharmacodynamics (Phase I), and the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) compared to histologic ‘ground truth’ determined from surgical resection specimens (Phase II).About Telix Pharmaceuticals Limited Telix is a clinical-stage 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 and the United States. Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.About JFE Engineering CorporationJFE Engineering is continuing to accelerate the globalization of its engineering business and supply leading-edge technologies to countries around the world. JFE Engineering is committed to creating the foundation for life and a better standard of living through innovation in energy, construction and healthcare. For more information, please visit www.jfe-eng.co.jp.           Telix Japan Contact                                                 Dr. Shintaro Nishimura                                               President & Chief Operating Officer                          Telix Pharmaceuticals Japan K.K.                                                     E: shintaro.nishimura@telixpharma.com                   W: www.telixpharma.com