Sirtex Medical reaches milestone 100,000th patient dose delivery of SIR-Spheres® Y-90 resin microspheres

Physicians and employees recognized for their role in this milestone and impact made on patient lives

WOBURN,Massachusetts,June 24,2019 --Sirtex Medical,a leading manufacturer of targeted liver cancer therapies,today announced delivery of the 100,000th patient dose of SIR-Spheres® Y-90 resin microspheres,a treatment for patients with liver cancer.* More than 1,000 healthcare providers and hospital systems across the globe offer this treatment.

"This milestone would not have been possible without the support of healthcare professionals around the world,along with Sirtex's significant investment in our Interventional Oncology clinical program. We are also very proud to have such dedicated employees who place patients first and are focused on achieving excellence in their effort to improve the quality and longevity of patients' lives," said Kevin Smith,interim CEO of Sirtex. "However,this is the first of many milestones as we continually strive to develop new ways to improve the delivery of SIR-Spheres Y-90 resin microspheres and advance the standard of care."

Since the company's creation,Sirtex has been committed to providing best-in-class training,support and education to the multi-disciplinary teams caring for patients with liver cancer to ensure those who will benefit the most from internal radiation therapy have access to treatment and care. Reaching the 100,000th dose mark is a recognition of efforts worldwide to expand the reach of liver-directed treatment with SIR-Spheres Y-90 resin microspheres therapy.

"Clinical research has long shown the benefits of Selective Internal Radiation Therapy (SIRT) with SIR-Spheres Y-90 resin microspheres for patients with colorectal liver metastases in the United States. This minimally invasive procedure is designed to control liver tumors,while being well-tolerated and maintaining patients' quality of life1,2,"said Dr. Charles Nutting,a leading Board-Certified,Fellowship-Trained Interventional Radiologist at Minimally Invasive Treatment Specialists in Colorado where he focuses on liver-directed cancer therapies. In 2002,Dr. Nutting was the first physician to administer SIR-Spheres Y-90 resin microspheres in the U.S. "I'm honored and excited to continue a partnership with Sirtex to provide this treatment to U.S. patients."

Professor Thomas Helmberger,Chairman of the Department of Radiology,Neuroradiology and Nuclear Medicine at Klinikum Bogenhausen in Munich,Germany,performed the first SIRT in Europe,the Middle East and Africa with SIR-Spheres Y-90 resin microspheres back in 2002. "This is a viable treatment option that I encourage patients to consider as part of their plan of care," said Pr. Helmberger. "I'm proud to join Sirtex and the medical community in celebrating this important milestone."

Professor Guy van Hazel,Medical Oncologist at Mount Hospital in West Perth and Clinical Professor of Medicine at the School of Medicine and Pharmacology at the University of Western Australia,was part of the early development of SIR-Spheres Y-90 resin microspheres. He comments,"This is an important treatment option for my patients and a milestone I'm glad to be a part of."

*In the United States,SIR-Spheres Y-90 resin microspheres received Premarket Approval (PMA) from the FDA and are indicated for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intrahepatic artery chemotherapy using floxuridine. SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumors in Australia,the European Union,Argentina,Brazil,Canada and several countries in Asia,such as India and Singapore.

About Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres

SIR-Spheres Y-90 resin microspheres is a prescription device for the treatment of inoperable liver tumors. It is a minimally invasive treatment that delivers high doses of high-energy beta radiation directly to the tumors. SIRT is administered to patients by interventional radiologists,who infuse millions of radioactive resin microspheres via a catheter into the liver arteries that supply blood to the tumors. By using the tumors' blood supply,the microspheres selectively target liver tumors with a dose of radiation that is up to 40 times higher than conventional radiotherapy,while sparing healthy tissue.

About Sirtex

Sirtex Medical is a global healthcare business with offices in the U.S.,Australia,Germany and Singapore,working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,000 medical centers in over 40 countries. For more information,visit www.sirtex.com.

SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd.

References

1 Kennedy A.,Cohn M.,Coldwell D.M. et al. (2017). "Updated survival outcomes and analysis of long-term survivors from the MORE study on safety and efficacy of radioembolization in patients with unresectable colorectal cancer liver metastases," Journal of Gastrointestinal Oncology. 8(4): 614-624. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5582033/,accessed 06/05/2019.

2Cosimelli M.,Golfieri R.,Cagol P.P. et al (2010). "Multi-centre phase II clinical trial of yttrium-90 resin microspheres alone in unresectable,chemotherapy refractory colorectal liver metastases," British Journal of Cancer. 103(3): 324–331. Available from: https://www.ncbi.nlm.nih.gov/pubmed/20628388,accessed 06/07/2019.

DOC ID:196-EUA-0619

Logo- http://cusmail.com/res/2023/07-22/18/c0a166e0da68ecc51f2d3a9706484fcd.jpg