Healthcare Industry News:  Y-90 resin microspheres 

Devices Oncology

 News Release - August 25, 2016

Sirtex Medical Inc. Announces 19 Percent Dose Sales Growth of SIR-Spheres(R) Y-90 resin microspheres in Fiscal Year 2016

WOBURN, Mass.--(Healthcare Sales & Marketing Network)--Sirtex Medical Inc., a subsidiary of Sirtex Medical Limited (SRX.AX), a leading manufacturer of targeted liver cancer therapies, today announced dose sales of SIR-Spheres® Y-90 resin microspheres grew 19 percent in the Americas region for the fiscal year ending June 30, 2016, compared to the previous corresponding period. Revenue climbed to $134.8M, with more than 8,420 doses being supplied across the region. SIR-spheres Y-90 resin microspheres are available at more than 550 hospitals in the region, up 14 percent from the previous fiscal year.

“The Americas region continues to perform strongly, which is directly reflected through the outstanding sales results achieved in this challenging market,” said Kevin Richardson, CEO Americas, Sirtex Medical Inc. “We continue to execute against our strategic initiatives and have made significant progress during this period in the U.S. market by continuing to increase the awareness and education about SIR-Spheres Y-90 resin microspheres therapy within the oncology community. We have also made substantial inroads in our other markets including the recent approval of SIR-Spheres Y-90 resin microspheres for the treatment of unresectable liver tumors in Canada and continued market development activities with key opinion leaders in Latin America.”

Gilman Wong, CEO of Sirtex Medical, commented, “The strong financial performance in fiscal year 2016 reflects the continued execution of our strategies that seek to expand our global footprint, build clinician awareness and referrals, and increase reimbursement coverage for patients suffering from liver cancer.”

Sirtex continues to generate and present additional Level 1 clinical data from the SIRFLOX study, which was first presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2015. More recently, the company released supplemental data further supporting the enduring effect that SIR-Spheres Y-90 resin microspheres can provide to patients when combined with chemotherapy.

“Sirtex is focused on educating the many medical professionals in the Americas region to support improved clinical outcomes for patients facing liver tumors resulting from metastatic colorectal cancer, as well as extending relevant information and education directly to patients in the U.S. market,” continued Richardson. “We are now in a position where our teams can fully discuss the SIRFLOX data with our customers. Looking forward, we eagerly await the overall survival data from the combined FOXFIRE, FOXFIRE Global and SIRFLOX studies, in 2017, representing more than 1,100 patients.”

The Americas region remains a key driver for dose sales and revenue growth globally, currently representing 70.6 percent of the company’s dose sales and 79.7 percent of revenue. Dose sales in Europe, Middle East and Africa (EMEA) of 2,528 units were up 11.2 percent compared to the same period last year, with revenues growing 20 percent. Dose sales in the Asia Pacific (APAC) region of 983 units increased 8.9 percent compared to the same period last year with revenue growth of 20.9 percent.

Sirtex’s two main Phase III studies in primary liver cancer, SARAH and SIRveNIB, completed patient recruitment by the end of the 2016 financial year. The results of these studies are expected in the first half of calendar year 2017.

About Selective Internal Radiation Therapy using SIR-Spheres® Y-90 resin microspheres

SIR-Spheres® Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as selective internal radiation therapy (SIRT), or radioembolization, which targets high doses of radiation directly to liver tumors. The treatment consists of tens of millions of radioactive Y-90 coated resin particles, each no bigger in diameter than a human hair. Interventional radiologists inject these resin particles, or microspheres, into the hepatic artery via a catheter inserted into the femoral artery through an incision in the groin. The Y-90 resin microspheres become lodged in the capillaries that surround liver tumors, where they deliver a high dose of short-range (mean 2.5 mm; maximum 11 mm) beta radiation to the liver tumors, while sparing healthy liver tissue. The low specific gravity of the Y-90 resin microspheres allows the blood flow to evenly distribute the radioactivity within and around the liver tumors.

Available at more than 550 treatment centers in the U.S., more than 67,000 doses of SIR-Spheres Y-90 resin microspheres have been supplied worldwide.

SIR-Spheres Y-90 resin microspheres have a Premarket Approval (PMA) by the FDA and are indicated for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intra-hepatic 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 Sirtex

Sirtex Medical Limited (SRX.AX) is an Australian-based global healthcare business 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 67,000 doses have been supplied to treat patients with liver cancer at more than 1,000 medical centers in over 40 countries.

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

Source: Sirtex Medical

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