Sirtex Medical Inc. Half-Year Dose Sales Up 18.7 Percent as SIRFLOX Study Published in Premier Oncology Journal

Americas Region Generates More Than 79 Percent of Global Revenue

WOBURN, Mass.--(BUSINESS WIRE)-- Sirtex Medical Inc., a subsidiary of Sirtex Medical Limited (ASX: SRX), has announced that dose sales of SIR-Spheres® Y-90 resin microspheres in the Americas region grew more than 18 percent for the first half of the company’s fiscal year compared to the corresponding period last year, with 4,027 doses supplied for the period July through December 2015. The gross sales gains in the region equate to $64.5M compared to $54.3M from the previous corresponding period. Globally dose sales for the six months reached 5,728 doses, an increase of 15.7 percent over the previous corresponding period. The financial information was released the same week the company announced that the landmark SIRFLOX study has been published in the premier oncology resource, The Journal of Clinical Oncology.

The Americas continue to remain a key driver for dose sales and revenue growth, contributing 79.4 percent of the global revenue over the reporting period. Sirtex attributes the sustained increase in dose sales to successful efforts by the Americas team to build awareness, education and utilization of SIR-Spheres Y-90 resin microspheres in a challenging environment.

“In terms of treatment algorithms, the metastatic colorectal cancer space is complex and rapidly evolving,” said Mike Mangano, president of Sirtex Medical Inc. “The good news for patients, is that there are many new agents and devices both available and in development. Some of the challenges this brings for both patients and physicians can be the overwhelming amount of new data. In an era of personalized medicine, physician treatment choices are evolving as they discover which treatments should be used, including the proper timing, for each individual patient. The Sirtex Americas team has made significant progress executing against the key strategic initiatives of increasing awareness and education around SIR-Spheres Y-90 resin microspheres, to ensure that physicians and patients have the information they need to make the best decisions. The publication this week of the SIRFLOX study in the preeminent oncology journal is a significant milestone, which we believe will reinforce SIR-Spheres Y-90 resin microspheres as an important tool for physicians and patients in the treatment of metastatic colorectal cancer.”

For more information visit www.Sirtex.com or find the latest updates on the SIR-Spheres Y-90 resin microspheres Facebook page (www.Facebook.com/SIRSpheresmicrospheres).

About 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 health liver tissue. The low specific gravity of Y-90 resin microspheres allows the blood flow to evenly distribute the radioactivity within and around the liver tumors.

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, and several countries in Asia, such as India and Singapore.

About the SIRFLOX Study

The SIRFLOX study was designed to evaluate whether standard-of-care chemotherapy (FOLFOX6m with or without biological therapy with bevacizumab) in combination with SIR-Spheres Y-90 resin microspheres is more effective than chemotherapy alone. The promising results showed a 7.9 month improvement in progression-free survival (PFS) in the liver for patients with unresectable mCRC treated first line with SIR-Spheres Y-90 resin microspheres -- the liver is the organ that the therapy directly targets. This is the first study ever to evaluate PFS in the liver.

SIRFLOX is the first of a group of three studies assessing the results of adding SIR-Spheres Y-90 resin microspheres to first-line chemotherapy in the treatment of mCRC. The other studies are FOXFIRE, a U.K. clinical trial that completed enrolment in November 2014, and FOXFIRE Global, an international study that completed enrolment in January 2015. The results of the three studies, which together enrolled more than 1,100 mCRC patients, will be combined in a pre-planned assessment of the overall survival benefit of adding SIR-Spheres Y-90 resin microspheres to first-line chemotherapy for mCRC. The combined results are expected in 2017.

About Sirtex

Sirtex Medical Limited (ASX: SRX) is an Australian-based global healthcare business working to improve treatment outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. Approximately 55,000 doses have been supplied to treat patients with liver cancer at more than 900 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.

Sirtex Medical Inc., 300 Unicorn Park Drive, Woburn, MA 01801 888.474.7839

©2016 Sirtex Medical Inc.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160224006096/en/

For Sirtex Medical Inc.
Elizabeth Romero, 919-457-0749
[email protected]

Source: Sirtex Medical Inc.

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