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

WOBURN, Mass.–(BUSINESS WIRE)–Sirtex
Medical Inc., a subsidiary of Sirtex Medical Limited (ASX:SRX), 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 (ASX:SRX) 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.
For more information, visit www.sirtex.com.
SIR-Spheres^® is a registered trademark of Sirtex SIR-Spheres
Pty Ltd.