TOKYO, June 2 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced
that it has submitted an application for Seizo Hanbai Shonin (Marketing
Authorization License) to Japan's Ministry of Health, Labour and Welfare
(MHLW)/ Pharmaceuticals and Medical Devices Agency (PMDA) to gain approval for
its XIENCE(TM) V Everolimus Eluting Coronary Stent System to treat coronary
artery disease. The Shonin application for XIENCE V consisted of safety and
efficacy data from the SPIRIT III clinical trial, including data from a
Japanese patient population. As previously reported, results from the SPIRIT
III U.S. pivotal clinical trial demonstrated the superiority of XIENCE V over
Boston Scientific's TAXUS(R) paclitaxel-eluting coronary stent system in the
primary endpoint of in-segment late loss at eight months.
"Results of the SPIRIT III Japan Registry were very similar with those of
the U.S. randomized clinical trial, which was the first head-to-head clinical
trial to demonstrate the superiority of one drug eluting stent over another
drug eluting stent," said Daniel Estay, divisional vice president, Abbott
Vascular Asia Pacific and Japan. "XIENCE V represents an advancement in drug
eluting stent science and reinforces Abbott's deep commitment to providing
physicians and patients in Japan with leading technologies and products in
cardiac and vascular care."
The XIENCE V stent utilizes everolimus, which has been shown to reduce
tissue proliferation in the coronary vessels following stent implantation, and
is built upon Abbott's MULTI-LINK VISION(R) Coronary Stent System, the world's
market-leading bare metal stent. The VISION platform has a flexible design and
facilitates ease of delivery, making it easier for physicians to maneuver the
stent and treat the diseased portion of the artery.
Abbott's Shonin submission for XIENCE V included data from SPIRIT III, a
large-scale, randomized clinical trial of 1,002 patients conducted in the
United States. The submission also included data from two non-randomized
registry arms: the SPIRIT III Japan Registry of 88 patients and the SPIRIT III
4.0mm Registry of 69 patients conducted in the United States. Key results
include:
* Statistical superiority for XIENCE V compared to TAXUS in the
primary endpoint of in-segment late loss at eight months in the
randomized clinical trial, where XIENCE V demonstrated a
statistically significant 50 percent reduction in late loss compared
to TAXUS (mean, 0.14 mm for XIENCE V vs. 0.28 mm for TAXUS).
In-segment late loss is a measure of vessel re-narrowing.
* Statistical non-inferiority for XIENCE V compared to TAXUS in the
co-primary endpoint of target vessel failure (TVF) at nine months in
the randomized clinical trial, where XIENCE V demonstrated an
observed 20 percent reduction in TVF compared to TAXUS (7.2 percent
for XIENCE V vs. 9.0 percent for TAXUS). TVF is a composite clinical
measure of safety and efficacy outcomes defined as cardiac death,
heart attack (myocardial infarction or MI) or target vessel
revascularization (TVR).
* An observed 43 percent reduction in major adverse cardiac events
(MACE) at nine months (4.6 percent for XIENCE V vs. 8.1 percent for
TAXUS) with XIENCE V compared to TAXUS in the randomized clinical
trial. MACE is an important clinical measure of safety and efficacy
outcomes for patients, defined as cardiac death, heart attack
(myocardial infarction or MI), or ischemia-driven target lesion
revascularization (TLR driven by lack of blood supply).
* Positive results confirming the efficacy and safety of XIENCE V from
the SPIRIT III Japan Registry. The Japan Registry met its primary
endpoint of in-segment late loss at eight months. A full analysis of
the SPIRIT III Japan Registry will be presented later this year.
"The strong, positive data indicate that XIENCE V is a true
next-generation drug eluting stent that combines advanced technology with
outstanding clinical benefits in the treatment of coronary artery disease,"
said Shigeru Saito, M.D., F.A.C.C., F.S.C.A.I., F.J.C.C., director, Cardiology
and Catheterization Laboratories, Shonan Kamakura General Hospital, and
principal investigator for the SPIRIT III Japan Registry.
Additional Long-term Data on XIENCE V
In May 2008, Abbott presented long-term data from the SPIRIT III
randomized clinical trial demonstrating that XIENCE V continues to deliver
clinically superior benefits for patients compared to TAXUS. Consistent with
earlier results, XIENCE V demonstrated a 45 percent reduction in the risk of
major adverse cardiac events (MACE) and a 32 percent reduction in the risk of
target vessel failure (TVF) at two years compared to TAXUS.
XIENCE V also demonstrated a low rate of stent thrombosis between one and
two years, defined as very late stent thrombosis, per Academic Research
Consortium (ARC) definition of definite/probable stent thrombosis and per the
SPIRIT III protocol.
About the SPIRIT III Clinical Trial
SPIRIT III is a prospective, multi-center, randomized, single-blind,
controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669
XIENCE V patients, 333 TAXUS patients) in the United States with either one or
two de novo native coronary artery lesions. The SPIRIT III Japan Registry is a
non-randomized, prospective, multi-center clinical trial of 88 XIENCE V
patients. The SPIRIT III 4.0 mm Registry is a non-randomized, prospective,
multi-center clinical trial of 69 XIENCE V patients conducted in the United
States.
With the SPIRIT III trial, Abbott was one of the first companies to
participate in Harmonization By Doing (HBD), an initiative to promote the
convergence of regulatory requirements, processes and timelines between Japan
and the United States. HBD represents an international collaboration between
Japan's Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical
Devices Agency, the U.S. Food and Drug Administration (FDA), industry,
clinical investigators, investigational sites and academia. By participating
in the HBD process, Abbott was able to evaluate XIENCE V in both Japan and the
United States concurrently in the same clinical trial as opposed to conducting
separate sequential trials in each country.
About XIENCE V
XIENCE V was launched in Europe and other international markets in October
2006. XIENCE V is currently an investigational device in the United States and
Japan, and is under review for approval by the U.S. Food and Drug
Administration (FDA). Abbott expects to gain FDA approval for XIENCE V in the
second quarter of 2008.
Abbott also supplies a private-label version of XIENCE V to Boston
Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System.
PROMUS is designed, studied and manufactured by Abbott and supplied to Boston
Scientific as part of a distribution agreement between the two companies. The
Shonin application also requests approval for PROMUS. Abbott will be the
Marketing Authorization Holder (MAH) for both XIENCE V and PROMUS.
Everolimus is licensed to Abbott by Novartis for use on its drug eluting
stents.
For images of Abbott's XIENCE V stent and other information, please visit
the company's online newsroom at http://www.abbottvascular.com/presskit.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world's leading
vascular care businesses. Abbott Vascular is uniquely focused on advancing the
treatment of vascular disease and improving patient care by combining the
latest medical device innovations with world-class pharmaceuticals, investing
in research and development, and advancing medicine through training and
education. Headquartered in Northern California, Abbott Vascular offers a
comprehensive portfolio of vessel closure, endovascular and coronary products
that are recognized internationally for their safety and effectiveness in
treating patients with vascular disease.
About Abbott
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The company
employs more than 68,000 people and markets its products in more than 130
countries.
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com.
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