Healthcare Industry News:  Abbott Vascular 

Devices Interventional Cardiology Regulatory

 News Release - June 2, 2008

Abbott Submits Application for Approval of XIENCE(TM) V Everolimus Eluting Coronary Stent System in Japan

Japan Submission Includes Clinical Data Demonstrating Superiority of XIENCE V Compared to TAXUS(R) Drug Eluting Stent

TOKYO, June 2 (HSMN NewsFeed) -- 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® 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® 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.


Source: Abbott

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