Biotech Values

[DewDiligence]

ABT Reports Additional Safety Data on Bioresorbable Stent

[ABT prefers the term, “bioresorbable” to the older term, “bioabsorbable,” but they mean the same thing: the stent disappears after it has done its job in remodeling the diseased vessel. ABT’s bioresorbable stent, called BVS, elutes NVS’ everolimus, the same drug eluted by Xience. BVS is miles ahead of similar programs from other companies, and it has a bona fide chance to be big-selling product, IMO. (See #msg-36292361 and #msg-32869939 for background.)

The data reported here are for the second cohort in the aptly-named ABSORB trial, consisting of 101 of the total 131 patients in the trial; these 101 patients were treated with a stent that was tweaked slightly relative to the version used by the first cohort of 30 patents. Solid 3-year data for the first cohort of 30 patients were reported in Nov 2009 (#msg-43664045); the 30-day data reported today for the second cohort suggest that the tweaks made by ABT have not adversely affected the stent’s performance.]

http://finance.yahoo.com/news/Abbott-Announces-Positive-prnews-4152083548.html?x=0&.v=1

›New Data From Second Phase Shows No Blood Clots, No Repeat Procedures and Very Low MACE in Patients Treated with Abbott's Innovative Device

Monday March 15, 2010, 7:30 am

ATLANTA, March 15 /PRNewswire-FirstCall/ -- Abbott (NYSE:ABT) today announced positive 30-day results from the first 101 patients enrolled in the second phase of the ABSORB trial. Patients treated with Abbott's bioresorbable vascular scaffold (BVS), under clinical investigation in Europe, demonstrated no cases of blood clots (thrombosis), no need for repeat procedures (ischemia-driven target lesion revascularization) and a very low rate of major adverse cardiac events (MACE(1) rate of 2.0 percent) at 30 days. These results build on the long-term success Abbott has seen with the BVS technology in the first phase of the ABSORB trial, which has generated positive data on 30 patients out to three years. Data from the second phase of the trial was presented at the American College of Cardiology's 59th annual scientific session in Atlanta.

"The positive 30-day results reaffirm my belief that a device that bioresorbs, or disappears, into the body after restoring blood flow is the next logical step in the treatment of cardiovascular disease," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. "The continuing positive results of the ABSORB trial and the clinical benefits demonstrated to date by Abbott's bioresorbable technology show promise that a bioresorbable scaffold is on its way to becoming a clinical reality and will be the next revolution in interventional cardiology."

This second phase of the ABSORB clinical trial (Cohort B) enrolled 101 patients from 12 centers in Europe, Australia and New Zealand, and incorporates device enhancements designed to improve deliverability and vessel support. Abbott is the only company with long-term, three-year clinical data on a complete patient set evaluating the safety and performance of a fully bioresorbable drug eluting scaffold.

"The encouraging 30-day results show that Abbott's BVS is able to restore blood flow with no cases of blood clots or repeat procedure, suggesting that there could be important clinical benefits for patients," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "If Abbott's bioresorbable technology continues to perform well in clinical trials, it has the potential to become the new standard of care for patients with coronary artery disease."

Abbott's investigational BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized by the body, and is completely dissolved over time. Since a permanent implant is not left behind, a vessel treated with BVS has the ability to ultimately move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration therapy, is what makes Abbott's BVS unique in the field of cardiology.

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and treated site thrombosis rates – at 30 days; six, nine, 12, 18 and 24 months; with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18 and 24 months.

Abbott's bioresorbable technology delivers everolimus, a drug that inhibits tissue proliferation. Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its vascular devices. Everolimus has been shown to inhibit treated site neointimal growth in the coronary vessels following vascular device implantation, due to its anti-proliferative properties.‹