Biotech Values

[DewDiligence]

ABT Reports Promising 3-Year Data on Bioabsorbable Stent

[These data come from a single-arm proof of concept study appropriately called ABSORB; the concept of a bioabsorbable drug-eluting stent appears to have been proven insofar as the stents were fully absorbed and the clinical outcomes were impressive to the extent that one can make such a determination in a single-arm study. ABT reported two-year data from the first phase of this study in early 2009 (#msg-36509882), and the three-year data contain no new AE’s or safety signals.

ABT is in the lead in the push to develop a bioabsorbable drug-eluting stent, which has the potential to be safer than DES’ on the market today; the basic idea is that the bioabsorbable stent can’t become a chronic safety risk once it has been fully absorbed and is no longer there! ABT’s bioabsorbable stent uses NVS’ everolimus (a/k/a/ Afinitor), the same drug employed by Xience. The probable launch date for the bioabsorbable stent is 2012 in Europe and 2013-2014 in the US.]

http://finance.yahoo.com/news/Abbott-Announces-Positive-prnews-979732557.html?x=0&.v=1

›New ABSORB EXTEND Trial to Study Performance of Revolutionary Bioabsorbable Device in Approximately 1,000 Patients

3:00 pm EST, Monday November 16, 2009

ORLANDO, Fla., Nov. 16 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today announced three-year data from the first 30 patients in the first phase of the ABSORB clinical trial, demonstrating that its fully bioabsorbable drug eluting coronary stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries. Patients in this first phase of the ABSORB trial experienced no stent thrombosis (blood clots) out to three years and no new major adverse cardiac events (MACE) between six months and three years (3.6 percent at three years). These results were presented at the 2009 American Heart Association's Scientific Sessions.

To build upon the promising results of the ABSORB trial, Abbott is initiating a large-scale trial called ABSORB EXTEND, which will enroll approximately 1,000 patients from up to 100 centers in Europe, Asia Pacific, Canada and Latin America. ABSORB EXTEND is a single-arm study designed to further evaluate the performance of Abbott's proprietary fully bioabsorbable stent technology. The study will enroll patients with more complex coronary artery disease and is slated to begin enrolling before the end of the year.

"Abbott's bioabsorbable stent has the potential to be a major breakthrough for coronary artery disease patients. The data show that patients continue to do well three years after treatment with the bioabsorbable coronary stent," 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 strong results confirm my belief that bioabsorbable technology is the next revolution in interventional cardiology."

Abbott also announced that patient enrollment is complete for the second phase of the ABSORB trial. The second phase of the ABSORB clinical trial enrolled 101 additional patients from 12 centers in Europe, Australia and New Zealand, and incorporated device enhancements designed to improve deliverability and vessel support. [I don’t think ABT has disclosed exactly what these improvements are.]

Abbott is the only company with three-year clinical data evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent. Abbott's bioabsorbable everolimus eluting coronary scaffold is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as absorbable sutures. As with a metallic coronary stent, Abbott's bioabsorbable technology is designed to restore blood flow by propping open a clogged vessel, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable scaffold is designed to be slowly metabolized by the body and is completely absorbed over time.

"Abbott continues to make advancements with its promising bioabsorbable technology," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "The second phase of the ABSORB trial enrolled very quickly, which is a testament to the excitement among the clinical community around the potential shown with this technology. We look forward to starting the ABSORB EXTEND trial to further evaluate promising attributes of our fully bioabsorbable technology in a broader patient population."

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label), two-phase study designed to enroll approximately 130 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety - MACE and stent thrombosis rates - at 30 days; six, nine, 12 and 18 months; and two years, with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent, 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 months, one year and two years.

Abbott's bioabsorbable drug eluting coronary device 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 drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

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.‹