Biotech Values

[DewDiligence]

ABT’s ABSORB stent meets primary endpoint in US/Chinese phase-3 trials:

http://abbott.mediaroom.com/2015-10-12-Abbott-Announces-Positive-Clinical-Results-of-Absorb-the-Naturally-Dissolving-Heart-Stent#assets_111

Abbott announced today positive one-year clinical results from the ABSORB III trial, which compared the safety and effectiveness of Abbott's fully dissolving Absorb heart stent to XIENCE, Abbott's market-leading, metallic drug eluting stent. The trial was conducted at 193 sites, primarily in the United States, and enrolled about 2,000 people with coronary artery disease, the most common type of heart disease.

The results, which showed that ABSORB III met its primary endpoint and will be used to support regulatory approval of Absorb in the U.S., were featured today during a late-breaking session at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation. In addition, the study results were published simultaneously in The New England Journal of Medicine.

…Key findings of ABSORB III…are as follows:

• A primary endpoint of target lesion failure (TLF) of 7.8 percent for Absorb and 6.1 percent for XIENCE (non-inferiority p<0.007).
• All pre-specified secondary endpoint results were not statistically different [i.e. what you want in a NI trial].
• There was no statistically significant difference in the rate of definite and/or probable stent thrombosis (ST).

…Abbott also presented positive one-year results from ABSORB China, a prospective, randomized, single-blinded, controlled trial that compared Absorb to XIENCE to support Absorb approval in China. The trial met its non-inferiority primary endpoint of in-segment late loss at one year, with Absorb at 0.19±0.38 mm and XIENCE at 0.13 ±0.38 mm (p non-inferiority=0.01). The trial enrolled 480 people at 24 sites throughout mainland China. The results were published simultaneously in the Journal of the American College of Cardiology.

ABSORB is already on the market in most major countries except the US and China. With the likely approval in the US and China based on the above data, ABSORB will move the needle materially in ABT’s medical-device business.