Abbott Laboratories (ABT) announced that it has completed enrollment of three clinical trials on Absorb, a drug-eluting coronary bioresorbable vascular scaffold (:BVS) device.
The ABSORB III trial (n=2000) will evaluate the potential benefits of Absorb in people with coronary artery disease in the U.S. The trials are being conducted to support approvals of Absorb in the U.S, Japan and China.
The primary endpoint of ABSORB III trial is target lesion failure (TLF), a combined measure of the safety and effectiveness of Absorb versus Xience family of drug eluting stents at the end of first year. The trials in Japan and China also have the same primary endpoint.
The vascular portfolio of Abbott Labs has drug eluting stents such as the Xience series and Absorb. We note that Absorb already has a marketing approval in Europe and is available in more than 60 countries around the world.
We are encouraged by the recent positive updates on Abbott Labs' vascular portfolio. In Mar 2014, the U.S. Food and Drug Administration (:FDA) approved Abbott Labs' Supera peripheral stent system for the treatment of people with blocked blood vessels in the upper leg caused by peripheral artery disease (PAD.V). Abbott Labs' acquired Supera stent through the acquisition of IDEV Technologies in Aug 2013.
Abbott Labs is continuously working to boost its vascular products portfolio and expects to launch several products in the next few years. The vascular business is an important part of Abbott Labs’ product portfolio and generated sales of $3.0 billion in 2013, down 1.5% from 2012.
The continued rollout of Absorb and Xience Xpedition along with new products such as Supera stents will strengthen Abbott Labs’ vascular portfolio in 2014. We note that China, Japan and the U.S. together account for more than 50% of the world's heart stent market.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. (ABBV), in Jan 2013.
The business environment was challenging in 2013 due to austerity measures undertaken by developed markets and weak economic conditions elsewhere. We believe Abbott Labs’ diversification in varied business lines will enable the company to counter the challenging business environment and maintain top-line growth.