$9.78 Billion ($39.9B total)
Miles D. White, Chairman & CEO
Thomas C. Freyman, Exec. VP of Finance & Chief Financial Officer
John M. Capek, Ph.D., Exec. VP, Medical Devices
Brian J. Blaser, Exec. VP, Diagnostic Products
Charles D. Foltz, VP, Vascular Products Operations
Heather L. Mason, Sr. VP, Diabetes Care
Murthy V. Simhambhatla, Sr. VP, Medical Optics
Kathryn S. Collins, VP, Chief Ethics and Compliance Officer
NO. OF EMPLOYEES: 92,938 (total)
GLOBAL HEADQUARTERS: Abbott Park, Ill.
Fiscal 2012 (ended Dec. 31) was a year of transition for Abbott Laboratories Inc. The 125-year-old firm announced in 2011 that it was splitting into two publicly traded companies, separating the medical products business from its research-based pharmaceutical arm. Last year, the firm went about the business of disconnecting the two halves, with January 2013 as the official “start” date for the newly reconfigured entities.
In March last year, as part of the groundwork laid for the transformation, the name of the spinoff was revealed: AbbVie, pronounced “abb-vee.”
The name is derived from a combination of Abbott and “vie,” which references the Latin root vi, which means life. AbbVie includes Abbott’s former portfolio of proprietary pharmaceuticals and biologics. Abbott retained the branded generic pharmaceutical, devices (including vascular and optics), diagnostics and nutritional businesses.
Miles D. White remains chairman and CEO of Abbott, and Richard A. Gonzalez, formerly executive vice president of Abbott’s Global Pharmaceuticals unit, became chairman and CEO of AbbVie
With a company as large and diverse as Abbott, there’s always a lot to talk about. But on the device side of the house in 2012, the company’s vascular device business was a standout for a few reasons. While the division’s sales were off compared to 2011 (and those woes continue into 2013), the new product rollouts were prolific.
In September, the company launched Absorb in Europe, as well as in parts of Asia and Latin America. Abbott claims it is the first drug-eluting bioresorbable vascular stent, or as the company calls it, a “scaffold,” creating the image of something that is disassembled over time. It is not yet available in the United States. Absorb works by restoring blood flow to the heart similar to a metallic stent, but then dissolves into the body, leaving behind a treated vessel that may resume more natural function and movement because it is free of a permanent metallic stent. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.
The potential long-term benefits of a scaffold that dissolves are significant, according to physicians and analysts. The vessel may expand and contract as needed to increase the flow of blood to the heart in response to normal activities such as exercising; treatment and diagnostic options are broadened; the need for long-term treatment with anti-clotting medications may be reduced; and future interventions would be unobstructed by a permanent implant.
Abbott ran five clinical trials in more than 20 countries around the world. Study data indicate that Absorb performs similar to a best-in-class drug eluting stent across traditional measures such as major adverse cardiovascular events and target lesion revascularization, while providing patients with the added benefits associated with a device that dissolves over time. As the Absorb scaffold dissolves, vascular function potentially is restored to the blood vessel, allowing more blood to flow through the vessel as the body requires.
In the first quarter of 2013, however, Abbott’s sales of medical devices fell 4.6 percent to $1.33 billion, with revenue from stents and related vascular products down almost 8 percent to $742 million, due largely to price pressures in the United States. Innovation is possibly the way out of this predicament and the dissolvable stent, analysts claim, could help. Absorb has competition now, however—Elixir Medical’s DESolve and Boston Scientific’s Synergy, both of which are CE marked, are gaining traction on the back of positive study data.
August saw the rollout of two more vascular products.
The Xience Xpedition everolimus-eluting coronary stent received CE mark in Europe for the treatment of coronary artery disease. Xience Xpedition features a new stent delivery system designed to optimize acute performance, particularly in challenging coronary anatomies. According to the company, the Xience family of stents has one of the broadest ranges of CE mark indications of drug eluting stents on the market in Europe. Specifically, Xpedition has indications to treat patients with complex disease such as diabetes, as well as an indication for a minimum duration of three months of dual anti-platelet therapy (DAPT). This indication represents an important advantage, as three months of DAPT is the shortest duration required for any major drug eluting stent offered in Europe. Long-term compliance to DAPT can be a challenge for patients and can lead to additional safety risks such as increased bleeding events. In addition, having a shorter DAPT duration after stent implantation may be beneficial in case a patient needs to interrupt or discontinue the medication prior to surgery or for other considerations. The stent is available in diameters ranging from 2.25 mm to 4 mm, including a unique 3.25 mm diameter, and lengths from 8 mm to 38 mm.
Also in August, the company received U.S. Food and Drug Administration (FDA) approval of the Omnilink Elite vascular balloon-expandable stent system for the treatment of iliac artery disease, a form of peripheral artery disease (PAD) that affects the lower extremities. Iliac artery disease can progress to where patients experience chronic pain and reduced ability to walk, potentially leading to permanent disability. The Omnilink stent uses a next-generation cobalt chromium alloy, which is stronger and more radiopaque than stainless steel, making the stent easy to see under X-ray while maintaining thin, flexible struts, the company said. Omnilink Elite adds to Abbott’s U.S. portfolio of endovascular products for the treatment of PAD, including balloon dilatation catheters to treat blockages in the lower extremities and vascular stents to open blocked kidney and carotid arteries.
Peripheral artery disease affects approximately 8 million to 12 million people in the United States and occurs when the blood vessels outside of the heart become narrowed with plaque, fatty deposits that build up within the vessels, according to data published the American Heart Association’s Circulation journal. While PAD is most commonly seen in the legs, blockages also can occur in the vessels that carry blood to the head, arms, kidneys and stomach.
Aortoiliac occlusive disease, more commonly known as iliac artery disease, occurs when the iliac arteries become narrowed with plaque, resulting in reduced blood flow to the lower limbs. Iliac artery disease is a type of PAD. While PAD refers to all of the arteries outside of the heart, iliac artery disease refers specifically to the arteries that start in the mid-abdomen—where the body’s main artery (the aorta) splits into branches that descend through the pelvis into the legs.
Earlier in the year, the FDA approved the Absolute Pro vascular self-expanding stent—another system for the treatment of iliac artery disease. Absolute Pro is a self-expanding nitinol stent system made of a flexible material designed to allow the stent to conform to challenging lesions. It incorporates advanced technologies for optimal stent visibility, with a delivery system that is designed to minimize friction during stent deployment and ensure precise stent placement at the lesion site, according to the company. As with the Omnilink Elite, FDA approval was supported by results of the Absolute Pro arm of company’s MOBILITY trial, a prospective, non-randomized, two-arm, multi-center study.
In April 2012, Abbott received approval from Japan’s Ministry of Health, Labor and Welfare for the Xience Prime drug-eluting coronary stent for the treatment of coronary artery disease. Xience Prime, which uses the same drug and biocompatible polymer as the Xience V stent system, features an enhanced stent design and a delivery system designed for greater flexibility, ideal radial strength, excellent longitudinal strength and more accurate stent placement, according to the company. Japan’s approval meant the stent is approved for use in all major markets worldwide.
The Xience family of stents has been studied in more than 100 trials in more than 45,000 patients.
Xience Prime received CE mark in 2009 and FDA approval in 2011.
Another noteworthy product approval—while not part of the company’s vascular group—targets the growing diabetes market. In March, the FDA cleared the FreeStyle InsuLinx blood glucose monitoring system, the first from Abbott to include a touch-screen interface, automated logbook and personalization features designed to improve the diabetes management experience for patients. The device is equipped with built-in software that allows patients to track progress, analyze trends and easily display data for healthcare providers. According to the American Diabetes Association, approximately 25.8 million people in the United States have diabetes, and of those, many require insulin to manage their condition.
By the numbers for fiscal 2012, the company’s medical device-based sales were $9.79 billion, comprising sales of core laboratory diagnostics ($3.5 billion, up 3.4 percent from 2011); molecular diagnostics ($445 million, up 0.5 percent); point-of-care diagnostics (348 million, up 15.7 percent); vascular technology ($3.1 billion, down 7.9 percent); diabetes care ($1.33 billion, down 2.8 percent); and medical optics ($1.1 billion, down 1.3 percent). The company attributed the slide in vascular sales to “market dynamics” and a slowdown compared to 2011, when Xience Prime was launched, though sales of the Xience stent line increased 2.7 percent for the year, totaling $1.6 billion. The company overall did $39.9 billion in sales, up 2.6 percent compared with fiscal 2011. The company’s sectors with the largest growth were point-of-care diagnostics and nutritionals. Net earnings for the company overall were healthy, up 26.1 percent to $5.96 billion.