OUTSTANDING OEM: ABBOTT LABORATORIES
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Despite recent concerns about drug-eluting stents (DES), Abbott Laboratories’ Xience V has received a warm welcome. Within three months of earning FDA approval, the next-generation stent became the market-leading DES. This accomplishment, coupled with the overall growth of Abbott, has prompted MD&DI to select Abbott as an Outstanding OEM for 2008.
Getting to the Heart of the Problem
Xience V treats coronary artery disease by propping open an artery and releasing the drug everolimus. John Capek, PhD, executive vice president of Abbott’s medical devices businesses, says that the company began working on the building blocks for Xience V in the mid-1990s, selecting the appropriate drug and polymer. In 2006, Abbott already had clinical trials of Xience V under way when fears surfaced about a connection between DES and a late onset of thrombosis—a clot in a patient’s blood vessel.
Thrombosis concerns crippled some stent manufacturers. The use of DES in hospitals declined over the last year, and companies such as Johnson & Johnson and Boston Scientific reported a drop in sales. But Capek says that the issue didn’t alter Abbott’s development of Xience V because the risk had always been on the company’s radar.
“Thrombosis occurs even with bare-metal stents,” Capek explains. As a result, Abbott had been experimenting with its bare-metal stents for more than a decade, pushing for what Capek calls a “vessel-friendly stent configuration.” It’s a configuration that the company says it has achieved by building Xience V on its Multi-Link Vision system, Abbott’s most successful bare-metal stent platform.
Data Drive Sales
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In the Spirit III clinical trial, Xience V demonstrated a 0.3% rate of very late stent thrombosis. A competitor’s first-generation stent was also tested in the study and showed a rate of 1%. Capek is pleased with the results but noted that larger postmarket studies are under way to assess the risk of thrombosis in a broader patient population.
In the same study, Xience V also bested the competing stent in the endpoint of major adverse cardiac events (MACE). Abbott’s stent showed a 45% reduction in the risk of MACE over the last two years when compared with a competitor’s first-generation product.
With such data, it’s easy to understand why Xience V is selling so well. FDA approved the stent in July 2008. By the third quarter of the year, the product became the market leader. Sales include a private-label version of Xience V called Promus, which is sold by Boston Scientific through a profit-sharing agreement between the two manufacturers. Major hospitals such as the Cleveland Clinic are among the institutions that have made the new stent available to its cardiologists.
A Well-Rounded Company
Abbott’s financial strength isn’t limited to its vascular products. The company reported total sales of more than $7 billion for Q3 2008, which represents a 17.6% increase from last year.
Among the company’s star performers is its diagnostics division. After a planned General Electric buyout of its core diagnostics business fell through in 2007, the company made a dynamic turnaround. Global diagnostics sales were up more than 15% for Q3 2008. Additionally, the diabetes care division made strides, earning FDA approval this year for its Freestyle Navigator continuous glucose monitoring system.
Capek credits Abbott CEO Miles White for much of the company’s success. He says White has diversified the firm over the last 10 years and has created opportunities for broad growth both in the United States and internationally.
Challenges
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Xience V expanded. (Image courtesy of Abbott.) |
Like most manufacturers, Abbott is not without its problems. The company, along with Johnson & Johnson and Boston Scientific, is the subject of an FDA inquiry. The agency is investigating whether biliary stents, which are approved only to clear bile ducts in liver cancer patients, were promoted by the three companies for off-label use. Abbott says that it is cooperating with the investigation.
Two senators also want to know more about the stent maker’s practices. Charles Grassley (R–IA) and Herb Kohl (D¬–WI) recently sent a letter to the Cardiovascular Research Foundation requesting information about its financial relationship with Abbott Laboratories and four other companies. Abbott says that it is working to provide information for the request. A company representative also noted that Abbott fully supports the Physician Payments Sunshine Act. The legislation, which is sponsored by the two senators, promotes the transparency of relationships between the medical device industry and the healthcare profession.
Staying Competitive
Abbott hopes to maintain the growth it has achieved by staying focused on innovation. “In vascular, clearly we’re not sitting still with Xience,” Capek says. “We continue to see opportunities with the drug-eluting stent pipeline to advance with next-generation technology, and are currently working on more flexible, more deliverable, and more lesion-specific stent designs.”
Abbott currently has a trial under way for a fully bioabsorbable DES called Absorb. It’s the only company to implant such a stent into patients’ coronary arteries. While the benefits have not yet been proved, Capek says that Absorb, which virtually disappears after two years, could allow a patient’s vessel to return to a more natural state. This would make it possible to image the vessel without the obstruction of metal. It would also allow patients to undergo subsequent surgical procedures that aren’t limited by the stent being in place.
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Xience V inside a vessel. (Image courtesy of Abbott.) |
Abbott is also excited about another first-in-human clinical trial. Its Strides trial is testing whether vascular technology has applications outside of the coronary arteries. The company has implanted a DES into the superficial femoral artery of patients suffering from peripheral artery disease. Abbott expects to present the results of the trial in October 2009.
When it comes to diagnostics, Ed Michael, executive vice president of Abbott’s diagnostics businesses, says that the company plans to reduce costs and improve efficiencies by streamlining global manufacturing operations and shifting some production to European plants. Michael also says that the company will continue to invest in technologies that support its businesses. Earlier this year, Abbott invested in Ibis Biosciences, a company that offers DNA-based technology.
Over the long term, Abbott sees the need to bring its growing businesses together to offer patients more advanced care. Citing how the construction of a DES requires medical technology, pharmaceutical, and pharmacological expertise, Capek says that he envisions increased collaboration among divisions as the company continues to develop drug-device combinations.
Being a giant company gives Abbott obvious advantages over other manufacturers, but it doesn’t shelter the company from the huge concerns about the safety of DES. Superior clinical results were required to arouse cardiologists’ interest in a device they had grown to doubt, and that is exactly what Abbott has delivered so far with Xience V. With its new stent technology, first-in-human clinical trials, and revived diagnostics division, Abbott is proving that big ideas are just as important as company size.
