For the last two and a half years, Abbott Laboratories has had the only dissolving drug-eluting coronary stent on the market anywhere in the world. But not any more. Last month Elixir Medical obtained European CE mark approval for DESolve, a device which will compete directly with Abbott’s Absorb product.
Now a private company with 2012 revenues of $2m must find a way to compete with a company which could earn ten thousand times that this year. Motasim Sirhan, Elixir’s CEO, tells EP Vantage that while Abbott’s device may have been the first to market, it may not be the best. The firm is “confident that we have a technology that would be best in class in the scaffold arena,” he says.
Both Elixir’s and Abbott’s devices, more properly called scaffolds than stents to reflect their temporary nature, are composed of polylactide, the same material from which dissolving stitches are made. The devices are also similar drugswise: Absorb elutes everolimus, the same antiproliferative used in its market-leading DES, Xience V, and DESolve leaches the related compound novolimus. Elixir’s stent breaks down completely, forming carbon dioxide and water, over the course of a year, but restores a great part of the vessel’s flexibility within six months.
The main advantage these scaffolds have over traditional drug-eluting stents (DESs), most of which are made from steel and all of which remain in the body permanently, is that they vastly lessen the risk of thrombosis. This can persist for three or four years after implantation. In tandem, the scaffolds free patients from having to take blood thinners for this duration.
Since Absorb’s debut on the European market in January 2011, it has taken a share of around 5-10% from metallic DESs – despite being significantly more expensive. Elixir must now make a dent in this same market with much fewer resources than Abbott could bring to bear on the problem.
“We are targeting Q4 [this year] to begin commercialising our scaffold,” Mr Sirhan says. “We’re evaluating different markets in terms of prioritisation for entry.” The company may use different sales strategies in different countries, he explains.
“We are going to be looking at, in certain geographies, using distributors, and in other geographies [sales] will be direct, and in others we’ll be looking at a hybrid structure between direct sales and either our distributors or other ways of distributing our product.”
Mr Sirhan is sanguine about the challenge of competing with Abbott, suggesting that the advantages of drug-eluting scaffolds mean that they could treat patients for whom DESs are unsuitable, thereby growing the market. “We’re happy to have multiple players in the segment in order to push innovation and continue expanding,” he says.
It could also help move the scaffolds from an interesting alternative to DESs to a standard workhorse product. “We believe that this industry will move towards scaffold adoption at a greater rate than it is today, and I think having multiple players is going to be very productive for everyone involved in the industry.”
As for the US market, Abbott will likely get there first too. The pivotal US trial of Absorb, called Absorb III, will compare the device to Abbott’s market-leading metal DES, Xience V. It started late last year and is due to read out in late 2015. Elixir plans to seek FDA permission next year to begin its pivotal US trial.
Elixir may have taken the silver medal, but considering the company’s size, its achievement is perhaps greater than Abbott’s. The next event will be less of a race and more of a wrestling match for European market share.
|Trial name||Trial ID|