2nd UPDATE: J&J Bets On New Stent, Taking On Abbott Device
16 Mars 2009 - 7:30PM
Dow Jones News
Johnson & Johnson (JNJ) is placing bets on a new
drug-releasing stent it hopes will vault the company back atop the
$4 billion market for the tiny heart devices while it cancels plans
for a different stent with more muted prospects.
The company is a stent-market pioneer but has seen its position
drop sharply thanks to the rise of newer devices, especially a
stent made by Abbott Laboratories (ABT) called Xience. In a show of
support for a still-unproven device called Nevo, J&J's Cordis
stent subsidiary will take on Xience in a big new study.
The randomized, 2,000-patient international study will pit Nevo,
which is still being researched and isn't on sale anywhere, against
what has become the top-selling stent in both Europe and the U.S.
Cordis is replacing a just-started, non-randomized study on Nevo
while saying it has a strong enough impression thus far to
challenge a popular product.
The new study will help support an eventual U.S. regulatory
filing. The beginning and end dates aren't yet set, but Cordis will
know more after it meets with regulatory agencies to finalize the
study design.
The move has risks, as Abbott's stent demonstrated its mettle by
besting a blockbuster device from Boston Scientific Corp. (BSX) in
a key study.
Campbell Rogers, the chief scientific officer at Cordis, called
Xience a "formidable" product. But "we have a lot of confidence in
Nevo," he added.
J&J doesn't yet have results from a smaller Nevo study that
could lead to European approval, but has talked to doctors using
the stent and has solicited input from leading cardiologists.
Shares of Dow Jones Industrial Average component J&J
recently traded up 64 cents, or 1.3%, to $51.28 on a day of broader
market gains.
Abbott spokesman Jonathon Hamilton said J&J's move isn't
surprising, given Xience's leadership position, and that Abbott
expects more head-to-head matchups.
While Cordis boosts Nevo's profile, it has also decided to stop
developing Cypher Elite, which is a next-generation version of the
Cypher stent J&J has sold domestically for six years. It is
less likely to make a splash in an increasingly crowded U.S. market
where Boston Scientific, Abbott and Medtronic Inc. (MDT) have all
released new stents since early 2008.
Nevo isn't designed as an incremental update. The coated stents
available today have medication attached by polymer that releases
to keep propped-open heart arteries from closing off again. Nevo's
drug is loaded into tiny reservoirs rather than coated on the
surface, and both the drug and polymer are designed to be totally
gone within three months. It's thought that the drug is only needed
initially, and polymers can be irritants.
This technology may sound familiar to people who remember Conor
MedSystems, a small stent developer J&J purchased in early 2007
for $1.4 billion. Conor launched a stent with this technology in
Europe, but J&J pulled it from the market soon after buying
Conor when an important trial failed.
That sapped J&J of its near-term ability to ward off rising
competition, and the effects have shown. In 2008 J&J's coated
stent sales fell 23% globally and nearly 39% in the U.S., the
world's biggest market.
J&J has long maintained that it was more interested in
Conor's technology than the failed device, and Rogers stressed that
Nevo is a totally redesigned product.
It appeared that not enough drug, the same one used on Boston
Scientific's Taxus stents, was used on the failed Conor stent. But
the overhauled Nevo stent uses the same drug as J&J's Cypher
devices, among other changes.
Abbott's Hamilton noted the company is working on a non-metal
stent that will be completely absorbed by the body, rather than
just shedding its drug and polymer.
J&J hopes to file for European Nevo approval by the end of
this year, suggesting potential approval in 2010, if a study
pitting Nevo against Boston Scientific's Taxus looks good.
Six-month data will be presented at a European heart conference in
May.
The company then plans to file for U.S. approval in late 2011,
indicating it will battle domestically with the market's oldest
coated stent - the original Cypher - for several more years. A
non-randomized study of about 1,000 patients will serve as the
"pivotal" trial aimed at supporting the eventual U.S.
application.
Another U.S. study of about 2,000 patients, designed to compare
clinical outcomes in Cypher patients who used anti-clotting drugs
for different durations, will serve as the control arm for the Nevo
stent's pivotal U.S. study. Cordis is working to expand Cypher's
approved uses in the U.S. and is also working on versions designed
for small and large arteries.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com