UPDATE: J&J: New Stent Outperforms Rival Device In Trial
20 May 2009 - 4:45AM
Dow Jones News
A new drug-releasing heart stent Johnson & Johnson (JNJ)
hopes will rejuvenate its standing in the $4 billion market for the
tiny devices outperformed a Boston Scientific Corp. (BSX) stent in
new study data, J&J said Tuesday.
The "Nevo Res I" study will be used in a European regulatory
filing, expected later this year, aimed at winning approval for the
"Nevo" stent there and in other international markets that follow
European rules. That suggests potential approval in 2010, which
would be followed by an application for the U.S. in late 2011
pending more study data.
Nevo represents J&J's big effort to return to prominence in
a heart-device market it helped develop and once led before new
devices triggered substantial market-share erosion. A stent sold by
both Abbott Laboratories (ABT) and Boston Scientific has
significantly contributed to J&J's slide over the last several
quarters.
The study data presented Tuesday at the EuroPCR cardiology
conference in Barcelona covers a short time span and just 394
patients, suggesting more proof will be needed to help the device
in an increasingly competitive market. But any positive
developments are good for a J&J stent business that has
recently been a negative weight on the conglomerate's financial
results.
Wachovia analyst Larry Biegelsen said Tuesday's data "should
help stabilize JNJ's (market) share and improve investor
sentiment." He also said Abbott, which sells a market-leading
device today, has the most to lose from the Nevo data.
The new J&J device has a design for loading medication that
turns it into a bare stent over time, which may cause less
irritation in heart arteries compared with stents that retain drugs
and polymers used to attach drugs for a long time.
Major stent makers are taking different approaches to develop
stents that mirror the performance of medicated devices in stopping
arteries from reclogging, but have the long-term profile of
bare-metal stents when it comes to avoiding artery irritation and
late-developing clots.
Boston Scientific is developing a new generation of stents based
on recently purchased "Labcoat" technology that uses a very thin
biodegradable polymer for attaching drugs, for example.
The current J&J study pitted Nevo against a big Boston
Scientific device, called Taxus Liberte, among patients followed
for six months. The study's main goal was to measure tissue growth
within the stent as tracked by an angiogram imaging system. On that
measure, Nevo had an 0.13 millimeters of growth compared with 0.36
millimeters for Taxus Liberte, a difference that is considered
statistically significant.
Among other performance measures tracked by the study, there was
a lower composite rate of major adverse events for patients with
the J&J device. J&J also noted its stent had no cases of
stent-related clots, although the big concern with such clots
mainly involves ones that develop after a year.
Citigroup analyst Matthew Dodds said the data "looked better
than expected and point to a strong new competitor" in
international markets J&J could reach next year.
Nevo's drug is loaded into tiny reservoirs rather than coated on
the surface, as with the current generation of top-selling stents,
and both Nevo's drug and polymer are designed to be totally gone
within three months. It's thought that the drug is only needed
initially.
Nevo is based on technology J&J acquired when it bought
Conor MedSystems for $1.4 billion about two years ago. J&J
pulled an initial Conor stent with this reservoir technology from
the market when the device failed a key study, then overhauled the
device and changed the drug. Nevo now uses the same drug used on
J&J's "Cypher" coated stents.
-By Jon Kamp, Dow Jones Newswires; 617-654-6728;
jon.kamp@dowjones.com