Johnson and Johnson 2005 Annual Report Download - page 15

REACHING MORE PEOPLE, SERVING MORE HEALTH NEEDS. PAGE 13
plaques. Centocor also submitted supplemental Biologics
License Applications to the U.S. FDA for REMICADE®
for the treatment of moderate to severe plaque psoriasis
and for the treatment of pediatric Crohn’s disease.
REMICADE®has been used to treat nearly 700,000
patients worldwide since it was first approved in 1998.
IONSYS™ (fentanyl hydrochloride (HCl) Patient-Activated
Transdermal System (PATS) 40 mcg/dose) represents the
convergence of a pharmaceutical and a delivery system.
IONSYS™, an iontophoretic transdermal system for acute
postoperative pain in a medically supervised setting, is
a compact, needle-free, self-contained, pre-programmed
system that offers patient-controlled analgesia. It is the
first product in development that incorporates ALZA
Corporation’s proprietary E-TRANS®drug delivery
system, which uses low-level electrical energy to actively
transport drugs through intact skin without the use of
needles or intravenous lines. Pending approval by the
U.S. FDA, Ortho-McNeil, Inc. will market IONSYS™ in
the U.S. IONSYS™ will be marketed in the European
Union by Janssen-Cilag companies.
Among recent pharmaceutical product approvals were
LEVAQUIN®(levofloxacin) 750 mg Tablets as a five-day
treatment for acute bacterial sinusitis, and RAZADYNE™
ER (galantamine hydrobromide), a once-daily treatment
formulation for the symptoms of mild to moderate
Alzheimer’s disease. Previously named REMINYL®in
the U.S., the product was renamed RAZADYNE™ ER to
help avoid confusion with a similarly
named prescription product. The
once-daily dosing formulation helps
make treatment more convenient for
patients and their families. Additionally,
TOPAMAX®(topiramate) Tablets and
TOPAMAX®(topiramate capsules)
Sprinkle Capsules received approval as
initial monotherapy in patients 10 years of age and older
with partial-onset or primary generalized tonic-clonic
seizures, the most widely recognized epileptic seizure.
Now approved in 64 countries, VELCADE®
(bortezomib) for Injection was approved during 2005
in several countries throughout Asia, Latin America
and the Middle East, as well as in Canada and Russia,
for treating multiple myeloma in patients who received
at least two prior therapies and demonstrated disease
progression on the last therapy. VELCADE®also was
approved in the U.S. and European Union for second-line
use and can now be used earlier to treat patients with
multiple myeloma. VELCADE®is being co-developed
by Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. and Millennium Pharmaceuticals,
Inc. Millennium is responsible for the commercialization
of VELCADE®in the U.S. Janssen Pharmaceutical K.K.
is responsible in Japan, and Janssen-Cilag and Ortho
Biotech-affiliated companies are responsible for com-
mercialization in Europe and the rest of the world.
Cilag GmbH International acquired European marketing
and development rights to NORATAK® (nesiritide) from
GlaxoSmithKline (GSK). Nesiritide was developed by
Scios Inc. and licensed to GSK in Europe prior to
the 2003 Johnson & Johnson acquisition of Scios.
Nesiritide is an important treatment option for patients
who go to a hospital for treatment of acutely decom-
pensated heart failure that is characterized by shortness
of breath while resting, or as a result of minimal activity
such as eating, talking or bathing. Janssen-Cilag com-
panies will market the product in Europe. The product
is approved in Switzerland and Israel and is marketed
there as NORATAK®
. In Argentina, Colombia, Dominican
Republic, Mexico, Brazil, Curacao and the U.S., it is
marketed as NATRECOR®
.
Left: Protein kinases serve as
control switches for many cell
activities inside the body and
also can contribute to both
the onset and progression of
diseases. Margaret Henson and
John Perumattam are members
of the Scios research and devel-
opment teams working on several
kinase inhibitor programs.