Johnson and Johnson 2006 Annual Report Download - page 30

J O H N S O N & J O H N S O N 2 0 0 6 A N N U A L R E P O R T
Two new pain medications
approved in 2006 use
novel drug delivery
systems developed by ALZA
Corporation to manage
moderate to severe pain.
IONSYS™ (fentanyl
iontophoretic transdermal
system), the first needle-free,
patient-activated analgesic
system, was approved in 2006
in both the United States and
Europe and is expected to
launch in the second half of
2007. IONSYS™ is indicated for
the short-term management
of acute post-operative pain
in adult patients requiring
opioid analgesia during
hospitalization. IONSYS™ is
a compact, self-contained
system that delivers on-
demand pain medication as
needed by the patient. The
patient double-clicks on a
dosing button and the system
delivers a preprogrammed
dose of fentanyl through
the skin. Each dose is
delivered over a 10-minute
period. IONSYS™ is the
first and only product to
incorporate the proprietary
E-TRANS® Iontophoretic
Transdermal Drug-Delivery
System developed by ALZA
Corporation. Iontophoresis
is a process in which a low-
intensity electric field,
generally imperceptible
to the patient, is used to
rapidly transport fentanyl
across the skin and into
the circulatory system.
JURNISTA® Prolonged-
Release Tablets (hydro-
morphone HCl), a new
prescription treatment for
severe pain, was developed
by ALZA Corporation and
utilizes the OROS® Push-
Pull™ delivery system. This
delivery technology releases
the opioid hydromorphone at
a consistent rate, providing
patients with up to 24 hours
of pain relief from a single
dose. JURNISTA® has launched
in Germany, Denmark,
Slovenia and Slovakia; is
scheduled to launch in other
European countries in 2007;
and will be registered and
marketed by other Janssen-
Cilag companies throughout
the world.
In addition to these
prescription pain medications
approved in 2006, PriCara, a
unit of Ortho-McNeil, Inc.,
and Biovail Corporation
launched ULTRAM® ER
(Tramadol HCI) Extended-
Release Tablets in the
U.S., the first extended-
release Tramadol product
in that market.
Looking ahead at the pain
pipeline, Johnson & Johnson
Pharmaceutical Research
and Development, LLC
hopes to file in 2007 a new
drug application in the U.S.
for Tapentadol, a centrally
acting analgesic it is co-
developing with Grunenthal.
Plans for Tapentadol call
for both immediate-release
and extended-release
formulations.
REMICADE®
Granted Four Significant
Indications in U.S.
REMICADE® (infliximab), the Centocor,
Inc. biologic for immune mediated
inflammatory disorders, garnered four
significant new U.S. indications in 2006.
REMICADE® is one of the world’s most
versatile biologics, with a total of nine
approved indications (i.e., unique patient
populations) ranging from rheumatoid
arthritis to plaque psoriasis, with 24
approved efficacy claims.
In 2006, REMICADE® was approved
in the U.S. for pediatric Crohn’s disease;
for the inhibition of progression of
structural damage and improved
physical function in psoriatic arthritis;
for treatment of chronic severe plaque
psoriasis in adults; and expanded for
maintaining long-term clinical remission
and mucosal healing in patients with
moderate to severely active
ulcerative colitis. REMICADE® is the
global market leader in anti-TNF therapy.
Also in 2006, REMICADE® received
regulatory approvals for four major
indications in 25 European countries
and five major new indications in
Canada, as well as numerous approvals
in the rest of the world.
Centocor also has two exciting
near-term products. CNTO 148 is a
next-generation anti-TNF antibody that
is likely to emerge as a best-in-class
product. It is initially being studied for
rheumatoid arthritis, psoriatic arthritis
and ankylosing spondylitis, and is
also being explored in a wide range of
other therapeutic areas. A fully human
antibody, it is being developed as both
a subcutaneously and intravenously
administered product with long
dosing intervals—unique in this class.
Centocor also is developing a novel
immunomodulator, CNTO 1275,
a first-in-class anti-IL-12/23. CNTO 1275
is in Phase III trials for psoriasis,
where it has already demonstrated
strong efficacy.
Two 2006 licensing deals further
enhanced the pharmaceuticals growth
engine in oncology from its foundation
of PROCRIT®/EPREX® (epoetin alfa)
and DOXIL® (doxorubicin HCl liposome
injection). These deals reinforce the
commitment to deliver innovative and
effective treatments for cancer patients
with unmet medical needs and those
who care for them.
Since 2003, the international
Janssen-Cilag businesses have marketed
a leading treatment for multiple
myeloma, VELCADE® (bortezomib),
a novel protease inhibitor for which
new uses are being co-developed with
Millennium Pharmaceuticals, Inc.
Recently, Ortho Biotech Products, LP
entered into a new agreement with
Millennium to jointly promote VELCADE®
to U.S.-based physicians who treat
mantle cell lymphoma or multiple
myeloma patients who have received
at least one prior therapy.
In addition, 2006 saw Janssen-Cilag
license from MGI PHARMA global
development and commercialization
rights outside North America to
DACOGEN™ (decitabine) for Injection—
a treatment for myelodysplastic
syndromes (MDS), a disease of the bone
marrow—which is currently in Phase III
trials in Europe. MGI PHARMA received
U.S. approval for DACOGEN™ in May.
Also in 2006, a supplemental
new drug application for DOXIL®—
as combination therapy with
VELCADE® to treat patients with
multiple myeloma whose disease has
progressed or relapsed after prior
therapy—was submitted for review to
the FDA, and Janssen Pharmaceutical
K.K. gained approval for VELCADE®
in Japan.
The near-term pipeline in
oncology includes two other promising
drugs: YONDELIS® (trabectedin),
co-developed with PharmaMar,
a subsidiary of the Zeltia Group;
and ZARNESTRA® (tipifarnib),
for acute myeloid leukemia (AML).
Licensing Deals Enhance Oncology Growth Engine
Two New Pain Medicines
Using Novel Delivery Systems Approved
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