Johnson & Johnson - Index

Johnson & Johnson - report - Index

Antipsychotics
$4.7
+12%
New Agent Available
for Hard-to-Treat
Bacterial Infections
Y E A R I N R E V I E W
Pharmaceutical Segment Sales
Sales by Major Product
PROCRIT®/
EPREX®
$2.9
(9%)
Other
$5.4
+11%
Physicians gained a new
option for the treatment of
complicated urinary tract
and intra-abdominal bacterial
infections with the U.S.
approval of DORIBAX TM (doripenem for
injection). Also under regulatory review in
the U.S. for hospital-acquired pneumonia
and in the EU for all three indications,
DORIBAX TM belongs to a class of
antibacterial agents called carbapenems,
which are important for treating serious
infections caused by gram-positive and
gram-negative bacteria. Licensed from
Shionogi & Co., Ltd., DORIBAX TM is
marketed in the U.S. by Ortho-McNeil-
Janssen Pharmaceuticals, Inc.
Another compound, ceftobiprole
(licensed from Basilea Pharmaceutica
Ltd.), is under regulatory review in the
U.S., the EU, Canada, Switzerland and
Australia for the treatment of complicated
skin and skin structure infections,
including diabetic foot infections.
(See related story on page 18.)
2007 Sales: $24.9 billion Growth Rate: 6.9%
(in billions of dollars)
REMICADE®
$3.3
+10%
CONCERTA®
$1.0
Hormonal
+11% Contraceptives
$0.9
(9%)
TOPAMAX®
$2.5
+21%
ACIPHEX®/
PARIET®
$1.4
+10%
DURAGESIC®
$1.2
(10%)
LEVAQUIN®/
FLOXIN®
$1.6
+8%
Regulatory Filings Made for
Novel Psoriasis Compound
Continuing a heritage of pioneering innovation
in immunology, Centocor, Inc. filed a Biologics
License Application with the U.S. FDA and
Janssen-Cilag filed a Marketing Authorization
Application with the European Medicines
Evaluation Agency for the regulatory review of
ustekinumab (formerly CNTO 1275), a human
monoclonal antibody for the treatment of
moderate to severe plaque psoriasis. A novel
biologic that targets interleukin-12 (IL-12)
and interleukin-23 (IL-23), naturally occurring
proteins that play a role in normalizing the
immune system, ustekinumab is being investigated
for use as an infrequently administered
subcutaneous injection.
Data supporting the regulatory submission
of the compound showed that more than twothirds
of patients with moderate to severe plaque
psoriasis who received two doses of ustekinumab
achieved at least a 75 percent reduction in
psoriasis by week 12, the primary endpoint of a
Phase 3 study. Centocor discovered ustekinumab
and has exclusive marketing rights in the United
States. The Janssen-Cilag companies will market
ustekinumab in all countries outside the U.S.
Late-Stage
Pipeline
We made significant progress in
advancing our late-stage pipeline in 2007
with a number of achievements, including
the approval of DORIBAX™ (doripenem
for injection) in the U.S. and several
regulatory filings for new molecular
entities (NMEs). These included
ceftobiprole, an antibacterial; paliperidone
palmitate, a long-acting injectable for
schizophrenia; ustekinumab, for psoriasis;
and dapoxetine, for premature ejaculation.
Additionally, in early 2008 we received
approval for INTELENCE™ (etravirine)
tablets, an anti-HIV medication, in
the U.S.; launched IONSYS™ (fentanyl
iontophoretic transdermal system) for
the management of pain, in Europe;
and filed tapentadol, a pain medication.
We expect to make seven to 10 filings
between 2008 and the end of 2010.
Several supplemental filings were
also made in 2007, including PREZISTA™
(darunavir) in the U.S. for treatmentnaive
HIV patients, CONCERTA®
(methylphenidate HCl) Extended-release
Tablets in the U.S. for adult ADHD,
and DORIBAX™ in the U.S. and EU for
nosocomial pneumonia.
LATE-STAGE NMEs
POTENTIAL REGULATORY FILINGS, 2007–2010
CNS Paliperidone
palmitate
Carisbamate*
Immunology Ustekinumab
(CNTO 1275) (U.S. & EU)
Infectious
Diseases
Golimumab (CNTO 148)
Ceftobiprole (U.S. & EU)
Telaprevir* (EU)
TMC 207
TMC 278
DORIBAX™*
INTELENCE™
Oncology DACOGEN™* (EU)
Pain
Management
Cardiovascular
Disease
Reproductive
Health
YONDELIS®*
Tapentadol*
Rivaroxaban*
Dapoxetine
(selected EU)
To be filed Filed Approved
*Carisbamate licensed from SK-Bio Pharmaceuticals,
ceftobiprole from Basilea Pharmaceutica, telaprevir from
Vertex Pharmaceuticals Incorporated, DORIBAX™ from
Shionogi & Co., DACOGEN™ from MGI Pharma, Inc.,
YONDELIS® from PharmaMar, tapentadol from Grunenthal
GmbH, rivaroxaban from Bayer HealthCare, dapoxetine
from PPD-GenuPro.
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