Johnson and Johnson 2008 Annual Report Download - page 25
Download and view the complete annual report
Please find page 25 of the 2008 Johnson and Johnson annual report below. You can navigate through the pages in the report by either clicking on the pages listed below, or by using the keyword search tool below to find specific information within the annual report.-
1 -
2
-
3
-
4
-
5
-
6
-
7
-
8
-
9
-
10
-
11
-
12
-
13
-
14
-
15 -
16 -
17 -
18 -
19 -
20 -
21 -
22 -
23 -
24 -
25 -
26 -
27 -
28 -
29 -
30 -
31 -
32 -
33 -
34 -
35 -
36
-
37
-
38
-
39
-
40
-
41
-
42
-
43
-
44
-
45
-
46
-
47
-
48
-
49
-
50
-
51
-
52
-
53
-
54
-
55
-
56
-
57
-
58
-
59
-
60
-
61
-
62
-
63
-
64
-
65
-
66
-
67
-
68
-
69
-
70
-
71
-
72
-
73
-
74
-
75
-
76
 |
 |
YEAR IN REVIEW 23
larger opportunities exist for rivaroxaban,
with possible additional indications for
venous thromboembolism treatment, stroke
prevention in atrial fibrillation, prevention of
DVT and PE in patients hospitalized with
medical illnesses, and acute coronary
syndrome. J&JPRD is c0-developing
rivaroxaban with Bayer HealthCare AG, which
holds marketing rights in countries outside
the U.S. If the drug is approved by the FDA,
Ortho-McNeil, a division of Ortho-McNeil-
Janssen Pharmaceuticals, Inc., will market it
in the U.S.
Two supplemental New Drug Applications
•
(sNDAs) were submitted to the FDA
requesting approval for the use of ®
(paliperidone) tablets for the treatment of
schizoaective disorder as monotherapy and
for use in combination with antidepressants
and/or mood stabilizers.
An NDA was submitted to the FDA for
•
carisbamate, an investigational compound
for the adjunctive treatment of partial-onset
seizures in patients age 16 and older. In 1999,
J&JPRD and SK Holdings Co., Ltd. entered
into a license agreement to develop and
commercialize carisbamate, with J&JPRD
receiving global marketing rights.
• ™ (ceftobiprole) has been
approved in Switzerland, Canada and the
Ukraine for the treatment of complicated
skin and soft tissue infections. It is under
review in the U.S., Europe, Australia and
several other countries and has the ability to
address a broad range of serious bacteria,
including methicillin-resistant staphylo-
coccus aureus (MRSA). Janssen-Cilag will
market the drug, which is licensed from and
co-developed with Basilea Pharmaceutica
Ltd., as ™ in Switzerland.
In addition, several of our currently marketed
and well-performing products received regula-
tory approval for new indications or received
approvals in additional markets in 2008:
The European Commission approved
•
once-daily dosing of 800 mg ®
(darunavir) with low-dose ritonavir as part
of combination therapy in treatment-naïve
adults (those who have never taken HIV
medication). This approval broadens the
previous indication of darunavir for treatment-
experienced HIV-1 patients and means that
® can be used for the full spectrum
of adult HIV/AIDS patients in the 27 EU
member states. In the U.S., ®
received full approval for twice-daily use in
treatment-experienced adult patients and an
expanded indication for once-daily dosing as
part of HIV combination therapy in patients
who have never taken HIV medicines.
• ™ (etravirine), which the
FDA approved in early 2008, received
marketing authorization in Canada and the
EU for HIV combination therapy.
An sNDA was submitted for the
•
combination of ® (doxorubicin
HCl liposome injection) and ®
(docetaxel) for the treatment of women with
advanced breast cancer who have received
prior anthracycline treatment.
An NDA was submitted for the use of
•
trabectedin in combination with ®
for the treatment of women with relapsed
ovarian cancer. Trabectedin is being
developed under a license from PharmaMar,
and ® is marketed by Ortho Biotech
Products, LP in the United States.
$1.2
+21%
$3.7
+13%
$2.7
+11%
$1.0
(11%)
$1.6
(3%)
$1.2
(15%)
$7.3
+11%
$2.1
(38%)
$1.3
+16%
$2.5
(15%)
(in billions of dollars)*
2008 Sales: $24.6 billion
Growth Rate: (1.2%)
* includes rounding