Johnson and Johnson 2008 Annual Report Download - page 38

36 JOHNSON & JOHNSON 2008 ANNUAL REPORT
PHARMACEUTICAL SEGMENT
Pharmaceutical segment sales in 2008 were $24.6 billion, a
decrease of 1.2% over 2007, with an operational decline of 3.1% and
1.9% increase due to the positive impact of currency fluctuations.
U.S. Pharmaceutical segment sales were $14.9 billion, a decrease of
4.9%. International Pharmaceutical segment sales were $9.7 billion,
an increase of 5.1%, which included 0.1% of operational growth and
5.0% related to the positive impact of currency fluctuations.
REMICADE® (infliximab), a biologic approved for the treat-
ment of Crohn’s disease, ankylosing spondylitis, psoriasis, psoriatic
arthritis, ulcerative colitis and use in the treatment of rheumatoid
arthritis, achieved sales of $3.7 billion in 2008, with growth of
12.7% over prior year. Growth was driven by increased demand due
to the introduction of new clinical data and overall market growth.
REMICADE® is competing in a market which is experiencing
increased competition due to new entrants and the expansion of
indications for existing competitors.
TOPAMAX® (topiramate), which has been approved for
adjunctive and monotherapy use in epilepsy, as well as for the pro-
phylactic treatment of migraines, achieved sales of $2.7 billion in
2008, an increase of 11.3% over prior year. The growth was primarily
due to increases in the migraine category partially offset by generic
competition in certain markets outside the U.S. The patent for
TOPAMAX® (topiramate) in the U.S. expired in September 2008.
In July 2008, the U.S. Food and Drug Administration (FDA) granted
pediatric exclusivity for TOPAMAX®, which extends market
exclusivity in the U.S. until March 2009. In 2008, U.S. sales of
TOPAMAX® were $2.3 billion. The expiration of the product patent
or loss of market exclusivity is likely to result in a significant
reduction in sales.
PROCRIT® (Epoetin alfa) and EPREX® (Epoetin alfa) had com-
bined sales of $2.5 billion in 2008, a decline of 14.7% compared to
prior year. The decline was primarily due to the declining markets
for Erythropoiesis Stimulating Agents (ESAs)in the U.S. The FDA
issued an order requiring a labeling supplement making specific
revisions to the label for ESAs, including PROCRIT®. The label for
PROCRIT® was updated July 30,2008, based on reviewof emerg-
ing safety data for the use of ESAs in patients with cancer. Outside
the U.S., new competition and the emerging safety data issues have
contributed to the lower sales results for EPREX®. Discussions with
European regulators regarding changes to the label for ESAs, includ-
ing EPREX®, are nearing finalization.
RISPERDAL® (risperidone), a medication that treats the symp-
toms of schizophrenia, bipolar mania and irritability associated with
autistic behavior in indicated patients, experienced a sales decline
of 37.8% to $2.1 billion in 2008. Market exclusivity for RISPERDAL®
oral in the U.S. expired on June 29, 2008. Loss of market exclusivity
for the RISPERDAL® oral patent has resulted in a significant reduc-
tion in sales in the U.S. In 2008, U.S. sales of RISPERDAL® oral were
$1.3 billion. In the first half of the 2008 fiscal year U.S. sales of
RISPERDAL® oral were $1.1 billion and $0.2 billion in the second half.
RISPERDAL® CONSTA® (risperidone), a long-acting injectable
for the treatment of schizophrenia, achieved sales of $1.3 billion
in 2008, representing an increase of 16.0% as compared to the
prior year. The growth was due to a positive shift from once per day
therapies to longer-acting RISPERDAL® CONSTA®.
CONCERTA® (methylphenidate HCl), a product for the treat-
ment of attention deficit hyperactivity disorder (ADHD), achieved
sales of $1.2 billion in 2008, representing an increase of 21.3% over
2007. Sales results were favorably impacted by approximately $115
million related to a change in the estimate of accrued sales reserves.
An additional contributor to the sales growth was market growth.
Although the original CONCERTA® patent expired in 2004, the
FDA has not approved any generic version that is substitutable
for CONCERTA®. Two parties have filed Abbreviated New Drug
Applications (ANDAs) for generic versions of CONCERTA®, which
are pending and may be approved at any time.
LEVAQUIN® (levofloxacin)/FLOXIN® (ofloxacin) and
ACIPHEX®/PARIET® (rabeprazole sodium) experienced sales
declines of 3.3% and 14.7%, respectively, versus the prior year due
to competition in the category. DURAGESIC®/Fentanyl Transdermal
(fentanyl transdermal system) sales declined 11.0% versus the prior
year due to generic competition.
In 2008, Other Pharmaceutical sales were$7.2billion, repre-
senting a growth of 10.9% over prior year. Contributors to the
increase were sales of VELCADE® (bortezomib), a product for the
treatment of multiple myeloma, PREZISTA® (darunavir), for the
treatment of HIV/AIDS patients and INVEGA® (paliperidone), a
once-daily atypical antipsychotic.
During 2008, the Company received regulatory approval in the
U.S., Canada and European Union for INTELENCETM (etravirine) for
HIV combination therapy. STELARATM (ustekinumab) was
approved in Canada and the European Union for the treatment of
moderate tosevere plaque psoriasis and is currently under review
with the FDA. In addition, NUCYNTATM (tapentadol) immediate-
release tablets for the relief of moderate to severe acute pain in
adults 18 years of age or older was approved in the U.S.
The Company also received approvals expanding the indica-
tions for several key products, including CONCERTA®, to treat
ADHD in adults ages 18 to 65 in the U.S., VELCADE®, in combina-
tion with melphalan and prednisone for the treatment of patients
with previously untreated multiple myeloma in the European Union
Major Pharmaceutical Product Revenues*:
%Change
_____________________
(Dollars in Millions) 2008 2007 2006 ’08 vs. ’07 ’07 vs. ’06
REMICADE® (infliximab) $ 3,748 3,327 3,013 12.7% 10.4
TOPAMAX® (topiramate) 2,731 2,453 2,027 11.3 21.0
PROCRIT®/EPREX® (Epoetin alfa) 2,460 2,885 3,180 (14.7) (9.3)
RISPERDAL® (risperidone) 2,126 3,420 3,334 (37.8) 2.6
LEVAQUIN®/FLOXIN® (levofloxacin/ofloxacin) 1,591 1,646 1,530 (3.3) 7.6
RISPERDAL® CONSTA® (risperidone) 1,309 1,128 849 16.0 32.9
CONCERTA® (methylphenidate HCl) 1,247 1,028 930 21.3 10.5
ACIPHEX®/PARIET® (rabeprazole sodium) 1,158 1,357 1,239 (14.7) 9.5
DURAGESIC®/Fentanyl Transdermal (fentanyl transdermal system) 1,036 1,164 1,295 (11.0) (10.1)
Other 7,161 6,458 5,870 10.9 10.0
Total $24,567 24,866 23,267 (1.2)% 6.9
*Prior year amounts have been reclassified to conform to current presentation.