Johnson and Johnson 2013 Annual Report Download - page 16

Infectious disease products achieved sales of $3.6 billion in 2013, representing an increase of 11.1% as compared to the
prior year. Major contributors were PREZISTA®(darunavir), due to the continued momentum in market share growth,
INCIVO®(telaprevir), EDURANT®(rilpivirine), INTELENCE®(etravirine) and the launch of OLYSIO™ (simeprevir).
Neuroscience products sales were $6.7 billion, a decline of 0.8% as compared to the prior year. Strong sales of
INVEGA®SUSTENNA®/XEPLION®(paliperidone palmitate) and INVEGA®(paliperidone palmitate) were partially offset
by lower sales of RISPERDAL®CONSTA®due to growth of INVEGA®SUSTENNA®/XEPLION®. Additionally, a decline
in U.S. sales of CONCERTA®/methylphenidate and lower sales of DURAGESIC®/Fentanyl Transdermal (fentanyl
transdermal system) and RISPERDAL®(risperidone) was due to continued generic competition.
Oncology products achieved sales of $3.8 billion in 2013, representing an increase of 43.5% as compared to the prior
year. This growth was primarily due to sales of ZYTIGA®(abiraterone acetate), VELCADE®(bortezomib) and DOXIL®/
CAELYX®(pegylated liposomal doxorubicin hydrochloride), due to returning supply of CAELYX®.
Other Pharmaceutical sales were $4.9 billion, an increase of 0.2% as compared to the prior year. Strong sales of
XARELTO®(rivaroxaban) and the launch of INVOKANA®(canagliflozin) were partially offset by lower sales of ACIPHEX®/
PARIET®(rabeprazole sodium) and EPREX®(Epoetin alfa) primarily due to generic competition.
During 2013, the company received several regulatory approvals including: The U.S. Food and Drug Administration (FDA)
approval of OLYSIO™ (simeprevir), an NS3/4A inhibitor, for the treatment of chronic hepatitis C infection as part of an
antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with
compensated liver disease, including cirrhosis; FDA approval for IMBRUVICA™ (ibrutinib) capsules for the treatment of
patients with mantle cell lymphoma who have received at least one prior therapy; The FDA and European Commission
(EC) approved INVOKANA®(canagliflozin), an oral, once-daily, selective sodium glucose co-transporter 2 inhibitor, for the
treatment of adults with type 2 diabetes; The FDA approved the use of STELARA®(ustekinumab) alone or in combination
with methotrexate for the treatment of adult patients with active psoriatic arthritis; The EC also approved STELARA®
(ustekinumab), alone or in combination with methotrexate for active psoriatic arthritis in adults when the response to
previous non-biological disease-modifying anti-rheumatic drug therapy has been inadequate; The EC approved an
expanded indication for SIMPONI®(golimumab) for the treatment of moderately to severely active ulcerative colitis in adult
patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or
azathioprine, or who are intolerant to or have medical contraindications for such therapies; SIMPONI®(golimumab) was
also approved by the FDA for the treatment of moderately to severely active ulcerative colitis in adult patients who have
demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral
aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine; The FDA also approved SIMPONI®ARIATM
(golimumab) for infusion for the treatment of adults with moderately to severely active rheumatoid arthritis in combination
with methotrexate. The EC approved the use of VELCADE®(bortezomib) as induction therapy in combination with
dexamethasone or thalidomide and dexamethasone and applies to adult patients with previously-untreated multiple
myeloma who are eligible for high-dose chemotherapy with hematological stem cell transplantation.
The Company submitted several New Drug Applications, including a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) and a New Drug Application (NDA) to the FDA seeking approval for the use of
ibrutinib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia /small lymphocytic
lymphoma, and an MAA for relapsed or refractory mantle cell lymphoma. An MAA was submitted to the EMA seeking
approval for a once-daily single tablet fixed-dose antiretroviral combination product containing darunavir, a protease
inhibitor, with cobicistat, a pharmacokinetic enhancer or boosting agent, developed by Gilead Sciences, Inc. for use in
combination with other human immunodeficiency virus medicines. A Biologic License Application to the FDA and an MAA
to the EMA were simultaneously submitted for siltuximab for the treatment of patients with multicentric Castleman disease
who are HIV-negative and human herpes virus-8 -negative. An MAA was submitted to the EMA for simeprevir for the
treatment of adult patients with chronic hepatitis C genotype 1 or genotype 4. Additionally, an MAA was submitted to the
EMA for canagliflozin/metformin fixed-dose combination therapy to treat patients with type 2 diabetes.
The Pharmaceutical segment achieved sales of $25.4 billion in 2012, representing an increase of 4.0% over the prior year,
with operational growth of 6.8% and a negative currency impact of 2.8%. U.S. sales were $12.4 billion, an increase of
0.3%. International sales were $12.9 billion, an increase of 7.9%, which included 13.6% operational growth and a
negative currency impact of 5.7%.
6•Johnson & Johnson 2013 Annual Report