Johnson and Johnson 2014 Annual Report Download - page 16

Infectious disease products achieved sales of $5.6 billion in 2014, representing an increase of 57.7% as compared to the
prior year. Major contributors to the growth were the launch of OLYSIO®/SOVRIAD®(simeprevir); PREZISTA®
(darunavir), due to market growth; and sales of EDURANT®(rilpivirine) .This was partially offset by lower sales of
INCIVO®(telaprevir), due to competitive pressures, and lower sales of vaccine products. The approval of competitive
products to OLYSIO®/SOVRIAD®(simeprevir) had a negative impact in the fourth quarter of 2014 and is expected to
continue to have a significant negative impact on future sales of OLYSIO®/SOVRIAD®(simeprevir).
Neuroscience products sales were $6.5 billion, a decline of 2.7% 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®. Additionally, a decline in sales of CONCERTA®/methylphenidate and
TOPAMAX®(topiramate) were due to continued generic competition.
Oncology products achieved sales of $4.5 billion in 2014, representing an increase of 18.1% as compared to the prior
year. Major contributors to the growth were strong sales of ZYTIGA®(abiraterone acetate), as well as the recent launch of
IMBRUVICA®(ibrutinib). Sales growth of VELCADE®(bortezomib) was more than offset by negative currency.
Other Pharmaceutical sales were $5.6 billion, an increase of 12.8% as compared to the prior year. Strong sales of
XARELTO®(rivaroxaban) and INVOKANA®/INVOKAMET™ (canagliflozin) were partially offset by lower sales of
ACIPHEX®/PARIET®(rabeprazole sodium) and PROCRIT®/EPREX®(Epoetin alfa).
During 2014, the Company received several regulatory approvals including: the U.S. Food and Drug Administration (FDA)
granted approval of IMBRUVICA®(ibrutinib) capsules, which is being jointly developed and commercialized by
Pharmacyclics, Inc. for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one
prior therapy; the European Commission (EC) granted conditional approval for SIRTURO®(bedaquiline) in the European
Union, for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis in adult
patients; the FDA and the EC granted approval of SYLVANT®(siltuximab) for the treatment of patients with multicentric
Castleman’s disease who are human immunodeficiency virus negative and human herpesvirus-8 negative; the EC granted
approval for VOKANAMET®(canagliflozin/metformin HCl), a fixed-dose therapy combining canagliflozin and immediate
release metformin hydrochloride in a single tablet for the treatment of adults with type 2 diabetes; OLYSIO®(simeprevir)
for the treatment of adult patients with genotype 1 or 4 chronic hepatitis C; and for INVEGA®(paliperidone ER) to extend
its adult indication of schizophrenia to include adolescents aged 15 years and older; the FDA granted approval for a third
indication for IMBRUVICA®(ibrutinib), for the treatment of patients with CLL who have the genetic mutation 17p deletion
(del 17p) and also granted IMBRUVICA®(ibrutinib) full approval for the treatment of patients with CLL who have received
at least one prior therapy; FDA granted approval for INVOKAMET™ (canagliflozin/metformin HCl) for the treatment of
adults with type 2 diabetes; The EC approved IMBRUVICA®(ibrutinib) for the treatment of adult patients with relapsed or
refractory mantle cell lymphoma and adult patients with chronic lymphocytic leukemia who have received at least one prior
therapy, or in first-line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
The EC also approved REZOLSTA®(darunavir/cobicistat) in combination with other antiretroviral medicinal products for
the treatment of human immunodeficiency virus-1 infection in adults aged 18 years or older.
The Company submitted several New Drug Applications (NDAs) to the FDA, including an NDA seeking approval for a
once-daily fixed-dose antiretroviral combination tablet containing darunavir, a protease inhibitor developed by Janssen
R&D Ireland and marketed as PREZISTA®in the U.S., with cobicistat, an investigational pharmacokinetic enhancer or
boosting agent, developed by Gilead Sciences, Inc. for use in combination with other human immunodeficiency virus
medicines; an NDA for three-month atypical antipsychotic paliperidone palmitate as a treatment for schizophrenia in
adults; and an NDA for YONDELIS®(trabectedin) for the treatment of patients with advanced soft tissue sarcoma,
including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
In addition, a supplemental New Drug Application (sNDA) was approved by the FDA for OLYSIO®in combination with the
nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc. for the treatment of chronic
hepatitis C. Additional sNDA’s were also submitted to the FDA for OLYSIO®for the treatment of adult patients in
genotype 4 chronic hepatitis C and patients co-infected with HIV; once-monthly atypical long-acting antipsychotic
INVEGA®SUSTENNA®(paliperidone palmitate) was approved to treat schizoaffective disorder as either monotherapy or
adjunctive therapy; and a Type II variation application was submitted to the European Medicines Agency (EMA) for an
additional indication of IMBRUVICA®(ibrutinib) for the treatment of patients with Waldenström’s macroglobulinemia, a
rare type of B-cell lymphoma.
A Marketing Authorization Application was submitted to the European Medicines Agency to expand the label for
VELCADE®(bortezomib) to include its use, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone,
for the treatment of adult patients with previously untreated mantle cell lymphoma.
6•Johnson & Johnson 2014 Annual Report