07.20.18
Headquarters: New Brunswick, NJ
twitter.com/JNJComm
www.jnj.com
Headcount: 134,000
Year Established: 1887
Revenues: $76,450 (+6%)
Pharma Revenues: $36,256 (+7%)
Net Income: $1,300 (-92%)
R&D: $10,554 (+16%)
TOP SELLING DRUGS
Johnson & Johnson’s pharmaceutical segment sales in 2017 were $36.3 billion, an increase of 7% from 2016. U.S. sales accounted for $21.5 billion while international sales were $14.8 billion, an increase of 6.7% and 10.8% respectively.
The pharma segment is focused on six therapeutic areas: immunology, infectious diseases and vaccines, neuroscience, oncology, cardiovascular and metabolism and pulmonary hypertension, a new therapeutic area established with the acquisition of Actelion in June 2017.
At $30 billion, J&J’s purchase of the Swiss biotech was by far the biggest pure biotech/pharma transaction of the year. Based in Allschwil, Actelion has a franchise of differentiated, innovative products for pulmonary arterial hypertension (PAH), as well as specialty in-market medicines and late-stage products. J&J said it will retain Actelion’s presence in Switzerland and leverage its complementary capabilities to shape medical paradigms.
As part of the deal, Actelion spun out its drug discovery operations and early-stage clinical development assets into a newly created Swiss biopharma company, R&D NewCo. J&J also received an option on ACT-132577, a product being developed for resistant hypertension currently in Phase II development.
Segment performance
Taking a closer look at results across the pharma segment, immunology products achieved sales of $12.2 billion in 2017, representing an increase of 2.3%. Growth was driven by strong uptake of Stelara, the launch of Tremfya and sales growth of Simponi/Simponi Aria outside the U.S. Lower sales of Remicade were due to biosimilar competition.
Infectious disease products sales were $3.2 billion, a decline of 1.7% from 2016. Lower sales of Olysio, vaccines and Prezista were partially offset by sales growth of Edurant, Prezcobix/Rexolsta and the launch of Symtuza.
Neuroscience products sales were $6 billion, a decrease of 1.6%. Lower sales of Risperdal Consta and Concerta as well as the impact of divestitures were partially offset by strong sales of Invega Sustenna/Xeplion/Trinza/Trevicta long-acting injectables.
Oncology products achieved by far the strongest sales growth in 2017 at $7.3 billion, representing an increase of 25%. Contributors to the growth of oncology products were strong sales of Darzalex and Imbruvica driven by market share and market growth and sales of Zytiga.
Cardiovascular and metabolism products sales dropped 1.7% to $6.3 billion due to lower sales of Invokana/Invokamet in the U.S. primarily due to an increase in price discounts and market share decline driven by competition. This was partially offset by sales growth of Xarelto with increased market growth and market share, as well as sales of non-PAH products from the Actelion acquisition.
Drug approvals
The U.S. FDA approved several new drugs and indications during the year. The drug agency approved Imbruvica for patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy. It is the first therapy specifically indicated for this rare blood cancer and represents the fifth indication for Imbruvica in the U.S.
The immunotherapy Darzalex was approved in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (an immunomodulatory agent) and a proteasome inhibitor (PI). Clinical trial results showed an overall response rate of 59.2 percent with Darzalex in combination with pomalidomide and dexamethasone in these patients.
FDA also approved Tremfya for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. In clinical studies, patients receiving Tremfya experienced significant improvement in skin clearance and greater improvement in symptoms of plaque psoriasis including itch, pain, stinging, burning and skin tightness when compared with placebo.
Imbruvica got the green light for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. Imbruvica is the first and only FDA-approved medication for adult patients with cGVHD, a potential consequence of an allogeneic stem cell or bone marrow transplant, which can be life-threatening and debilitating.
During the year Actelion was approved for a new 32 mg tablet for oral suspension for Tracleer. It is indicated for pediatric patients aged three years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability. With this approval, Tracleer becomes the first FDA-approved medicine for pediatric PAH patients in the U.S. PAH is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs.
Also, an expanded indication for Stelara was approved in 2017 for the treatment of adolescents 12 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The approval marks a significant milestone for this age group as approximately one-third of individuals who develop plaque psoriasis do so before 20 years of age, and there are limited treatment options for adolescents.
Rounding out the approvals in 2017, FDA ok’d the 10 mg once-daily dose of Xarelto for reducing the continued risk for recurrent venous thromboembolism after completing at least six months of initial anticoagulation therapy and approved Juluca, the first complete single-pill, two-drug regimen for the treatment of HIV-1 infection in certain adults with the disease who are
virologically suppressed.
Pipeline research partnerships
J&J continued to push its pipeline forward in 2017 through several research partnerships. With Synthetic Genomics, Janssen Vaccines & Prevention B.V. entered a research and licensing option agreement to apply replicon RNA technology for the design and development of novel RNA-based medicines for infectious diseases. Synthetic Genomics replicon RNA technology enables a tunable, multigenic approach to elicit desired antigen expression and immune response for a variety of applications. The company believes that this technology will enable the development of RNA-based therapies and vaccines that enhance and fine tune immune response against infectious diseases and cancer.
Janssen Biotech formed a clinical research pact with Bristol-Myers Squibb (BMS) to evaluate the combination of BMS’ Immuno-Oncology (I-O) agent Opdivo and Janssen’s CD38-directed cytolytic antibody Darzalex in Phase Ib/II trials in multiple myeloma and solid tumors including non-small cell lung cancer, pancreatic cancer, colorectal cancer (CRC), triple negative breast cancer and head and neck cancer.
X-Chem announced during the year that it also expanded its collaboration with Janssen Biotech to discover new drug leads for the treatment of inflammatory disease. The multi-target expansion builds on their existing discovery and license partnership entered into in December 2014. This agreement will apply X-Chem’s DEX platform to identify novel modulators for challenging disease targets, following the licensing of multiple series of X-Chem-discovered small molecules by Janssen in 2016.
Janssen Biotech also entered into a worldwide exclusive license and collaboration agreement with Protagonist Therapeutics to develop, manufacture and commercialize PTG-200, a first-in-class, oral interleukin-23 receptor (IL-23R) antagonist drug candidate in development for the treatment of Crohn’s disease and ulcerative colitis (UC). PTG-200 is currently in Investigational New Drug (IND) enabling studies and the initiation of a Phase I trial is planned in 2017.
BioMed X entered a collaboration agreement with Janssen R&D to foster early-stage preclinical biomedical research and development projects. Under the agreement, the BioMed X Innovation Center in Heidelberg, Germany will accommodate as many as five Janssen research projects. The first research project will focus on rapid identification of auto-antigens in autoimmune diseases. Epidemiological data provide evidence of a steady increase in autoimmune diseases worldwide over the last decades. New platform technologies or concepts may lead to identification of antigens recognized by T cells involved in autoimmune responses.
Additionally, Janssen Pharmaceuticals entered into a worldwide exclusive license and collaboration agreement with Bavarian Nordic to leverage their MVA-BN technology with Janssen’s own AdVac and DNA-based vaccine technologies in the development and commercialization of potential new vaccine regimens against hepatitis B virus (HBV) and the human immunodeficiency virus (HIV-1). This agreement stems from successful and ongoing collaborations between the companies to develop vaccines to address Ebola and Human Papillomavirus (HPV).
Lastly, on the cancer research front, Janssen Biotech entered into a worldwide collaboration and license agreement with Legend Biotech USA and Legend Biotech Ireland Ltd., subsidiaries of Genscript Biotech Corporation, to develop, manufacture and commercialize a CAR T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen. LCAR-B38M is currently accepted for review by the China Food and Drug Administration (CFDA) and in the planning phase of clinical studies in the U.S. for multiple myeloma. LCAR-B38M is the first CAR-T therapy accepted for review by the CFDA. Janssen made an upfront payment of $350 million as part of the deal.
twitter.com/JNJComm
www.jnj.com
Headcount: 134,000
Year Established: 1887
Revenues: $76,450 (+6%)
Pharma Revenues: $36,256 (+7%)
Net Income: $1,300 (-92%)
R&D: $10,554 (+16%)
TOP SELLING DRUGS
| Drug | Indication | 2017 Sales | (+/-%) |
| Remicade | rheumatoid arthritis | $6,315 | -9% |
| Stelara | psoriasis | $4,011 | 24% |
| Invega Sustenna | schizophrenia | $2,569 | 16% |
| Zytiga | prostate cancer | $2,505 | 11% |
| Xarelto | deep vein thrombosis | $2,500 | 9% |
| Imbruvica | oncology | $1,893 | 51% |
| Simponi | rheumatoid arthritis | $1,833 | 5% |
| Prezista | HIV/AIDS | $1,821 | -2% |
| Darzalex | cancer | $1,242 | flat |
| Velcade | mantle cell lymphoma | $1,114 | -9% |
| Invokana | type 2 diabetes | $1,111 | -21% |
Johnson & Johnson’s pharmaceutical segment sales in 2017 were $36.3 billion, an increase of 7% from 2016. U.S. sales accounted for $21.5 billion while international sales were $14.8 billion, an increase of 6.7% and 10.8% respectively.
The pharma segment is focused on six therapeutic areas: immunology, infectious diseases and vaccines, neuroscience, oncology, cardiovascular and metabolism and pulmonary hypertension, a new therapeutic area established with the acquisition of Actelion in June 2017.
At $30 billion, J&J’s purchase of the Swiss biotech was by far the biggest pure biotech/pharma transaction of the year. Based in Allschwil, Actelion has a franchise of differentiated, innovative products for pulmonary arterial hypertension (PAH), as well as specialty in-market medicines and late-stage products. J&J said it will retain Actelion’s presence in Switzerland and leverage its complementary capabilities to shape medical paradigms.
As part of the deal, Actelion spun out its drug discovery operations and early-stage clinical development assets into a newly created Swiss biopharma company, R&D NewCo. J&J also received an option on ACT-132577, a product being developed for resistant hypertension currently in Phase II development.
Segment performance
Taking a closer look at results across the pharma segment, immunology products achieved sales of $12.2 billion in 2017, representing an increase of 2.3%. Growth was driven by strong uptake of Stelara, the launch of Tremfya and sales growth of Simponi/Simponi Aria outside the U.S. Lower sales of Remicade were due to biosimilar competition.
Infectious disease products sales were $3.2 billion, a decline of 1.7% from 2016. Lower sales of Olysio, vaccines and Prezista were partially offset by sales growth of Edurant, Prezcobix/Rexolsta and the launch of Symtuza.
Neuroscience products sales were $6 billion, a decrease of 1.6%. Lower sales of Risperdal Consta and Concerta as well as the impact of divestitures were partially offset by strong sales of Invega Sustenna/Xeplion/Trinza/Trevicta long-acting injectables.
Oncology products achieved by far the strongest sales growth in 2017 at $7.3 billion, representing an increase of 25%. Contributors to the growth of oncology products were strong sales of Darzalex and Imbruvica driven by market share and market growth and sales of Zytiga.
Cardiovascular and metabolism products sales dropped 1.7% to $6.3 billion due to lower sales of Invokana/Invokamet in the U.S. primarily due to an increase in price discounts and market share decline driven by competition. This was partially offset by sales growth of Xarelto with increased market growth and market share, as well as sales of non-PAH products from the Actelion acquisition.
Drug approvals
The U.S. FDA approved several new drugs and indications during the year. The drug agency approved Imbruvica for patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy. It is the first therapy specifically indicated for this rare blood cancer and represents the fifth indication for Imbruvica in the U.S.
The immunotherapy Darzalex was approved in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (an immunomodulatory agent) and a proteasome inhibitor (PI). Clinical trial results showed an overall response rate of 59.2 percent with Darzalex in combination with pomalidomide and dexamethasone in these patients.
FDA also approved Tremfya for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. In clinical studies, patients receiving Tremfya experienced significant improvement in skin clearance and greater improvement in symptoms of plaque psoriasis including itch, pain, stinging, burning and skin tightness when compared with placebo.
Imbruvica got the green light for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. Imbruvica is the first and only FDA-approved medication for adult patients with cGVHD, a potential consequence of an allogeneic stem cell or bone marrow transplant, which can be life-threatening and debilitating.
During the year Actelion was approved for a new 32 mg tablet for oral suspension for Tracleer. It is indicated for pediatric patients aged three years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability. With this approval, Tracleer becomes the first FDA-approved medicine for pediatric PAH patients in the U.S. PAH is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs.
Also, an expanded indication for Stelara was approved in 2017 for the treatment of adolescents 12 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The approval marks a significant milestone for this age group as approximately one-third of individuals who develop plaque psoriasis do so before 20 years of age, and there are limited treatment options for adolescents.
Rounding out the approvals in 2017, FDA ok’d the 10 mg once-daily dose of Xarelto for reducing the continued risk for recurrent venous thromboembolism after completing at least six months of initial anticoagulation therapy and approved Juluca, the first complete single-pill, two-drug regimen for the treatment of HIV-1 infection in certain adults with the disease who are
virologically suppressed.
Pipeline research partnerships
J&J continued to push its pipeline forward in 2017 through several research partnerships. With Synthetic Genomics, Janssen Vaccines & Prevention B.V. entered a research and licensing option agreement to apply replicon RNA technology for the design and development of novel RNA-based medicines for infectious diseases. Synthetic Genomics replicon RNA technology enables a tunable, multigenic approach to elicit desired antigen expression and immune response for a variety of applications. The company believes that this technology will enable the development of RNA-based therapies and vaccines that enhance and fine tune immune response against infectious diseases and cancer.
Janssen Biotech formed a clinical research pact with Bristol-Myers Squibb (BMS) to evaluate the combination of BMS’ Immuno-Oncology (I-O) agent Opdivo and Janssen’s CD38-directed cytolytic antibody Darzalex in Phase Ib/II trials in multiple myeloma and solid tumors including non-small cell lung cancer, pancreatic cancer, colorectal cancer (CRC), triple negative breast cancer and head and neck cancer.
X-Chem announced during the year that it also expanded its collaboration with Janssen Biotech to discover new drug leads for the treatment of inflammatory disease. The multi-target expansion builds on their existing discovery and license partnership entered into in December 2014. This agreement will apply X-Chem’s DEX platform to identify novel modulators for challenging disease targets, following the licensing of multiple series of X-Chem-discovered small molecules by Janssen in 2016.
Janssen Biotech also entered into a worldwide exclusive license and collaboration agreement with Protagonist Therapeutics to develop, manufacture and commercialize PTG-200, a first-in-class, oral interleukin-23 receptor (IL-23R) antagonist drug candidate in development for the treatment of Crohn’s disease and ulcerative colitis (UC). PTG-200 is currently in Investigational New Drug (IND) enabling studies and the initiation of a Phase I trial is planned in 2017.
BioMed X entered a collaboration agreement with Janssen R&D to foster early-stage preclinical biomedical research and development projects. Under the agreement, the BioMed X Innovation Center in Heidelberg, Germany will accommodate as many as five Janssen research projects. The first research project will focus on rapid identification of auto-antigens in autoimmune diseases. Epidemiological data provide evidence of a steady increase in autoimmune diseases worldwide over the last decades. New platform technologies or concepts may lead to identification of antigens recognized by T cells involved in autoimmune responses.
Additionally, Janssen Pharmaceuticals entered into a worldwide exclusive license and collaboration agreement with Bavarian Nordic to leverage their MVA-BN technology with Janssen’s own AdVac and DNA-based vaccine technologies in the development and commercialization of potential new vaccine regimens against hepatitis B virus (HBV) and the human immunodeficiency virus (HIV-1). This agreement stems from successful and ongoing collaborations between the companies to develop vaccines to address Ebola and Human Papillomavirus (HPV).
Lastly, on the cancer research front, Janssen Biotech entered into a worldwide collaboration and license agreement with Legend Biotech USA and Legend Biotech Ireland Ltd., subsidiaries of Genscript Biotech Corporation, to develop, manufacture and commercialize a CAR T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen. LCAR-B38M is currently accepted for review by the China Food and Drug Administration (CFDA) and in the planning phase of clinical studies in the U.S. for multiple myeloma. LCAR-B38M is the first CAR-T therapy accepted for review by the CFDA. Janssen made an upfront payment of $350 million as part of the deal.
