Tim Wright, Editor, Contract Pharma07.15.20
Headquarters: New Brunswick, NJ
twitter.com/JNJComm
www.jnj.com
Headcount: 132,200
Pharma Revenues: $42,198 (+4%)
Net Income: $15,119 (-1%)
R&D: $11,355 (+5%)
TOP SELLING DRUGS
Johnson & Johnson’s pharmaceutical segment sales in 2019 were $42.2 billion, an increase of 3.6% from 2018. U.S. sales were up 2.5% to $23.9 billion, while international sales grew 5% to $18.3 billion.
Star portfolio performers for the year were Stelara, a biologic for the treatment of a number of immune-mediated inflammatory diseases, Darzalex, for the treatment of multiple myeloma, Imbruvica, an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, Tremfya, a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and Erleada, a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer.
J&J’s reported growth for 2019 was partially offset by biosimilar and generic competition, primarily declines in Remicade, a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, U.S. Zytiga, an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer and international Velcade, a proteasome inhibitor for the treatment of multiple myeloma.
Advancing the pipeline
J&J’s pharmaceutical investments in research and development continue to fuel growth. During the year it gained approval and launched two new transformational medicines: Spravato for treatment-resistant depression and Balversa for metastatic urothelial cancer.
J&J also submitted numerous filings and received approvals for new line extensions for key brands, including Stelara, Darzalex, Imbruvica, Tremfya and Erleada, many with peak sales potential that is greater than $500 million, the company said.
J&J continued to expand its portfolio with the strategic licensing and acquisition of new assets and platforms, including cusatuzumab from Argenx, an investigational antibody for the treatment of acute myeloid leukemia and high risk myelodysplastic syndromes.
In a collaboration deal, Janssen teamed up with MeiraGTx Holdings, a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia (ACHM) caused by mutations in either CNGB3 or CNGA3, and X-linked retinitis pigmentosa (XLRP). Further, the companies have formed a research collaboration to explore new targets for other inherited retinal diseases and further develop adeno-associated virus (AAV) manufacturing technology.
MeiraGTx will grant Janssen an exclusive worldwide license to certain clinical assets in MeiraGTx's inherited retinal disease portfolio. The companies have also formed a research collaboration to develop a pipeline of products addressing novel gene targets, giving Janssen the exclusive option to license new treatments for other inherited retinal diseases.
During the year, the Janssen Pharmaceutical Companies of J&J acquired the investigational compound bermekimab, which has multiple dermatological indications, along with certain employees, from XBiotech Inc., for $750 million. Should Janssen pursue bermekimab indications outside of dermatology, XBiotech may be eligible to receive additional payments upon the receipt of certain commercialization authorizations. Janssen Research & Development, LLC will develop bermekimab. The agreement was executed through Janssen Biotech, Inc.
Bermekimab is an anti-IL-1alpha monoclonal antibody (mAb) in Phase 2 development for the treatment of atopic dermatitis and hidradenitis suppurativa. It is the only antibody targeting IL-1a currently in clinical development and has the potential for superior efficacy and safety compared to the current standard of care.
J&J also acquired TARIS Biomedical, a privately-owned biotechnology company specializing in the development of a novel drug delivery technology for the treatment of bladder diseases including cancer. The company's lead clinical-stage product, TAR-200, uses the proprietary TARIS System, which features a silicone-based drug delivery device that allows for the continuous release of medication into the bladder. Financial terms of the transaction were not disclosed.
Driving data science
During the year, Janssen Research & Development formed a collaboration with the University of California, Berkeley and the University of California, San Francisco (UCSF), with the goal of inspiring data-driven approaches to improve health and develop the next generation of leaders in healthcare data sciences. This program is the first of its kind in the San Francisco Bay Area, which serves as a hub of both tech and biotech industries and is home to two of the world’s top universities. The agreement was facilitated by Johnson & Johnson Innovation.
The parties will collaborate to create and establish a data science health innovation fellowship program, run by UCSF and UC Berkeley, working with product and platform teams within Janssen. The program will recruit serial cohorts of up to five outstanding data scientists from industry or academia to conduct innovative research in areas of unmet patient need. Fellows will have access to computer science, engineering, and statistics expertise and technology innovation at UC Berkeley and clinical expertise and data at UCSF, which they will use with other health and biological datasets to conduct research projects over two years with mentorship from Janssen, UCSF and UC Berkeley.
Fellows will carry out their research at the Berkeley Institute for Data Science (BIDS) at UC Berkeley and the Bakar Computational Health Sciences Institute (BCHSI) at UCSF. Projects could include artificial intelligence-driven apps to inform patients about next steps in their treatment, or to give them early warning signs of disease, or new methods to manage and recruit participants for clinical trials. Such projects could ultimately lead to new companies that bridge the gap between growing healthcare datasets and meaningful insights.
Accelerating COVID-19 vax candidate
As this issue was going to press, J&J announced the acceleration of its COVID-19 vaccine candidate as it continues to build its manufacturing capacity and partnerships to meet global need. Through Janssen it has sped up the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.
The randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, response to vaccination, and immune response of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium.
The company is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule, pending outcome of Phase 1 studies and approval of regulators.
Simultaneously, J&J is continuing efforts to build global partnerships and invest in vaccine production technology and manufacturing capabilities. J&J plans on supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
twitter.com/JNJComm
www.jnj.com
Headcount: 132,200
Pharma Revenues: $42,198 (+4%)
Net Income: $15,119 (-1%)
R&D: $11,355 (+5%)
TOP SELLING DRUGS
| Drug | Indication | 2019 Sales | (+/-%) |
| Stelara | psoriasis | $6,361 | 23% |
| Remicade | rheumatoid arthritis | $4,086 | -16% |
| Darzalex | Multiple myeloma | $2,998 | 48% |
| Zytiga | prostate cancer | $2,795 | -20% |
| Invega Sustenna | schizophrenia | $2,696 | 11% |
| Xarelto | deep vein thrombosis pulmonary embolism | $2,313 | -7% |
| Simponi | rheumatoid arthritis | $2,188 | 5% |
| Prezista | HIV/AIDS | $2,110 | 8% |
| Imbruvica | oncology | $1,856 | 25% |
| Opsumit | hypertension | $1,327 | 9% |
Johnson & Johnson’s pharmaceutical segment sales in 2019 were $42.2 billion, an increase of 3.6% from 2018. U.S. sales were up 2.5% to $23.9 billion, while international sales grew 5% to $18.3 billion.
Star portfolio performers for the year were Stelara, a biologic for the treatment of a number of immune-mediated inflammatory diseases, Darzalex, for the treatment of multiple myeloma, Imbruvica, an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, Tremfya, a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and Erleada, a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer.
J&J’s reported growth for 2019 was partially offset by biosimilar and generic competition, primarily declines in Remicade, a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, U.S. Zytiga, an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer and international Velcade, a proteasome inhibitor for the treatment of multiple myeloma.
Advancing the pipeline
J&J’s pharmaceutical investments in research and development continue to fuel growth. During the year it gained approval and launched two new transformational medicines: Spravato for treatment-resistant depression and Balversa for metastatic urothelial cancer.
J&J also submitted numerous filings and received approvals for new line extensions for key brands, including Stelara, Darzalex, Imbruvica, Tremfya and Erleada, many with peak sales potential that is greater than $500 million, the company said.
J&J continued to expand its portfolio with the strategic licensing and acquisition of new assets and platforms, including cusatuzumab from Argenx, an investigational antibody for the treatment of acute myeloid leukemia and high risk myelodysplastic syndromes.
In a collaboration deal, Janssen teamed up with MeiraGTx Holdings, a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia (ACHM) caused by mutations in either CNGB3 or CNGA3, and X-linked retinitis pigmentosa (XLRP). Further, the companies have formed a research collaboration to explore new targets for other inherited retinal diseases and further develop adeno-associated virus (AAV) manufacturing technology.
MeiraGTx will grant Janssen an exclusive worldwide license to certain clinical assets in MeiraGTx's inherited retinal disease portfolio. The companies have also formed a research collaboration to develop a pipeline of products addressing novel gene targets, giving Janssen the exclusive option to license new treatments for other inherited retinal diseases.
During the year, the Janssen Pharmaceutical Companies of J&J acquired the investigational compound bermekimab, which has multiple dermatological indications, along with certain employees, from XBiotech Inc., for $750 million. Should Janssen pursue bermekimab indications outside of dermatology, XBiotech may be eligible to receive additional payments upon the receipt of certain commercialization authorizations. Janssen Research & Development, LLC will develop bermekimab. The agreement was executed through Janssen Biotech, Inc.
Bermekimab is an anti-IL-1alpha monoclonal antibody (mAb) in Phase 2 development for the treatment of atopic dermatitis and hidradenitis suppurativa. It is the only antibody targeting IL-1a currently in clinical development and has the potential for superior efficacy and safety compared to the current standard of care.
J&J also acquired TARIS Biomedical, a privately-owned biotechnology company specializing in the development of a novel drug delivery technology for the treatment of bladder diseases including cancer. The company's lead clinical-stage product, TAR-200, uses the proprietary TARIS System, which features a silicone-based drug delivery device that allows for the continuous release of medication into the bladder. Financial terms of the transaction were not disclosed.
Driving data science
During the year, Janssen Research & Development formed a collaboration with the University of California, Berkeley and the University of California, San Francisco (UCSF), with the goal of inspiring data-driven approaches to improve health and develop the next generation of leaders in healthcare data sciences. This program is the first of its kind in the San Francisco Bay Area, which serves as a hub of both tech and biotech industries and is home to two of the world’s top universities. The agreement was facilitated by Johnson & Johnson Innovation.
The parties will collaborate to create and establish a data science health innovation fellowship program, run by UCSF and UC Berkeley, working with product and platform teams within Janssen. The program will recruit serial cohorts of up to five outstanding data scientists from industry or academia to conduct innovative research in areas of unmet patient need. Fellows will have access to computer science, engineering, and statistics expertise and technology innovation at UC Berkeley and clinical expertise and data at UCSF, which they will use with other health and biological datasets to conduct research projects over two years with mentorship from Janssen, UCSF and UC Berkeley.
Fellows will carry out their research at the Berkeley Institute for Data Science (BIDS) at UC Berkeley and the Bakar Computational Health Sciences Institute (BCHSI) at UCSF. Projects could include artificial intelligence-driven apps to inform patients about next steps in their treatment, or to give them early warning signs of disease, or new methods to manage and recruit participants for clinical trials. Such projects could ultimately lead to new companies that bridge the gap between growing healthcare datasets and meaningful insights.
Accelerating COVID-19 vax candidate
As this issue was going to press, J&J announced the acceleration of its COVID-19 vaccine candidate as it continues to build its manufacturing capacity and partnerships to meet global need. Through Janssen it has sped up the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.
The randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, response to vaccination, and immune response of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will take place in the U.S. and Belgium.
The company is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule, pending outcome of Phase 1 studies and approval of regulators.
Simultaneously, J&J is continuing efforts to build global partnerships and invest in vaccine production technology and manufacturing capabilities. J&J plans on supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
