Johnson & Johnson 2021: Built for times like these

J&J has been investing in and applying the best science to take on the most serious public health threats for more than a century, including global efforts to combat COVID-19.

By Andrew Humphreys • [email protected]

 

Johnson & Johnson

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

Telephone: 732-524-0400

Website: jnj.com

 

OUTCOMES CREATIVITY INDEX SCORE: 30

Manny Awards — 2

Cannes Lions — 7

Clio Health — 3

Creative Floor Awards — 12

MM+M Awards — 6

One Show — N/A

 

Financial Performance 

(All figures are in millions of dollars, except EPS.)

2020

Revenue $82,584  

Net income $14,714  

Diluted EPS $5.51  

R&D expense $12,159  

1H 2021  

Revenue $45,633  

Net income $12,475 

Diluted EPS $4.67  

R&D expense $6,572  

 

Best-Selling Rx Products

(All sales are in millions of dollars.)

2020

Stelara $7,707  

Darzalex $4,190  

Imbruvica $4,128  

Remicade $3,747  

Invega Sustenna/Xeplion, Invega Trinza/ Invega Trevicta $3,653  

Zytiga/abiraterone acetate $2,470  

Xarelto $2,345  

Simponi, Simponi Aria $2,243  

Prezista, Prezcobix/Rezolsta, Symtuza $2,184  

Opsumit $1,639  

Tremfya $1,347 

Uptravi $1,093  

Edurant/rilpivirine $964  

Invokana, Invokamet $795  

Erleada $760  

Risperdal Consta $642  

Concerta/methylphenidate $622   

Procrit/Eprex $552  

Velcade $408  

1H 2021 

Stelara $4,422  

Darzalex $2,798  

Imbruvica $2,241  

Invega Sustenna/Xeplion, Invega Trinza/ Invega Trevicta $1,989 

Remicade $1,665 

Zytiga/abiraterone acetate $1,201  

Xarelto $1,158  

Simponi, Simponi Aria $1,146  

Prezista, Prezcobix/Rezolsta, Symtuza $1,051  

Opsumit $913  

Tremfya $897  

Uptravi $618  

Erleada $563  

Edurant/rilpivirine $505  

Concerta/methylphenidate $332 

Risperdal Consta $312  

Invokana, Invokamet $310  

Procrit/Eprex $254  

 

As the world’s largest and most broadly based healthcare company, we have both a unique perspective on global health and a profound responsibility to lead when called. As soon as the DNA sequencing of the COVID-19 virus was made available, our role was clear even though success was anything but guaranteed: We at Johnson & Johnson would do everything in our power to develop a safe, effective, and efficient vaccine for the largest number of people around the world,” stated J&J Chairman and Chief Executive Officer Alex Gorsky.

Exactly one year after officially starting the development process, the company was able to share positive top-line results from the Phase III ENSEMBLE clinical trial for J&J’s single-dose COVID-19 vaccine. Shortly after, based on the totality of scientific evidence, J&J received Emergency Use Authorization from the U.S. Food and Drug Administration for the vaccine and immediately began shipping doses in the United States.

“This monumental achievement will be an enduring point of pride for us for decades to come. Perhaps most remarkable of all: The successful development of our COVID-19 vaccine was only one of the many incredible accomplishments that made 2020 a year like no other for our company,” according to Gorsky. 

“While the development of our COVID-19 vaccine in just 12 months is an incredible triumph of science, it was not our only significant achievement,” Gorsky noted about Johnson & Johnson’s 2020 performance. “Our Pharmaceutical business continued to outperform the industry across therapeutic areas and regions. And 2020 marked the ninth consecutive year of above-market adjusted operational growth – all while keeping our pipeline submissions and approvals on track, as well as achieving greater patient enrollment in clinical trials compared to 2019. We received approval for a subcutaneous formulation of multiple myeloma drug Darzalex (daratumumab) in 2020 – ahead of our scheduled U.S. PDUFA date. This new formulation took a multi-hour intravenous treatment down to a subcutaneous delivery that is executed in just minutes. We focused on educating healthcare practitioners and successfully launched the product in a virtual environment – reaffirming our strong commercial capabilities.”

New Leader On The Way

Johnson & Johnson announced in August 2021 that Gorsky will serve as executive chairman and transition the CEO post to Joaquin Duato, who has served as vice chairman of the company’s executive committee, effective January 3, 2022. Following the transition of the CEO position, Duato will additionally be appointed as a member of the company’s board of directors.

“It has been an honor and privilege to lead this company as chairman and CEO for nearly a decade, and I am pleased to serve as executive chairman to help oversee Johnson & Johnson’s ongoing progress improving the health of people and communities everywhere,” Gorsky said. “Over the course of my 30-year career at Johnson & Johnson, guided by Our Credo, I have witnessed the profound impact of the company’s evolution and expansion of life-enhancing medicines. The past decade alone has been transformational for Johnson & Johnson as we dramatically increased investment in R&D, drove some of the most important global advances in healthcare, made significant strategic shifts across the business and delivered record performance. Most of all, I am humbled to lead our talented and dedicated team of 136,000 associates around the world, and I am immensely proud of how we have upheld the company’s 134-year legacy of delivering solutions to address the world’s most urgent, unmet healthcare needs.”

Gorsky has served as chairman and CEO since 2012. Gorsky has overseen a more than 60 percent increase in R&D investments to $12 billion during 2020, making J&J one of the industry’s top investors in research and development. During his tenure, J&J has carried out hundreds of acquisitions and partnerships that contributed to the company’s growth across three business segments and an increase in adjusted earnings per share of 85 percent based on 2021 guidance [as of July 21]. A primary focus of R&D investment under Gorsky’s leadership has been oncology, with J&J’s sales in this segment growing from $2 billion in 2011 to more than $12 billion during 2020. Acquisitions have included Actelion, the largest in J&J’s history, which significantly expanded the company’s Pharmaceutical business portfolio of rare-disease treatments.

Covid-19 Vaccine

Johnson & Johnson’s single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of J&J, received Emergency Use Authorization from the Food and Drug Administration on Feb. 27, 2021, to prevent COVID-19 in individuals 18 years of age and older. This decision was based on the totality of scientific evidence, including data from the Phase III ENSEMBLE trial that showed the vaccine was 85 percent effective in preventing severe disease across all regions studied, and demonstrated protection against COVID-19 related hospitalization and death, starting 28 days after vaccination.

New data reinforcing the strong and long-lasting protection of the company’s COVID-19 vaccine were reported in September 2021. New data additionally demonstrated that protection against COVID-19 increases when a booster shot of the J&J vaccine is administered. Management says the safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.

“Our large real-world evidence and Phase III studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations. Additionally, our Phase III trial data further confirm protection against COVID-19-related death,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases.”

According to Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J, “It is critical to prioritize protecting as many people as possible against hospitalization and death given the continued spread of COVID-19. A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population. At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.”

The company announced on Aug. 25 data supporting the use of the COVID-19 vaccine as a booster shot for people previously vaccinated with the single-shot Johnson & Johnson vaccine. During July, J&J reported interim Phase I/2a data published in the New England Journal of Medicine that showed neutralizing antibody responses generated by the single-shot COVID-19 vaccine were strong and stable through eight months after immunization. According to data, T-cell responses – including the important CD8+ T-cells that seek out and destroy infected cells – persisted over the eight-month timeframe examined. 

In anticipation of the potential necessity for boosters, J&J performed two Phase I/IIa trials in individuals previously vaccinated with the single-shot vaccine. Interim data from those trials show that a booster dose of the vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination. Significant increases in binding antibody responses were observed in participants between the ages 18 and 55 years, and in those 65 years and older who received a lower booster dose. The trial summaries were submitted to medRxiv on Aug. 24.

Johnson & Johnson announced data on July 1 that showed the COVID-19 vaccine generated strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data demonstrated that the durability of the immune response lasted through at least eight months, the length of time assessed to date. The two preprint study summaries were submitted to bioRxiv. 

“Current data for the eight months studied so far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody response that does not wane; rather, we observe an improvement over time. In addition, we observe a persistent and particularly robust, durable cellular immune response,” Dr. Mammen said. “With each new dataset, we build on our solid foundation of evidence that our single-shot COVID-19 vaccine plays a critical role in ending the pandemic, which continues to evolve and pose new challenges to global health.”

The Food and Drug Administration extended the shelf life for the single-shot COVID-19 vaccine to six months, as announced by the company on July 28. The decision is based on data from ongoing stability assessment studies, which have shown the vaccine is stable at six months when refrigerated at temperatures of 36 – 46 degrees Fahrenheit (2 – 8 degrees Celsius).

J&J welcomed the U.S. government’s decision in July to donate an initial 12 million doses of the company’s vaccine via the COVAX Facility to multiple lower-income countries across three continents. Separately, the United States had already donated 8 million doses of J&J’s vaccine through a series of bilateral agreements with higher-income countries including Brazil, Colombia, Mexico and South Korea. The dose donations to COVAX were enabled by a tripartite deal signed by the U.S. government, J&J and Gavi, the Vaccine Alliance. The U.S. government’s donations were in addition to J&J’s own commitment to provide up to a combined 900 million single-shot vaccines directly to COVAX and the African Union through 2022.

Johnson & Johnson on March 12 announced that the World Health Organization (WHO) issued Emergency Use Listing (EUL) for the single-shot vaccine to prevent COVID-19 in individuals 18 years of age and older.

The company’s COVID-19 vaccine received Conditional Marketing Authorization from the European Commission on March 11, 2021, to prevent COVID-19 in individuals 18 years of age and older. Health Canada granted an Interim Order (IO) authorization on March 5 for the Janssen vaccine to prevent COVID-19 in individuals 18 years of age and older.

Since January 2020, J&J has worked directly with governments, health authorities and other companies to help end the worldwide pandemic. During early March 2021, Merck became the ninth manufacturer to join J&J’s global network via a collaboration to deliver the Janssen COVID-19 vaccine globally.

U.S. Opioid Settlement Agreement

Johnson & Johnson and Janssen Pharmaceutical Companies announced during July 2021 the finalization of a nationwide settlement agreement to resolve opioid-related claims and litigation by states, cities, counties and other subdivisions in the United States. As previously announced, J&J will contribute up to $5 billion to the settlement, depending on the amount of state and local governments that elect to opt into the settlement deal.

According to J&J’s July 21 press release, “The company’s actions relating to the marketing and promotion of important prescription opioid medications were appropriate and responsible. Duragesic, Nucynta and Nucynta ER accounted for less than one percent of total opioid prescriptions in the U.S. since launch. This national settlement agreement is designed to resolve the vast majority of litigation-based claims regarding the past sales of the company’s prescription opioid medications. This is not an admission of any liability or wrongdoing and the company will continue to defend against any litigation that the final agreement does not resolve. The company no longer sells prescription opioid medications in the United States as part of our ongoing efforts to focus on transformational innovation and serving unmet patient needs.”

Voluntary Recall

Johnson & Johnson Consumer voluntarily recalled all lots of five Neutrogena and Aveeno aerosol sunscreen product lines to the consumer level, according to a July 14 announcement. Internal testing identified low levels of benzene in some product samples. 

Management says this recall did not have a material impact on the company’s fiscal second-quarter 2021 financial results and is not expected to have a material impact on the overall results for the remainder of the year.

Financial Performance

After generating global sales of $82.06 billion during 2019 and $82.58 billion in 2020, Johnson & Johnson’s worldwide sales for the first-half 2021 period vaulted up to $45.63 billion. The first-half 2021 global sales performance represented a total year-over-year increase of 16.9 percent, including an operational increase of 13.7 percent versus 2020 first fiscal six months sales of $39.03 billion. Management says currency fluctuations had a positive impact of 3.2 percent for first-half 2021. The net impact of acquisitions and divestitures on worldwide operational sales growth was reported at negative 0.7 percent.

Sales by J&J’s U.S. companies amounted t0 $23.03 billion in the first fiscal six months of 2021, representing growth of 13.8 percent versus the same prior-year period. The net impact of acquisitions and divestitures on the U.S. operational sales growth was a negative 0.1 percent for the 2021 first half. 

Sales by international companies for the 2021 first half ended July 4 rose 20.3 percent to $22.6 billion, including operational growth of 13.7 percent, and a positive currency impact of 6.6 percent compared to the 2020 six-month period ended June 28. The net impact of acquisitions and divestitures on the international operational sales growth during 2021’s first half was a negative 1.1 percent.

Sales by companies in Europe during the first fiscal six months of 2021 totaled $11.08 billion for growth of 24.7 percent, which included an operational increase of 15.6 percent and a positive currency impact of 9.1 percent. Sales by companies in the Western Hemisphere reached $2.79 billion, excluding the United States, representing growth of 5.9 percent that included an operational increase of 5.4 percent and a positive currency impact of 0.5 percent. Sales by companies in the Asia-Pacific, Africa region achieved growth of 20.2 percent to $8.73 billion, including an operational increase of 14.2 percent and a positive currency impact of 6 percent. 

Pharmaceutical segment sales for Johnson & Johnson during the first fiscal six months of 2021 came in at $24.8 billion, representing 13.3 percent growth versus same-time 2020, with an operational increase of 10.3 percent and a positive currency impact of 3 percent. U.S. Pharmaceutical sales rose 9.3 percent to $13.32 billion. International Pharmaceutical sales went up 18.3 percent to $11.48 billion, including operational growth of 11.4 percent and a positive currency impact of 6.9 percent. For the 2021 fiscal first half, the net impact of acquisitions and divestitures on the Pharmaceutical segment operational sales growth was negative 0.4 percent.

The Medical Devices segment produced sales of $13.56 billion during the first fiscal six months of 2021, rising 32.7 percent year-over-year, with an operational increase of 28.7 percent and a positive currency impact of 4.0 percent. U.S. Medical Devices sales went up 33.5 percent to $6.35 billion. International Medical Devices sales rose 31.9 percent to $7.2 billion, including an operational increase of 24.5 percent and a positive currency impact of 7.4 percent. During the first fiscal six months of 2021, the net impact of acquisitions and divestitures on the operational sales growth of the Medical Devices business was a negative 1 percent primarily due to the divestiture of the Advanced Sterilization Products (ASP) business.

J&J’s Consumer Health segment generated sales of $7.28 billion during the first fiscal six months of 2021, rising 5.2 percent year-over-year, including operational growth of 2.7 percent and a positive currency impact of 2.5 percent. U.S. Consumer Health segment sales increased 2 percent to $3.36 billion. International Consumer Health segment sales amounted to $3.92 billion with 8.1 percent growth, including operational growth of 3.3 percent and a positive currency impact of 4.8 percent. In the first fiscal six months of 2021, J&J reported that the net impact of acquisitions and divestitures on the Consumer Health segment operational sales growth was a negative 0.6 percent.

For Johnson & Johnson’s full-year 2021 guidance as of July that includes sales from the company’s COVID-19 vaccine, operational sales are projected to be $92.5 billion to $93.3 billion (12 percent to 13 percent growth versus full-year 2020) and estimated reported sales are expected to be $93.8 billion to $94.6 billion (13.5 percent to 14.5 percent year-over-year growth).

Product Approvals & Pipeline Updates

Rybrevant (amivantamab-vmjw) was the recipient of U.S. accelerated approval during May 2021 as the first targeted treatment for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations. Rybrevant represents the first fully human, bispecific antibody approved in lung cancer. The simultaneous approval of a companion diagnostic aids in the identification of exon 20 insertion mutations, according to Janssen.

Rybrevant was approved by U.S. regulators for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. The marketing clearance follows the Food and Drug Administration’s decision to grant Breakthrough Therapy Designation during March 2020 and to initiate a Priority Review of the Biologics License Application (BLA) in December 2020. The accelerated approval was based on overall response rate and duration of response.

Cabenuva (rilpivirine and cabotegravir) during January 2021 became the first long-acting regimen approved by the FDA for the treatment of HIV. The combination medicine, consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir, offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression. The novel regimen was jointly developed as part of a collaboration with ViiV and builds on Janssen’s 25-year dedication to make HIV history. ViiV is the U.S. marketing authorization holder for Cabenuva.

Janssen announced during February the filing of a supplemental NDA to the FDA by ViiV for expanded use of Cabenuva as an HIV treatment for use every two months. Positive long-term data were unveiled in March from the global Phase IIIb study of the first complete, long-acting (LA), two-drug injectable regimen for treating human immunodeficiency virus type 1 (HIV-1) infection in adults. The 96-week findings of the Antiretroviral Therapy as Long-Acting Suppression Every 2 Months (ATLAS-2M) study confirmed the primary endpoint, met at Week 48, and met the secondary endpoint, demonstrating efficacy of both monthly dosing and every two-month dosing during the long term in virologically suppressed adults with HIV-1. 

The Food and Drug Administration in September approved Invega Hafyera (6-month paliperidone palmitate), the first twice-yearly injectable for treating schizophrenia in adults. Before transitioning to the new long-acting atypical antipsychotic, patients must be adequately treated with Invega Sustenna (1-month paliperidone palmitate) for at least four months, or Invega Trinza (3-month paliperidone palmitate) for at least one 3-month injection cycle.

According to Janssen, Invega Hafyera offers patients the fewest doses per year for a life less defined by schizophrenia medication. Phase III non-inferiority trial results demonstrated more than 92 percent of participants were relapse-free at 12 months. The FDA approval is backed by nearly two decades of proven efficacy and safety of Janssen’s long-acting injectable portfolio of schizophrenia products.

FDA approval was granted in January 2021 to Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of Darzalex, in combination with bortezomib (Velcade), cyclophosphamide and dexamethasone (D-VCd) for treating adults with newly diagnosed light chain (AL) amyloidosis. The regulatory nod marks the first FDA-approved treatment for patients with this blood cell disorder that is associated with the production of an abnormal protein, which results in the deterioration of vital organs, most notably the heart, kidneys and liver. Accelerated approval of the comb0 regimen was supported by the Phase III ANDROMEDA trial showing a significantly higher hematologic complete response rate in this rare and serious blood cell disorder.

In further analysis from the Phase III ANDROMEDA trial reported in May 2021, longer-term results from a median follow-up of 20.3 months demonstrated rates of hematologic complete response (hemCR) remained significantly higher in patients treated with Darzalex Faspro in combination D-VCd versus VCd alone (Abstract #8003). 

The FDA approved an expanded indication for Xarelto (rivaroxaban) plus aspirin to include patients after lower-extremity revascularization (LER) due to symptomatic peripheral artery disease (PAD). Xarelto is the first therapy indicated for both coronary artery disease (CAD) and peripheral artery disease, now including PAD patients post-LER. Xarelto is also the only anticoagulant in 20 years to demonstrate significant benefit in patients with PAD who remain at high risk for major thrombotic events, including acute limb ischemia and amputation.

A New Drug Application (NDA) was filed with the FDA for the use of Xarelto in pediatric patients, as announced by Janssen in June 2021. The NDA seeks two pediatric indications: the treatment of venous thromboembolism (VTE, or blood clots) and the reduction in the risk of recurrent VTE in patients aged birth to less than 18 years old after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure. Xarelto would be the first oral Factor Xa inhibitor indicated in the United States for use in pediatric patients if approved for marketing.

Uptravi (selexipag) gained U.S. marketing clearance during July 2021 for intravenous use in adult patients with pulmonary arterial hypertension (PAH). Janssen says the new formulation allows for uninterrupted treatment for PAH patients temporarily unable to take oral therapy. Uptravi tablets were initially approved by the FDA during 2015 to delay disease progression and reduce the risk of hospitalization for PAH.

Findings from an analysis of the first 500 patients enrolled in the SPHERE registry (SelexiPag: tHe usErs dRug rEgistry) found 76 percent of PAH patients treated with Uptravi either maintained (56 percent) or reduced (20 percent) their one-year mortality risk score. The SPHERE results were published in the April 2021 edition of the Journal of Heart and Lung Transplantation (JHLT).

Ponvory (ponesimod) was granted U.S. approval in March 2021 to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator is the first FDA-approved oral disease modifying therapy studied against an established oral comparator. 

Head-to-head pivotal study results showed Ponvory treatment led to nearly one-third fewer annual relapses than Sanofi’s Aubagio (teriflunomide). The marketing clearance follows more than 10 years of cumulative data from Phase II and Phase III trials showing the medicine’s efficacy and safety.

The European Commission granted marketing authorization in May for Ponvory as a once-daily, oral therapy for treating adults with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features. Janssen said the pivotal Phase III OPTIMUM study demonstrated treatment with ponesimod resulted in a 30.5 percent reduction in annual relapse rate (p<0.001) compared to treatment with teriflunomide – an active comparator and widely used first-line oral treatment – in adult patients with relapsing multiple sclerosis (RMS). The OPTIMUM study is the first of its kind to compare head-to-head two oral disease modifying treatments (DMTs) in RMS. 

In another first during May, Janssen presented clinical results of the only head-to-head study of biologic therapies in patients with moderate-to-severe Crohn’s disease (CD). SEAVUE data demonstrated treatment with Stelara showed high rates of clinical remission, corticosteroid-free remission, clinical response and endoscopic response through one year in biologic-naïve patients with moderately to severely active CD, although the primary endpoint of statistical superiority versus adalimumab was not demonstrated.

The European Commission during February authorized the expanded use of Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate-to-severe episode of Major Depressive Disorder (MDD), as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgment constitute a psychiatric emergency. Janssen said this milestone makes esketamine nasal spray the first N-methyl-D-aspartate (NMDA) antagonist to be approved for MDD patients in a psychiatric emergency.

Updated Phase III trial results reported in June demonstrated the Imbruvica (ibrutinib) plus venetoclax (I+V) combination regimen showed superior progression-free survival in adults with previously untreated chronic lymphocytic leukemia (CLL). The clinical trial showed superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus chlorambucil plus obinutuzumab (Clb+O) as a first-line treatment of CLL. The study additionally demonstrated improved duration of remission and significantly improved depth of remission.

Janssen announced OS results from the Phase III MAIA (NCT02252172) trial demonstrating the addition of Darzalex to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit versus lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression. After nearly five years of follow-up, median PFS was not reached, and a significant OS benefit was observed.

New Phase IIIb psoriatic arthritis (PsA) results released in early June demonstrated first-in-class Tremfya (guselkumab) achieved robust joint symptom improvement and complete skin clearance in patients with inadequate response to tumor necrosis factor inhibition (TNFi-IR). Data showed 57.7 percent achieved ≥20 percent improvement in joint symptoms (ACR20) and 53.4 percent achieved complete skin clearance (PASI 100) at one year in COSMOS, the first clinical trial of a selective interleukin (IL)-23 inhibitor in a true TNFi-IR patient population.

Previously in April, Phase III data showed Tremfya provided durable complete skin clearance through five years in moderate-to-severe plaque psoriasis (PsO) and robust joint symptom improvement through 52 weeks in active PsA. Tremfya is the first selective interleukin (IL)-23 inhibitor therapy approved for both PsO and PsA.

Phase III data for Tremfya released in March demonstrated more than 50 percent of adults with active PsA achieved complete skin clearance (PASI 100) and over 70 percent achieved at least 20 percent improvement in joint symptoms (ACR 20). These data represent the first long-term Phase III trial results for a selective IL-23 inhibitor therapy in PsA, which include impact on radiographic progression through two years.

Data from two papers published during September 2021 in The Lancet Infectious Diseases showed that the J&J Ebola vaccine regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo), generated robust humoral (antibody) immune responses in adults and children (ages 1-17) with the immune responses persisting in adults for at least two years. The data additionally demonstrated that booster vaccination with Ad26.ZEBOV, administered to adults two years after the initial vaccination, induced a strong anamnestic (immune) response within seven days. These findings support the potential prophylactic use of the vaccine regimen, which was developed by Janssen in collaboration with Bavarian Nordic, and was granted Marketing Authorization by the European Commission in July 2020 and Prequalification from the World Health Organization (WHO) during April 2021.

The clinical data from the Phase III EBOVAC-Salone trial demonstrated that the vaccine regimen was well-tolerated and induced antibody responses to the Zaire ebolavirus species 21 days after the second dose in 98 percent of all participants. The company reported that there were no safety signals of concern from the study. 

J&J joined the World Health Organization during May in efforts to prevent the spread of Ebola in West Africa. Up to 200,000 J&J Ebola vaccine regimens were made available as part of a WHO early access clinical program under way in Sierra Leone. The company’s Ebola vaccine regimen additionally received Prequalification from the WHO. J&J’s vaccine regimen is designed to be used proactively to induce immunity against Ebola in adults and children.

Janssen Pharmaceutical announced new data in September showing robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with Erleada (apalutamide) in the real-world clinical setting. The strong PSA response was additionally seen in a separate post-hoc analysis that demonstrated a correlation between rapid and deep PSA response and prolonged survival in metastatic castration-sensitive prostate cancer (mCSPC) and nmCRPC. The post-hoc analysis of the Phase III TITAN and SPARTAN trials additionally supports the use of PSA as a predictive biomarker in treating patients with advanced prostate cancer. 

Janssen announced during May 2021 that long-term Erleada patient-reported outcomes data in metastatic castration-sensitive prostate cancer showed maintenance of health-related quality of life for patients. Results presented at ASCO 2021 from the Phase III TITAN trial final analysis confirmed survival benefit was achieved with the addition of Erleada to androgen deprivation therapy (ADT) without significant side effect burden.

Final analysis from TITAN in February 2021 showed Erleada provided statistically significant overall survival benefit and consistent safety profile in patients with advanced prostate cancer, regardless of extent of disease, versus placebo plus ADT.

Janssen announced in April that regulatory submissions based on the Phase III ACIS trial, which tested the combination of Erleada and Zytiga (abiraterone acetate) plus prednisone in patients with chemotherapy-naïve mCRPC, would not be pursued.

Breakthrough Therapy Designation (BTD) was granted by the FDA for Janssen’s teclistamab in the treatment of relapsed or refractory multiple myeloma (MM), as reported by the company on June 1. This designation for teclistamab – an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors – follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier during 2021. According to management, this BTD represented the 11th received by Janssen’s Oncology Therapeutic Area.

In other multiple myeloma drug news announced on June 1, new data for ciltacabtagene autoleucel (cilta-cel) – an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy – showed sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM). The 18-month follow-up from the pivotal CARTITUDE-1 trial, including PFS data, was presented at the 2021 ASCO and EHA Annual Meetings.

During December 2020, Janssen announced the initiation of a rolling submission of the company’s Biologics License Application (BLA) to the FDA for cilta-cel for the treatment of adults with RRMM.

Cilag GmbH International, one of the Janssen Pharmaceutical Companies, announced during June the decision not to continue the collaboration and license agreement with argenx for cusatuzumab. The investigational therapeutic antibody targets CD70.

Medical Device Updates

Johnson & Johnson Vision – a worldwide leader in eye health and part of the Johnson & Johnson Medical Devices Companies – announced in May 2021 the FDA approval of TECNIS Synergy and TECNIS Synergy Toric II IOLs, and the Health Canada approval of TECNIS Synergy Toric II IOLs. The company says this next-generation PCIOL is built on the legacy TECNIS platform and delivers the widest range of continuous vision with the best near vision among leading PCIOLs, superior contrast even in low-light conditions, and reduced spectacle wear. In a company-sponsored study, nine out of 10 patients who received TECNIS Synergy IOL lenses did not require glasses post-surgery.

The Johnson & Johnson Medical Devices Companies announced in January that DePuy Synthes received 510(k) clearance from the FDA for the VELYS Robotic-Assisted Solution designed for use with the ATTUNE Total Knee System and its cleared indications for use. VELYS is adaptable technology that helps simplify surgeons’ existing workflow, and is designed around how surgeons plan, execute and perform surgery for total knee replacement.

Johnson & Johnson Medical Devices Company Ethicon announced during June the launch of the ENSEAL X1 Curved Jaw Tissue Sealer. The new advanced bipolar energy device increases procedural efficiency and provides stronger sealing and better access to more tissue than LigaSure Maryland. Ethicon says the device is indicated for colorectal, gynecological, bariatric surgery and thoracic procedures.