Johnson & Johnson 2020: Navigating the COVID-19 landscape

Johnson & Johnson is concentrated on advancing the development of new products to help address pandemics and save lives, including a novel coronavirus vaccine.

By Andrew Humphreys • [email protected]

 

 

Johnson & Johnson

One Johnson & Johnson Plaza
New Brunswick, NJ 08933
Telephone: 732-524-0400
Website: jnj.com

 

FINANCIAL PERFORMANCE

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

2019

Revenue $82,059  

Net income $15,119  

Diluted EPS $5.63 

R&D expense $11,355  

1H 2020

Revenue $39,027  

Net income $9,422  

Diluted EPS $3.53 

R&D expense $5,287  

 

BEST-SELLING Rx PRODUCTS

(All sales are in millions of dollars)

2019

Stelara $6,361 

Remicade $4,380  

Imbruvica $3,411  

Invega Sustenna/Xeplion, Invega Trinza/Invega Trevicta $3,330

Darzalex $2,998  

Zytiga/abiraterone acetate $2,795   

Xarelto $2,313  

Simponi, Simponi Aria $2,188   

Prezista, Prezcobix/Rezolsta, Symtuza $2,110 

Opsumit $1,327  

Tremfya $1,012  

Edurant/rilpivirine $861  

Uptravi $819  

Procrit/Eprex $790  

Velcade $751  

Invokana, Invokamet $735  

Concerta/methylphenidate $696    

Risperdal Consta $688  

1H 2020

Stelara $3,516  

Imbruvica $1,980  

Remicade $1,925  

Darzalex $1,838  

Invega Sustenna/Xeplion, Invega Trinza/Invega Trevicta $1,762  

Zytiga/abiraterone acetate $1,258  

Prezista, Prezcobix/Rezolsta, Symtuza $1,089  

Xarelto $1,086 

Simponi, Simponi Aria $1,075  

Opsumit $795  

Tremfya $638 

Uptravi $532 

Edurant/rilpivirine $480  

Invokana, Invokamet $354  

Risperdal Consta $323 

Concerta/methylphenidate $320  

Erleada $313  

Procrit/Eprex $291   

Velcade $206  

 

Outcomes Creativity Index Score: 67
Manny Awards – 9
Cannes Lions – N/A
LIA: Health & Wellness – 11
Clio Health – 9
One Show: HW&P – 2
MM&M Awards – N/A
Global Awards – 20
Creative Floor Awards – 16

 

“We are developing innovative medicines and revolutionary products that are changing and saving people’s lives,” says Johnson & Johnson Chairman and CEO Alex Gorsky. “We are working to cure cancer, offer less invasive surgeries and eradicate global pandemics. This is what the world expects of us and this is what our global workforce is united around, committed to and prepared to do.”

Gorsky is one of nine CEOs to announce a historic pledge in September, outlining a united commitment to uphold the integrity of the scientific process as their companies work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the most complex and deadly public health threats around the globe.

Also during September, CEOs from 16 companies including Gorsky as well as Bill and Melinda Gates – co-chairs of the Bill & Melinda Gates Foundation – signed a landmark Communiqué on Expanded Global Access commitment to ensure that people everywhere have access to the potential COVID-19 innovations under development at the companies regardless of their income level. The communiqué calls on governments, NGOs and other stakeholders to join the cause and help accelerate the end of the pandemic.

Johnson & Johnson’s lead SARS-CoV-2 investigational vaccine candidate is JNJ-78436735, also known as Ad26.COV2.S, which is being developed by Janssen Pharmaceutical Companies. During September, the first participants were dosed in the Phase 3 study ENSEMBLE evaluating the safety and efficacy of Janssen’s COVID-19 vaccine candidate. ENSEMBLE will enroll up to 60,000 volunteers across three continents and will assess the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19. 

During September, data were published in Nature Medicine demonstrating that the company’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited an immune response as demonstrated by “neutralizing antibodies” and prevented severe clinical disease – including weight loss, pneumonia and mortality – in Syrian golden hamsters upon challenge. 

This publication followed J&J’s announcement that the vaccine candidate elicited an immune response in a pre-clinical study in non-human primates (NHP), that correlated with protection against SARS-CoV-2, providing complete protection against viral replication in the lungs. The pre-clinical studies were performed by researchers from Beth Israel Deaconess Medical Center (BIDMC) in collaboration with the Janssen Pharmaceutical Companies of J&J and others as part of an ongoing collaboration.

Janssen entered into an agreement during August with the U.S. government for the large-scale domestic manufacturing and delivery in the U.S. of 100 million doses of Ad26.COV2.S for use in the United States following approval or Emergency Use Authorization by the U.S. FDA. The Biomedical Advanced Research and Development Authority (BARDA) – part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response – in collaboration with the U.S. Department of Defense, is committing more than $1 billion for this agreement. J&J says the vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The U.S. government may additionally purchase another 200 million doses of Ad26.COV2.S under a subsequent deal.

The company is testing one-dose and two-dose regimens and working diligently to ensure broad, worldwide access to the vaccine following approval or authorization by health regulators. J&J aims to meet the company’s goal to supply more than 1 billion doses worldwide through the course of 2021, provided the vaccine is safe and effective.

The company’s SARS-CoV-2 vaccine program leverages Janssen’s AdVac technology. The same technology was used to develop Janssen’s European Commission-approved Ebola vaccine and construct the company’s HIV, RSV and Zika vaccine candidates. More than 90,000 individuals have been vaccinated as of Aug. 5 using the Janssen AdVac-based platform.

J&J announced during August the company’s founding and co-leading of the new CARE (Corona Accelerated R&D in Europe) consortium, Europe’s largest, multi-partner scientific research initiative dedicated to discovering and developing urgently needed treatment options for COVID-19. “In this role, we are helping bring together Europe’s best and brightest scientific minds from 37 renowned academic institutions, research organizations and pharmaceutical companies, together with partners from the United States and China. CARE is supported by the Innovative Medicines Initiative, the world’s largest public-private partnership in the life sciences, which is funded by the European Union and the private sector,” J&J management says.

Johnson & Johnson acquires Momenta Pharmaceuticals 

Johnson & Johnson entered into a definitive agreement during August to acquire Momenta Pharmaceuticals in an all-cash transaction for $6.5 billion, and the deal was completed on Oct. 1. Momenta discovers and develops novel therapies for immune-mediated diseases.

The acquisition provides an opportunity for Janssen Pharmaceutical to broaden the company’s leadership in immune-mediated diseases and drive further growth via expansion into autoantibody-driven disease. The transaction includes full global rights to nipocalimab (M281), a clinically validated, potentially best-in-class anti-FcRn antibody. Nipocalimab allows Janssen the opportunity to reach significantly more patients by pursuing indications across various autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology. 

Nipocalimab has received a rare pediatric disease designation from the U.S. Food and Drug Administration. Momenta’s expertise in FcRn mechanisms is especially significant for nipocalimab, supporting and accelerating the development of a medicine designed to target autoantibody-driven conditions across several of Janssen’s established therapeutic areas. Janssen anticipates nipocalimab will contribute to the company’s goals of achieving above-market growth during the mid and long term.

With competitively differentiated, parallel development programs and full worldwide commercial rights for nipocalimab, Janssen has the potential to introduce multiple launches – many as first-in-class indications with potential for significant peak year sales, some of which could top $1 billion – supporting management’s goal of continuing to deliver above-market performance over the long term.

“This acquisition broadens Janssen’s leadership in autoimmune diseases and provides us with a major catalyst for sustained growth. Autoantibody-driven diseases are often serious, and patients are underserved by current treatment options,” says Jennifer Taubert, Executive VP, Worldwide Chairman, Pharmaceuticals, J&J. “We’re excited by the opportunity to further advance patient care by combining Johnson & Johnson’s world-class R&D, commercial and supply chain capabilities with Momenta’s talented people, pipeline and deep expertise in this important area.”

In addition to Momenta’s employees and lead asset nipocalimab, Janssen acquired the company’s pipeline of clinical and pre-clinical assets. The transaction was driven by the important opportunity evident in nipocalimab, along with the scientific capability Janssen acquired with the Momenta team. Janssen’s plans for other assets in the Momenta pipeline will be determined as more data become available and could offer additional upside potential.

“Nipocalimab, and the rest of Momenta’s pipeline, built over many years by outstanding scientists who have turned important insights into actionable biology, expands and complements our portfolio by giving us clinical-stage and discovery-stage compounds in autoantibody biological pathways. Combining Momenta’s discoveries with our 20-year heritage in immunology, global scope, and scientific and medical expertise, we see a real opportunity to create an entire ‘pipeline in a pathway,’” says Mathai Mammen, M.D., Ph.D., Global Head of Janssen R&D, J&J. “We are excited about the significant potential to expand on Momenta’s excellent progress in rare diseases, and to increase our impact on patients both within and beyond our current focus areas.”

Janssen intends to retain Momenta’s presence in Cambridge, Massachusetts. This site will increase J&J’s existing innovation footprint and capabilities in the greater Boston area “given Momenta’s talented scientists, suite of proprietary technologies, sophisticated laboratories and proximity to top talent in this innovation hub,” J&J management says.

2020 Performance & Outlook

Worldwide sales for J&J in first-half 2020 totaled more than $39 billion, representing a decline of 3.8%, including an operational decrease of 2.2% versus the company’s performance during January-June 2019. According to J&J, currency fluctuations had a negative impact of 1.6% for the first fiscal six months of 2020. The net impact of acquisitions and divestitures on global operational sales growth was a negative 0.5%.

Sales by J&J’s U.S. companies amounted to $20.2 billion in the first fiscal six months of 2020, a decrease of 1.4% versus same-time 2019. During first-half 2020, the net impact of acquisitions and divestitures on the U.S. operational sales growth was a negative 0.6%. J&J sales by international companies were reported at $18.8 billion, down 6.3%, including operational decline of 2.9% and a negative currency impact of 3.4%. The net impact of acquisitions and divestitures on the international operational sales growth was a negative 0.3% for the 2020 first half.

During the first fiscal six months of 2020, sales by companies in Europe fell 4.8% year-over-year, including an operational decrease of 2.1% and a negative currency impact of 2.7%. J&J sales by companies in the Western Hemisphere, excluding the United States, experienced a  10.9% decline, which included an operational decline of 0.1% and a negative currency impact of 10.8%. Sales by companies in the Asia-Pacific, Africa region during first-half 2020 dropped off year-over-year by 6.3%, including an operational decline of 4.9% and a negative currency impact of 1.4%. 

For J&J’s Pharmaceutical segment during the first fiscal six months of 2020, sales improved 5.4% to reach $21.9 billion, with operational growth of 7.0% and a negative currency impact of 1.6%. U.S. Pharmaceutical sales rose 7.2% versus the one-year-earlier period. International Pharmaceutical sales during January-June 2020 advanced by 3.2%, including operational growth of 6.7% and a negative currency impact of 3.5%. The net impact of acquisitions and divestitures on the Pharmaceutical segment operational sales growth was negligible during the 2020 first half.

J&J’s Medical Devices segment generated $10.2 billion in first-half 2020 sales, a decline of 21.1% versus the one-year-earlier corresponding period, with an operational decrease of 19.8% and a negative currency impact of 1.3%. U.S. Medical Devices sales fell 23.1% year-over-year. International Medical Devices sales were down 19.2%, including an operational decline of 16.8% and a negative currency impact of 2.4%. In the first half of 2020, the net impact of acquisitions and divestitures on the Medical Devices segment operational sales growth was a negative 1.0%, primarily due to the divestiture of the ASP business.

First-half 2020 Consumer Health segment sales totaled $6.9 billion, representing an increase of 0.9% as compared to the one-year-earlier period, including operational growth of 3.6% and a negative currency impact of 2.7%. U.S. Consumer Health segment sales increased by 10.8% compared to the 2019 first-half period. International Consumer Health segment sales for J&J decreased 6.8%, including an operational decline of 1.9% and a negative currency impact of 4.9%. The net impact of acquisitions and divestitures on the Consumer Health segment operational sales growth was negligible in first-half 2020.

Including the estimated impact of the COVID-19 pandemic, J&J’s full-year 2020 guidance as of July reflects: adjusted operational sales change of (0.8%) – 1.0% versus the prior year; operational sales of $81.0 to $82.5 billion; estimated reported sales of $79.9 to $81.4 billion; adjusted operational EPS (diluted) of $7.85 to $8.05; and adjusted EPS (diluted) of $7.75 – $7.95.

Pharma Product Approvals & Pipeline Updates IN 2020

Simponi Aria (golimumab) won FDA clearance in September as a treatment for polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA) in patients 2 years of age and older in combination with methotrexate. Simponi Aria is the first fully human anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous (IV) infusion approved for pediatric use in both active pJIA and active psoriatic arthritis (PsA). 

In addition to the treatment of children ages 2 years and older with active pJIA or active PsA, Simponi Aria is approved in the United States for treating adults with moderately to severely active rheumatoid arthritis, active PsA, and active ankylosing spondylitis. The product is approved for one or more of these indications in 24 countries. Administered via a 30-minute infusion, the medicine targets soluble and transmembrane bioactive forms of human TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can result in inflammation. By binding with and blocking TNF-alpha, the product helps control inflammation. 

Darzalex (daratumumab), in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone (DKd), was approved by the U.S. FDA in August for treating adult patients with relapsed/refractory multiple myeloma (MM) who have received one to three previous lines of therapy. Darzalex was approved in combination with two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS trials, representing the first-ever approval of an anti-CD38 with carfilzomib.

Janssen is dedicated to exploring the potential of Darzalex for multiple myeloma across the spectrum of the disease. Darzalex has been cleared for marketing in eight indications, three of which are in the frontline setting, including newly diagnosed patients with MM who are transplant eligible and ineligible.

In August 2012, Janssen entered into an exclusive worldwide license and development deal with Genmab to develop, manufacture and commercialize Darzalex. According to Janssen, Darzalex has become a backbone therapy in the treatment of MM, having been used in the treatment of more than 143,000 patients globally and more than 68,000 patients in the United States since U.S. FDA approval in 2015. Darzalex represents the first CD38-directed antibody approved worldwide to treat MM.

Darzalex Faspro (daratumumab and hyaluronidase-fihj) won U.S. clearance in May as the first subcutaneous CD38-directed antibody approved in the treatment of multiple myeloma. The U.S. FDA approved Darzalex Faspro as a new subcutaneous formulation of daratumumab. The medicine is available in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, Darzalex Faspro can be administered over three to five minutes, significantly less time than Darzalex, which is administered intravenously over hours. 

In the Phase 3 COLUMBA trial supporting the approval, Darzalex Faspro showed a consistent overall response rate and pharmacokinetics and a similar safety profile compared with intravenous Darzalex in patients with relapsed or refractory multiple myeloma. Additionally, there was a nearly two-thirds reduction in systemic administration-related reactions (ARRs) for Darzalex Faspro versus intravenous Darzalex (13 percent vs. 34 percent, respectively).

During June, the European Commission granted marketing authorization for the subcutaneous formulation for all currently approved intravenous formulation indications for Darzalex. The new subcutaneous, fixed-dose form of daratumumab reduces treatment time from hours to minutes, with comparable efficacy and fewer infusion-related reactions. Daratumumab is the first approved subcutaneous CD38-directed antibody for treating these multiple myeloma indications in Europe.

Results from the first randomized Phase 3 trial studying subcutaneous daratumumab in treating patients with newly diagnosed light chain amyloidosis, a rare and potentially fatal disease, were unveiled by Janssen in June. The data showed subcutaneous daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone (D-CyBorD) resulted in a higher hematologic complete response rate versus CyBorD. Treatment with D-CyBorD delayed the time to major organ deterioration progression-free survival, and enhanced event-free survival based on MOD-PFS criteria with the time to initiation of next therapy. The combination demonstrated a safety profile consistent with subcutaneous daratumumab or CyBorD alone.

Spravato (esketamine) CIII nasal spray was cleared for marketing by the U.S. FDA during August for a new indication: taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Spravato represents the first approved antidepressant medication demonstrated to begin improving depressive symptoms with the first dose in this challenging-to-treat patient population. Spravato is also the first approved medicine that has been demonstrated to reduce depressive symptoms within 24 hours.

Spravato is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor – an ionotropic glutamate receptor. The medicine has a novel mechanism of action. Spravato is available in the United States, in conjunction with an oral antidepressant, to treat adults with treatment-resistant depression (TRD) and depressive symptoms in adults with MDD with acute suicidal ideation or behavior. The product has been filed for health authorities’ review for TRD and adults with MDD who have current suicidal ideation with intent in other markets globally, including Europe. The FDA granted Breakthrough Therapy Designation to esketamine nasal spray for TRD during November 2013 and for MDD with imminent risk for suicide during August 2016.

Janssen’s blockbuster brand Tremfya (guselkumab) received U.S. marketing clearance for a new indication in July as the medicine was approved for adult patients with active psoriatic arthritis (PsA). Tremfya represents the first treatment approved for active PsA that selectively inhibits interleukin (IL) 23, a naturally occurring cytokine involved in normal inflammatory and immune responses associated with the symptoms of PsA. Tremfya is the first biologic approved for treating active PsA to have improvement in fatigue as measured by FACIT-F in the product label.

Developed by Janssen, Tremfya is available in the United States, Canada, European Union, Japan and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). The medicine is also approved in the United States, Japan and Brazil for treating adult patients with active PsA. IL-23 is an important driver of the pathogenesis of inflammatory diseases, including psoriasis and psoriatic arthritis.

Imbruvica (ibrutinib) won U.S. approval in April in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. The marketing clearance is based on positive results from the landmark Phase 3 E1912 trial that was designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. The marks the 11th U.S. FDA approval for Imbruvica across six disease areas and represents the sixth approval for Imbruvica in CLL.

A once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor administered orally, Imbruvica is jointly developed and commercialized by Janssen Biotech and AbbVie company Pharmacyclics. Imbruvica represents the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical studies and five Phase 3 trials (as of April) supporting the U.S. label. Clinical studies include six pivotal Phase 3 trials in CLL, including more than five years of efficacy, safety and tolerability data. Imbruvica is the only BTK inhibitor with long-term data in the U.S. label showing progression-free survival in large randomized clinical trials.

Imbruvica is available in more than 95 countries for at least one indication. The product was initially approved by the U.S. FDA in November 2013 and is indicated in six disease areas, including five hematologic cancers – CLL with or without 17p deletion (del17p), SLL with or without del 17p, Waldenström’s macroglobulinemia, previously treated patients with mantle cell lymphoma, previously treated patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy – and previously treated patients with chronic graft-versus-host disease after failure of one or more lines of systemic therapy.

The U.S. FDA granted accelerated approval for a new pediatric formulation for Sirturo (bedaquiline) as part of a combination therapy to treat children with pulmonary multidrug-resistant tuberculosis (MDR‑TB). Sirturo is indicated for use as part of combination therapy in treating adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary MDR‑TB.

The May 27 marketing clearance by the FDA marks the first regulatory approval for the pediatric formulation (20 mg tablet) of Sirturo and is a key component of J&J’s global pediatric R&D program for the medicine. Sirturo initially won U.S. accelerated approval for use in eligible adult patients during 2012 as the first novel TB medicine in more than 40 years. During 2019, the FDA granted marketing clearance for Sirturo 100 mg tablets as part of combination therapy in adolescent patients (12 to less than 18 years of age and weighing at least 30 kilograms (66 pounds)) with pulmonary MDR-TB, when an effective treatment regimen cannot otherwise be provided. Additional research is under way in children aged 2 to 4 years, and in infants younger than 2 years old.

J&J is part of a first-of-its-kind global collaboration – Project to Accelerate New Treatments for Tuberculosis (PAN-TB collaboration) – launched in February to develop transformative treatment regimens for tuberculosis. The new collaboration of philanthropic, non-profit and private sector organizations is working together to accelerate the development of novel tuberculosis treatment regimens for all TB patients. The PAN-TB collaboration aims to create treatment regimens consisting of medicines to which there is limited or no drug resistance and that are ready for Phase 3 development.

The European Commission’s approval for Janssen’s preventive Ebola vaccine, announced on July 1, marks the first major regulatory approval of a vaccine developed by the company. Marketing Authorization was granted for the Ebola vaccine regimen for the prevention of Ebola Virus Disease. Enabled by this approval, Janssen is collaborating with the World Health Organization on vaccine pre-qualification, which should help accelerate registration of the preventive Ebola vaccine regimen in African countries and facilitate broader access to those most in need. 

Janssen filed a New Drug Application with U.S. health authorities in September for Uptravi (selexipag) as an injection for IV use for treating pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class (FC) II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy. The drug has been approved for treating PAH to delay disease progression and reduce the risk of hospitalization for the disorder.

Two Marketing Authorization Applications (MAAs) were filed with the European Medicines Agency (EMA) for the vaccines composing the two-dose regimen, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). The Ebola vaccine regimen leverages Janssen’s AdVac technology in combination with Bavarian Nordic’s established MVA-BN technology. Janssen’s Ebola vaccine regimen is indicated for active immunization for the prevention of Ebola Virus Disease caused by the Zaire ebolavirus species in individuals aged 1 year and older.

Janssen announced in June the company’s decision to discontinue the Phase 3 LOTUS trial of Stelara (ustekinumab) in systemic lupus erythematosus due to lack of efficacy in SLE. The decision is based on data from a pre-planned interim efficacy analysis. A human IL-12 and IL-23 antagonist, Stelara is available in the United States for treating adults and children 12 years and older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy; adults with active PsA, used alone or in combination with methotrexate; adults with moderately to severely active Crohn’s disease; and adults with moderately to severely active ulcerative colitis.

Results were presented in May from the final analysis of the pivotal Phase 3 SPARTAN trial showing Erleada (apalutamide) in combination with androgen deprivation therapy significantly improved OS, compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases. Erleada became the first FDA-approved therapy for patients with nmCRPC during February 2018. In September 2019, Erleada won U.S. marketing clearance for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) based on results from the Phase 3 TITAN trial, which achieved statistical significance in the dual primary endpoints of OS and radiographic progression-free survival (rPFS). The product significantly extends OS across two indications in advanced prostate cancer (nmCRPC and mCSPC). Erleada is approved in more than 65 countries, and labels are being updated worldwide to reflect data from the SPARTAN final analysis.

The landmark Phase 3 VOYAGER PAD trial of Xarelto (rivaroxaban) plus aspirin demonstrated significant benefit in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, meeting primary efficacy and principal safety endpoints as reported in March. According to Janssen, Xarelto has the potential to be the first anticoagulant in 20 years to show a benefit in these high-risk patients. Two major Phase 3 studies have assessed Xarelto vascular dose plus aspirin in treating patients with atherosclerotic disease.

The oral anticoagulant Xarelto is a blockbuster medicine marketed for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the treatment and reduction of risk of recurrence of DVT and PE.

During March, Janssen announced results of the Phase 3 trial FLAIR (First Long-Acting Injectable Regimen) showing the safety and efficacy of the long-acting injectable HIV treatment regimen of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir through 96 weeks. Also on March 11, the company announced 48-week results of the global Phase 3b ATLAS-2M (Antiretroviral Therapy as Long-Acting Suppression every 2 Months) trial demonstrating the safety and efficacy of rilpivirine and cabotegravir administered every two months.

The non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine is marketed as Edurant for the treatment of HIV in combination with other antiretrovirals, and is being developed by Janssen Sciences Ireland UC in a long-acting formulation (Rilpivirine LA). The investigational injectable nanoparticle suspension for intramuscular injection is not approved by regulatory authorities anywhere in the world.

Janssen, in collaboration with Apple, opened enrollment for the Heartline Study during February. The study is designed to explore if the Heartline Study app on iPhone and heart health features on Apple Watch can improve health outcomes, including reducing stroke risk, with earlier detection of atrial fibrillation (AFib).