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Company of the Year 2018 — Johnson & Johnson: Defining the future of healthcare

Written by: | andrew.humphreys@medadnews.com | Dated: Tuesday, October 23rd, 2018

 

The executive management team of this “132-year-old startup” company is excited about a future that lies beyond the intersection of science and technology.

 

johnson-and-johnson-logo

 

Johnson & Johnson

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

 

Best-Selling Rx Products

Product 2017 Sales 2016 Sales
Remicade

$6,315

$6,966

Stelara

$4,011 $3,232

Invega Sustenna/
Xeplion, Invega Trinza/
Invega Trevicta

$2,569

$2,214

Zytiga

$2,505

$2,260

Xarelto

$2,500

$2,288

Imbruvica $1,893 $1,251
Simponi, Simponi Aria $1,833 $1,745

Prezista, Prezcobix/Rezolsta, Symtuza

$1,821

$1,851

Darzalex $1,242 $572
Velcade

$1,114

$1,224  

Invokana, Invokamet

$1,111

$1,407

Procrit/Eprex

$962

$1,105

Risperdal Consta

$805

$893

Concerta/methylphenidate $791

$863

Edurant/rilpivirine

$714

$573

Opsumit $573

All sales are in millions of dollars.

 

Financial Performance

  2017 2016
Revenue

$76,450

$71,890

Net income

$1,300

$16,540

Diluted EPS

$0.47

$5.93

R&D expense

$10,554

$9,095

  1H 2018 1H 2017
Revenue

$40,839

$36,605

Net income

$8,321

$8,249

Diluted EPS

$3.05

$3.00

R&D expense

$5,043

$4,346

All sales are in millions of dollars except
earnings per share.

 

 

Throughout the decades, Johnson & Johnson has advanced with the evolution of science and technology – whether via the company’s pioneering development of sterile surgery at the turn of the 20th century – or today as 134,000 employees work together to develop a differentiated robotic-assisted surgery platform in orthopaedics, build novel regimens to boost T cells and train them to recognize and attack cancer through groundbreaking immuno-oncology efforts, and focus to create the first vaccine for HIV/AIDS. Management says these are just some of the many examples that underscore J&J’s commitment to lead the next frontier of health.

With more than 260 operating companies worldwide, executives describe J&J as the world’s largest and most broadly based healthcare company. J&J is organized into three business segments: Pharmaceutical, Medical Devices, and Consumer.

The Pharmaceutical segment is concentrated on six therapeutic areas: Immunology (e.g., rheumatoid arthritis, inflammatory bowel disease and psoriasis), Infectious Diseases and Vaccines (e.g., HIV/AIDS), Neuroscience (e.g., mood disorders and schizophrenia), Oncology (e.g., prostate cancer and hematologic malignancies), Cardiovascular and Metabolism (e.g., thrombosis and diabetes) and Pulmonary Hypertension (e.g., Pulmonary Arterial Hypertension). The latter is a new therapeutic area that was established with the acquisition of Actelion in June 2017. The Medical Devices segment consists of a broad range of products used in the orthopaedic, surgery, cardiovascular, diabetes care and eye health fields. The Consumer segment encompasses a wide array of products used in the baby care, oral care, beauty, over-the-counter pharmaceutical, women’s health and wound-care markets.

“Our Pharmaceutical business has delivered outstanding and sustained performance for more than seven years, driven by the successful launch and growth of many blockbuster medicines,” states J&J Chairman and CEO Alex Gorsky. “As we move forward, we will drive the continued growth of our existing medicines, while also delivering on our near-term pipeline. And, we remain focused on driving robust innovation to address high unmet medical needs and leveraging our strong commercial capabilities across each of our six therapeutic areas.”

Chairman & CEO Alex Gorsky: “Our strong second-quarter (2018) results reflect double-digit growth in our Pharmaceutical business and the accelerating sales momentum in our Medical Devices business, driven by the continued growth of our market leading products and strategic new launches. We remain focused on investing in innovation and meeting the needs of our customers by delivering innovative products and solutions that position the company to deliver long-term, sustainable growth. Our talented J&J colleagues are united in our efforts to address some of the most critical health and consumer needs of people around the world.”

According to Gorsky, increasing investment in innovation is the most important aspect of J&J’s strategy. During 2017, the company attained record levels of investment: $10.6 billion in R&D and $35.2 billion in M&A. This resulted in various and new collaborations, including Actelion – J&J’s largest-ever acquisition – which added the sixth therapeutic area to the company’s Pharmaceutical business. “Adding Actelion’s portfolio to our already strong Pharmaceutical business has created a distinct opportunity for Johnson & Johnson by expanding our portfolio with leading, differentiated in-market medicines, cutting-edge new therapies and promising late-stage products,” Gorsky notes.

“Additionally, adding Abbott Medical Optics to our portfolio allows us to expand into new areas within the eye health space. In total, we completed 17 acquisitions and licensing agreements of various sizes, 60 innovation deals and made 21 new investments through Johnson & Johnson Innovation – JJDC Inc. during 2017,” Gorsky says.

J&J remains a preferred partner in collaborative innovation. In late 2017, J&J announced a collaboration with China-headquartered Legend Biotech to develop a breakthrough investigational CAR-T cell immunotherapy against multiple myeloma. “We are hopeful that by applying shared knowledge and expertise, we can create regimens that aim for a cure,” Gorsky explains.

According to Gorsky, “We will invest as much as possible in innovation and the R&D of new solutions and new products. Johnson & Johnson ranks among the top five companies in the U.S. across all industries for investment in R&D — demonstrating our commitment to driving growth through innovation across all operations. We strongly believe this is the best way to stimulate economic growth throughout our industry, company, and communities. Most importantly, we believe that increased and focused investment in innovation and R&D is the best way to ultimately benefit and positively impact our patients, consumers and shareholders around the world.

“Johnson & Johnson’s total shareholder return for 2017 was more than 24%, exceeding our competitor composite, as well as exceeding most major indices which, I am proud to say, Johnson & Johnson has done over the last three-, five-, ten- and twenty-year periods,” Gorsky says. “Our shareholder return for 2017 is indicative of the strength of our business, as well as the long-term strategic focus and execution that our leaders and teams have delivered over the past several years.”

 

2018 Performance & Outlook

Worldwide sales for Johnson & Johnson during first-half 2018 totaled $40.84 billion, representing 11.6 growth over same-time 2017, including operational growth of 8.6 percent. According to J&J, currency fluctuations had a positive impact of 3 percent for 2018’s first six months. The net impact of acquisitions and divestitures on global operational sales growth was a positive 3.3 percent.

Sales by J&J U.S. companies in January-June 2018 amounted to $20.59 billion, up 7.8 percent versus the 2017 first half. International sales were reported at $20.25 billion, rising 15.7 percent over the 2017 corresponding period, including operational growth of 9.3 percent and a positive currency impact of 6.4 percent.

Global first-half 2018 Pharmaceutical segment sales came in at $20.2 billion, up 19.7 percent year-over-year (YoY), with operational growth of 16.4 percent and a positive currency impact of 3.3 percent. U.S. Pharmaceutical sales rose 13.9 percent versus the January-June 2017 period, reaching $11.25 billion. International Pharmaceutical sales improved 27.8 percent to $8.95 billion, with operational growth of 19.9 percent and a positive currency impact of 7.9 percent.

Company executives say the net impact of acquisitions and divestitures on the Pharmaceutical segment’s operational sales growth during the first half of 2018 was a positive 7.1 percent.

Leading the global sales charge for J&J’s Pharmaceutical segment during first-half 2018 was Remicade at nearly $2.71 billion, which was down 15.4 percent compared to the product’s first-half 2017 performance, mainly due to patent expirations. Stelara generated $2.4 billion, which was up 33 percent year-over-year. Zytiga produced $1.75 billion, a 62.3 percent YoY improvement. The Invega product franchise recorded almost $1.42 billion in worldwide first-half 2018 sales (+14.8 percent YoY). Xarelto totaled nearly $1.26 billion (+8.8 percent YoY).

The blockbuster brand Stelara is marketed for treating various immune-mediated inflammatory diseases. J&J’s immunology products achieved operational growth of 11.5 percent during first-half 2018 compared to the same period one year earlier, driven by strong uptake of the biologic Stelara in Crohn’s disease.

J&J’s Medical Devices segment generated first-half 2018 global sales growth of 5.5 percent to reach $13.74 billion, with operational growth of 2.5 percent and a positive currency impact of 3 percent. U.S. Medical Devices sales rose 1.7 percent compared to the 2017 first-half period, coming in at $6.43 billion. International Medical Devices sales of $7.31 billion for January-June 2018 advanced by 9.2 percent YoY, representing operational growth of 3.3 percent and a positive currency impact of 5.9 percent. The net impact of acquisitions and divestitures on the Medical Devices segment operational sales growth was a positive 0.5 percent in the first half of 2018.

The top-selling Medical Devices franchises globally in 2018’s first six months were Surgery at almost $4.94 billion (up 6.1 percent versus first-half 2017) and Orthopaedics at $4.51 billion (down 1.2 percent YoY).

Consumer segment sales for first-half 2018 reached $6.9 billion worldwide, representing growth of 2.9 percent compared to same-time 2017, with operational growth of 0.4 percent and a positive currency impact of 2.5 percent. U.S. Consumer segment sales rose 0.4 percent to $2.91 billion. International Consumer segment sales advanced by 4.9 percent to $4 billion, consisting of an operational increase of 0.5 percent and a positivecurrency impact of 4.4 percent. The impact of acquisitions and divestitures on the Consumer segment operational sales growth was minus 1 percent.

Pacing global Consumer segment sales in the first six months of 2018 was the Beauty franchise at $2.19 billion (up 6.6 percent versus first-half 2017) and OTC at $2.14 billion (+5.9 percent).

Global R&D costs during the first half of 2018 amounted to $5.04 billion, accounting for 12.3 percent of sales (compared to 11.9 percent of sales during first-half 2017). The growth was mainly due to continued investment spending to advance the product development pipeline.

J&J management updated the company’s sales guidance for full-year 2018 to a range of $80.5 to $81.3 billion upon reporting the first-half financial results. This forecast reflects an increase in expected operational growth to a range of 4.5 percent to 5.5 percent, partially offset by the estimated lower favorable impact of currency. J&J updated the adjusted earnings guidance for full-year 2018 to a range of $8.07 to $8.17 per share, reflecting an increase in expected operational growth to a range of 8.5 percent to 9.9 percent, partially offset by the estimated lower favorable impact of currency.

According to EvaluatePharma’s (EP) World Preview 2018 report, J&J’s worldwide Rx sales are projected to produce a 5 percent CAGR between 2017 and 2024, which would represent the highest growth percentage of any of the top eight companies forecast during that period. J&J is predicted to rank No. 5 among all companies in terms of biotech sales by 2024, with a CAGR forecast of 6 percent from 2017.

Oncology sales are anticipated to be a growth driver for J&J during the years to come, with a projected 2017-2024 CAGR of 13 percent to $14.31 billion, which would place the company in the fourth overall spot among all industry players. The Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica is predicted to lead the oncology sales charge for J&J, with 2024 projected sales of almost $9.56 billion between joint marketers J&J and AbbVie. The EvaluatePharma forecast would place Imbruvica as the world’s sixth-best-selling pharma medicine in 2024.

According to the EP report, J&J will pace all companies with four of the world’s 16 best-selling prescription products in 2024. In addition to Imbruvica, the anti-IL-12 and IL-23 MAb Stelara is anticipated to rank 10th with sales of nearly $6.47 billion, followed by No. 12-ranked anti-CD38 MAb Darzalex at $6.03 billion and the Factor Xa inhibitor Xarelto at almost $5.9 billion (for which sales are also recorded by Bayer). Among newer medicines, EvaluatePharma expects 2024 global sales of almost $3.49 billion for the anti-IL-23 MAb Tremfya (No. 35 rank).

J&J was the No. 2 spender in pharma R&D during 2017. EvaluatePharma predicts that the company will remain in that spot in 2024 with a 3 percent CAGR resulting in an R&D expenditure of $10 billion.

 

Product Approvals/Launches & Pipeline Updates During 2018

PHARMA

Symtuza is the first complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults. Containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (D/C/F/TAF), Symtuza won FDA approval in July as a new treatment option for adults living with HIV-1 infection. According to the Janssen Pharmaceutical Companies, the new medicine delivers the durability and high barrier to drug resistance of darunavir and the safety profile of tenofovir alafenamide.

FDA approval for Symtuza was based on data from two 48-week, non-inferiority, pivotal Phase III trials that assessed the drug’s safety and efficacy versus a control regimen in adults with no prior ARV history (AMBER) and in virologically suppressed adults (EMERALD). Results from each study showed that Symtuza was effective and well-tolerated, with up to 95 percent achieving or maintaining virologic suppression (HIV-1 RNA <50c/mL).

Symtuza was previously approved by the European Commission and Health Canada for treating HIV-1 infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg. European clearance enables Janssen to market the product in all member states of the EU and the European Economic Area. Janssen intends to submit additional regulatory filings in other markets and more Symtuza data, including data from the Phase III rapid-initiation study DIAMOND.

Janssen reported in July that data from the Phase III EMERALD study reinforce the safety and efficacy of switching to Symtuza for treating HIV-1 regardless of previous treatment regimen among treatment-experienced patients. In addition, data from the Phase III DIAMOND study provide evidence to support a darunavir-based regimen when rapidly initiating treatment in people who are newly diagnosed with HIV-1.

Janssen and Gilead Sciences amended a licensing deal in December 2014 for the development and commercialization of a once-daily, darunavir-based STR including Gilead’s TAF, emtricitabine and cobicistat. Janssen and its affiliates are responsible for the global manufacturing, registration, distribution and commercialization of Symtuza.

Janssen Pharmaceutical Companies during August announced U.S. regulatory approval of Imbruvica (ibrutinib) in combination with rituximab for treating the rare blood cancer Waldenström’s macroglobulinemia (WM). The FDA approval expanded the product’s label in WM beyond Imbruvica’s already-approved use as a monotherapy to include combination use with rituximab.

The oral, once-daily therapy Imbruvica is approved for treating certain B-cell malignancies. J&J’s oncology products generated operational sales growth of 38.7 percent for the first six months of 2018. Contributing to that growth was a strong sales performance by Imbruvica due to increased patient uptake.

The August 2018 U.S. marketing clearance represents the first approved non-chemotherapy combination option for the treatment of WM. The blockbuster medicine gained FDA clearance for WM as a monotherapy during January 2015 through the Breakthrough Therapy Designation pathway, making Imbruvica the first FDA-approved therapy for the disease. The expanded label marks the ninth FDA approval since the medicine’s initial regulatory green light in 2013. The medicine is jointly developed and commercialized by Janssen Biotech and Pharmacyclics, an AbbVie company.

Imbruvica’s recent approval is based on results from the randomized, double-blind, placebo-controlled iNNOVATE study (PCYC-1127), the largest Phase III trial of a non-chemotherapy combination in WM patients. The once-daily oral drug works differently than chemotherapy and immunotherapy treatments as Imbruvica blocks the BTK protein. The BTK protein sends important signals that lead to B cells abnormally maturing and multiplying. The product targets and blocks BTK, inhibiting the survival and spread of cancer cells, and can interfere with the disease process of other serious conditions.

Imbruvica is indicated in six disease areas, including five hematologic cancers – chronic lymphocytic leukemia (CLL) with or without 17p deletion; small lymphocytic lymphoma (SLL) with or without del17p; WM; previously treated mantle cell lymphoma (MCL); and previously treated marginal zone lymphoma (MZL) – and previously-treated chronic graft-versus-host disease (cGVHD). Imbruvica is the only FDA-approved medication in WM, MZL and cGVHD. Granted four Breakthrough Therapy Designations by the U.S. regulatory agency, Imbruvica was one of the first medicines to win FDA approval via the Breakthrough Therapy Designation pathway. The medicine is approved in more than 90 countries, and has been used to treat 115,000 patients across approved indications as of late August.

Imbruvica is one of the most comprehensively studied molecules in the drug industry. The robust clinical oncology development program includes more than 150 active clinical studies evaluating Imbruvica alone and in combination with other medicines in several blood cancers and other serious diseases.

The blockbuster medication Darzalex (daratumumab) in May won FDA approval for a new indication: in combination with the proteasome inhibitor Velcade (bortezomib), the alkylating agent melphalan, and prednisone – VMP – for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. This U.S. marketing clearance marks the fifth indication in multiple myeloma for Darzalex, which is the first monoclonal antibody approved for newly diagnosed patients. Clinical study results demonstrated that Darzalex in combination with VMP reduced the risk of disease progression or death by 50 percent versus treatment with VMP alone.

Darzalex received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July recommending broadening the existing marketing authorization for use in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for ASCT.

Darzalex represents the first CD38-directed antibody approved anywhere worldwide and the first antibody granted regulatory clearance for newly diagnosed patients with multiple myeloma who are transplant ineligible. The medicine was initially approved by FDA regulators during November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. Darzalex garnered additional approvals during November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy. During June 2017, the product was granted regulatory clearance in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI.

Janssen Biotech and Genmab entered into a worldwide pact in August 2012 granting Janssen an exclusive license to develop, manufacture and commercialize Darzalex. Janssen commercializes the product in the U.S.

The surface protein CD38 is highly expressed across multiple myeloma cells, regardless of disease stage. Darzalex is believed to induce tumor cell death via multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell result in its death. Subsets of myeloid derived suppressor cells (MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by the drug.

Darzalex is being evaluated in a comprehensive clinical development program across various treatment settings in multiple myeloma, including in frontline and relapsed settings. Other studies are under way or planned to assess the product’s potential in other malignant and pre-malignant hematologic diseases in which CD38 is expressed, such as smoldering myeloma, as well as in solid tumors.

Janssen in August revealed the filing of a supplemental biologics license application to the U.S. FDA and a Type II Variation to the European Medicines Agency seeking approval of a split dosing regimen for Darzalex. The applications seek to update the prescribing information and summary of product characteristics to provide health-care professionals with the option to split the first infusion of the medicine over two consecutive days.

In other approval news, the European Commission during May granted marketing authorization for Juluca (dolutegravir 50mg [ViiV Healthcare]/rilpivirine 25mg [Janssen Sciences Ireland UC]) for treating HIV-1. ViiV Healthcare is responsible for marketing dolutegravir/rilpivirine in all countries in the European Union and European Economic Area.

Through a collaboration with ViiV, dolutegravir/rilpivirine offers a complete daily treatment regimen for virologically suppressed adults living with HIV-1 in a single pill. Juluca represents the first two-drug regimen, once-daily, single pill for treating human immunodeficiency virus type 1 infection in adults who are virologically suppressed on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor. Juluca combines just two antiretrovirals in a single-pill regimen, reducing the cumulative drug exposure in people living with HIV-1 while maintaining the efficacy of traditional three-drug regimens at 48 weeks.

The dolutegravir and rilpivirine combo received marketing clearance from the U.S. FDA during November 2017 and from Health Canada in May 2018. Juluca was approved in those countries as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine. ViiV has filed regulatory marketing applications in other countries.

“Dolutegravir/rilpivirine signifies an evolution in HIV-1 treatment options by combining two antiretrovirals into a once-daily, single pill,” says Dr. Josep M Llibre, Infectious Diseases Department, University Hospital Germans Trias i Pujol, in Badalona, Barcelona. “It maintains the efficacy of a three-drug regimen but reduces the number of antiretrovirals, along with their potential toxicities, that virologically suppressed HIV-1 patients have to take and are therefore exposed to in the long-term.”

Janssen announced during July that Juluca maintains viral suppression with two drugs in a once-daily, single pill according to 100-week results from the drug’s Phase III program. The data from the SWORD 1 and SWORD 2 studies highlight the durable efficacy and safety of the medicine, with most patients achieving virological suppression (HIV-1 RNA <50 copies/mL) through Week 100.

J&J’s anticipated blockbuster medication Erleada (apalutamide) was granted FDA approval during February. The next-generation androgen receptor represents the first FDA-approved therapy to treat patients with non-metastatic castration-resistant prostate cancer. U.S. regulatory clearance followed an FDA priority review and was based on Phase III SPARTAN data demonstrating Erleada decreased the risk of distant metastasis or death by 72 percent and improved median metastasis-free survival by more than two years. The major efficacy outcome was supported by statistically significant improvements for secondary endpoints, such as time to metastasis, progression-free survival and time to symptomatic progression.

The androgen receptor (AR) inhibitor Erleada binds directly to the ligand-binding domain of the AR. The medicine inhibits AR nuclear translocation, inhibits DNA binding, and impedes AR-mediated transcription. As a major metabolite, N-desmethyl apalutamide is a less potent inhibitor of AR and exhibited one-third the activity of Erleada in an in vitro transcriptional reporter assay. Administration of the medicine resulted in decreased tumor cell proliferation and increased apoptosis leading to decreased tumor volume in mouse xenograft models of prostate cancer.

In May, Janssen presented a post-hoc analysis from the Phase III SPARTAN study that demonstrated treatment with Erleada significantly reduced the risk of prostate specific antigen progression in patients with non-metastatic castration-resistant prostate cancer who had a rapidly rising prostate specific antigen (PSA) while receiving continuous androgen deprivation therapy.

Janssen reported during February new findings from SPARTAN that showed treatment with Erleada decreased risk of metastasis or death by 72 percent and improved median metastasis-free survival by more than two years (difference of 24.3 months) in patients with non-metastatic castration-resistant prostate cancer whose PSA is rapidly rising, compared to placebo.

In another February announcement, a new indication was approved by the FDA for Zytiga in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). The marketing clearance is based on Phase III data from the pivotal LATITUDE study, which found that in patients with metastatic high-risk CSPC, Zytiga (abiraterone acetate) in combination with prednisone reduced the risk of death by 38 percent versus placebos.

The European Commission on Nov. 20, 2017, issued approval to broaden the marketing authorization for Zytiga in combination with prednisone or prednisolone to include newly diagnosed high-risk metastatic HSPC. Similar regulatory filings have been submitted in Japan, Canada, Mexico, Switzerland, Singapore and the Philippines, with approval also occurring in Brazil and Taiwan. If successful, these submissions will broaden the product’s use in combination with prednisone or prednisolone to include an earlier stage of prostate cancer than Zytiga’s current indications.

Zytiga in combination with prednisone was previously FDA-approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) during April 2011. Since that time, the medicine has been cleared for marketing in combination with prednisone or prednisolone in at least 105 countries. As of February 2018, more than 330,000 patients worldwide – including 113,000 in the U.S. – have received treatment with Zytiga, which was the No. 1-prescribed oral medication in the United States for patients with metastatic CRPC during 2016.

At the start of 2018, the once-per-month schizophrenia treatment Invega Sustenna (paliperidone palmitate) became the first antipsychotic to receive FDA approval for inclusion of real-world data in its product labeling. The data come from the Paliperidone Palmitate Research In Demonstrating Effectiveness (PRIDE) study. Invega Sustenna is the first antipsychotic to show superior effectiveness in delaying time to relapse versus a group of seven commonly prescribed oral antipsychotics in adults with schizophrenia who face common real-world circumstances.

The Invega product line of long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults was one of Johnson & Johnson’s growth drivers during the first half of 2018 with global sales of $2.57 billion.

Invega Sustenna was initially approved by U.S. regulators in July 2009 as the first once-monthly, atypical, long-acting injection to treat schizophrenia. The medicine has been approved in more than 80 countries. During November 2014, the FDA approved the medication for treating schizoaffective disorder, making it the only once-monthly drug to treat that condition; however, people living with schizoaffective disorder were not studied as part of the PRIDE trial.

Janssen is seeking U.S. regulatory approval of esketamine nasal spray, which if successful would be one of the first new approaches to treat refractory major depressive disorder available to patients in the last 50 years. A New Drug Application was filed with the Food and Drug Administration for esketamine nasal spray for treatment-resistant depression in adults. The investigational, rapidly acting antidepressant works differently than currently available therapies for major depressive disorder. Through glutamate receptor modulation, esketamine is believed to help restore connections between brain cells in people with treatment-resistant depression.

U.S. regulators granted Breakthrough Therapy Designations for esketamine nasal spray for treatment-resistant depression and for a second indication, major depressive disorder with imminent risk for suicide. Janssen is performing Phase III trials for the second indication.

Janssen intended to file a Marketing Authorization Application to the European Medicines Agency for the esketamine treatment-resistant depression indication before year-end 2018. In June, Janssen presented Europe data from pivotal Phase III trials that found continuing treatment with esketamine nasal spray plus an oral antidepressant in patients beyond 16 weeks demonstrated clinically meaningful and statistically significant superiority to treatment with an oral antidepressant plus placebo nasal spray in delaying time to relapse of symptoms of depression.

Janssen reported in May data from two Phase III studies for adults with treatment-resistant depression demonstrating that flexibly dosed esketamine nasal spray plus a newly initiated oral antidepressant showed a statistically significant, clinically meaningful rapid reduction of depressive symptoms as compared to placebo nasal spray plus a newly initiated oral antidepressant. Data from a second clinical trial – the first study of its kind – in elderly patients aged 65 years and older with treatment-resistant depression, demonstrated that treatment with flexibly dosed esketamine plus a newly initiated oral antidepressant showed clinically meaningful effects compared to placebo nasal spray plus a newly initiated oral antidepressant.

Janssen in August confirmed positive top-line results from the worldwide, Phase III Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study of the first investigational long-acting injectable two-drug regimen (2DR) for HIV-1 treatment. The ATLAS study results demonstrated Janssen Sciences Ireland’s long-acting rilpivirine and ViiV’s cabotegravir injected once per month had similar efficacy to a standard-of-care daily, oral three-drug regimen at week 48.

Janssen ended early the Phase III CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) clinical study that evaluated the efficacy and safety of Invokana (canagliflozin) compared to placebo when used in addition to standard of care for patients with chronic kidney disease and type 2 diabetes. Reported by J&J in July, the decision was based on a recommendation from the study’s Independent Data Monitoring Committee (IDMC) that met to review the data during a planned interim analysis.

In another Invokana July update, Janssen announced that the U.S. FDA extended the review timeline for a supplemental new drug application seeking a new indication: to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or are at risk for CV disease. The sNDA application additionally applies to the Invokana fixed-dose combinations, Invokamet and Invokamet XR. Janssen announced the sNDA submission during October 2017 and the three-month extension pushed back the FDA action date into October 2018.

Janssen’s erdafitinib was awarded FDA Breakthrough Therapy Designation during March for the treatment of urothelial cancer. The oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor is being studied in Phase II and III trials in patients with advanced urothelial cancer.

New Tremfya (guselkumab) data was reported by Janssen in February showing long-term skin clearance in patients with moderate-to-severe plaque psoriasis. As part of the Phase III VOYAGE 2 study, the vast majority of patients with moderate-to-severe plaque psoriasis receiving Tremfya who achieved at least 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28 maintained a PASI 90 response with continuous treatment through week 72. Findings from the study additionally showed that a vast majority of patients originally randomized to Tremfya, but withdrawn from treatment at week 28, regained a PASI 90 response within six months of initiating retreatment with the medicine.

Announced in January, the FDA Mini-Sentinel assessment confirmed the safety and effectiveness of Xarelto (rivaroxaban) as established in the Phase III ROCKET AF studies. Building on the mounting real-world evidence studied in more than 200,000 people, these findings are consistent with conclusions from other analyses and again confirm the medicine’s safety and effectiveness across a broad array of patients. The FDA Mini-Sentinel report additionally notes a lower risk of ischemic stroke was associated with the use of Xarelto versus warfarin and lasted throughout the more than three-year analysis.

The Sentinel Initiative started during 2008 as a multi-year effort to create a national electronic system for monitoring the safety of approved and FDA-regulated medical products using existing electronic healthcare data from multiple sources.

MEDICAL DEVICES

The iDESIGN Refractive Studio, part of a next-generation LASIK platform that measures the eye inside and out to enable highly precise personalized vision correction, was approved by the FDA in June. This is the first system to use topography-integrated, wavefront-guided technology, enabling doctors to take a precise measurement of the eye inside and out to deliver a LASIK procedure personalized to the individual patient. iDESIGN Refractive Studio is approved for myopia, hyperopia, and mixed astigmatism. Additionally, this is the only available LASIK platform indicated for monovision LASIK in presbyopic myopic patients.

Cerenovus, part of the Johnson & Johnson Medical Devices Companies, won 510(k) clearance from the U.S. Food and Drug Administration in May for the Embotrap II Revascularization Device. The next-generation stent retriever is used to capture and remove life-threatening blood clots from the brain after an ischemic stroke.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, in June announced the U.S. launch of the Femoral Recon Nail System. The system provides new options for the surgical treatment of various long thigh bone fractures.

The Carto Vizigo Bi-directional Guiding Sheath was launched in the United States during May by Biosense Webster, a worldwide leader in the diagnosis and treatment of heart arrhythmias and part of Johnson & Johnson Medical Devices Companies. Carto Vizigo is the first commercially available steerable guiding sheath that can be visualized on the Carto 3 System during a catheter ablation procedure, aiding electrophysiologists in reducing dependency on fluoroscopy.

Johnson & Johnson Vision announced a revolutionary contact lens innovation in April with Acuvue Oasys with Transitions Light Intelligent Technology. The first-of-its-kind contact lens provides wearers with vision correction and a dynamic photochromic filter that helps to continuously balance the amount of light entering the eye.

 

2018 Acquisitons & Collaborations

PHARMA

A global collaboration was entered into in April by Janssen with Bristol-Myers Squibb to develop and commercialize Factor XIa inhibitors, including BMS-986177, for the prevention and treatment of major thrombotic conditions. Janssen Pharmaceuticals and Bristol-Myers Squibb will advance BMS-986177 into Phase II studies and establish a broad development program across multiple therapeutic indications. The companies are sharing development costs along with commercial profits and losses.

Janssen Biotech completed the acquisition of BeneVir Biopharm in May. The privately held biopharmaceutical company has specialized in the development of oncolytic immunotherapies. BeneVir uses a proprietary T-Stealth Oncolytic Virus Platform to engineer oncolytic viruses, tailored to infect and destroy cancer cells. The deal was facilitated by Johnson & Johnson Innovation.

With BeneVir, Janssen anticipates advancing pre-clinical candidates as standalone therapies and in combination with other immunotherapies for treating solid tumor cancers (such as lung, prostate, colorectal, etc.). BeneVir is maintaining a research presence in Rockville, Md., and has become part of the Janssen Oncology Therapeutic Area.

Janssen Pharmaceutical Companies in February reported a worldwide collaboration with an affiliate of Theravance Biopharma to develop TD-1473. The potential first-in-class oral, gastrointestinal restricted pan-Janus kinase (JAK) inhibitor is intended for the treatment of inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Theravance will complete a Phase II trial in Crohn’s disease and a Phase IIb/III induction and maintenance study in UC, planned to begin in 2018.

Following availability of Phase II data from both clinical trials, Janssen Biotech may elect to enter into an exclusive license arrangement for the program and would then assume a lead role in the subsequent development of TD-1473 in Crohn’s disease. Theravance will continue to conduct TD-1473 development in UC via the conclusion of the Phase IIb/III program.

If TD-1473 is commercialized, Theravance has the option to jointly commercialize the product in the United States, and Janssen would have sole non-U.S. commercialization responsibilities. Theravance will receive an upfront payment and is eligible to receive other amounts if Janssen elects to remain in the collaboration following the completion of the Phase II activities.

MEDICAL DEVICES

J&J subsidiary DePuy Synthes Products during July completed the acquisition of assets from Medical Enterprises Distribution. The acquired assets for the privately held developer of surgical impactor technology included the automated ME1000 Surgical Impactor for use in hip replacement. ME1000 is a battery-powered device that automates bone preparation, implant assembly and positioning in Total Hip Arthroplasty.

Johnson & Johnson received a binding offer from Fortive Corporation in June to acquire the Advanced Sterilization Products (ASP) business – a division of J&J’s Ethicon – for an aggregate value of $2.8 billion, consisting of $2.7 billion of cash proceeds from Fortive and $0.1 billion of retained net receivables.

Johnson & Johnson in June accepted a $2.1 billion binding offer from Platinum Equity for J&J’s LifeScan business, which was first announced on March 16. LifeScan is a global leader in blood glucose monitoring and manufacturer of the OneTouch brand of products.

The acquisition of Orthotaxy, a privately held developer of software-enabled surgery technologies – including a differentiated robotic-assisted surgery – was completed in February. The proprietary technology is undergoing early-stage development for total and partial knee replacement. The Johnson & Johnson Medical Devices Companies intend to broaden the technology’s application for various orthopedic surgery procedures. The goal is to build a next-generation robotic-assisted orthopaedic surgery solution that is cost-effective, time-efficient, and user-friendly in a range of care settings.

CONSUMER

Johnson & Johnson Consumer announced during July a definitive deal to acquire Zarbee’s, a privately held company that is a leader in naturally based healthcare products. The acquisition includes the full line of Zarbee’s Naturals products for children and adults.

 

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October 2018 Focus: Top 50 Pharma, Company of the Year and more!

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