Johnson
By Andrew Humphreys – [email protected]
Johnson
FINANCIAL PERFORMANCE
(All figures are in millions of dollars, BPA)
2019
Revenue $82059
Net source of income $15119
Diluted EPS $5. 63
Expenses R
1:20 20 a. m.
Turnover $39027
Net source of income $9422
Diluted EPS $3. 53
Expenses R
RX PRODUCTS MORE SOLD
(They’re all 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 $ 2795
Xarelto $2,313
Simponi, Simponi Aria $2,188
Prezista, Prezcobix / Rezolsta, Symtuza $2,110
Opsumit $1,327
Tremfya $1,012
Uplifting / rilpivirine $861
Uptravi $819
Outlaw / Eprex $790
Velcade $751
Invokana, Invokamet $735
Concerta / methylphenidate $696
Risperdal Consists $688
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Stelara $ 3,516
Imbruvica $1,980
Remicade $1,925
Darzalex $1,838
Invega Sustenna / Xeplion, Invega Trinza / Invega Trevicta $1762
Zytiga / abiraterone acetate $ 1,258
Prezista, Prezcobix / Rezolsta, Symtuza $1,089
Xarelto $1,086
Simponi, Simponi Aria $1075
Opsumit $795
Tremfya $ 638
Uptravi $532
Edurant / rilpivirine $480
Invokana, Invokamet $354
Risperdal Consists $323
Concerta / methylphenidate $320
Erleada $ 313
Outlaw / Eprex $291
Velcade $206
“We are creating cutting-edge drugs and innovative products that replace and save people’s lives,” says Alex Gorsky, President and CEO of Johnson
Gorsky is one of nine CEOs who announced a historic engagement in September, underscores a joint commitment to maintaining the integrity of the clinical procedure as its corporations paint on prospective global regulatory presentations and approvals for the first COVID-19 vaccines. Corporations have jointly developed more than 70 new vaccines that have helped eliminate some of the world’s most complex and fatal public health threats.
Also in September, the CEOs of 16 companies, adding Gorsky, such as Bill and Melinda Gates, co-chairs of Bill
Lead candidate for Johnson’s SarS-CoV-2 experimental vaccine
In September, Nature Medicine learned that the company’s serotype 26 (Ad26) vector-based experimental vaccine triggered an immune reaction, as demonstrated through “neutralizing antibodies,” and prevented serious clinical illnesses, adding weight loss, pneumonia and mortality, into the challenging Syrian. golden hamsters.
The announcement of this post J
Janssen reached an agreement in August with the US government. But it’s not the first time For large-scale manufacturing and delivery to the United States of one hundred million doses of Ad26. V2. S for use in the United States after approval or approval of emergency use through the U. S. FDA. But it’s not the first time The Advanced Biomedical Research and Development Authority (BARDA) – component of the Undersecretary of Preparation and Response of the U. S. Health and Human Services DecomposantThe U. S. in collaboration with the U. S. Defense DecomposerU. S. , you’re committing over $1 billion to the deal.
The company tests one- and two-dose regimens and works diligently to make the vaccine broader and more comprehensive after approval or approval by fitness regulators.
The company’s SARS-CoV-2 vaccination programme is based on Janssen’s AdVac generation, which was used to expand the Janssen Ebola vaccine, approved by the European Commission, and to create the company’s candidate vaccines against HIV, RSV and Zika. Another 90,000 people had been vaccinated by August 5 on the Janssen AdVac platform.
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Johnson
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This acquisition gives Janssen Pharmaceutical the opportunity to expand the company’s leadership in immunomediated diseases and stimulate its expansion through the emergence of diseases caused by autoantiantibodys. The transaction includes the full global rights of nipocalimab (M281), a clinically validated and potentially better drug. Class anti-FcRn antibody. Nipocalimab allows Janssen to succeed in many more patients by seeking indications for autoimmune diseases with medical needs not truly extensive in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology.
Nipocalimab has earned a rare pediatric disease designation from the US Food and Drug Administration. But it’s not the first time Momenta’s experience in FcRn mechanisms is critical to nipocalimab, as it supports and accelerates the progression of a drug designed to attack autoantibate-induced diseases in several established janssen healing areas. nipocalimab will contribute to the company’s objectives of achieving above-market expansion in the medium and long term.
With competitively differentiated parallel progression systems and comprehensive global advertising rights for nipocalimab, Janssen has the ability to introduce several releases, many of which are top-notch indications with maximum annual sales prospects, some of which can exceed $1 billion, supporting the management’s purpose of delivering incredible long-term market functionality.
“This acquisition reinforces Janssen’s leadership in autoimmune diseases and provides us with a major catalyst for sustained growth. Autoantibody diseases are serious and patients are neglected through existing remedies,” says Jennifer Taubert, executive vice president, global president, pharmacist, J.
In addition to Momenta workers and nipocalimab’s core assets, Janssen acquired the company’s portfolio of clinical and preclinical assets. The transaction was motivated by the apparent significant opportunity in nipocalimab, as well as the clinical capacity Janssen acquired with momenta’s team. plans for other assets in momenta’s pipeline will be decided as more knowledge becomes known and may offer greater potential for improvement.
“Nipocalimab and the rest of the Momenta pipeline, built over many years through remarkable scientists who have reshaped data in usable biology, expands and complements our portfolio by providing us with clinical compounds and the level of discovery in the biological pathways of autoantiantibodys. Combining Momenta’s discoveries with our 20-year legacy in immunology, global success, and clinical and medical expertise, we see a genuine opportunity to create a “pipe somehow,” says Mathai Mammen, MD, Ph. D. , Global Director of R
Janssen intends to have Momenta present in Cambridge, Massachusetts. This site will strengthen J’s existing footprint and innovation capabilities
Performance and Outlook 2020
J sales
Sales of U. S. corporations J
In the first fiscal part of 2020, commercial sales in Europe fell by 4. 8% year-on-year, adding an operating drop of 2. 1% and a negative exchange rate has an effect of 2. 7%.
For the pharmaceutical segment of J
J’s gadget segment
In the first part of 2020, sales in the Consumer Health segment amounted to $6. 9 billion, an increase of 0. 9% over the previous year’s era, with an operational expansion of 3. 6% and a negative change effect of 2. 7%. Sales from the U. S. Consumer Health segment to the U. S. But it’s not the first time They increased by 10. 8% compared to the first part of 2019.
Including the estimated effect of the COVID-19 pandemic, J’s prognosis
Pharmaceutical approvals and pipeline updates EN 2020
Simponi Aria (golimumab) was approved through the FDA in September as a remedy for juvenile polyarticular idiopathic arthritis (AJIp) and juvenile psoriatic arthritis (PYD) in patients 2 years of age or older in mixture with methotrexate. Simponi Aria is the first anti-biological -tumor necrosis (TNF) -All-human alpha agent administered by intravenous (IV) infusion approved for pediatric use in active AJI and active psoriatic arthritis (PSA).
In addition to treating children 2 years and older with active ENI or active RP, Simponi Aria is approved in the United States for the treatment of adults with moderate to severe active rheumatoid arthritis, progressive PSA and active ankylosing spondylitis. for one or more of these indications in 24 countries. Administered through a 30-minute infusion, the drug aims at human TNF-alpha transmembrane and soluble bioactive bureaucracy, a protein that, when over-produced in the framework due to chronic inflammatory diseases, can lead to inflammation by binding to TNF-alpha and blocking it, the product helps control inflammation.
Darzalex (daratumumab), mixed with Amgen Kyprolis (carfilzomib) and dexamethasone (DKd), was approved by the US FDA in August for the treatment of adult patients with relapsed / refractory multiple myeloma (MM) who won one to three lines of remedies above. Darzalex was approved in admixture with two carfilzomib regimens, 70 mg / m2 once weekly and 56 mg / m2 twice weekly, based on the positive effects of the Phase 3 CANDOR and Phase 1b EQUULEUS trials, which represent the first approval of an anti-CD38 with carfilzomib.
Janssen is committed to exploring the possibility of Darzalex myeloma across the entire spectrum of the disease. Darzalex has been authorized for marketing in 8 indications, 3 of which are on the front line, adding newly diagnosed MM patients who are eligible for transplantation and ineligible.
In August 2012, Janssen entered into an exclusive global licensing and progression agreement with Genmab to develop, manufacture and market Darzalex. According to Janssen, Darzalex has become a key cure in MM remedy, having been used in the remedy of more than 143,000 international patients and more than 68,000 patients in the United States since US FDA approval. In 2015, Darzalex represents the first internationally approved cd38 antibody to treat MM.
Darzalex Faspro (daratumumab and hyaluronidase-fihj) was authorized in the United States in May as the first cd38-approved subsaneous antibody in the treatment of multiple myeloma. The U. S. FDA approved Darzalex Faspro as a new subcutaneous formula of daratumumab. in 4 treatment regimens in five indications in patients with multiple myeloma, adding newly diagnosed, transplant-eligible patients as well as relither or refractory patients. much less time than Darzalex, which is administered intravenously for hours.
In the phase 3 COLUMBA trial in the approval phase, Darzalex Faspro demonstrated a consistent general reaction and pharmacokinetics and a protection profile similar to that of intravenous Darzalex in patients with relapsing or refractory multiple myeloma. In addition, there was a relief of approximately two-thirds in systemic reactions related to administration (ARR) of Darzalex Faspro compared to intravenous Darzalex (13% vs. 34%, respectively).
In June, the European Commission granted marketing authorisation for subcutaneous training for all recently approved intravenous training indications for Darzalex. The new form of subcutaneous fixed dose of daratumumab reduces the duration of the remedy from a few hours to a few minutes, with comparable efficacy and fewer infusion-related reactions. Daratumumab is the first sub-aneous antibody to be directed as opposed to cd38 approved for the treatment of multiple myeloma indications in Europe.
The effects of the first randomized Phase 3 trial that read daratumumab subsaneously on the remedy of patients with newly diagnosed soft-chain amylosis, a rare and life-threatening disease, were revealed through Janssen in June. Knowledge showed that daratumumab subpersasate in mixture with cyclophosphamide, bortazomib and dexamethasone (D-CyBorD) resulted in a higher rate of complete haematological reaction than CyBorD. Treatment with D-CyBorD delayed the schedule, progression-free survival of primary organ deterioration, and event-free survival advanced based on MOD-PFS criteria with the start time of the next remedy. The arrangement demonstrated a protection profile consistent with south-level daratumumab or CyBorD alone.
The SPravato nasal spray (sketamina) CIII was approved for commercialization through the US FDA. But it’s not the first time In August for a new indication: taken with an oral antidepressant, to treat depressive symptoms in adults with primary depressive disorder (CT) with acute suicidal behavior or mentality. the first approved antidepressant drug that has been shown to begin to present depressive symptoms with the first dose in this population of difficult-to-treat patients. Spravato is also the first approved drug that has been shown to reduce depressive symptoms within 24 hours.
Spravato is a non-selective and non-competitive N-methyl-D-aspartate receptor antagonist (NMDA), an ionotropic glutamate receptor. The drug has a new mechanism of action. Spravato is available in the United States, in mixture with an oral antidepressant, for the treatment of adults with treatment-resistant depression (RDT) and depressive symptoms in adults with CT with acute suicidal behavior or mentality. The product has been reviewed through fitness governance for DRD and adults with CT who lately have an intended suicidal mind in other markets around the world, adding in Europe. The FDA granted the designation of revolutionary treatment for skeptamine nasal spray for TRD in November 2013 and for MDD with an imminent suicide threat in August 2016.
Janssen’s a Success logo Tremfya (guselkumab) obtained marketing approval in the United States for a new indication in July, as the drug was approved for adult patients with progressive psoriatic arthritis (PSA). Tremfya represents the first approved remedy for active PSA that selectively inhibits interleucine (IL) 23, an herbal cytokine that deals with general inflammatory and immune responses related to PSA symptoms. Tremfya is the first biological product approved for the active PSA remedy that has an improvement in fatigue measured through FACIT-F on the product label.
Developed through Janssen, Tremfya is available in the United States, Canada, the European Union, Japan and other countries for the treatment of adults with moderate to severe plaque psoriasis who would possibly benefit from injections or pills (systemic therapy) or light therapy. (remedy using ultraviolet or ultraviolet light). The drug is also approved in the United States, Japan and Brazil for the remedy of adult patients with active PSA. IL-23 is a vital thing in the pathogenesis of inflammatory diseases, adding psoriasis and psoriatic arthritis.
Imbruvica (ibrutinib) obtained US approval. But it’s not the first time In April in mixture with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to treatment. The marketing authorization is based on the positive effects of the Phase 3 E1912 Trial, which was designed and conducted through the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored through the National Cancer Institute, a component of the National Institutes of Health. Marks Imbruvica’s eleventh approval by the US FDA. pathological spaces and represents the sixth approval for Imbruvica in the LLC.
Imbruvica, Bruton’s first-class oral tyrosine kinase inhibitor, which is administered once daily, is developed and announced jointly through Janssen Biotech and AbbVie Pharmacyclics. Imbruvica is the most studied BTK inhibitor, with more than 150 clinical studies underway and five phase 3 trials (in April) supporting the US label. Clinical studies come with six key CLL Phase 3 trials, which add more than five years of knowledge of efficacy, protection and tolerability. giant randomized clinical trials.
Imbruvica is available in more than 95 countries for at least one indication. The product was first approved by the US FDA. But it’s not the first time In November 2013 and is indicated in six pathological domains, adding five haematological cancers: CLL with or without 17p (17p) delenation, 17p SLL with or without 17p, Waldenstrom macroglobulinemia, patients treated in the past with a systemic remedy and have gained at least one anti-CD20 remedy in the past , and patients in the past treated with chronic disease graft opposed to the host after the failure of one or more systemic remedies.
The U. S. FDA has not been able to do so. But it’s not the first time It has granted accelerated approval for a new paediatric formula of Sirturo (bedaquiline) as a component of a mixed cure to treat young people with multidrug-resistant pulmonary tuberculosis (MDR-TB). remedy for adult and pediatric patients (5 years or older weighing at least 15 kg) with pulmonary MDR-TB
The May 27 FDA marketing authorization marks the first regulatory approval of Sirturo’s pediatric formulas (20 mg tablet) and is a key component of the R program.
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The European Commission’s approval of Janssen’s Ebola preventive vaccine, announced on 1 July, marks the first primary regulatory approval of a vaccine developed through the company. Janssen collaborates with the World Health Organization in vaccine prequalification, which helps speed up the registration of the Ebola preventive vaccination programme in African countries and facilitates wider access to those who want it most.
Janssen filed an application for a new drug with the US government of fitness. But it’s not the first time In September for UPtravi (selexipag) for intravenous injection for the remedy of pulmonary arterial hypertension (WHO Group I) in adults of functional elegance (FC) II-III of WHO, who are recently prescribed oral Uptravi but temporarily cannot take the oral remedy. The drug has been approved for the remedy of THE HAP to stop the progression of the disease and decrease the threat of hospitalization by the disease.
Two marketing authorisation (MMA) programmes have been submitted to the European Medicines Agency (EMA) for two-dose vaccines, Zabdeno (Ad26. ZEBOV) and Mvabea (MVA-BN-Filo). The Ebola vaccination scheme uses Janssen’s AdVac generation. combined with Bavarian Nordic’s established MVA-BN generation. Janssen’s Ebola vaccination scheme is indicated for active immunization for the prevention of Ebola virus disease caused by the Zaire Ebola virus species in others older than 1 year.
Janssen announced in June the company’s decision to suspend the LOTUS Stelara Phase 3 trial (ustekinumab) in systemic lupus erythematosus due to the lack of efficacy in SLE. Resolution is based on knowledge of a pre-planned intermediate power analysis. IL-12 and IL-23, Stelara is available in the United States for the treatment of adults and young people 12 years and older with moderate to severe plaque psoriasis, light therapy applicants or systemic therapy; Adults with active PSA, used alone or in mixture with methotrexate; Adults with moderate to severe active Crohn’s disease; adults with moderate to severe active ulcerative colitis.
The effects were presented in May from the last research of the pivotal phase 3 SPARTAN trial in which Erleada (apalutamide) was presented in mixture with an androgenic deprivation remedy, a particularly advanced SG, compared to TED alone, in patients with castration-resistant non-metastatic prostate cancer (nmCRPC) who had a high threat of metastasis. Erleada has become the first FDA-approved remedy for nmCRPC patients in February 2018. In September 2019, Erleada received marketing approval in the United States for the remedy of patients with castration-sensitive metastatic prostate cancer (mCSPC) based on the effects of the Titan Phase 3 trial, which achieved statistical significance in the two main evaluation criteria for SG and non-radiographic progression survival (rPFS). The product particularly expands GS into two indications of complex prostate cancer (nmCRPC and mCSPC). Erleada is approved in more than 65 countries and the labels are internationally updated to reflect knowledge of SPARTAN’s latest research.
The former Phase 3 VOYAGER PAD trial of Xarelto (rivaroxaban) related to aspirin demonstrated significant advantages in patients with symptomatic peripheral artery disease (PAE) after lower limb revascularization, meeting the main efficacy and tolerance criteria reported in March. Janssen, Xarelto has the prospect of being the first anticoagulant in 20 years to show advantages in high-risk patients. Two phase 3 primary studies evaluated the vascular dose of Xarelto plus aspirin in the treatment of patients with atherosclerosis.
Xarelto oral anticoagulant is a commercially successful drug for the prevention of deep vein thrombosis (PPI), which can cause pulmonary embolism (PE) in patients undergoing hip or knee replacement, at risk of stroke and systemic embolism in patients with non-valvular diseases. atrial fibrillation, and to treat and threat of recurrence of PST and EP.
In March, Janssen announced the effects of the first long-acting injectable Schimen trial (Phase 3 FLAIR) showing the protection and efficacy of the long-acting anti-HIV injectable remedy regimen for Janssen rilpivirine and ViiV Healthcare cabotégravir for 96 weeks. On 11 March, the corporation announced the effects of 48 weeks of the global phase 3b ATLAS-2M trial (long-acting antiretroviral cure every 2 months) demonstrating the protection and efficacy of rilpivirine and cabotégravir administered every two months.
The non-nucleoside opposite transcriptase inhibitor (INNTI) rilpivirine is advertised as Edurant for HIV remedy in mixture with other antiretrovirals, and develops through Janssen Sciences Ireland UC in a long-acting formula (Rilpivirine LA). Experimental suspension of injectable nanoparticles for intramuscularly Injection is not approved by the regulatory government anywhere in the world.
Janssen, in collaboration with Apple, opened heartline enrollment in February. The study is designed to explore whether the Heartline Study app on the iPhone and fitness center features on Apple Watch can improve fitness outcomes, adding stroke threat reduction, with pre-detection of traumatic inflammation (FA) headset.