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Johnson & Johnson: Transformational Innovation And Growth

Written by: | andrew.humphreys@medadnews.com | Dated: Wednesday, October 11th, 2017

 

With proven worldwide commercial capabilities and a robust product pipeline, Johnson & Johnson is firmly positioned to continue generating strong, long-term, sustainable growth.

 

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Johnson & Johnson

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

 

Best-Selling Rx Products

Product 2016 Sales

2015 Sales

Remicade

$6,966

$6,561

Stelara

$3,232 $2,474

Xarelto

$2,288

$1,868

Zytiga

$2,260

$2,231

Invega Sustenna/
Xeplion, Invega Trinza

$2,214

$1,830

Prezista, Prezcobix/Rezolsta

$1,851

$1,810

Simponi, Simponi Aria $1,745 $1,328
Invokana, Invokamet

$1,407

$1,308   

Imbruvica $1,251 $689
Velcade

$1,224

$1,618

Procrit/Eprex

$1,105

$1,068

Risperdal Consta

$893

$970

Concerta/methylphenidate $863

$821

Edurant

$573

$410

Darzalex $572 $20

All sales are in millions of dollars.

 

Financial Performance

  2016 2015
Revenue

$71,890

$70,074

Net income

$16,540

$15,409

Diluted EPS

$5.93

$5.48

R&D expense

$9,095

$9,046

  1H2017 1H2016
Revenue

$36,605

$35,964

Net income

$8,249

$8,454

Diluted EPS

$3.00

$3.02

R&D expense

$4,345

$4,277

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

 

 

J&J’s Janssen Pharmaceutical Companies announced plans during May to launch or submit for regulatory approval more than 10 new products with blockbuster potential between 2017 and 2021, as well as 50-plus line extensions of existing and new drugs that will bring the company’s transformational medicines to an even broader patient population. Management also revealed plans to continue driving sustainable growth by leveraging the company’s strong portfolio of core blockbuster products, the industry-leading productivity of its innovation model, and the acquisition of the Swiss-based biotechnology company Actelion.

“With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world,” states Alex Gorsky, chairman and CEO of J&J. “Our pharmaceutical business will continue to be a significant driver of innovation and growth for Johnson & Johnson. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth.”

“Our second-quarter (2017) results reflect strong adjusted earnings growth and we are optimistic that the investments we are making will accelerate our sales growth in the second half of this year. Our pharmaceutical pipeline continued its strong momentum with the approval of Tremfya as well as the submission and approval of several key line extensions. The Actelion acquisition establishes a new therapeutic area as well as another engine for growth and we are pleased to welcome the Actelion colleagues to the Johnson & Johnson Family of Companies. Together with all of our businesses, we will continue to transform the lives of patients around the world,” says Chairman and CEO Alex Gorsky.

 

As an industry leader in research productivity, Janssen has received US FDA approval for 11 new molecular entities since 2011. With a portfolio concentrated on five core therapeutic areas – Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism, and Oncology – J&J’s Pharmaceutical segment is delivering transformational new medicines for unmet medical needs around the globe, and added a sixth therapeutic area in Pulmonary Arterial Hypertension upon the completed acquisition of Actelion.

Since the May announcement, J&J achieved FDA approval for one of the anticipated blockbuster NMEs: Tremfya (guselkumab) for psoriasis. Late-stage products with annual sales potential of at least $1 billion that are projected to be submitted for regulatory approvals between 2017 and 2021 include apalutamide (ARN-509) for pre-metastatic prostate cancer; esketamine for treatment-resistant depression; talacotuzumab (CSL362) for acute myeloid leukemia; the FGFR inhibitor erdafitinib for solid tumors; niraparib for prostate cancer; imetelstat for myelofibrosis; pimodivir (JNJ-3872) for influenza A; lumicitabine (JNJ-1575) for respiratory syncytial virus infection; and the orexin-2 antagonist JNJ-7922 for adjunctive treatment for major depressive disorder.

Beyond 2021, the company’s early-stage pipeline is expected to continue delivering breakthrough medicines while additionally strengthening focus on eliminating disease through prevention, interception and cures.

During mid-June 2017, Johnson & Johnson announced the completed acquisition of Actelion for a total purchase price of $30 billion in cash. Having acquired all publicly held shares of the leading biopharmaceutical company for $280 per share, Actelion is now a member of the Janssen Pharmaceutical Companies of Johnson & Johnson.

“We are very pleased to complete this compelling transaction and look forward to the value it will create for Johnson & Johnson and for patients around the world suffering from pulmonary arterial hypertension (PAH) and other serious illnesses,” Gorsky notes. “Adding Actelion to our already strong pharmaceutical business expands our portfolio with leading, differentiated in-market medicines and promising late stage products.”

“Through this transaction, Janssen will establish a sixth therapeutic area that will be a growth engine for us as our combined team builds on the market-leading position of Actelion’s therapies,” says Joaquin Duato, executive VP and worldwide chairman of Pharmaceuticals for Johnson & Johnson. “Actelion’s PAH franchise, including differentiated, innovative medicines Opsumit, Uptravi and Tracleer expands our Janssen business and provides a leading commercial position in an established area of transformational medical innovation for patients with serious illnesses and significant unmet medical needs.”

In connection with the completion of the public tender offer, Actelion spun off the company’s drug discovery operations and early-stage clinical development assets into a newly created Swiss biopharmaceutical company known as Idorsia Ltd. Shares of Idorsia were distributed to Actelion’s shareholders as a stock dividend and began trading on the SIX Swiss Exchange as of June 16. A subsidiary of Johnson & Johnson will initially hold 9.9 percent of the shares of Idorsia and, subject to certain limitations, will have the right to another 22.1 percent of Idorsia’s outstanding equity through a convertible note. A subsidiary of Johnson & Johnson additionally has an option on ACT-132577, a compound in development for resistant hypertension for which the phase 2 study results were recently announced.

Johnson & Johnson expects the transaction to add $1.3 billion in sales for 2017 and be accretive to 2017 adjusted earnings per share by 7 cents. In the first full year after close, management expects the transaction to be accretive to adjusted earnings per share by 35 cents to 40 cents.

 

2017 Performance & Outlook

J&J’s global sales for the first six months of 2017 amounted to $36.6 billion, up 1.8 percent versus first-half 2016, including operational growth of 2.5 percent. Currency fluctuations had a negative impact of 0.7 percent for the 2017 first half. The net impact of acquisitions and divestitures on worldwide operational sales growth was a positive 1.7 percent during January-June 2017.

U.S. company sales for J&J totaled $19.1 billion in first-half 2017, which represented 1.1 percent growth versus same-time 2016. The net impact of acquisitions and divestitures on the U.S. operational sales growth improved 2.0 percent. Sales generated by international companies during the first six months of 2017 reached $17.5 billion, representing a 2.5 percent increase, including operational growth of 4.0 percent partially offset by a negative currency impact of 1.5 percent versus first-half 2016. The net impact of acquisitions and divestitures on the international operational sales growth was a positive 1.3 percent during the 2017 first half.

Pharmaceutical segment sales for first-half 2017 came in at $16.9 billion, rising 0.3 percent versus same-period 2016, with an operational increase of 1.2 percent and a negative currency impact of 0.9 percent. U.S. Pharmaceutical sales fell 2.0 percent year over year. International Pharmaceutical sales improved 3.7 percent versus first-half 2016, including operational growth of 5.9 percent partially offset by a negative currency impact of 2.2 percent. The net impact of acquisitions and divestitures on the Pharmaceutical segment operational sales growth registered at negative 0.1 percent. Adjustments to previous reserve estimates, as compared to the 2016 period, negatively impacted the Pharmaceutical segment operational growth for first-half 2017 by 3.0 percent, primarily in the Immunology and Cardiovascular/Metabolism/Other therapeutic areas.

During first-half 2017, Medical Devices sales totaled $13 billion, advancing 4 percent year over year, with operational growth of 4.7 percent and a negative currency impact of 0.7 percent. U.S. Medical Devices sales rose 4.1 percent. International Medical Devices sales declined by 3.9 percent, including an operational increase of 5.3 percent and a negative currency impact of 1.4 percent. The net impact of acquisitions and divestitures on the Medical Devices segment operational sales growth was a positive 3.3 percent during the first six months of 2017.

Consumer segment sales in the 2017 first half amounted to $6.7 billion, registering a 1.4 percent increase compared to same-time 2016, including operational growth of 1.6 percent partially offset by a negative currency impact of 0.2 percent. U.S. Consumer segment sales went up 5.8 percent in first-half 2017. International Consumer segment sales dropped off by 1.7 percent, including an operational decrease of 1.3 percent and a negative currency impact of 0.4 percent. The impact of acquisitions and divestitures on the Consumer segment operational sales growth was a positive 3.2 percent in the 2017 first half.

Based on the company’s first-half 2017 results, J&J management raised the company’s sales guidance for full-year 2017 to $75.8 billion to $76.1 billion. Adjusted earnings guidance for full-year 2017 was also raised, to $7.12 to $7.22 per share.

 

Product Approvals/Launches & Pipeline Updates During 2017

J&J’s anticipated blockbuster medicine Tremfya received U.S. regulatory clearance in July. Developed by Janssen, the human monoclonal antibody selectively blocks the protein interleukin (IL)-23. Tremfya received FDA approval for treating adult patients 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 European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Tremfya for approval during September. The final European Commission decision on the approval is expected by year-end 2017. Applications seeking marketing clearance in Japan and other countries are under review.
A Phase 3 program assessing Tremfya in the treatment of active psoriatic arthritis is ongoing. Another Phase 3 trial evaluating the efficacy of the drug compared with Cosentyx (secukinumab) in the treatment of moderate to severe plaque psoriasis is also under way. Additionally, a Phase 3 program in Crohn’s disease is planned.

Imbruvica (ibrutinib) was granted FDA marketing approval during early August as a treatment for adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy. Imbruvica represents the first FDA-approved medication for adult patients with cGVHD, a potential consequence of an allogeneic stem cell or bone marrow transplant, which can be life-threatening and debilitating. The first-in-class Bruton’s tyrosine kinase (BTK) inhibitor is jointly developed and commercialized by Janssen Biotech and Pharmacyclics, an AbbVie company.

Imbruvica was one of the first therapies to win FDA approval after having received the U.S. regulatory agency’s Breakthrough Therapy Designation. The medicine works by blocking BTK, a specific protein. The protein sends important signals that tell B cells to mature and produce antibodies, and is needed by specific cancer cells to multiply and spread. Imbruvica targets and blocks the protein, inhibiting the survival and spread of cancer cells, and impacting signaling associated with other serious conditions.

Imbruvica was previously approved to treat adults with: chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); CLL/SLL with 17p deletion; Waldenström’s macroglobulinemia (WM); mantle cell lymphoma (MCL) in patients who have received at least one prior therapy; and marginal zone lymphoma (MZL) in patients who require systemic therapy and have received at least one prior anti-CD20-based therapy.

The FDA approved a new indication for Darzalex (daratumumab) during June: in combination with pomalidomide and dexamethasone for treating patients with multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent and a proteasome inhibitor (PI).

Darzalex (daratumumab), the first CD38-directed antibody approved anywhere in the world, won FDA approval in June 2017 for a new indication: in combination with pomalidomide and dexamethasone for treating patients with multiple myeloma who have received at least two prior therapies.

 

Darzalex represents the first CD38-directed antibody approved anywhere worldwide. Darzalex was initially approved by the FDA during November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent or who are double refractory to a PI and immunomodulatory agent. The medicine is additionally approved in Europe, Canada and several other countries for a similar patient population. Darzalex gained U.S. regulatory clearance in November 2016 for use in combination with lenalidomide and dexamethasone, or bortezomib (marketed as Velcade) and dexamethasone, in patients with multiple myeloma who have received at least one prior therapy. Darzalex was granted Breakthrough Therapy Designation from U.S. regulators for this indication during July 2016.

The European Commission during April granted extended approval for the first-in-class CD38-directed monoclonal antibody Darzalex for use in combination with two standard of care regimens. Darzalex was cleared for EU marketing for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating adults with multiple myeloma who have received at least one prior therapy.

The initial marketing authorization was issued during May 2016 for daratumumab as monotherapy for treating adults with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. That authorization was marked as conditional based on Janssen providing additional data from the MMY3003 (POLLUX) and MMY3004 (CASTOR) trials. With the provision of these results, the EC has considered the Specific Obligations associated with the conditional Marketing Authorization to have been fulfilled, enabling the switch from conditional to full approval.

The biologic daratumumab targets CD38, a surface protein highly expressed across multiple myeloma cells, regardless of disease stage. The drug induces rapid tumor cell death via apoptosis (programmed cell death) and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Daratumumab has additionally shown immunomodulatory effects that contribute to tumor cell death through a decrease in immune suppressive cells including T-regs, B-regs and myeloid-derived suppressor cells.

Daratumumab is being studied in a comprehensive clinical development program that includes five Phase 3 trials across a range of treatment settings in multiple myeloma. Other studies are under way or planned to evaluate the product’s potential in other malignant and pre-malignant diseases in which CD38 is expressed.
The FDA during September approved a new 32-mg tablet for oral suspension for Tracleer (bosentan) for use in pediatric patients aged 3 years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. With this marketing clearance, Tracleer becomes the first FDA-approved medicine for pediatric PAH patients in the United States.

Available in more than 60 markets, Tracleer was initially approved by the FDA during November 2001 for the treatment of patients with PAH (WHO Group 1). The new approval covers a new 32-mg dosage featuring a scored tablet that can be dispersed in a teaspoon of water before oral administration. The lower dosage and score lines on the tablets are designed to enable physicians to vary the prescribed dose by the weight of the patient.

Actelion expected to launch the 32-mg dosage option by the fourth-quarter 2017. The existing 62.5-mg and 125-mg dosages for adult use remain available.
Tracleer is an orally active endothelin receptor antagonist (ERA), which is a medication that helps PAH patients by blocking the effects of the extra endothelin their bodies produce. Endothelin is a naturally occurring chemical in the body involved in blood flow.

 

2017 Acquisitions & Collaborations

Janssen Biotech received a complete response letter from the U.S. FDA for the Biologics License Application seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA), as announced on Sept. 22. The complete response letter indicates additional clinical data are necessary to further assess the safety of sirukumab in the treatment of moderately to severely active RA.

The FDA’s Arthritis Advisory Committee on Aug. 2 did not recommend approval of sirukumab (proposed trade name Plivensia) for the treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). An anti-interleukin (IL)-6 monoclonal antibody, sirukumab blocks the IL-6 pathway differently than IL-6 inhibitors currently approved for treating RA. Janssen Biotech announced filing of a BLA to the FDA seeking approval of sirukumab on Sept. 23, 2016.

A Positive Opinion was issued by the CHMP to Janssen-Cilag in July recommending marketing authorization for Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]). If approved, once-daily Symtuza would be the first darunavir-based single tablet regimen (STR) indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg, with genotypic testing guiding use.

Regulatory submissions were made to the European Medicines Agency and FDA for a single-tablet, two-drug regimen of dolutegravir (marketed as Tivicay by ViiV Healthcare) and rilpivirine (marketed as Edurant by Janssen), as announced on June 1. If cleared for marketing, this would be the first two-drug regimen for the maintenance treatment of HIV-1 infection and offer those living with HIV who are virally suppressed the option to switch to a regimen that does not include a nucleotide reverse transcriptase inhibitor (NRTI).

A Priority Review voucher was filed with U.S. regulators along with the dolutegravir and rilpivirine two-drug regimen New Drug Application.

ViiV Healthcare and Janssen Sciences Ireland during June 2014 announced a partnership to investigate the potential of combining dolutegravir and rilpivirine in a single tablet to expand the treatment options available to people living with HIV.

Edurant is a prescription HIV medicine used with other antiretroviral medicines to treat HIV-1. Tivicay is a human immunodeficiency virus type 1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for treating HIV-1 infection in adults and pediatric patients weighing at least 30 kg.
Janssen Biotech in September announced the filing of a supplemental New Drug Application to the U.S. FDA seeking to expand the indication of Zytiga in combination with prednisone and ADT to include treatment of patients with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC). The submission is based on Phase III data from the pivotal LATITUDE clinical study, which found that in newly diagnosed patients with high-risk mHNPC, Zytiga in combination with prednisone and ADT significantly increased overall survival and radiographic progression-free survival (rPFS) versus placebo plus ADT.

Comprising abiraterone acetate, Zytiga is indicated in combination with prednisone for treating patients with metastatic castration-resistant prostate cancer (mCRPC). The medicine blocks CYP17-mediated androgen production, which fuels prostate cancer growth, at three sources: in the testes, adrenals, and the prostate tumor tissue. Zytiga is the first approved therapy in mCRPC that inhibits production of androgens at all three of those sources. Zytiga has proven efficacy in patients with mCRPC who have progressed on androgen deprivation therapy.

Since initial marketing clearance during 2011, Zytiga has been approved in combination with prednisone/prednisolone in 105 countries. More than 330,000 men around the globe have received treatment with the product. Zytiga was the No. 1 prescribed oral medication for American men with mCRPC during 2016.

The FDA accepted for Priority Review a supplemental New Drug Application for Xarelto (rivaroxaban) to include a 10 mg once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy. This application is based on data from the Phase 3 study EINSTEIN CHOICE, the first clinical trial to find a non-vitamin K antagonist oral anticoagulant (NOAC) – specifically two doses of Xarelto (10 mg and 20 mg) – to be superior to aspirin in reducing the risk of recurrent VTE, with comparable rates of major bleeding.

Xarelto is the first non-vitamin K antagonist oral anticoagulant (NOAC) to demonstrate superiority over aspirin with comparable rates of major bleeding in reducing the risk of recurrent venous thromboembolisms after initial treatment.

 

As of late June, Xarelto had six FDA-approved indications, including the treatment of VTE (15 mg twice daily for the first 21 days followed by 20 mg once daily for the remainder of treatment), and reduction in the risk of recurrent VTE (20 mg once daily).

Results revealed in August from the pivotal Phase 3 COMPASS trial found that the Xarelto vascular dose (2.5 mg twice daily) plus aspirin 100 mg once daily significantly reduced the risk of major cardiovascular events defined as CV death, heart attack or stroke by 24 percent in patients with stable coronary and/or peripheral artery disease (CAD/PAD) compared to aspirin alone. According to J&J, this finding was driven by a robust 42 percent reduction in any stroke and 22 percent reduction in CV death. The risk of major bleeding was significantly higher in patients taking the Xarelto/aspirin regimen versus aspirin alone, with no significant increase in fatal or intracranial bleeds. Findings from the worldwide, randomized, superiority study were announced by Janssen Research & Development at the ESC Congress 2017 and simultaneously published in The New England Journal of Medicine.

Xarelto is used: to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem; to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again; and to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

New Phase 3 data reported during June demonstrated that the anti-TNF alpha Simponi Aria (golimumab) significantly improved arthritis and skin manifestations in patients with active psoriatic arthritis. Results from the GO-VIBRANT clinical trial showed that treatment with intravenous golimumab improved joint and skin symptoms in patients with active psoriatic arthritis, and inhibited the progression of structural damage, which are significant treatment goals in the management of the progressive, inflammatory disease.

Simponi Aria is undergoing FDA review for treating adults with active psoriatic arthritis and treating adults with ankylosing spondylitis. The medicine is approved in the United States for treating adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate.
The infusible, fully human anti-TNF-alpha monoclonal antibody targets soluble and transmembrane bioactive forms of TNF-alpha, a protein that can cause inflammation and damage to bones, cartilage and tissue. By binding with and blocking TNF-alpha, the medicine helps control inflammation. As of June, Simponi Aria was approved in 23 countries as a 30-minute infusion for treating adults with moderately to severely active RA with methotrexate.

In other June news, results from the landmark CANVAS Program showed Invokana (canagliflozin) significantly reduced the combined risk of cardiovascular death, myocardial infarction, and nonfatal stroke compared to placebo in patients with type 2 diabetes mellitus (T2DM) at risk for or with a history of CV disease. The results additionally demonstrated canagliflozin treatment was associated with a reduced risk for hospitalization for heart failure (HHF) and showed potential renal protective effects. The data from the integrated analysis of the CANVAS and CANVAS-R trials were published in the New England Journal of Medicine.

Canagliflozin was evaluated in the longest, largest and broadest completed CV outcomes program of any sodium glucose cotransporter-2 (SGLT2) inhibitor. The CANVAS Program is the first to study the efficacy, safety, and durability of canagliflozin in more than 10,000 patients with T2DM who had either a prior history of CV disease or at least two CV risk factors.

The FDA approved Invokana as a single agent during March 2013. The medicine is the No. 1-prescribed SGLT2 inhibitor with more prescriptions than all other such inhibitors combined in the United States during 2017 (as of May 26). Since the drug’s launch, more than 14 million U.S. prescriptions have been written for Invokana.

Janssen Pharmaceuticals in May reported real-world evidence demonstrating people with type 2 diabetes initiated on oral Invokana 300 mg were as likely as matched patients initiated on injectable GLP-1 receptor agonists (GLP-1 RAs) to achieve the recognized HEDIS standard of blood glucose control of A1C less than 8.0 percent. Invokana patients were additionally less likely to discontinue their medication or be prescribed a new antihyperglycemic agent (AHA).

Janssen Biotech Inc. announced during February new two-year data from the ongoing IM-UNITI long-term extension (LTE) trial assessing the efficacy and safety of subcutaneous Stelara (ustekinumab) in adults with moderately to severely active Crohn’s disease. The data demonstrated that treatment with ustekinumab maintained clinical response and remission for up to two years with no new safety signals observed.

Containing the active chemical ustekinumab, Stelara is the first interleukin (IL)-12/23 inhibitor licensed for Crohn’s disease.

 

Stelara is used to treat patients 18 years and older with moderately to severely active Crohn’s disease who have already taken other medicine that did not work well enough or they could not tolerate it. The recommended treatment regimen is one intravenous infusion of the amount of medication based on body weight administered by a medical professional at week 0, followed by a 90-mg injection given under the skin as directed by a physician at week 8 and then every 8 weeks thereafter.

The human interleukin (IL)-12 and IL-23 antagonist Stelara indicated in the United States for treating adults with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis, alone or in combination with methotrexate; and moderately to severely active Crohn’s disease who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a TNF blocker, or who failed or were intolerant to treatment with one or more TNF blockers.

In the Medical Devices area, the FDA during September issued 510(k) clearance to the Idylla Respiratory (IFV-RSV) Panel. The non-invasive test developed by Janssen Diagnostics identifies respiratory infection in adult and pediatric patients. The diagnostic test was developed by Janssen Diagnostics scientists in partnership with Biocartis Group. The test offers fast and easy access to molecular diagnostic information and can help physicians in identifying viral respiratory infections in patients, and thereby allow for treatment selection.

During the second quarter, FDA granted approval for the 30-minute STERRAD VELOCITY Biological Indicator System for low temperature H202 sterilization as well as approval for the SURGICEL Powder Absorbable Hemostat for adjunctive hemostasis during surgery.

Janssen Biotech entered into a clinical trial collaboration with Bristol-Myers Squibb in January to study the combination of Darzalex and the checkpoint inhibitor nivolumab in Phase 1b/Phase 2 clinical trials in multiple myeloma and several solid tumor types. Nivolumab is developed and commercialized as Opdivo by BMS. Janssen licensed daratumumab from Genmab and is responsible for worldwide development, marketing and manufacturing.

DePuy Synthes Products, part of the Johnson & Johnson Medical Devices Companies, announced in June its acquisition of Innovative Surgical Solutions. Doing business as Sentio, the privately held company based in Wixom, Mich., markets innovative nerve localization technology for spine surgery. According to management, the acquisition underscores the DePuy Synthes and Johnson & Johnson Medical Device Companies strategy of investing in faster-growing segments with technologies that are designed to help improve patient outcomes and bring value to customers.

Ethicon struck a deal in February to acquire Torax Medical. The privately held medical device company manufactures and markets the LINX Reflux Management System, a novel minimally invasive device for the surgical treatment of GERD. The acquisition allows Ethicon to offer patients a safe and effective alternative to the anatomy-altering laparoscopic Nissen fundoplication surgical procedure.

Ethicon Endo-Surgery agreed to acquire Megadyne Medical Products during January. The privately held medical device company develops, manufactures and markets electrosurgical tools used in operating rooms around the globe. According to company officials, the acquisition unites the intelligence of Ethicon’s advanced energy devices with Megadyne’s innovative portfolio of electrosurgical tools representing a major step forward in Ethicon’s goal to deliver the most comprehensive suite of intelligent energy solutions that enhance precision and efficiency in the operating room.

DePuy Synthes Products agreed in January on an asset purchase and development agreement with Interventional Spine. The privately held company manufactures expandable cage and minimally invasive surgery (MIS) technologies for spinal fusion.

Janssen Research & Development and the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) agreed on a collaboration during September to develop a comprehensive portfolio of therapeutics and vaccines to protect communities in the event of an influenza pandemic and other infectious disease threats. Through the agreement that was created under the U.S. Government’s Other Transaction Authority (OTA), Janssen and BARDA – a component of ASPR – will invest equally to advance Janssen’s extensive portfolio of investigational influenza medicines and vaccines throughout the duration of the collaboration.

Related assets within Janssen’s portfolio include JNJ-5806 (formerly AL-794), a potent small molecule inhibitor of influenza A and B viruses including strains with pandemic potential, as well as a “universal” vaccine candidate that aims to protect against all influenza strains. Other investigational products in the portfolio include therapeutic monoclonal antibodies and new targets for emerging pathogens of potential public health concern.

This agreement further builds on the collaborations Janssen and BARDA have already established in influenza with pimodivir, a potential first-in-class inhibitor of the PB2 subunit of the influenza A polymerase complex, as well as in response to the 2014 Ebola outbreak in West Africa. This partnership provides a further portfolio of potential solutions to address the impact of influenza, according to J&J management.

Codman Neuro during April announced the acquisition of Neuravi, a privately held Irish company committed to advancing neurovascular therapies and improving clinical outcomes for acute ischemic stroke patients. DePuy Ireland, an affiliate of Codman Neuro, is the acquiring entity of Neuravi.

 

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