Johnson & Johnson: Focused On Growth Drivers
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New Brunswick, New Jersey 08933
Best-Selling Rx Products
|Product||2014 Sales||2013 Sales|
|Simponi, Simponi Aria||$1,187||$932|
All sales are in millions of dollars.
All sales are in millions of dollars.
Johnson & Johnson continues to make investments to accelerate long-term growth. To that end, the company executed more than 100 strategic partnerships, licenses, and acquisitions across its Pharmaceutical, Medical Devices and Consumer segments during 2014. According to management, J&J has built significant momentum in the company’s Pharmaceutical business, is realizing the benefits of innovation, scale and breadth in the Medical Devices segment and continues market leadership with iconic brands in the Consumer sector.
Pharmaceutical sales pace the way amongst J&J’s three major segments of operation. The Pharmaceutical business has produced annual worldwide double-digit growth in recent years, growing from $25.35 billion in 2012 to $28.13 billion during 2013 to $32.31 billion for 2014. With 14 new medicines introduced since 2009, J&J’s Pharmaceutical segment is the fastest-growing of the top 10 pharma businesses in the United States, Europe and Japan, according to data resources and company leadership.
In a May 2015 meeting with industry analysts, senior leaders from the Janssen Pharmaceutical Companies of Johnson & Johnson revealed plans to file for regulatory approval more than 10 new products between 2015 and 2019. Each of the promising medicines have the potential to top $1 billion in annual revenue. During that time frame, Janssen also intends to file for regulatory clearance more than 40 line extensions of existing and new drugs.
With a portfolio concentrated on five core therapeutic fields – Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism and Oncology – J&J’s Pharmaceutical segment is delivering transformational new medicines for unmet medical needs worldwide, company leadership says. Of the 14 new products launched since 2009 through May 2015, seven already exceed or are on track to generate sales topping $1 billion in 2015. These new products, along with core growth brands, have fueled industry-leading sales growth and contributed significantly to J&J’s increased earnings. Management says the combined strength of Janssen’s in-market portfolio and robust near-term product pipeline provides the momentum to sustain above-industry compound annual growth through 2019.
“In the past two years, our performance and growth rates have been industry-leading, and we look forward to continuing to drive above-industry growth with our current in-market portfolio and next wave of medicines,” noted Joaquin Duato, Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. “We are working with our partners to advance the innovative products in our pipeline and to deliver significant benefits to patients.”
Late-stage medicines anticipated to receive marketing approval and drive growth during the next several years include daratumumab for multiple myeloma; sirukumab for rheumatoid arthritis; guselkumab for psoriasis; JNJ-927 (ARN-509) for pre-metastatic prostate cancer; imetelstat for myelofibrosis; the FGFRi kinase inhibitor JNJ-493 for urothelial cancer; esketamine for treatment-resistant depression; AL-8176 for respiratory syncytial virus; fulranumab for osteoarthritic pain; JNJ-872 (VX-787) for influenza A; the orexin-2 antagonist JNJ-922 for primary insomnia; and AL-335 for hepatitis C. Also, daratumumab and esketamine have been granted Breakthrough Therapy Designations from the U.S. Food and Drug Administration. Janssen during 2015 filed a Biologic Licensing Application to the FDA and a Marketing Authorization Application to the EMA for daratumumab in double refractory multiple myeloma.
“Our innovation model and capital allocation framework provide us the flexibility to source both internal and external innovations to create an industry-leading portfolio that is advancing our vision of a world without disease,” stated Dominic J. Caruso, VP of Finance and Chief Financial Officer, J&J.
Janssen announced during February 2015 the launch of three new research platforms concentrated on disease prevention, disease interception, and the microbiome to underpin ongoing research and propel scientific knowledge in these fields of significant potential to change the way diseases are managed. The Janssen Prevention Center concentrates on prevention of chronic, non-communicable diseases; the Disease Interception Accelerator is focused on tackling the origins of disease and intercepting progression to disease for people at-risk – before they get sick; and the Janssen Human Microbiome Institute concentrates on the diverse population of bacteria living in and on the human body to develop therapeutic targets and diagnostic capabilities that have the potential to transform human health.
“The future of health care lies in not only treating disease but also preventing and intercepting diseases before illness occurs,” commented William N. Hait, M.D., Ph.D., Global Head of Janssen Research & Development LLC. “Using our powerful research platforms in combination with our five focused therapeutic areas, underpinned by strong in-house capabilities and cutting-edge external partnerships, we are striving to deliver the next generation of medical innovations that prevent, intercept and treat disease.”
Company performance and overview
As the largest and most diversified health-care company worldwide, J&J has about 127,000 employees working at 265 operating companies in 60 countries. J&J delivered solid financial results during 2014, with full-year 2014 sales totaling $74.33 billion and adjusted net earnings amounting to $17.11 billion. Near-term priorities were achieved last year, exceeding financial targets with full-year operational 2014 sales growth of 6.1 percent. Excluding the net impact of acquisitions and divestitures, on an operational basis, global sales rose 8 percent versus the 2013 result. Across the company’s three major business segments, J&J had 24 brands and platforms generate more than $1 billion in revenue during 2014.
The $32.31 billion in 2014 global Pharmaceutical sales for J&J represented a 14.9 percent increase compared to 2013, with operational growth of 16.5 percent and a negative impact from currency of 1.6 percent. Domestic sales rose 25 percent to $17.43 billion. International sales advanced 5 percent to $14.88 billion, with operational growth of 8.3 percent and a negative currency impact of 3.3 percent.
Worldwide Medical Devices totaled $27.52 billion in 2014 sales, representing a 1.6 percent operational decrease. Excluding the net impact of acquisitions and divestitures, on an operational basis, global sales grew 1.6 percent. The Medical Devices business holds a strong leadership position in the industry, including 10 platforms exceeding $1 billion in sales. More than 50 major new products have been launched since 2012, with 30 major new filings planned between early 2015 and year-end 2016.
Global Consumer sales for J&J during 2014 amounted to $14.5 billion, representing an operational increase of 1 percent. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales advanced 2.8 percent versus the previous year. Positive sales contributors to operational results included Tylenol and Motrin analgesics as well as Zyrtec allergy OTC products; Aveeno and Neutrogena skin care products; and Listerine oral care products.
For the first six months of 2015, J&J global sales reached $35.16 billion, which was down 6.5 percent compared to first-half 2014 (operational results improved 1.1 percent and the negative impact of currency was 7.6 percent). The 2015 first-half sales breakdown was nearly identical between the United States ($17.6 billion, up 1.5 percent year-over-year) and internationally ($17.56 billion, down 13.4 percent).
J&J’s Pharmaceutical segment produced sales of $15.67 billion in the first two quarters of 2015, a 2.1 decrease versus the one-year-earlier time frame (operational results grew 5.3 percent and the negative impact of currency was 7.4 percent). For Medical Devices, sales in first-half 2015 amounted to $12.62 billion, representing an 11.8 percent decline (operational results decreased 4.6 percent and the negative impact of currency was 7.2 percent). Consumer sales of $6.87 billion were down 5.9 percent compared to first-half 2014 (operational results rose 2.8 percent and the negative impact of currency was 8.7 percent).
Johnson & Johnson’s net earnings for January-June 2015 totaled $8.84 billion, down 2.4 percent versus the one-year-earlier period. Diluted earnings per share for first-half 2015 were reported at $3.13, a 0.6 percent decline. On the other hand, R&D expenditure improved 5 percent to $4.03 billion for the first six months of 2015.
Johnson & Johnson’s best-selling prescription medicine remains Remicade (infliximab), which treats various immune-mediated inflammatory diseases. The biologic produced sales of $6.87 billion during 2014 (up 2.9 percent compared to 2013) and $3.27 billion in first-half 2015 for J&J (down 4.3 percent on a reported basis versus the one-year-earlier period).
Remicade patents for certain countries in Europe (Germany, Spain, United Kingdom, Sweden, Austria, Belgium, Switzerland, Denmark, France, Greece, Italy, Luxembourg and the Netherlands) expired during February 2015. J&J managers in early 2015 said loss of exclusivity would likely result in a sales reduction as biosimilar versions were introduced to the market. The company’s first-half 2015 international sales for Remicade were down 19.4 percent on a reported basis.
The hepatitis C medicine Olysio/Sovriad (simeprevir) quickly ascended to the No. 2 pharmaceutical sales post in 2014 for J&J after debuting in the marketplace in 2013. Sales grew from $23 million in 2013 to $2.3 billion for 2014. However, the sales momentum was short-lived as the first-half 2015 total came in at $498 million versus $1.19 billion for January-June 2014. Primarily because of new market competition, Olysio U.S. sales during the 2015 first half fell to $148 million after coming in at $1.02 billion for the first six months of 2014.
The NS3/4A protease inhibitor Olyvio/Sovriad was developed by Janssen Sciences Ireland UC in collaboration with Medivir AB. In November 2013, Olysio gained its first marketing approval from the FDA, and the European Commission granted marketing authorization in May 2014. Subsequent marketing approvals followed in several other countries globally. Janssen is responsible for the worldwide clinical development of Olysio and has exclusive, global marketing rights, except in the Nordic countries. Medivir retains marketing rights for the drug in those countries under the marketing authorization held by Janssen-Cilag International NV.
Zytiga (abiraterone acetate) broke the $2 billion sales barrier for the first time in 2014. Launched in 2011, the drug’s 2014 sales came in at $2.24 billion and the first-half 2015 result was $1.1 billion. The oral, once-daily medication is available for use in combination with prednisone for treating 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 has proven efficacy in individuals with mCRPC who have progressed on androgen deprivation therapy.
The human interleukin (IL)-12 and IL-23 antagonist Stelara generated sales of $2.07 billion during 2014 (an increase of 37.8 percent versus the prior year) and $1.12 billion for first-half 2015 (rising 13.7 percent over the biologic’s one-year-earlier performance). The Janssen Pharmaceutical Companies maintain exclusive global marketing rights to Stelara (ustekinumab), which is available for treating moderate-to-severe plaque psoriasis in at least 84 countries and psoriatic arthritis in at least 55 countries.
Sales growth during 2014 of Velcade (bortezomib) was more than offset by negative currency, declining 2.5 percent year-over-year to $1.62 billion. The downswing continued in first-half 2015, with sales falling 15.8 percent to $683 million from the drug’s January-June 2014 result. Velcade is marketed for the treatment of multiple myeloma and mantle cell lymphoma.
Invega Sustenna/Xeplion (paliperidone palmitate) has produced strong sales growth in recent years, growing from $796 million in 2012 to $1.25 billion for 2013 to $1.59 billion during 2014. Worldwide sales growth continued during the first six months of 2015, advancing 10.4 percent year-over-year to $847 million
Invega Sustenna was cleared for FDA approval during July 2009 as the first once-monthly atypical long-acting injectable antipsychotic to treat schizophrenia. The medicine has been approved for marketing in 80-plus countries.
During June 2015, paliperidone palmitate became the first schizophrenia treatment to become available for administration just four times a year, under the brand name Invega Trinza. Before starting Invega Trinza, patients must be adequately treated with Invega Sustenna for at least four months.
The oral anticoagulant Xarelto (rivaroxaban) had a strong sales showing during 2014, increasing to $1.52 billion after tallying $864 million in 2013 and $239 million in 2012. The sales performance remained strong during first-half 2015, increasing 34.3 percent year-over-year to $913 million. Xarelto works by blocking the blood clotting Factor Xa, does not require routine blood monitoring, and is FDA-approved for six indications.
The Simponi (golimumab) franchise produced 2014 sales of $1.19 billion, after totaling $932 million during 2013 and $607 million in 2012. The biologic agent accounted for January-June 2015 sales of $608 million, up from $541 million in first-half 2014.
The human monoclonal antibody Simponi targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can result in inflammation and damage to bones, cartilage and tissue. Simponi has been cleared for marketing in 85 countries for rheumatologic indications. The drug is available either via the SmartJect autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection.
Janssen Biotech Inc. discovered and developed Simponi and markets the biologic in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Europe, Russia and Turkey, Janssen Biotech licenses distribution rights to Simponi to Schering-Plough (Ireland) Co., a subsidiary of Merck & Co. In Japan, Indonesia and Taiwan, Janssen Biotech licenses distribution rights to Simponi to Mitsubishi Tanabe Pharma Corp. and has retained joint-marketing rights in those countries.
Recent product approvals and pipeline updates
In terms of 2014 research and development, J&J invested an industry-leading $8.49 billion. According to management, J&J’s strong pipelines are anticipated to yield 20 key consumer product launches worldwide in 2015; 30 new major medical device product submissions between 2014 and 2016; and 10 major new pharma filings and 25 line extensions between 2013 and 2017.
A marketing authorization application was submitted for which accelerated assessment was granted for the investigational, human anti-CD38 monoclonal antibody daratumumab in September 2015 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The application is for the treatment of patients with relapsed and refractory multiple myeloma. Daratumumab was granted Orphan Drug Status by the EMA during July 2013 for treating plasma cell myeloma.
On Sept. 4, 2015, the biologics license application for daratumumab was granted priority review as a treatment for patients with multiple myeloma who are refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who have received three or more previous lines of therapy, including a PI and an IMiD. This is known as “double refractory” multiple myeloma, which takes place when a patient’s disease has become resistant to at least two of the most commonly used and active classes of anti-myeloma agents. FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016 to make a decision on the daratumumab BLA.
The U.S. and EU approval applications include data from the Phase II MMY2002 (SIRIUS) monotherapy trial, the Phase I/II GEN501 clinical monotherapy study, and from three other supportive studies. A deal was entered into with Genmab A/S in August 2012 granting Janssen Biotech an exclusive global license to develop, manufacture, and commercialize daratumumab. Janssen is the worldwide sponsor of all but one clinical trial and holds U.S. marketing rights.
Daratumumab has the potential to be the first anti-CD38 monoclonal antibody to gain regulatory clearance for treating multiple myeloma. Daratumumab acts by binding to CD38, a signalling molecule found on the surface of multiple myeloma cells. In doing so, the drug triggers the patient’s own immune system to attack the cancer cells, leading to rapid tumor cell death via multiple immune-mediated and other mechanisms of action.
Five Phase III trials with daratumumab in relapsed and front-line settings were under way as of the end of May 2015. Additional ongoing clinical studies as well as those in the planning stage will assess the drug’s potential in other malignant and pre-malignant diseases on which CD38 is expressed, including smoldering myeloma and non-Hodgkin’s lymphoma.
Phase II data revealed in late May 2015 demonstrated that daratumumab achieved a pronounced overall response rate as a single agent with a tolerable safety profile in heavily pre-treated multiple myeloma patients.
A supplemental new drug application for Imbruvica (ibrutinib) was filed with FDA for front-line use in patients with chronic lymphocytic leukemia (CLL) during September 2015. The sNDA submission is based on data from the randomized, multi-center, open-label Phase III RESONATE-2 (PCYC-1115) study assessing the use of ibrutinib compared to chlorambucil in patients with treatment-naïve CLL or small lymphocytic lymphoma (SLL) aged 65 years and older. The drug is co-developed and co-commercialized in the United States by Janssen Biotech and Pharmacyclics LLC, an AbbVie company. Pharmacyclics is the investigational new drug holder for Imbruvica in the United States and filed the application with FDA on behalf of both companies. Janssen affiliates market ibrutinib in EMEA (Europe, Middle East and Africa) and the rest of the world.
Imbruvica was one of the first therapies to gain FDA marketing clearance after having received breakthrough therapy designation. The medicine works by blocking a specific protein known as Bruton’s tyrosine kinase (BTK). The BTK protein sends important signals that tell B cells to mature and produce antibodies, and is required by specific cancer cells to multiply and spread. Imbruvica targets and blocks BTK, thereby inhibiting the survival and spread of cancer cells.
The European Commission during July 2015 approved Imbruvica capsules as a treatment option for adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or in first-line treatment for patients unsuitable for chemo-immunotherapy. There were previously no approved treatment options in Europe for WM, a rare and slow-growing form of blood cancer. FDA approval for the WM indication was granted during the first month of 2015, the fourth indication received for Imbruvica for the U.S. marketplace.
Data from the Phase III CLL3001 (HELIOS) study announced in May 2015 showed that the combination of ibrutinib with bendamustine and rituximab (BR) reduced the risk of progression or death by 80 percent and significantly improved overall response rate compared to placebo plus BR in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. In March 2015, Janssen Research & Development announced that the HELIOS trial met its primary endpoint of progression-free survival in patients with previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma at a pre-planned interim analysis
U.S. regulators approved an sBLA for Simponi Aria (golimumab for infusion) for treating moderately to severely active rheumatoid arthritis to include measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36). According to the revised labeling, Simponi Aria – when administered in combination with methotrexate – improved patients’ physical and emotional well-being as measured by the SF-36 assessment. The drug initially was granted FDA approval in July 2013 for treating moderately to severely active RA and is the only intravenous anti-tumor necrosis factor-alpha administered as a 30-minute infusion.
Simponi received its fifth European approval during June 2015. The new indication is for treating adults with severe active non-radiographic axial spondyloarthritis (nr-AxSpA) with objective signs of inflammation (OSI), as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to or are intolerant to NSAIDs. Nr-AxSpA is a type of spondyloarthritis, a chronic inflammatory disease affecting the spine in which the predominant symptom is back pain and stiffness.
Janssen Pharmaceuticals Inc. and development partner Bayer HealthCare announced in early September 2015 results from PMSS (Post-Marketing Safety Surveillance) and XANTUS (Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation). The landmark real-world trials are evaluating the safety of Xarelto in individuals with non-valvular atrial fibrillation (NVAF). According to the results, the rates and patterns of major bleeding in routine clinical practice were low (2.89 and 2.1 per 100 person-years, respectively) and generally consistent with those observed in Phase III research. The trials collectively included more than 45,000 patients from 22 countries.
The two companies initiated the PMSS and XANTUS observational studies to evaluate the real-world safety performance of Xarelto in patients with NVAF as part of the worldwide development program for the product. PMSS is a continuing, five-year, observational study evaluating major bleeding in NVAF patients in the U.S. taking once-daily Xarelto over the course of treatment. The two-year data demonstrated that the rates and patterns of major bleeding were generally consistent with the Phase III ROCKET AF study.
Bayer HealthCare designed XANTUS as an international, prospective, single-arm, observational study to observe the rates of major bleeding and stroke for one year for individuals with NVAF taking once-daily Xarelto for stroke prevention in Europe, Canada and Israel. Similar to PMSS, XANTUS found the rates and patterns of major bleeding in routine clinical practice to be generally consistent with Phase III research. Of the 6,784 patients taking the drug, the incidence of major bleeding was 2.1 per 100 person-years. Similar studies to XANTUS (XANTUS-EL and XANAP) are being conducted in the EMEA (Europe, Middle East & Africa), Latin America and Asia-Pacific regions.
Regarding other Xarelto R&D developments, new real-world data were presented during March 2015 demonstrating that patients diagnosed with deep-vein thrombosis and treated with rivaroxaban were admitted to the hospital less frequently than those treated with the standard treatment of low-molecular-weight heparin and warfarin. The reduction in hospital admissions with Xarelto resulted in significant cost savings with no difference in subsequent hospital visits compared to the standard of care.
Paliperidone palmitate is awaiting EU marketing approval to become the first antipsychotic schizophrenia medication to be administered four times a year. Janssen-Cilag International announced the filing of an extension MAA to the European Medicines Agency during August 2015. If cleared for approval, the drug will be marketed as Trevicta in Europe.
Paliperidone palmitate is already approved in the European Union as a once-monthly formulation and marketed as Xeplion. The atypical long-acting injection for treating schizophrenia and is available in 80-plus countries. The drug can help individuals with schizophrenia to maintain continuous treatment, control their symptoms and avoid relapse. Paliperidone palmitate once-every-three-months formulation – marketed in the United States as of June 2015 under the brand name Invega Trinza for patients previously treated with the once-monthly formulation – has an extended dosing interval compared to Xeplion.
FDA issued a complete response letter regarding the sNDA for the once-monthly long-acting antipsychotic Invega Sustenna during May 2015. The sNDA seeks to expand the product’s label to include data demonstrating that treatment with Invega Sustenna is effective six months longer than commonly prescribed oral antipsychotics for individuals with schizophrenia.
A study published in The Journal of Clinical Psychiatry during April 2015 demonstrated that long-acting Invega Sustenna was effective six months longer than commonly prescribed oral antipsychotics in patients with schizophrenia, delaying relapse including hospitalization, arrest and incarceration. Carried out over a 15-month term, the Paliperidone Palmitate Research In Demonstrating Effectiveness (PRIDE) trial is the first prospective, randomized study to evaluate schizophrenia treatments within the context of many real-world issues faced by patients in their daily lives. Those issues include challenging situations such as recent incarceration or substance abuse.
An sNDA was filed by Janssen Therapeutics with U.S. regulators during July 2015 to update the label for once-daily, all-oral Olysio. The hepatitis C virus (HCV) NS3/4A protease inhibitor is already available for use with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection as a 12-week treatment for patients without cirrhosis or a 24-week treatment regimen for patients with cirrhosis. The nucleotide analog NS5B polymerase inhibitor sofosbuvir is an active chemical in the mega-brands Harvoni and Sovaldi marketed by Gilead Sciences Inc.
Olysio was FDA-approved during November 2014 in combination with sofosbuvir based on the Phase II COSMOS study. The sNDA is based on results from the Phase III OPTIMIST-1 and OPTIMIST-2 studies, which evaluated 12 and eight weeks of therapy for treatment-naïve and treatment-experienced genotype 1 CHC adult patients without cirrhosis, and 12 weeks of therapy for treatment-naïve and treatment-experienced genotype 1 CHC adult patients with cirrhosis.
In April 2015, Janssen Sciences Ireland announced SVR12 rates with 12 weeks of treatment with an all-oral, once-per-day regimen of simeprevir and sofosbuvir in genotype 1 HCV patients with and without cirrhosis. Data from the OPTIMIST-1 and OPTIMIST-2 studies demonstrated SVR12 rates of 97 percent and 84 percent, with SVR12 rates of up to 100 percent achieved among subgroups in each study.
Phase IIb results published during July 2015 in The New England Journal of Medicine demonstrated up to 86 percent of patients with moderate to severe plaque psoriasis receiving guselkumab (CNTO 1959) achieved a Physician’s Global Assessment (PGA) score of cleared psoriasis or minimal psoriasis at week 16, the clinical trial’s primary endpoint. The X-PLORE study demonstrated significantly higher levels of efficacy for all guselkumab doses at week 16 versus the placebo group, and responses were maintained through week 40 of the trial. The study additionally included an active comparator arm, which showed several guselkumab dosage regimens provided better response rates versus the anti-TNF-alpha agent, adalimumab, which is marketed by AbbVie as Humira. An investigational human monoclonal antibody that targets the protein interleukin (IL)-23, guselkumab is undergoing Phase III development as a subcutaneously administered therapy for treating moderate to severe plaque psoriasis.
Stelara received EC approval during June 2015 for treating moderate-to-severe plaque psoriasis in adolescent patients ages 12 years and older who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. The drug already was approved for treating moderate-to-severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA). Stelara additionally is available for treating moderate-to-severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. The medicine is indicated alone or in combination with MTX for treating active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.
FDA during March 2015 approved a label update for Zytiga plus prednisone based on the final analysis of the Phase III, randomized, double-blind, placebo-controlled COU-AA-302 trial. The study demonstrated that Zytiga with prednisone significantly prolonged median overall survival versus placebo plus prednisone in chemotherapy-naïve men with metastatic castration-resistant prostate cancer. After a median follow-up of four-plus years (49.2 months), the Janssen Research & Development-sponsored registration trial showed a median OS of nearly three years (34.7 months) in the patients randomized to Zytiga plus prednisone versus 30.3 months in the placebo + prednisone arm (median OS, 34.7 vs. 30.3 months, respectively; HR= 0.81 [95% CI, 0.70-0.93]; p = 0.0033).
The European Commission approved a variation to the terms of the marketing authorization of Velcade in February 2015. The additional indication was granted for Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for treating adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for blood stem-cell transplantation. Velcade already was marketed in the European Union for treating multiple myeloma (MM), another rare blood-based cancer, either as monotherapy or in combination with other treatment regimens.
Priority review was granted by FDA during February 2015 for the New Drug Application for Yondelis (trabectedin). The potential new product is intended to treat patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. Submitted by Janssen, the NDA was filed with U.S. regulators on Nov. 24, 2014.
The novel, multimodal, synthetically produced antitumor agent Yondelis originally derived from the sea squirt, Ecteinascidia turbinata. The anti-cancer drug works by preventing tumor cells from multiplying. Yondelis is approved for marketing in at least 77 countries within North America, Europe, South America and Asia for treating advanced soft-tissue sarcomas as a single agent, and in at least 70 countries for relapsed ovarian cancer in combination with Doxil/Caelyx (doxorubicin HCl liposome injection).
Through a license deal with PharmaMar SA – a wholly owned member of the Zeltia Group – Janssen Products LP has the rights to develop and sell Yondelis worldwide except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals Co. Ltd. If approved for marketing by FDA, Yondelis would be commercialized by Janssen Biotech.
The Food and Drug Administration during late January 2015 cleared for marketing Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets, an HIV-1 protease inhibitor combined with a CYP3A4 inhibitor. The oral product was approved for treating human immunodeficiency virus (HIV-1) in combination with other antiretroviral agents for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions. Darunavir is marketed as Prezista in the United States. The pharmacokinetic enhancer or “boosting” agent cobicistat was developed and is marketed as Tybost by Gilead.
Acquisitions, deals and collaborations
The 100-plus strategic partnerships, licenses, and acquisitions executed across J&J’s three business segments in 2014 included two significant acquisitions added to the company’s innovation portfolio. One was Alios BioPharma Inc., a privately held clinical-stage biopharma company concentrated on developing therapies for viral diseases. The other was Covagen AG, a privately held biopharmaceutical company specialized in developing multi-specific protein therapeutics via the FynomAb technology platform.
Johnson & Johnson Consumer Inc. completed the divestiture of the Splenda brand to Heartland Food Products Group on Sept. 25, 2015. Financial terms of the deal were not initially disclosed. Worldwide 2014 sales for the brand totaled $370 million.
Janssen’s Crucell Holland B.V. was granted a $28.5 million funding award in September 2015 from The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. The finding will help accelerate the development of the company’s investigational Ebola prime-boost vaccine regimen. The regimen combines AdVac technology from Crucell Holland and MVA-BN technology from Bavarian Nordic A/S.
Phase I studies of the prime-boost vaccine regimen started in the United Kingdom and United States during December 2014, followed by several sites in Africa. A Phase II trial in the United Kingdom and France began in July 2015. Plans were well advanced for the commencement of a safety and immunogenicity clinical trial in Sierra Leone and other Phase II studies outside the outbreak area in Africa. BARDA will concentrate on supporting manufacturing development of the regimen’s prime and boost components.
J&J on May 28, 2015, announced the acceptance of the March 1 binding offer from Cardinal Health Inc. to acquire its Cordis Corp. business for $1.94 billion. The transaction closed on Oct. 4, 2015. Cordis is regarded as a leader in the development and manufacture of interventional vascular technology with 2014 revenue reaching $780 million.
“This initiative is part of our ongoing disciplined portfolio management approach to focus on our most promising opportunities to help patients and drive growth,” noted Gary Pruden, Worldwide Chairman, Global Surgery Group, Johnson & Johnson. “Cordis has made significant contributions to the field of cardiovascular care, and we believe the business has a promising future with Cardinal Health, a company with which we have a long-standing relationship. We are grateful for the many contributions that Cordis employees have made over the years.”
Janssen Biotech reached an exclusive, worldwide license deal with the privately held biotech company Alligator Bioscience AB during August 2015 for ADC-1013. The immuno-oncology agent is undergoing Phase I trials. The transaction was facilitated by Johnson & Johnson Innovation of London.
Janssen holds rights to develop and commercialize ADC-1013, which is an agonistic fully human monoclonal antibody. The new drug candidate targets CD40, which is an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulating this receptor initiates a process, resulting in an increase in T cells attacking a tumor.
Janssen Pharmaceuticals entered into an exclusive global license and collaboration arrangement with Achillion Pharmaceuticals Inc. in May 2015. The companies agreed to develop and commercialize one or more of Achillion’s lead hepatitis C virus assets, which include ACH-3102, ACH-3422 and sovaprevir.
A primary objective of the collaboration is to develop a short-duration, highly effective, pan-genotypic, oral regimen for treating HCV. An initial regimen that is intended to be explored will feature Achillion’s NS5A inhibitor ACH-3102 – which is undergoing Phase II trials and has been granted Fast Track designation by FDA – in combination with an NS3/4A HCV protease inhibitor and an NS5B HCV polymerase inhibitor from the collaboration.
Achillion granted Janssen an exclusive, global license to develop and, upon regulatory clearance, commercialize HCV products and regimens containing one or more of the licensed HCV assets. Achillion is eligible to receive milestone payments based upon the achievement of specified development, regulatory and sales milestones as well as tiered royalties on future global sales.
J&J forged a first-of-its-kind partnership revealed in May 2015 that enlists a third party to review requests made to the Janssen Pharmaceutical Companies for compassionate use of its investigational medicines. This new approach will start as a pilot program concentrated on one Janssen investigational medicine and, if successful, will become a model that will be applicable more broadly across J&J.
J&J says in keeping with the company’s long-standing dedication to the highest standards of ethical decision-making that serves the needs of patients, Janssen Research & Development agreed to the new partnership with the Division of Medical Ethics at the NYU School of Medicine to obtain independent advice, further ensuring that the evaluation of requests for investigational medicines before their approval by FDA or other worldwide health authorities are treated in the most fair and ethical manner.
As part of the collaboration, the NYU School of Medicine has established the Compassionate-Use Advisory Committee. CompAC represents an external group of 10 internationally recognized medical experts, bioethicists and patient reps who are piloting the new approach. Commencing with a Janssen investigational drug, CompAC will make recommendations regarding individual patient requests from anywhere globally. The committee’s careful consideration and recommendations based on its independent review will inform Janssen clinicians, who will make the final decision.
Johnson & Johnson and IBM announced plans during April 2015 to collaborate around a new generation of intelligent virtual coaching solutions and applications designed to transform the patient experience and deliver improved health outcomes. Johnson & Johnson Innovation of London identified and facilitated the transaction.
The planned collaboration is expected to provide healthcare systems with holistic virtual coaching and rehabilitation solutions striving to transform the patient experience and healthcare delivery model by creating an integrated view of patient care.
J&J and IBM’s newly formed Watson Health unit plan to use advanced data analysis and insights to help develop personalized patient engagement and coaching solutions that span consumer wellness and chronic condition management. J&J will additionally leverage IBM’s relationship with Apple Inc. to deliver new iPhone and iPad applications, providing a seamless user experience and intuitive design.
During early April 2015, Janssen Pharmaceuticals (JPI) completed the divestiture of its U.S. license rights to Nucynta, Nucynta ER extended-release tablets, and Nucynta oral solution to Depomed Inc. for $1.05 billion. JPI’s licensed U.S. commercialization rights to the Nucynta (tapentadol) franchise from Grunenthal GmbH were assigned to Depomed. JPI retains license rights to the Nucynta product line in Canada, Japan, and other countries outside the United States.
J&J’s medical device company Ethicon during March 2015 entered into a strategic collaboration with Google Inc. Ethicon agreed to work with Google’s Life Sciences team on advancing surgical robotics to benefit surgeons, patients and health-care systems. The companies are combining their capabilities, intellectual property and expertise to create an innovative robotic-assisted surgical platform capable of integrating advanced technologies with the goal of improving health-care delivery in the operating room. The collaboration was facilitated by Menlo Park, Calif.-based Johnson & Johnson Innovation.
Also during March, Janssen Pharmaceuticals acquired XO1 Ltd. The privately held asset-centric virtual biopharma company was established to develop the anti-thrombin antibody ichorcumab. The recombinant human antibody ichorcumab has been developed to mimic the activity of a human antibody that appears to produce an anticoagulated state without predisposition to bleeding.
The new drug candidate ichorcumab was initially developed by Cambridge University Hospitals and Cambridge University with support from Cambridge Enterprise, the University’s commercialization arm. Cambridge Enterprise licensed the technology to XO1 for development. XO1 was established by Index Ventures as an asset centric company – a model advanced by Index – through a fund launched during 2012 in which Johnson & Johnson Innovation is an investor.
Janssen Pharmaceutical Companies is investing $10 million in a new UK government-led global dementia discovery fund, as announced in March 2015. The fund is supporting innovative research to help find new ways to prevent and treat dementia as well as Alzheimer’s disease. The investment was to be processed via Johnson & Johnson Innovation.