Johnson & Johnson: Excellence In Diversification
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
Telephone: 732-524-0400
Website: jnj.com
Best-Selling Rx Products
| PRODUCT | 2013 SALES | 2012 SALES |
|---|---|---|
| Remicade | $6,673 | $6,139 |
| Zytiga | $1,698 | $961 |
| Prezista | $1,673 | $1,414 |
| Velcade | $1,660 | $1,500 |
| Stelara | $1,504 | $1,025 |
| Procrit/Eprex | $1,364 | $1,462 |
| Risperdal Consta | $1,318 | $1,425 |
| Invega Sustenna/Xeplion | $1,248 | $796 |
| Simponi | $932 | $607 |
| Xarelto | $864 | $239 |
| Concerta/methylphenidate | $782 | $1,073 |
| Invega | $583 | $550 |
| Incivo | $517 | $443 |
| Aciphex/Pariet | $470 | $835 |
| Intelence | $379 | $349 |
All sales are in millions of dollars.
Financial Performance
| 2013 | 2012 | |
|---|---|---|
| Revenue | $71,312 | $67,224 |
| Net income | $13,831 | $10,853 |
| EPS | $4.81 | $3.86 |
| R&D expense | $8,183 | $7,665 |
| 1H14 | 1H13 | |
|---|---|---|
| Revenue | $37,610 | $35,382 |
| Net income | $9,053 | $7,330 |
| EPS | $3.15 | $2.55 |
| R&D expense | $3,836 | $3,730 |
Based on 2013 figures, Johnson & Johnson reported having the seventh-largest pharmaceutical business worldwide, the No. 6 biotech business, the largest medical devices and diagnostics business, and the sixth-biggest healthcare consumer business. J&J’s impressive business results during 2013 were paced by a stellar performance in the company’s Pharmaceutical segment; the strength of key brands in the U.S. over-the-counter medicines business; and continued progress in integrating Synthes Inc. into its Medical Devices and Diagnostics business. The company additionally advanced its longer-term growth drivers of bringing innovative solutions to the worldwide health-care market.
“A key goal for us has been to prioritize our product portfolios, be decisive, and focus our energies in areas where we have the greatest opportunities to lead and meet the evolving needs of customers in markets around the world,” comments Alex Gorsky, J&J chairman and CEO. “We’ve made strong progress on this front in each of our segments last year (2013) and made significant contributions to advancing patient and consumer care.”
Pharmaceuticals represented 39 percent of J&J’s overall 2013 sales on a strong operational growth of 12 percent versus 2012. Medical Devices and Diagnostics accounted for 40 percent of the company’s sales with operational growth of 6.1 percent. The Consumer segment produced the other 21 percent, increasing 2.8 percent on an operational basis year-over-year.
According to J&J execs, the company’s depth of leadership is reflected in the fact that 70 percent of sales come from products with the No. 1 or 2 worldwide market share position. With these strong sales results, J&J produced adjusted earnings per share growth of 8.2 percent and strong free cash flow of almost $14 billion in 2013.
“I am pleased with the progress we have made in the two years I have been honored to serve as the CEO of Johnson & Johnson, and there remains so much more to do in the global health-care space,” Mr. Gorsky notes. “Too many regions across the world – from developed to emerging markets – are still far from providing high-quality health care to the people who need it. As the world’s largest health-care company, serving more than 1 billion patients and consumers around the world every day, we do not just consider it our responsibility to do all we can to reach the next billion, and the billion after that – we consider it a responsibility and privilege.”
J&J leaders note that the performance of the Pharmaceutical business segment was exceptional during 2013. Management adds that J&J is the fastest-growing top 10 pharmaceutical company in the United States, Europe and Japan. The 13 new products launched by J&J since 2009, along with other core brands like Prezista (darunavir) for HIV treatment and Remicade (infliximab) for treating various immune-mediated inflammatory diseases, significantly contributed to 2013 growth. The pharmaceutical pipeline was anticipated to remain growing throughout 2014.
Integrating Synthes continues to be a priority for J&J. DePuySynthes Companies is regarded as the world’s largest and most comprehensive orthopaedics company.
For the company’s Consumer business, significant progress was made during 2013 in restoring a reliable supply of OTC products to the U.S. marketplace. Managers note that some products have gained traction, especially Tylenol and Motrin, which helped spur U.S. OTC growth of 19.7 percent in 2013. By the end of that year, U.S. OTC brands were the No. 1 and 2 product SKUs in the adult and pediatric pain product categories, according to J&J. Management additionally has identified specific consumer need states and 12 major brands that will drive growth, such as Neutrogena, Listerine, and Johnson’s Baby.
During the past five years, J&J has consistently invested roughly 11 percent of sales to support its R&D efforts. That investment equated to more than $8 billion enterprise-wide in 2013. The R&D program continues to deliver results, as about 25 percent of the company’s 2013 sales stemmed from products launched in just the past five years. Additionally, 14 out of 18 key in-line product platforms gained or held market share during 2013.
The Pharmaceutical segment benefitted from strong productivity out of the J&J pipeline in 2013, including the market introduction of three new major products: Invokana (canagliflozin) for treating Type 2 diabetes, Imbruvica (ibrutinib) for mantle cell lymphoma, and Olysio (simeprevir) as a treatment of chronic hepatitis C.
J&J shareholders during 2013 were rewarded with a total return of almost 35 percent, which outpaced nearly every major index the company benchmarks itself against. J&J has generated 30 consecutive years of adjusted earnings increases and is one of only six companies in the S&P 100 to have produced 51 consecutive years of dividend increases.
According to management, J&J is truly a worldwide company with a global mindset, backed by 275-plus operating companies in 60 countries. As of early 2014, 55 percent of the company’s business was generated outside the United States, and 22 percent of sales stemmed from fast-growing emerging markets such as Brazil, Russia, India and China.
Financial Performance
J&J reported 2013 global sales of $71.3 billion, representing growth of 6.1 percent versus the 2012 result. U.S. companies for J&J generated $31.9 billion in 2013, $29.8 billion during 2012 and $28.9 billion for 2011. These totals represent increases of 7 percent in 2013 and 3.2 percent during 2012, with a decrease of 1.8 percent in 2011. Sales by international companies amounted to $39.4 billion during 2013, $37.4 billion for 2012 and $36.1 billion in 2011; representing growth of 5.4 percent in 2013, 3.5 percent in 2012 and 12.4 percent in 2011. The acquisition of Synthes, net of the related divestiture, increased total global sales growth and operational growth by 2.5 percent and 3.1 percent during 2013 and 2012.
The five-year compound annual growth rates for worldwide, U.S. and international sales in 2013, 2012, and 2011 totaled 2.3 percent, (0.2) percent and 4.6 percent respectively. The 10-year compound annual growth rates for worldwide, U.S. and international sales amounted to 5.5 percent, 2.4 percent and 9.0 percent respectively.
Sales in Europe during 2013 generated growth of 9.8 percent versus the previous calendar term, including operational growth of 7.7 percent and a positive currency impact of 2.1 percent. Sales in the Western Hemisphere (excluding the U.S.) produced growth of 3 percent year-over-year, including operational growth of 8.9 percent and a negative currency impact of 5.9 percent. Sales in the Asia-Pacific, Africa region delivered 1.1 percent growth compared to the 2012 result, including operational growth of 8.6 percent and a negative currency impact of 7.5 percent.
The Pharmaceutical segment produced sales of $28.1 billion for 2013, accounting for 10.9 percent growth over the previous year, with strong operational growth of 12.0 percent and a negative currency impact of 1.1 percent. U.S. sales amounted to $13.9 billion, an increase of 12.3 percent versus the 2012 result. International sales reached $14.2 billion, rising 9.6 percent, which included 11.8 percent operational growth and a negative currency impact of 2.2 percent. The Pharmaceutical segment’s operational growth was impacted by 0.8 percent in 2013 because of a positive adjustment to previous estimates for Managed Medicaid rebates.
Amongst the Pharmaceutical segment breakdown, Immunology products attained 2013 sales of $9.2 billion, an increase of 16.7 percent over the 2012 amount. Neuroscience products sales totaled $6.7 billion, decreasing 0.8 percent year-over-year. Oncology products generated 2013 sales of $3.8 billion, up 43.5 percent versus the previous year. Other Pharmaceutical sales amounted to $4.9 billion, an increase of 0.2 percent.
According to J&J, the company’s Medical Devices and Diagnostics business is anchored by 11 “billion-dollar-plus-platforms” including vision care, trauma, sutures, endoscopy, and electrophysiology. The MD&D business produced 2013 sales of $28.5 billion, a 3.9 percent improvement versus 2012, with operational growth of 6.1 percent and a negative currency impact of 2.2 percent. U.S. sales reached $12.8 billion, rising 3.5 percent versus the prior 12-month period year. International sales were reported at $15.7 billion, advancing 4.2 percent year-over-year, with operational growth of 8.3 percent and a negative currency impact of 4.1 percent. The Synthes acquisition, net of the related trauma business divestiture, increased total sales growth and operational growth for the MD&D segment by 6.0 percent and 7.9 percent in 2013 and 2012 respectively.
Major Medical Devices and Diagnostics franchise sales for 2013 broke down as follows: Orthopaedics $9.51 billion (up 21.9 percent versus 2012); Surgical Care $6.27 billion (down 3.3 percent); Vision Care $2.94 billion (down 2 percent); Specialty Surgery $2.59 billion (up 2.6 percent); Diabetes Care $2.31 billion (down (11.7 percent); Cardiovascular Care $2.08 billion (up 4.6 percent); Diagnostics $1.89 billion (down 8.9 percent); and Infection Prevention/Other $912 million (down 4.2 percent).
Consumer segment sales for 2013 reached $14.7 billion, rising 1.7 percent year-over-year, including 2.8 percent operational growth and a negative currency impact of 1.1 percent. U.S. Consumer segment sales totaled $5.2 billion, an increase of 2.3 percent versus 2012. International sales were reported at $9.5 billion, an increase of 1.4 percent, including 3.1 percent operational growth and a negative currency impact of 1.7 percent.
The global Consumer segment sales for 2013 broke down as follows: OTC $4.03 billion (up 7 percent over 2012); Skin Care $3.7 billion (up 2.4 percent); Baby Care $2.3 billion (up 1.8 percent); Oral Care 1.62 billion (down 0.1 percent); Women’s Health $1.57 billion (down 3.5 percent); and Wound Care/Other $1.48 billion (down 5.1 percent).
For the first half of 2014, global sales rose 6.3 percent year-over-year to $37.6 billion, including operational growth of 7.4 percent. Currency fluctuations had a negative impact of 1.1 percent during the January-June 2014 period. Worldwide sales during first-half 2013 were positively impacted by an adjustment to previous estimates for Managed Medicaid rebates under the Affordable Care Act, primarily related to new data received from the states during first-quarter 2013. This negatively impacted global sales growth during the first two quarters of 2014 by 0.6 percent versus same-time 2013.
J&J U.S. companies generated first-half 2014 sales of $17.3 billion, growing 8.5 percent over the corresponding one-year-earlier period. Sales by international companies reached $20.3 billion for a total increase of 4.4 percent, including an operational improvement of 6.4 percent, and a negative currency impact of 2.0 percent year-over-year.
Sales by companies in Europe during January-June 2014 produced an 8.6 percent increase, including operational growth of 5.3 percent and a positive currency impact of 3.3 percent. Sales by companies in the Western Hemisphere (excluding the United States) fell 3.5 percent, including operational growth of 6.8 percent and a negative currency impact of 10.3 percent. Sales by companies in the Asia-Pacific, Africa region generated sales growth of 3.1 percent over first-half 2013, including operational growth of 7.7 percent and a negative currency impact of 4.6 percent.
Pharmaceutical segment sales during January-June 2014 amounted to $16.0 billion, rising 16.1 percent year-over-year, with an operational increase of 16.8 percent and a negative currency impact of 0.7 percent. U.S. Pharmaceutical sales advanced 22.0 percent versus the first two quarters of 2013. International Pharmaceutical sales improved 10.2 percent, including operational growth of 11.6 percent and a negative currency impact of 1.4 percent. Pharmaceutical segment sales in first-half 2013 included a positive adjustment to previous estimates for Managed Medicaid rebates; this negatively impacted Pharmaceutical operational sales growth in January-June 2014 by 1.7 percent.
For major Pharmaceutical therapeutic area sales in first-half 2014, Immunology rose 11.9 percent to $4.97 billion compared to January-June 2013; Infectious Diseases jumped up 65.9 percent year-over-year to $2.96 billion; Neuroscience declined 4.6 percent to $3.27 billion; Oncology improved 27 percent to $2.13 billion; and Other sales advanced 8.7 percent to $2.67 billion.
First-half 2014 Medical Devices and Diagnostics segment sales amounted to $14.3 billion, rising 0.3 percent year-over-year, with an operational increase of 1.3 percent and a negative currency impact of 1.0 percent. U.S. Medical Devices and Diagnostics sales dropped down 1.5 percent compared to the first two quarters of 2013. International Medical Devices and Diagnostics sales improved 1.8 percent, including operational growth of 3.6 percent and a negative currency impact of 1.8 percent.
During the first six months of 2014, Orthopaedics sales advanced 2.5 percent to $4.89 billion over the corresponding one-year-earlier period; Surgical Care sales amounted to $3.08 billion (down 0.4 percent); Specialty Surgery/Other increased 2.9 percent to $1.78 billion; Vision Care edged down 0.1 percent to $1.47 billion; Cardiovascular Care reached $1.11 billion (up 6.3 percent); Diabetes Care declined 10 percent to $1.07 billion; and Diagnostics decreased 5.8 percent versus first-half 2013 to $904 million.
Consumer segment sales during the first two quarters of 2014 amounted to $7.3 billion, down 0.4 percent versus the one-year-earlier period, including operational growth of 1.5 percent and a negative currency impact of 1.9 percent. U.S. Consumer segment sales dropped down 1.7 percent year-over-year. International Consumer segment sales rose 0.3 percent in January-June 2014, including operational growth of 3.3 percent and a negative currency impact of 3 percent.
First-half 2014 over-the-counter sales came in at $2.01 billion (increasing 2 percent versus the January-June 2013 result); Skin Care totaled $1.88 billion (up 4 percent); Baby Care rose 0.2 percent to $1.15 billion; Oral Care totaled $824 million (increasing 1.9 percent); Wound Care/Other decreased 2.3 percent to $760 million; and Women’s Health fell 17.6 percent to $669 million.
Rx Product Performance
Sales of J&J’s largest prescription product, Remicade (infliximab), accounted for 9.4 percent of the company’s overall revenue during 2013. The medicine’s global sales of $6.67 billion advanced 8.7 percent compared to its 2012 performance. Worldwide first-half 2014 sales improved 4.3 percent to $3.41 billion, including U.S. sales growth of 6.4 percent to $2.02 billion.
Certain patents related to Remicade expired in Canada during March 2012. In certain European countries, the patent has been extended until February 2015 (Germany, Spain, United Kingdom, Sweden, Austria, Belgium, Switzerland, Denmark, France, Greece, Italy, Luxembourg and the Netherlands). Remicade’s U.S. patents run out during 2018.
In addition to competing in the immunology arena with Remicade, J&J is also marketing Stelara (ustekinumab), Simponi (golimumab) and Simponi Aria. These next-generation immunology products have remaining patent lives of 10 years, according to J&J.
Stelara has rapidly grown into one of J&J’s best-selling medicines. The biologic is marketed for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis. Worldwide sales rose from $1.03 billion during 2012 to $1.5 billion for 2013. First-half 2014 sales advanced 36.8 percent year-over-year (YoY) to $984 million, including $622 million in sales derived from the United States (up 35.5 percent YoY).
Simponi sales are also growing at a fast rate. During 2013, Simponi’s global total reached $932 million, increasing 53.5 percent over its 2012 result. Simponi Aria was granted its first FDA approval during 2013. For the first six months of 2014, Simponi franchise sales totaled $541 million, up 31.3 percent versus the one-year-earlier period. During that time frame, international sales led the way at $305 million (up 32 percent YoY).
Significant contributors to J&J’s Infectious disease product sales of $3.6 billion in 2013 were Prezista, Incivo (telaprevir), Edurant (rilpivirine), Intelence (etravirine) and Olysio, which launched during the year.
Prezista sales during 2013 continued to rise at a double-digit pace, advancing 18.3 percent YoY to $1.67 billion. For first-half 2014, the drug’s sales improved 16.8 percent versus January-June 2013 to $937 million.
Incivo sales also grew at a double-digit rate during 2013, increasing 16.7 percent compared to 2012 to $517 million. First-half 2014 was a different story though, as sales decreased 45.2 percent to $183 million due to competitive pressures.
The 2014 sales leader amongst J&J’s Infectious disease portfolio is actually the newest product to market, Olysio/Sovriad. Sales for the medicine reached $1.19 billion during 2013, its first year on the marketplace. The chronic hepatitis C infection drug was able to duplicate its 2013 total in the first half of 2014 with sales of $1.19 billion.
First-half 2014 sales for Edurant reached $173 million compared to $99 million in the corresponding one-year-earlier period, with most of the sales generated in international markets.
J&J’s Neuroscience segment consists of a couple of blockbuster brands. Risperdal Consta was the top 2013 sales generator in this group at $1.32 billion, down from its prior-year total of $1.43 billion. The sales decline continued in the first six months of 2014, decreasing 8.8 percent YoY to $612 million.
InvegaSustenna/Xeplion took over the Neuroscience segment sales lead during first-half 2014 by generating $767 million, up 33.6 percent over the January-June 2013 result. For full-year 2013, the drug’s sales came in at $1.25 billion, representing 56.8 percent YoY growth. Invega sales totaled $583 million during 2013 (up 6 percent YoY) and $323 million in first-half 2014 (up 14.5 percent YoY).
Concerta/methylphenidate sales are on the decline. Full-year 2013 sales dropped off 27.1 percent from 2012 to $782 million and the first-half 2014 amount was down 37.4 percent YoY to $295 million.
J&J’s Oncology segment is going strong with two billion-dollar brands. Zytiga (abiraterone acetate) sales have risen from $301 million in 2011 to $961 million during 2012 to $1.7 billion for 2013. Sales for first-half 2014 improved 45.3 percent YoY to $1.07 billion.
Velcade sales annually exceeded $1.2 billion during 2011-2013, rising to $1.66 billion for 2013. Sales in the first two quarters of 2014 advanced 10.8 percent YoY to $811 million, all generated in international markets.
Amongst other J&J prescription products, Xarelto is leading the way in terms of annual growth. The oral anticoagulant produced sales of $25 million in 2011, $239 million for 2012, and $864 million during 2013. Strong growth continued during first-half 2014, as sales advanced 96 percent YoY to $680 million.
Procrit/Eprex remains a blockbuster generator, though sales have been decreasing annually. The totals have decreased from $1.62 billion in 2011 to $1.46 billion during 2012 to $1.36 billion for 2013. First-half 2014 global sales fell 11.8 percent YoY to $629 million, which included a U.S. sales drop-off of 16.3 percent to $354 million.
Various products throughout the Medical Devices and Diagnostics segment performed well in the marketplace during 2013 and first-half 2014. Among them wereEchelon Flex Powered Endopath Stapler.
In The Pipeline/Recent Product Approvals
R&D expenditure for J&J of $8.18 billion in 2013 represented a 6.8 percent increase over the prior year. The Pharmaceutical segment spent $5.81 billion, the Medical Devices and Diagnostics business accounted for $1.78 billion, and the Consumer segment’s expenditure was $590 million. In first-half 2014, total R&D costs for J&J reached $3.84 billion, up 10.2 percent year-over-year.
J&J during 2013 gained various regulatory approvals for key pharmaceutical products from major health authorities. FDA granted clearance of the NS3/4A inhibitor Olysio. The drug was approved for treating chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.
U.S. regulators approved Imbruciva capsule during November 2013 for treating patients with mantle cell lymphoma who have received at least one prior therapy.
FDA and the European Commission (EC) granted clearance for Invokana. The oral, once-daily, selective sodium glucose co-transporter 2 inhibitor is available for treating adults with type 2 diabetes.
Stelara was granted an additional indication by FDA: alone or in combination with methotrexate for treating adult patients with active psoriatic arthritis. EC authorities also approved the medicine, alone or in combination with methotrexate, for active psoriatic arthritis in adults when the response to previous non-biological disease-modifying anti-rheumatic drug therapy has been inadequate.
The EC granted an expanded indication for Simponi as a treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications. Simponi was cleared by U.S. health regulators for treating moderately to severely active ulcerative colitis in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. FDA additionally granted approval to Simponi Aria for infusion for treating adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.
European health regulators approved Velcade as induction therapy in combination with dexamethasone or thalidomide and dexamethasone, and applies to adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with hematological stem cell transplantation.
J&J filed several New Drug Applications during the course of 2013 with U.S. and EU health authorities. An MAA and NDA were submitted for ibrutinib as a treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Also, an MAA was filed for relapsed or refractory mantle cell lymphoma.
An MAA was filed to the EMA seeking approval for a once-daily single tablet fixed-dose antiretroviral combination product containing the protease inhibitor darunavir and the pharmacokinetic enhancer/boosting agent cobicistat. The latter was developed by Gilead Sciences Inc. for use in combination with other human immunodeficiency virus medicines.
A Biologic License Application and an MAA were simultaneously filed for Sylvant (siltuximab) for treating patients with multicentricCastleman disease who are HIV-negative and human herpes virus-8-negative. An MAA was additionally filed for simeprevir for the treatment of adult patients with chronic hepatitis C genotype 1 or genotype 4. Also, an MAA was submitted to the EMA for Vokanamet (canagliflozin/immediate-release metformin) as a fixed-dose, single-tablet combination therapy to treat patients with type 2 diabetes.
Moving into the first quarter of 2014, FDA gave approval to Imbruciva capsule as a treatment for patients with chronic lymphocytic leukemia who have received at least one prior therapy. Imbruciva represents the first once-daily, single-agent, oral Bruton’s tyrosine kinase inhibitor for patients with chronic lymphocytic leukemia (CLL) who have received one prior therapy.
Also, the European Commission granted conditional EU approval for Sirturo (bedaquiline). Announced in March 2014, the conditional approval was for use of Sirturo as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis in adult patients.
Additionally during the second quarter, the Committee for Medicinal Products for Human Use adopted several positive opinions recommending marketing authorization in the European Union. One recommendation was for simeprevir in combination with other medicinal products for treating chronic hepatitis C in adult patients; another was for siltuximab for treating adult patients with multicentricCastleman’s disease who are HIV-negative and human herpes virus-8 negative; and Vokanametwas recommended for treating adults with type 2 diabetes.
A New Drug Application was filed with U.S. regulators in 1Q 2014 for the once-daily fixed-dose antiretroviral combination tablet containing J&J’s darunavir and cobicistat.
The second quarter of 2014 also was filled with significant regulatory approvals and marketing application submissions. FDA and the EC granted clearance of Sylvant. Containing siltuximab, the drug is indicated for the treatment of patients with multicentricCastleman’s disease (MCD) who are HIV-negative and human herpes virus-8 negative. Sylvant represents the first approved treatment for MCD in the United States and European Union.
Also during 2Q 2014, the European Commission approved Vokanamet. The EC in May 2014 cleared for marketing Olysio for treating adult patients with genotype 1 or 4 chronic hepatitis C. Invega’s adult schizophrenia indication was expanded during June 2014 to include adolescents 15 years and older.
A supplemental New Drug Application (sNDA) was filed with FDA in May 2014 to approve Olysio in combination with Gilead’s nucleotide analog NS5B polymerase inhibitor sofosbuvir for treating genotype 1 chronic hepatitis C in adult treatment-naive patients with advanced fibrosis and null responders with all stages of liver fibrosis. An sNDA was filed with U.S. regulators for the once-monthly atypical long-acting antipsychotic InvegaSustenna (paliperidonepalmitate) as a treatment for schizoaffective disorder as either monotherapy or adjunctive therapy, also announced in May 2014.
An MAA was submitted to the European Medicines Agency in June 2014 to expand the label for Velcade (bortezomib). The expanded label would include Velcade’s use in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of mantle cell lymphoma.
Invokamet was FDA-approved during August 2014 as a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet for treating adults with type 2 diabetes. The new medicine provides the clinical attributes of Invokana (canagliflozin), the first sodium glucose co-transporter 2 (SGLT2) inhibitor available in the United States, along with metformin, which is commonly prescribed early in treating type 2 diabetes. Invokamet represents the first fixed-dose combo of an SGLT2 inhibitor with metformin approved by FDA.
The sNDA for Imbruvia capsule was approved by FDA in July 2014 for treating patients with CLL who have received at least one prior therapy. The U.S. regulatory agency additionally approved the new product for CLL patients with del 17p,1 a genetic mutation that occurs when part of chromosome 17 has been lost. CLL patients with del 17p are regarded to have the poorest prognosis. Imbruvica is co-developed and co-commercialized by JanssenBiotech Inc. and Pharmacyclics Inc. Also during July, the Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of a marketing authorization in the EU. Imbruvica was recommended for treating adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with CLL who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Janssen Research & Development LLC and development partner Bayer HealthCare announced in late August 2014 the expansion of the EXPLORER worldwide cardiovascular research program for Xarelto (rivaroxaban) to include additional high-risk patient populations. New clinical trials will investigate rivaroxaban – the most studied Factor Xa inhibitor – for treating acute coronary syndrome, embolic stroke of undetermined source, and peripheral artery disease. If this research is successful, Janssen may seek U.S. regulatory clearance for these indications.
EXPLORER is an integral part of the extensive pipeline program for rivaroxaban in studying its use for various cardiovascular conditions. The worldwide clinical-development program for rivaroxaban, including EXPLORER, covers 17 Phase III studies, 10 of which are completed. Ultimately, more than 275,000 patients will have participated in the rivaroxaban clinical-development program, including completed and ongoing clinical trials, independent registries and non-interventional studies.
Janssen Pharmaceuticals announced in July 2014 the filing of an sNDA for InvegaSustenna. If approved, the label change would include new data showing significantly delayed time to relapse in patients prescribed the once-monthly atypical long-acting antipsychotic compared to selected oral antipsychotic therapies in treating schizophrenia. The sNDA is supported by the landmark PaliperidonePalmitate Research In Demonstrating Effectiveness study (PRIDE), which is the first prospective, randomized clinical study to evaluate schizophrenia treatments within the context of many “real world” issues faced by patients in their daily lives. These include one of the most challenging circumstances – recent incarceration.
Janssen Research & Development LLC announced in February 2014 the initiation of CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation), a worldwide multicenter study of Invokana. The Phase III, randomized, double-blind, placebo-controlled, parallel group trial is designed to enroll more than 3,700 patients with type 2 diabetes and diabetic nephropathy. The study’s objective is to explore whether canagliflozin can slow the progression of diabetic nephropathy, a form of renal impairment that is the most common cause of end-stage renal disease globally.
As for the Medical Devices and Diagnostics business, J&J during the past two years has received various approvals from FDA. Evarrest Fibrin Sealant Patch is a novel product that rapidly and reliably aids in stopping bleeding during surgery. The Enseal G2 Articulating Tissue Sealer provides surgeons with easier access to difficult-to-reach parts of the anatomy. Additionally, the ThermocoolSmarttouch Catheter enhances the safety and efficacy of ablation procedures. According to J&J, these innovations have strengthened the company’s global leadership position in medical devices and diagnostics, where 85 percent of its key platforms hold the No. 1 or 2 market position.
J&J introduced new consumer products worldwide in 2013. The company continues to expand globally with the acquisition of Shanghai Elsker Mother & Baby Co., a leading baby-care products company located in China. J&J introduced Listerine Advanced Defence Gum Treatment in the United Kingdom and Ireland.
Acquisitions, Deals, & Collaborations
Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies, announced in August 2014 its acquisition of Covagen AG. Financial terms of the deal were not initially disclosed. A privately held biopharma company, Covagen specializes in the development of multispecific protein therapeutics via the FynomAb technology platform. The company’s lead product, COVA 322, is a bispecific anti-tumor necrosis factor (TNF)-alpha/anti-interleukin (IL)-17A FynomAb. The drug compound is in a Phase Ib study for psoriasis and holds potential as a treatment for a wide range of inflammatory diseases, such as rheumatoid arthritis.
FynomAbs are multi-specific protein therapeutics developed by fusing Covagen’s fully human Fynomer binding proteins to antibodies. The tailored architecture and novel mode of action of FynomAb therapeutics may offer enhanced efficacy in treating a broad array of inflammatory diseases and other conditions.
Janssen Pharmaceuticals entered into an exclusive license pact with Vertex Pharmaceuticals Inc. in June 2014 for the global development, manufacturing and commercialization of VX-787. The novel medicine is undergoing Phase II studies for treating influenza A. VX-787 is designed to directly inhibit replication of the influenza A virus, including recent H1 (pandemic) and H5 (avian) influenza strains, based on in-vitro data.
Janssen R&D Ireland Ltd. entered into a collaboration with ViiV Healthcare in June 2014 to develop and commercialize a new one-tablet regimen. The drug candidate consists of Janssen’s non-nucleoside reverse transcriptase inhibitor Edurant and ViiV’sintegrase inhibitor Tivicay (dolutegravir) as the sole active ingredients for the maintenance treatment of people living with HIV. The companies will also investigate development of this drug combo for pediatric use.
Janssen R&D Ireland is examining in Phase III studies the efficacy and safety of simeprevir in combination with the nucleotide inhibitor sofosbuvir for treating chronic genotype 1 hepatitis C virus infection in treatment-naïve and treatment-experienced patients with and without cirrhosis. OPTIMIST represents the first Phase III trials of those two treatments in a regimen without interferon and ribavirin.
During early 2014, J&J announced through Janssen Research & Development a clinical trial data sharing agreement with Yale School of Medicine’s Open Data Access (YODA) Project. This agreement extends J&J’s dedication to sharing clinical-trials data to enhance public health and advance science and medicine. According to J&J, this is the first time any company has collaborated with a completely independent third party to review and make decisions about every request for pharma clinical data.
On June 30, 2014, J&J completed the divestiture of its Ortho-Clinical Diagnostics business to The Carlyle Group for $4.15 billion, subject to customary adjustments. The Ortho-Clinical Diagnostics franchise generated net sales of $1.9 billion for J&J during 2013.
