Additionally during October, Incyte and MacroGenics came to terms on an exclusive worldwide
collaboration and license pact for MacroGenics’
MGA012. The investigational monoclonal antibody inhibits programmed cell death protein 1.
Incyte obtained exclusive global rights for the development and commercialization of MGA012 for
“Anti-PD-1 therapy is becoming a mainstay of
cancer treatment across multiple tumor types, and
we believe the addition of MGA012 to our clinical
pipeline is important to ful;lling our long-term
development strategy in immuno-oncology,” Dr.
Stein noted. “This collaboration with MacroGenics
will allow us to rapidly explore the potential clinical
bene;t of developing MGA012 as a monotherapy
and also combining anti-PD-1 therapy with several of our existing portfolio assets.”
Johnson & Johnson revealed an impressive four-year plan during May 2017. Company management anticipates more than 10 new
blockbuster products to launch or be ;led for regulatory approval by 2021; more than 50 line-ex-tension regulatory submissions are projected
by 2021; and beyond that year, J&J’s early-stage
pipeline will continue delivering breakthrough
medicines while additionally strengthening focus
on eliminating disease through prevention, interception and cures.
As an industry leader in research productivity,
J&J’s Janssen garnered FDA approval for 11 new
molecular entities since 2011 through May 2017.
The portfolio has concentrated on ;ve core therapeutic areas – Immunology, Infectious Diseases &
Vaccines, Neuroscience, Cardiovascular & Metabolism, and Oncology – and a sixth therapeutic ;eld
in Pulmonary Arterial Hypertension was added
with the completed acquisition of Actelion during
June 2017 for $30 billion in cash. According to
management, the addition of Actelion’s specialty
in-market medicines and late-stage products is
consistent with Johnson & Johnson’s e;orts to
grow in attractive and complementary therapeutic areas and serve patients with serious illnesses
and signi;cant unmet medical need. In addition,
the transaction structure provides J&J ;exibility to
accelerate investment in its industry-leading, innovative pipeline to drive additional growth.
During 2016, Janssen ;led two NMEs that were
expected to be approved and launched during
2017: guselkumab for psoriasis and sirukumab
for rheumatoid arthritis. Guselkumab won FDA
clearance in July under the trade name Tremfya.
Janssen Biotech during September reported that
it received a complete response letter from the U.S.
FDA indicating additional clinical data are needed
to further evaluate the safety of sirukumab in the
treatment of moderately to severely active RA.
Other late-stage blockbuster products projected to be ;led 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; erda;tinib
(FGFR Inhibitor) for solid tumors; niraparib for prostate cancer; imetelstat for myelo;brosis; pimodivir
(JNJ-3872) for in;uenza A; lumicitabine (JNJ-1575)
for respiratory syncytial virus (RSV) infection; and
JNJ-7922 (orexin- 2 antagonist) for adjunctive
treatment for major depressive disorder.
The once-monthly schizophrenia treatment In-vega Sustenna (paliperidone palmitate) in January
became the ;rst antipsychotic to have the FDA
approve real-world data for its labeling. These data
derive from the Paliperidone Palmitate Research
In Demonstrating E;ectiveness (PRIDE) study. In-vega Sustenna is the only antipsychotic to show
superior e;ectiveness in delaying time to relapse
versus a group of seven commonly prescribed oral
antipsychotics in adults with schizophrenia who
face common real-world circumstances.
The J&J product portfolio produced some
prominent approvals during fourth-quarter 2017,
for both new brands and existing indications for
already-marketed medicines. During the quarter,
the U.S. FDA cleared Juluca (rilpivirine and dolutegravir) as the ;rst, complete, single-pill, two-drug
regimen for treating human immunode;ciency
virus type 1 (HIV-1) infection; a 10-mg once-daily
dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism after completing at least six months of initial
anticoagulation therapy; and Simponi Aria (
go-limumab) for the treatment of adults with active
psoriatic arthritis or active ankylosing spondylitis.
The European Commission approved Tremfya as
a treatment for adults with moderate-to-severe
plaque psoriasis and granted marketing clearance
to broaden the existing marketing authorization
for Zytiga (abiraterone acetate) plus prednisone/
prednisolone to include the treatment of newly diagnosed high-risk metastatic hormone-sensitive
“The approval of Juluca marks a signi;cant
milestone in the treatment of HIV,” commented
Brian Woodfall, Global Head of Late Development,
Janssen Research & Development. “As the ;rst
single-pill, complete two-drug regimen, Juluca
maintains the safety and e;cacy of a traditional
three-drug regimen without an N(t)RTI. This is ex-
citing because it o;ers those living with HIV who
are compliant and stably suppressed a new, sim-
pli;ed treatment option to consider.”
Additionally during fourth-quarter 2017, regu-
latory applications for approval were ;led to the
FDA and European Medicines Agency to expand
the current indication of Darzalex (daratumum-
ab) for use in combination with bortezomib, mel-
phalan and prednisone as a treatment for newly
diagnosed patients with multiple myeloma inel-
igible for autologous stem cell transplantation. A
supplemental New Drug Application was submit-
ted to U.S. regulatory o;cials for two new Xarelto
vascular indications: reducing the risk of major car-
diovascular (CV) events including CV death, heart
attack or stroke in patients with chronic coronary
and/or peripheral artery disease (CAD/PAD), and
for reducing the risk of acute limb ischemia in pa-
tients with PAD.
Johnson & Johnson Innovation kicked o; 2018
by announcing more than a dozen new collaborations to drive the development of novel solutions
to impact healthcare. These collaborations bring
the total amount of strategic transactions executed by Johnson & Johnson Innovation to more
than 350 since its establishment in 2012.
This most recent series of deals concentrates on
leveraging advances in science and technology to
address areas of high unmet medical need, including the use of arti;cial intelligence to detect signs
of Alzheimer’s disease years before it becomes apparent; the identi;cation of throat cancers with a
simple saliva test; and harnessing the microbiome
to treat sleep disorders.
“Our approach to external innovation has been
incredibly fruitful, as we established more than 60
signi;cant new strategic relationships in 2017,”
stated Robert G. Urban, Ph.D., Global Head of
Johnson & Johnson Innovation.
In December 2017, J&J executed a global collaboration and license deal with Chinese company Legend Biotech, a subsidiary of GenScript Biotech, to develop, manufacture and commercialize
a chimeric antigen receptor (CAR) T-cell therapy.
LCAR-B38M is intended to target B-cell maturation
antigen for treating multiple myeloma. The new
product candidate has been accepted for review
by the China Food and Drug Administration and is
undergoing the planning phase of clinical trials in
the United States for multiple myeloma.
“Dark horse Nanjing Legend Biotech was one of
the surprising stars of ASCO last summer with its
CAR-T data, and now Johnson & Johnson is paying
$350 million upfront to join forces with the company and look for a working ‘cure’ for certain blood
cancers,” say analysts at FierceBiotech.
J&J’s Janssen Biotech during December announced that the U.S. FDA granted Priority Review
designation for the New Drug Application for
apalutamide. The investigational, next-generation
oral androgen receptor inhibitor is being developed for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC).
There are not yet FDA-approved treatments for
patients with non-metastatic CRPC. Apalutamide
represents the ;rst agent ;led for approval to treat
earlier-stage CRPC at high risk for metastasis. U.S.
regulators assigned a Prescription Drug User Fee
Act target date of April 2018 to render a decision
on the apalutamide NDA.
Janssen Research & Development announced
in December that the Phase 3 iNNOVATE (PCYC-
1127) trial assessing Imbruvica (ibrutinib) in combination with rituximab (branded as Rituxan) in
relapsed/refractory and treatment-naïve patients
with Waldenström’s macroglobulinemia (WM)
successfully met its primary endpoint of progression-free survival. An Independent Data Monitoring Committee advised unblinding iNNOVATE
based on e;cacy results observed in the pre-speci;ed interim analysis. Imbruvica represents a ;rst-in-class Bruton’s tyrosine kinase inhibitor jointly
developed and commercialized by Janssen Biotech and AbbVie company Pharmacyclics.
On the eve of World AIDS Day (December 1),
Johnson & Johnson revealed that its Janssen Phar-
maceutical Companies along with a consortium
of global partners initiated the ;rst e;cacy study
for an investigational mosaic HIV-1 preventive
vaccine. The Bill & Melinda Gates Foundation and
National Institutes of Health joined forces with
Johnson & Johnson to advance the potential pre-
vention option, which is designed to be a “global
vaccine” that could prevent a wide array of viral
strains responsible for the HIV pandemic.
“Having a preventive vaccine would be a vital
tool in a comprehensive global strategy to end the
HIV pandemic,” noted Dr. Johan Van Hoof, Janssen
Vaccines & Prevention and Therapeutic Area Head,
R&D, Infectious Diseases & Vaccines. “Our investi-
gational vaccine is based on mosaic antigens that
have been engineered using genes from a wide
range of di;erent HIV subtypes. The ultimate goal
is to deliver a ‘global vaccine’ that could be de-
ployed in any geographic region to help protect
vulnerable populations at risk of infection.”
Janssen Research & Development in Novem-
ber reported longer-term results from a Phase 2
trial testing Tremfya, the ;rst selective anti-inter-
leukin- 23 monoclonal antibody to demonstrate
positive results in treating active psoriatic arthritis.
Based on the Phase 2 results, Janssen initiated two
Phase 3 trials to investigate the e;cacy and safety
of Tremfya for patients with active psoriatic arthri-
tis who may have been previously treated with an-
ti-tumor necrosis factor alpha therapies (DISCOV-
ER-1), and in patients who have not received prior
treatment with a biologic therapy (DISCOVER- 2).
Janssen Pharmaceutica announced in October 2017 that the pivotal Phase 3 AMBER study
achieved its primary endpoint, which focused
on virologic response rate, and showed that the
investigational single-tablet regimen (STR) containing darunavir 800 mg, cobicistat 150 mg,
emtricitabine 200 mg and tenofovir alafenamide
10 mg (D/C/F/TAF) was non-inferior to darunavir/
cobicistat (D/C) plus emtricitabine and tenofovir
disoproxil fumarate (F/TDF) in previously untreated human immunode;ciency virus type 1 positive adults.
An NDA for D/C/F/TAF was submitted on Sept.
22, 2017, with the U.S. FDA for treating HIV-1 infection in adults and pediatric patients 12 years of
age and older, based on the results from the pivotal Phase 3 trials EMERALD and AMBER. Three days
later, the European Commission approved the use
of Symtuza (darunavir/cobicistat/emtricitabine/
tenofovir alafenamide) for treating HIV-1 infection
in adults and adolescents aged 12 years and older
with body weight of at least 40 kg. This approval
allows Janssen to market D/C/F/TAF in all EU member states and the European Economic Area.
A supplemental New Drug Application was
;led with U.S. regulatory o;cials in October for
a new indication for Invokana (canagli;ozin): to
reduce the risk of major adverse cardiovascular
events (MACE) – composed of cardiovascular (CV)
death, myocardial infarction and stroke – in adults
with type 2 diabetes who have established CV disease or are at risk for CV disease. The sNDA additionally applies to Invokana’s ;xed-dose combinations, Invokamet and Invokamet XR, and is based
on ;ndings from the landmark CANVAS clinical
Merck continues to be at the forefront of research to advance the prevention andtreatmentofdiseasesthatthreaten
people and communities around the globe – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases such as HIV and Ebola.
Despite having been approved for U.S. marketing back in September 2014, Keytruda remains
Merck’s most signi;cant pipeline asset. The anti-cancer agent’s sales vaulted from $1.4 billion in
2016 to $3.81 billion for 2017, re;ecting the com-
Johnson & Johnson
Industry-Leading Pipeline & Commercial Excellence
Priority: Drive continued growth while delivering
on our near-term pipeline
Strategy: Focus on six therapeutic areas of high
unmet medical need, robust innovation and commercial
Plans for Growth:
• Expand profile on key lifesaving and life changing
products, such as DARZALEX®, IMBRUVICA®, and
• Enable best in class uptake of TREMFYA®
• Secure regulatory approvals for apalutamide
• Submit NMEs and line extensions