1. Healthcare

Major developments
2014
Novartis announced that the Japanese Ministry of Health, Labour and
Welfare (MHLW) approved Cosentyx (secukinumab, formerly known as
AIN457), for the treatment of both psoriasis vulgaris and psoriatic
arthritis (PsA) in adults who are not adequately responding to
systemic therapies (except for biologics). This approval marks the
first country approval for Cosentyx in the world and makes it the first
interleukin-17A (IL-17A) inhibitor to receive regulatory approval in
either of these indications in Japan.
December
Alcon, announced that its treatment for patients with glaucoma,
Travatan Eye Drops Solution, was granted an additional indication by
the European Commission to decrease elevated intraocular pressure in
pediatric patients, aged two months to less than 18 years, with ocular
hypertension or pediatric glaucoma. Travatan is currently indicated to
decrease elevated intraocular pressure in adult patients with ocular
hypertension or open-angle glaucoma. Elevated eye pressure, or IOP,
is considered the main risk factor for glaucoma.
Novartis announced that the FDA approved Signifor long-acting release
(LAR) for injectable suspension, for intramuscular use, for the
treatment of patients with acromegaly who have had an inadequate
response to surgery and/or for whom surgery is not an option. The
approval of Signifor LAR, a next-generation somatostatin analog (SSA),
helps address a critical unmet need among the acromegaly patient
population. Signifor LAR has been studied and found effective in both
medically naïve patients with acromegaly who have had prior surgery
or for whom surgery was not an option, as well as patients whose
disease is not fully controlled on first generation SSAs.
Novartis announced that the Phase IIIb CLEAR study for Cosentyx
demonstrated superiority to Stelara® and met its primary endpoint of
achieving PASI 90, which represents clear or almost clear skin at
Week 16 for psoriasis patients. The study also met the secondary
endpoint of achieving PASI 75 at Week 4. Safety results were
consistent with previously reported Phase III clinical trials for
Cosentyx. The CLEAR study is the second head-to-head study for
Cosentyx versus established psoriasis biologic treatments. It follows
on from the Phase III FIXTURE study, which showed that Cosentyx was
superior to Enbrel®, a current standard-of-care, in clearing psoriasis
skin with a comparable safety profile.
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At the 56th Annual Meeting of the American Society of Hematology,
Novartis announced data from the largest clinical trial of
myelofibrosis patients treated with Jakavi, supporting the safety profile
and efficacy benefit as measured in primary and secondary endpoints
respectively. In an analysis of 1,144 patients treated with Jakavi to
date in this ongoing expanded access study, 69% of patients achieved
>50% reduction in spleen size from baseline and patients also
experienced a clinically meaningful improvement in myelofibrosis
symptom score, important treatment goals for patients with
myelofibrosis.
Six-year results from the randomized Phase III ENESTnd study
continue to demonstrate the superiority of Tasigna compared to
Glivec/Gleevec at achieving higher rates of early, deep and sustained
molecular responses in newly-diagnosed Philadelphia chromosomepositive chronic myeloid leukemia (Ph+ CML) patients. Further, there
were fewer progressions to accelerated phase/blast crisis (AP/BC)
with Tasigna versus Glivec/Gleevec. The six-year update from the
ENESTnd trial was presented at the 56th annual meeting of the
American Society of Hematology.
Sandoz announced Phase III data that demonstrated similarity of its
investigational biosimilar filgrastim compared to the US-licensed
reference product, Amgen's NEUPOGEN® (filgrastim) in the
prevention of severe neutropenia in patients with breast cancer
receiving neoadjuvant myelosuppressive chemotherapy. The study
also showed that repeated switching at each cycle between the
investigational biosimilar and the originator filgrastim showed no
impact on efficacy, safety or immunogenicity.
Findings from continued clinical studies of investigational chimeric
antigen receptor (CAR) therapy CTLO19 presented at the Annual
Meeting of the American Society of Hematology demonstrate its
potential role in the treatment of certain types of lymphocytic
leukemia. In one long-term study of pediatric patients with acute
lymphoblastic leukemia (ALL), results showed that 36 of 39 pediatric
patients with relapsed/refractory ALL, or 92%, experienced complete
remissions with CTL019. Additionally, sustained remissions were
achieved up to one year or more with 6-month event-free survival of
70% and overall survival of 75%, in most cases without further
therapy.
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Novartis announced that the Committee for Medicinal Products for
Human Use granted accelerated assessment to LCZ696, an
investigational medicine for patients with heart failure with reduced
ejection fraction (HFrEF). The expedited review procedure is granted
infrequently by the EMA and has never been awarded in the
cardiovascular area until now. The designation allows the CHMP to
grant an opinion at day 150 versus a normal 210 day procedure,
meaning a decision on EU approval is expected within 2015.
November
Novartis announced that the FDA has extended their priority review
period by up to three months for the new drug application (NDA) of
LBH589 (panobinostat) in combination with bortezomib and
dexamethasone for patients with previously treated multiple myeloma.
The NDA for LBH589 was submitted to the FDA in March 2014. In
May 2014, the FDA granted priority review status to LBH589,
reducing the standard 12-month review period to eight months. The
extension to the LBH589 NDA review period followed an FDA
Oncologic Drugs Advisory Committee meeting earlier in the month.
Novartis announced that the European Commission approved Signifor
as a new long acting release formulation for once monthly
intramuscular injection to treat adult patients with acromegaly for
whom surgery is not an option or has not been curative and who are
inadequately controlled on treatment with a first-generation
somatostatin analogue (SSA). Next-generation SSA Signifor offers the
first alternative treatment option directly targeting the pituitary tumor
for patients whose acromegaly remains inadequately controlled on
currently available SSAs.
The Committee for Medicinal Products for Human Use adopted a
positive opinion recommending approval of Cosentyx (secukinumab,
formerly known as AIN457) as a first-line systemic treatment of
moderate-to-severe plaque psoriasis in adults who are candidates for
systemic therapy. This recommendation means doctors could use
secukinumab first-line to treat their psoriasis patients, as an
alternative to other first-line systemic treatments, which have
significant side effects. Currently, all biologic treatments for psoriasis,
including anti- tumor necrosis factor therapies (anti-TNFs) and
ustekinumab are recommended for second-line systemic therapy in
Europe.
New data presented at the American Heart Association Scientific
Sessions 2014 and simultaneously in Circulation on Novartis'
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investigational medicine, LCZ696, for patients with heart failure with
reduced ejection fraction (HFrEF) shows it has the potential to change
the course of the disease for patients. These data show LCZ696 cut
incidence of sudden deaths, emergency room visits, hospitalizations,
worsening symptoms and need for more intense treatment in HFrEF
patients versus enalapril. Patients' and doctors' assessments of
disease severity were also significantly better with LCZ696 than
enalapril.
At the American College of Rheumatology Congress, Novartis
announced first ever results from the pivotal Phase III FUTURE 1 and
FUTURE 2 studies showing AIN457 (secukinumab) demonstrated
rapid and significant clinical improvements versus placebo in
improving the signs and symptoms of psoriatic arthritis (PsA). At the
same congress, Novartis presented results from the MEASURE 1 and
MEASURE 2 pivotal Phase III studies of AIN457 in ankylosing
spondylitis (AS). Joint regulatory filings of secukinumab in AS and
psoriatic arthritis are planned for 2015.
Novartis announced that, through Power of One, enough funds have
been raised to deliver three million antimalarial treatments for
children in Zambia. Launched in September 2013, Malaria No More's
Power of One campaign is supported by Novartis as the exclusive
treatment sponsor. Although preventable and treatable, malaria still
kills a child every minute. Every dollar donated to the campaign buys
and delivers a treatment for a child with malaria in Africa. Using
social, mobile, and e-commerce technologies, donors can see the
impact of their donation on the ground, share the experience with
their networks and recruit other donors.
Novartis announced it entered into a definitive agreement to divest its
influenza vaccines business to CSL Limited (CSL) for an agreed price
of USD 275 million. This transaction requires regulatory approvals
and is expected to close in the second half of 2015. CSL has more
than 40 years of experience in the influenza vaccines business and
operates in 27 countries with more than 13,000 employees
worldwide. The Novartis influenza vaccines unit will be combined with
CSL's subsidiary, bioCSL.
October
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory
Committee (DODAC) to the FDA voted unanimously to support the
approval of AIN457 (secukinumab), a selective interleukin-17A (IL17A) inhibitor, for the treatment of moderate-to-severe plaque
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psoriasis in adult patients who are candidates for systemic therapy (a
drug that is absorbed into the bloodstream and distributed to all
parts of the body) or phototherapy (light therapy). The DODAC based
its recommendation on the safety and efficacy outcomes from 10
psoriasis Phase II/III clinical studies which included nearly 4,000
patients with moderate-to-severe plaque psoriasis.
Preliminary results from two pilot clinical trials published in the New
England Journal of Medicine (NEJM), authored by Novartis and the
University of Pennsylvania’s Perelman School of Medicine evaluated
the efficacy and safety of CTL019 in patients with relapsed/refractory
acute lymphoblastic leukemia (r/r ALL). The studies, conducted by
Penn, demonstrated that 27 of 30 pediatric and adult patients, or
90%, experienced complete remissions with the investigational
chimeric antigen receptor (CAR) therapy CTL019. These data build
on earlier research findings and are part of two pilot clinical studies
that demonstrated sustained remissions of up to two years in
pediatric and adult patients with r/r ALL.
Novartis presented new analyses at the European Association of
Dermatology and Venerology Congress of AIN457 (secukinumab).
These Phase III studies showed that treatment with secukinumab 300
mg resulted in higher rates of clear to almost clear skin at Week 12
versus placebo, regardless of patients' psoriasis disease severity
(p<0.0001). In the analyses, the majority of patients across two
disease severity subgroups, including those with severe psoriasis,
experienced complete clear to almost clear skin measured as 100 or
90% reduction of respective baseline PASI (Psoriasis Area and
Severity Index) (p<0.0001). Skin clearance was sustained through one
year of treatment (p<0.0001).
Novartis confirmed today that following completion of the
transactions with GlaxoSmithKline (GSK) and Eli Lilly and Company
(Lilly) in the coming months, that the three business leaders of the
Novartis divisions at the center of the transaction will leave the
Executive Committee of Novartis (ECN). George Gunn, currently
Division Head, Novartis Animal Health, will reach his contractual
retirement age in July 2015 and will retire from Novartis. Brian
McNamara, currently Division Head, Novartis OTC, will transition to
GSK as Head of Americas and Europe for the consumer health
businesses, reporting to the President of GSK Consumer Healthcare,
effective at closing of the transaction. Andrin Oswald, currently
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Division Head, Novartis Vaccines, will be leaving Novartis to pursue
other opportunities following closing of the transaction with GSK.
Novartis announced that it had entered into a clinical collaboration
with Bristol-Myers Squibb Company to evaluate the safety, tolerability
and preliminary efficacy of three molecularly targeted compounds in
combination with Bristol-Myers Squibb's investigational PD-1 immune
checkpoint inhibitor, Opdivo® (nivolumab), in Phase I/II trials of
patients with non-small cell lung cancer (NSCLC). Combination
studies will evaluate compounds that have demonstrated evidence of
targeting mutations associated with tumor growth in patients with
NSCLC. The collaboration highlights promising new treatment
approach for patients and underscores Novartis' commitment to
patients and the lung cancer community.
At the European Society for Medical Oncology (ESMO) 2014 Congress,
Novartis announced new data showing patients with anaplastic
lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC)
lived an average of more than 18 months without their cancer
progressing when taking Zykadia (ceritinib) as their first ALK inhibitor.
Overall, data from the pivotal study confirmed ceritinib continues to
demonstrate efficacy in ALK+ NSCLC patients regardless of whether
or not they received previous treatment with an ALK inhibitor. In
addition, patients who entered the study with brain metastases
experienced similar results following treatment with ceritinib.
September
The Committee for Medicinal Products for Human Use (CHMP) of the
EMA adopted a positive opinion for Signifor (pasireotide) long acting
release (LAR) formulation to treat adult patients with acromegaly for
whom surgery is not an option or has not been curative and who are
inadequately controlled on treatment with a first-generation
somatostatin analogue (SSA). If approved in the EU, this nextgeneration SSA could fill a current unmet need, providing a new
therapeutic option for the approximately 45% of acromegaly patients
whose growth hormone (GH) or insulin-like growth factor-1 (IGF-1)
levels remain inadequately controlled despite treatment with currently
available SSAs.
Data published in The Lancet Oncology demonstrated a statistically
significant and clinically relevant 4-month improvement in median
progression-free survival (PFS) for patients with relapsed or relapsed
and refractory multiple myeloma when using the investigational
compound LBH589 (panobinostat) in combination with bortezomib
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and dexamethasone compared to placebo plus the same combination.
In the Phase III PANORAMA-1 (PANobinostat ORAl in Multiple
MyelomA) trial, the addition of LBH589 also led to clinically
meaningful increases in complete and near complete response rates
and duration of response. The effect of LBH589 was observed across
all patient subgroups.
Novartis announced new analyses at the Joint ACTRIMS-ECTRIMS
Meeting, which confirmed the high efficacy of Gilenya (fingolimod) in
achieving 'no evidence of disease activity' (NEDA) in people with
relapsing-remitting multiple sclerosis (RRMS) across four key disease
measures - relapses, MRI lesions, brain shrinkage (brain volume loss)
and disability progression. Specifically, patients taking Gilenya had a
more than four-times greater likelihood of achieving NEDA across
these four key measures. These analyses from the phase III
FREEDOMS and FREEDOMS II trials reinforce the value of including
brain shrinkage to the definition of NEDA. The inclusion of brain
shrinkage into the NEDA definition would allow physicians to obtain a
more complete assessment of a patient's disease, including the
underlying damage in MS.
Alcon, announced the winners of the 2014 eXcellence in
Ophthalmology Vision Award (XOVA) at the EURETINA Congress. The
XOVA, an annual award scheme that funds projects aimed at
delivering sustained improvements in eye care globally, including
developing countries, has been rewarding projects since 2010. The
projects can be educational (for example, training of local eye care
professionals) or can involve an innovation in eye care (for example, a
novel approach in monitoring visual acuity).
Novartis presented new data that demonstrated once-daily Ultibro
Breezhaler (indacaterol/glycopyrronium bromide) was superior in
reducing exacerbations (flare ups) and improving lung function
compared to twice-daily Seretide® Accuhaler®
(salmeterol/fluticasone (SFC)), in patients with moderate-to-severe
chronic obstructive pulmonary disease (COPD). These findings from
the head-to-head LANTERN study were presented for the first time at
the European Respiratory Society (ERS) International Congress.
In studies published simultaneously at the European Society of
Cardiology congress and in the New England Journal of Medicine,
Novartis revealed that its investigational heart failure medicine,
LCZ696, was superior to ACE-inhibitor enalapril on key endpoints in
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August
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the largest heart failure study ever done. In PARADIGM-HF patients
with heart failure with reduced ejection fraction (HF-REF) who were
given LCZ696 were more likely to be alive and less likely to have been
hospitalized for sudden deterioration of their heart failure than those
given ACE-inhibitor enalapril. Patients received LCZ696 or enalapril
on top of current best treatment. The magnitude of benefit with
LCZ696 against enalapril in HF-REF patients was highly statistically
significant and clinically important. In the study, the benefit of
LCZ696 was seen early, was sustained and was consistent across
subgroups.
At the 11th annual International Biotechnology Leadership Camp
(BioCamp), a three-day seminar at the Novartis campus,
biotechnology and business experts came together with more than 60
selected students from leading international universities in 25
countries and territories to consider the challenges of a growing aging
population.
Novartis signed an exclusive worldwide licensing agreement with the
Global Alliance for TB Drug Development (TB Alliance) for compounds
to fight tuberculosis (TB) that have been discovered at the Novartis
Institutes for Tropical Diseases (NITD). According to the World Health
Organization, there are more than 8.6 million cases of tuberculosis
each year, with more than 1.3 million deaths reported annually. TB is
a global disease, but has its deadliest impact in resource-poor
countries. Current therapies for TB require 6-30 month dosing
regimes and there are increasingly drug resistant strains of TB
emerging.
Clinical trial results published in the New England Journal of Medicine
showed that Novartis antimalarial drug candidate, KAE609
(cipargamin), cleared the parasite rapidly in Plasmodium falciparum (P.
falciparum) and Plasmodium vivax (P. vivax) uncomplicated malaria
patients. Novartis currently has two drug candidates in development.
Both KAE609 and KAF156 are new classes of anti-malarial
compounds that treat malaria in different ways from current
therapies, important to combat emerging drug resistance. Novartis
has also identified PI4K as a new drug target with potential to
prevent, block and treat malaria.
July
Novartis announced initial results of a large-scale vaccination
campaign with Bexsero (Meningococcal Group B Vaccine [rDNA,
component, adsorbed]) to help protect against meningitis B within the
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Saguenay-Lac-Saint-Jean region of Québec, Canada. This regional
program is the first of its kind globally and has reached 81% of the
campaign's target population within the first three months. This
encompasses more than 45,000 infants, young children and
adolescents from two months to 20 years of age. The high rate of
uptake in this public vaccination program with Bexsero demonstrates
the value placed on preventing meningitis B within communities that
are afforded access.
Alcon announced that Simbrinza eye drops suspension (brinzolamide
10mg/mL and brimonidine tartrate 2mg/mL) was approved by the
European Commission to decrease elevated intraocular pressure (IOP)
in adult patients with open-angle glaucoma or ocular hypertension, for
which monotherapy provides insufficient IOP reduction. Simbrinza,
administered with one drop into the affected eye(s) twice daily,
combines two well-established treatments for elevated IOP into one
multi-dose bottle. It is also the only fixed-combination glaucoma
treatment without a beta-blocker, which are commonly prescribed to
lower IOP, but are contraindicated for many glaucoma patients
suffering from certain respiratory or cardiac conditions.
Sandoz announced that the FDA accepted its Biologics License
Application for filgrastim, which was filed under the new biosimilar
pathway created in the Biologics Price Competition and Innovation
Act of 2009 (BPCIA). Sandoz is the first company to announce it has
filed for approval of a biologic under the biosimilars pathway created
in the Biologics Price Competition and Innovation Act of 2009
(BPCIA). The FDA's acceptance of Sandoz's filing is an important first
step in increasing US patient access to affordable, high-quality
biologics.
Alcon announced that it entered into an agreement with a division of
Google Inc. to in-license its "smart lens" technology for all ocular
medical uses. Novartis' interest in this technology is currently focused
in helping diabetic patients manage their disease by providing a
continuous, minimally invasive measurement of the body's glucose
levels via a "smart contact lens" which is designed to measure tear
fluid in the eye and connects wirelessly with a mobile device; and for
people living with presbyopia who can no longer read without glasses,
the "smart lens" has the potential to provide accommodative vision
correction to help restore the eye's natural autofocus on near objects
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in the form of an accommodative contact lens or intraocular lens as
part of the refractive cataract treatment.
Novartis announced a collaboration with Banner Alzheimer's Institute
(BAI) on a pioneering clinical study in Alzheimer's disease (AD)
prevention. The study will determine whether two Novartis
investigational anti-amyloid treatments can prevent or delay the
emergence of symptoms of AD in people identified as being at genetic
risk for developing the late-onset form of the disease. Using an
innovative trial design, the two treatments will be given in cognitively
healthy people at genetic risk of developing the build-up of amyloid
protein in the brain that may eventually lead to AD.
Detailed results from two pivotal phase III studies evaluating the
Novartis interleukin-17A (IL-17A) inhibitor secukinumab (AIN457)
were published in the New England Journal of Medicine (NEJM).
Secukinumab met all primary and key secondary endpoints at week
12 in the ERASURE and FIXTURE studies, showing superiority to
Enbrel® (etanercept) in improving moderate-to-severe plaque psoriasis
symptoms in the FIXTURE study, and superiority over placebo in both
studies. Over half of secukinumab 300 mg patients experienced clear
or almost clear skin, described as Psoriasis Area and Severity Index
90 or 100 (PASI 90 or 100). In comparison, only 20.7% of Enbreltreated patients experienced PASI 90 or 100.
Novartis published a Corporate Responsibility (CR) Performance
Report for 2013. The report reflects the best-in-class reporting
standard, the Global Reporting Initiative's (GRI) G4 guidelines, one
year in advance of required implementation. The Performance Report
enhances the company's transparency in several key areas, including
in human resources, supply chain and ethics, and aims to meet the
needs and expectations of CR professional audiences by offering easy
access to key data. The report also details progress against Novartis
priorities, defined following a CR materiality analysis completed in
2013.
Novartis announced that the FDA granted Breakthrough Therapy
status to CTL019, an investigational chimeric antigen receptor (CAR)
therapy for the treatment of pediatric and adult patients with
relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The filing
was submitted by the University of Pennsylvania's Perelman School of
Medicine which has an exclusive agreement with Novartis to research,
develop and commercialize personalized CART cell therapies for the
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treatment of cancers. This is the fifth Breakthrough Therapy
designation for Novartis, continuing the company's trajectory as a
leader in developing innovative therapies to help treat diseases in
which there remains significant unmet medical need.
Sandoz announces a long-term commitment to help prevent the
deaths of millions of children worldwide by supplying a key antibiotic
formulation, as part of the United Nation's new Every Newborn Action
Plan. The commitment involves providing long-term global supplies
of amoxicillin 250 mg dispersible tablets to developing countries via
the UN Commission for Lifesaving Commodities. More than five
million children under five are estimated to die worldwide every year,
mainly in Africa and Asia, and nearly a quarter of those deaths are
due to pneumonia alone, making it the single largest killer in that age
range.
June
Novartis submits application to the FDA for meningitis B vaccine
candidate Bexsero (Multicomponent Meningococcal Group B Vaccine
[recombinant, adsorbed]) to help protect US adolescents and young
adults. Submission follows receipt of Breakthrough Therapy
designation in April 2014, highlighting unmet need for a licensed
vaccine for serogroup B in the US. Bexsero, approved in 34 countries,
was recently provided to two US universities under an Investigational
New Drug designation in response to outbreaks.
Novartis Holly Springs facility becomes the first US pandemic-ready
site licensed by the US Food and Drug Administration (FDA) to
produce cell- culture influenza vaccines. Cell-culture technology is a
modern alternative to manufacture influenza vaccines without chicken
eggs, with potential to rapidly respond to a pandemic. Flucelvax
(Influenza Virus Vaccine), an FDA-approved antibiotic- and
preservative-free seasonal flu vaccine, will be manufactured at this
site for the US market. The licensure marks a milestone in Novartis'
public-private partnership to improve US capabilities to respond to
seasonal epidemics and emerging public health threats.
Novartis Foundation for Sustainable Development to work with
Netherlands Leprosy Relief to help reduce leprosy transmission.
Collaboration to provide evidence on the impact of preventatively
treating high risk groups to reduce the transmission of leprosy in
several countries across Asia, Africa and Latin America. Research
shows that a single preventative dose of antibiotic rifampicin can
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reduce the risk of developing leprosy by 50 to 60% among contacts of
leprosy patients.
Pivotal Phase III data show polycythemia vera (PV) patients on Jakavi®
(ruxolitinib) achieved significant improvement in disease control. 77%
of patients on Jakavi vs 20% on best available therapy achieved
hematocrit control or spleen reduction, key treatment goals in PV.
Global regulatory filings are underway based on these data; if
approved, ruxolitinib will be the first JAK 1/2 inhibitor available for PV
patients.
A study shows Zykadia™ (ceritinib) shrank tumors in the majority of
patients with anaplastic lymphoma kinase-positive (ALK+) non-small
cell lung cancer (NSCLC), regardless of prior ALK treatment. Ceritinib
achieved overall response rate of 58.5%, with a median progressionfree survival of 8.2 months. Similar findings were observed in
patients who started the study with brain metastases, addressing one
of the biggest challenges in treating ALK+ NSCLC. Zykadia is the only
FDA-approved therapy for patients with ALK+ metastatic NSCLC who
have progressed on or are intolerant to crizotinib.
Novartis presents results from a pivotal Phase III trial showing a 37%
improvement in progression-free survival (PFS) when using the
investigational compound LBH589 (panobinostat) in combination with
bortezomib and dexamethasone in patients with relapsed or relapsed
and refractory multiple myeloma the Annual Meeting of the American
Society of Clinical Oncology (ASCO). If approved, LBH589 will be first
in its class of anticancer agents available to this population.
Results of a pivotal Phase II trial demonstrate that patients with
locally advanced (laBCC) or metastatic basal cell carcinoma (mBCC)
taking the investigational oral compound LDE225 (sonidegib) had
marked and sustained tumor shrinkage after a median follow-up of
13.9 months. The study met the primary endpoint with objective
response rates of 41.8% and 32.5% respectively in the 200 mg and
800 mg treatment arms. These data, presented for the first time at
ASCO, will be used as the basis for worldwide regulatory submissions
beginning in 2014.
Novartis announces the appointment of Bruno Strigini as President of
Novartis Oncology, effective June 1, 2014. With 25 years of
experience in pharmaceuticals, animal health, OTC and vaccines in
both international and local roles, he has a global perspective on the
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healthcare industry, with expertise across diverse geographies,
including both mature and emerging markets.
The Committee for Medicinal Products for Human Use (CHMP) has
adopted a negative opinion the use of RLX030 (serelaxin) in the
treatment of acute heart failure (AHF) indicating that further evidence
is required for a license to be granted in the EU. This follows the
company's request for re-examination after a previous negative
opinion was issued in January. Novartis aims to resubmit for approval
as soon as additional data is available from the ongoing global trial
program, including the 6,300 patient RELAX-AHF-2 study, one of the
largest and most robust programs undertaken by a company for an
AHF drug.
May
Alcon receives positive CHMP opinion for Simbrinza® eye drops
suspension (brinzolamide 10 mg/mL and brimonidine tartrate 2
mg/mL), a new fixed-dose combination medicine to treat patients
with glaucoma. It is the only beta blocker-free, fixed-dose combination
treatment in Europe for patients contraindicated for beta blockers due
to certain respiratory or cardiac conditions. If approved, Simbrinza
will reduce patients' treatment burden, increase options to control
high intraocular pressure, the only known modifiable risk factor for
glaucoma.
Novartis announces positive results at the American Thoracic Society
(ATS) International Conference for once-daily Ultibro® Breezhaler®
(indacaterol/glycopyrronium) 110/50 mcg versus combination
therapy. The QUANTIFY study met the primary endpoint
demonstrating non- inferiority of Ultibro Breezhaler vs tiotropium 18
mcg plus formoterol 12 mcg in improving health-related quality of life
outcomes and the secondary endpoint demonstrating superiority by
improving lung function. Ultibro Breezhaler provides the convenience of
a once-daily fixed- dose combination in a single inhalation device for
the treatment of chronic obstructive pulmonary disease (COPD).
Novartis announces the signing of a licensing and commercialization
agreement with Ophthotech Corporation for the exclusive rights to
market Fovista® (anti-PDGF aptamer) outside the United States.
Fovista is the most advanced anti-PDGF technology in development,
and if approved, is expected to be first to market in this class of
therapies for wet AMD.
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The FDA has issued a Complete Response Letter for the Biologics
License Application (BLA) for RLX030 (serelaxin) for acute heart
failure. The agency stated further evidence of the efficacy of RLX030
is required for US approval. Novartis intends to resubmit with
additional data when it is available.
Novartis settles patent litigation on Gleevec® (imatinib mesylate) with
a subsidiary of Sun Pharmaceutical Industries Ltd. The litigation
settlement upholds the validity of US patents covering polymorphic
forms of Gleevec and permits the Sun Pharma subsidiary to launch a
generic version on February 1, 2016.
Novartis drug Signifor® LAR (pasireotide LAR; SOM230) shows
superior efficacy in acromegaly patients not controlled on first
generation somatostatin analogues. The study findings showed that
patients taking pasireotide long-acting release (LAR) achieved greater
disease control when compared to continued treatment with the
standard somatostatin analogue therapies, octreotide LAR or
lanreotide Autogel. These data, supported by a previously published
Phase III study, are the basis for worldwide regulatory filings for
pasireotide LAR in the treatment of acromegaly.
Novartis announces new data presented at American Academy of
Neurology (AAN) Annual Meeting showing Gilenya® (fingolimod)
slowed the rate of brain volume loss in multiple sclerosis (MS)
patients. The data showed significantly more Gilenya-treated patients
(vs. patients on placebo) had brain volume loss rates comparable to
people without MS. Brain volume loss, one of the four key measures
of MS disease activity, starts early in the disease and is a predictor of
long-term disability.
April
Novartis announces positive first results from the Phase III head-tohead LANTERN study, which showed the superiority of
once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium)
110/50 mcg in improving lung function compared to twice-daily
Seretide® Accuhaler® (salmeterol/fluticasone (SFC)) 50/500 mcg in
COPD patients with or without a history of moderate-to-severe
exacerbations in the previous year. Ultibro Breezhaler met both the
primary and key secondary objectives. These Positive results will be
part of the regulatory submission for Ultibro Breezhaler in China later
this year.
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The FDA approves Zykadia™ (ceritinib, previously known as LDK378)
for the treatment of patients with anaplastic lymphoma kinasepositive (ALK+) metastatic non-small cell lung cancer (NSCLC) who
have progressed on or are intolerant to crizotinib. The approval of
Zykadia addresses an unmet medical need for patients with this type
of lung cancer who have progressed on prior therapy.
The CHMP has issued a positive opinion to expand the EU label for
Gilenya® (fingolimod) in relapsing remitting multiple sclerosis
(RRMS). The recommendation is to expand the label to include adult
patients who have not responded to at least one disease-modifying
therapy (DMT), including newly-approved oral DMTs. Gilenya is
currently licensed in the EU for adult patients with RRMS who have
not responded to treatment with interferons, or have rapidly evolving
severe MS. Novartis also announced new pooled analyses from the
pivotal FREEDOMS and FREEDOMS II trials in multiple sclerosis (MS),
confirming the consistent efficacy of Gilenya across four key measures
of MS (relapse rates, MRI lesions, brain volume loss and disability
progression). Addressing these four measures through effective
treatment and disease management is important for improving the
course of MS for patients.
Novartis announces that it has reached a definitive agreement with
GlaxoSmithKline plc (GSK) to exchange certain assets, building
global leadership in key segments and focusing the company's
portfolio. Under the agreement, Novartis would strengthen the
company's innovative pharmaceuticals business by acquiring GSK
oncology products, and would divest Vaccines (excluding flu) to them.
The two companies would also create a joint venture, combining their
consumer divisions to create a world-leading consumer healthcare
business. Separately, the company announced a definitive
agreement with Eli Lilly and Company to divest the Animal Health
Division, further focusing its portfolio on the leading businesses of
innovative pharmaceuticals, eye care and generics. All transactions
are subject to closing conditions. The transaction with GSK is
expected to close in the first half of 2015, and the transaction with
Lilly is expected to close in the first quarter of 2015. Novartis also
commenced a sale process to divest its flu vaccines business.
Novartis announced the creation of a shared services organization,
Novartis Business Services (NBS), to improve profitability and free up
resources that can be reinvested in growth and innovation. NBS will
consolidate a number of business support services currently spread
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across divisions, including IT, Financial Reporting and Accounting,
Real Estate & Facility Services, Procurement, Payroll and Personnel
Administration and the Pharmaceuticals Global Business Services.
Novartis appoints Jeff George as Division Head, Alcon and names
Richard Francis as new Division Head, Sandoz. These new leaders will
continue to build global scale and innovation power in two of the
leading Novartis businesses.
Novartis announced today that two million treatments of its pediatric
antimalarial are arriving in Zambia thanks to the ongoing efforts of the
company in collaboration with Malaria No More's Power of One
campaign. Zambia is the first beneficiary country of this campaign
sponsored by Novartis. One million treatments of Coartem®
Dispersible have been funded through public donations and Novartis
matched these with a further one million treatments. These
antimalarials will reduce the disease burden in Zambia, which
accounts for up to 40% of infant mortality in that country.
Novartis meningitis B vaccine Bexsero® (Meningococcal Group B
Vaccine [rDNA, component, adsorbed]) receives FDA Breakthrough
Therapy designation in the US. The designation highlights the
potential of Bexsero to meet the urgent need for a licensed vaccine in
the US against unpredictable and devastating meningitis. Bexsero,
already approved in Europe, Canada and Australia, is the only broad
coverage meningitis B vaccine that can be used from two months of
age.
Novartis announces that the Data Monitoring Committee (DMC)
unanimously recommended early closure of the PARADIGM-HF study,
indicating patients with chronic heart failure with reduced ejection
fraction (HF-REF) who received LCZ696 lived longer without being
hospitalized for heart failure than those who received standard care
with ACE-inhibitor enalapril. Based on the compelling efficacy and
primary endpoint having been met, the trial will now close early. This
follows two previous interim analyses that showed the safety profile of
LCZ696 was acceptable. PARADIGM-HF is the largest ever trial of a
heart failure treatment, robustly designed to assess LCZ696 in
patients with chronic heart failure with reduced ejection fraction.
March
Novartis announces that the FDA Cardiovascular and Renal Drugs
Advisory Committee (CRDAC) voted against approval for RLX030
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(serelaxin) for the treatment of acute heart failure (AHF). Novartis will
work with the FDA on a path forward for RLX030 for AHF.
A Novartis study published in the New England Journal of Medicine
shows LDK378 (ceritinib) demonstrated an overall response rate of
58% in patients with ALK+ NSCLC. Data showed investigational
treatment LDK378 also achieved a median progression-free survival of
seven months. Patients with this type of lung cancer, especially those
for whom prior therapies have failed, are in need of new treatment
options.
Novartis announces results from the pivotal phase III FEATURE and
JUNCTURE studies showing secukinumab (AIN457), an interleukin17A (IL-17A) inhibitor, demonstrated consistent high efficacy when
administered with a convenient pre-filled syringe (PFS) or
autoinjector/pen (AI). These results, along with patient-reported
outcomes showing high patient satisfaction with PFS and AI, were
presented for the first time at the Annual Meeting of the American
Academy of Dermatology (AAD). Secukinumab is the first IL-17A
inhibitor with phase III data presented and regulatory submissions
filed with global health authorities.
Novartis announces FDA approval of Xolair® (omalizumab) for chronic
idiopathic urticaria (CIU). Xolair is the first and only licensed therapy
in the US for the nearly 50% of patients with CIU who do not respond
to approved doses of H1-antihistamines.
Novartis announces that the Joint Committee on Vaccination and
Immunisation (JCVI) in the UK has recommended the inclusion of
Bexsero® (Meningococcal Group B Vaccine [rDNA, component,
adsorbed]) in the National Immunisation Programme. According to
the recommendation, Bexsero should be routinely used in infants
from two months of age to help protect against meningococcal
serogroup B (meningitis B). The implementation will be carried out by
the Department of Health through the National Health Service (NHS),
following the public procurement process.
CLEAR, a new phase IIIb head-to-head study of IL-17A inhibitor
secukinumab (AIN457) versus Stelara® (ustekinumab) in moderateto- severe plaque psoriasis has started patient enrollment. Nearly 3%
of the world's population, or more than 125 million people, are
affected by plaque psoriasis, with more than one third of these
suffering from its moderate-to-severe form. Between 40-50% of
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patients are dissatisfied with their current psoriasis therapies,
indicating an unmet need for convenient therapies that act faster and
longer to relieve the debilitating symptoms.
Results from the secondary endpoint of the Phase III BOLERO-2
(Breast cancer trials of OraL EveROlimus-2) study of Afinitor®
(everolimus) trial were presented at the 9th European Breast Cancer
Conference (EBCC-9). A median overall survival duration of 31
months was seen in the combination arm versus 26.6 months for
those on exemestane monotherapy, a difference of 4.4 months. This
secondary endpoint did not reach the threshold of statistical
significance. The median overall survival is the longest reported to
date in a Phase III hormone receptor- positive, human epidermal
growth factor receptor-2 negative (HR+/HER2-) advanced breast
cancer trial following prior treatment with a non-steroidal aromatase
inhibitor (NSAI).
Novartis Bexsero® (Meningococcal Group B Vaccine [rDNA,
component, adsorbed]) meningitis B vaccine receives clinical
recommendation for use in infants and adolescents in Australia. The
Australian recommendation adds to clinical recommendations in the
Czech Republic, Poland and funding decisions in regions of Germany
and Italy. The recommendations highlight support for inclusion of
Bexsero on routine childhood immunization schedules to help protect
against this devastating disease.
Novartis announces that a pivotal Phase III trial of Jakavi®
(ruxolitinib) compared to best available therapy has met its primary
endpoint of maintaining hematocrit control (red blood cell volume)
without the need for phlebotomy (a procedure to remove blood from
the body to reduce the concentration of red blood cells) and reducing
spleen size in patients with polycythemia vera resistant to or
intolerant of hydroxyurea. The safety profile of ruxolitinib was
generally consistent with previous studies based on initial review of
the data. Ruxolitinib is the first selective JAK 1/2 inhibitor to
demonstrate efficacy in a Phase III trial for treating polycythemia
vera.
The European Commission (EC) approves the use of Xolair®
(omalizumab) as an add-on therapy for the treatment of chronic
spontaneous urticaria (CSU) in adult and adolescent patients (12
years and above) with inadequate response to H1-antihistamine
treatment. Xolair is the first and only approved therapy in the
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European Union (EU) for the up to 50% of CSU patients with
inadequate response to licensed doses of H1-antihistamines.
Novartis announces additional steps to extend its leadership in
clinical trial data transparency. Since 2005, and before
requirements were in place, Novartis has been voluntarily disclosing
summaries of Clinical Study Reports of its innovative medicines on its
own website. In addition, the company is committed to enhancing
Clinical Study Report summaries for all new pivotal studies to
include easy to understand consumer language summaries and
additional interpretation of data as of the end of 2014. Novartis has
long supported data transparency and was the first company to
publish positive and negative study results of its innovative medicines
within one year of the study completion further enabling clinical
research while protecting patient privacy.
February
Novartis provides Bexsero® (Meningococcal Group B Vaccine [rDNA,
component, adsorbed]) to be used as part of a vaccination program
at the University of California Santa Barbara (UCSB) to help protect
students and staff against potentially deadly meningitis B disease.
The FDA granted special use of Bexsero for nearly 20,000 UCSB
students and staff in response to an outbreak. The vaccine is licensed
in Europe, Australia and Canada.
Novartis shows continued commitment in Japan with approval of the
fourth Japanese indication for Lucentis® (ranibizumab) for the
treatment of patients with diabetic macular edema. Lucentis is the
first anti-VEGF therapy approved for diabetic macular edema (DME) in
Japan. Pivotal clinical data in Asian patients show a significant
increase in mean visual acuity following treatment with Lucentis
compared with laser therapy. Diabetic macular edema is a leading
cause of blindness in most developed countries in the working-age
population.
Novartis investigational compound LDE225 (sonidegib) met the
primary endpoint in a pivotal trial for patients with advanced basal
cell carcinoma. Results show LDE225 achieved clinically significant
tumor response including disappearance of the tumor in some
patients within six months of treatment.
Novartis announces it is broadening its cancer immunotherapy
research program with the acquisition of CoStim Pharmaceuticals
Inc., a Cambridge, MA-based, privately held biotechnology company
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focused on harnessing the immune system to eliminate immuneblocking signals from cancer. Increasing evidence points to the role of
the immune system in controlling cancer and to opportunities for
creating effective oncology therapies for cancer patients by
stimulating a targeted immune response. Already leading in cancer
immunotherapy, with investigative chimeric antigen receptor (CAR)
technology being developed in collaboration with the University of
Pennsylvania, with this acquisition Novartis is adding late discovery
stage immunotherapy programs directed to several targets, including
PD-1. These medicines could benefit patients by circumventing
cancer's ability to develop resistance against current single drugs.
Novartis reports that the CHMP has adopted a positive opinion for the
use of for Xolair® (omalizumab) as an add-on therapy for chronic
spontaneous urticaria (CSU) in adult and adolescent patients 12 years
and above with inadequate response to H1 antihistamines. Xolair
showed consistent high efficacy across three Phase III CSU studies
and in many cases completely cleared symptoms with safety
comparable to placebo. CSU is also known as chronic idiopathic
urticaria (CIU) in the US, and is a severe and distressing skin
condition characterized by red, swollen, itchy and sometimes painful
hives or wheals on the skin that spontaneously present and re-occur
for more than six weeks. Up to 40% of CSU patients also experience
angioedema, a swelling in the deep layers of the skin.
January
Novartis will shortly submit a revised filing package, including new
data analyses, for re-examination for conditional approval of RLX030
(serelaxin) for acute heart failure (AHF) by the CHMP following a
negative opinion. RLX030 is currently the only drug for which a
reduction in mortality has been observed in patients with AHF in a
major study. Data shows RLX030 is generally well tolerated. The
second phase III study, RELAX-AHF-2, started enrolment in
September 2013 with the goal to replicate the key findings of RELAXAHF.
2013
Analyses of the Phase III COMFORT-I and COMFORT-II studies show
patients with myelofibrosis initially randomized to treatment with
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Jakavi (ruxolitinib) lived longer than those randomized to treatment
with placebo or conventional therapy.
Findings from three large, randomized Phase III studies demonstrate
the superiority of Tasigna (nilotinib) compared to Glivec (imatinib) at
achieving deeper molecular responses across various Philadelphia
chromosome-positive chronic myeloid leukemia (Ph+ CML) patient
populations, including newly diagnosed patients, patients with
residual disease who switched to Tasigna after long-term treatment
with Glivec, and patients who failed to respond to frontline Glivec (as
defined by 2013 European LeukemiaNet [ELN] guidelines).
Results of a Phase III trial show the investigational compound
LBH589 (panobinostat) in combination with bortezomib and
dexamethasone met the primary endpoint of significantly extending
progression-free survival (PFS) in patients with relapsed or relapsed
and refractory multiple myeloma when compared to bortezomib plus
dexamethasone alone.
Novartis scientists report the discovery of a new drug target for
treating malaria. The discovery, which is published online in the
journal Nature, identifies phosphatidylinositol-4 kinase (PfPI4K) as
the target of the imidazopyrazines, a novel experimental antimalarial
compound class that inhibits the development of multiple malariacausing Plasmodium species at each stage of infection in the human
host.
November
The World Forum for Ethics in Business (WFEB) awards Novartis the
Ethics in Business Award in the Outstanding Corporation category.
The WFEB is the public interest foundation focused on promoting and
defending ethical approaches to business and corporate governance.
Novartis announces that it will co-locate certain scientific resources in
order to improve the efficiency and effectiveness of our global
research organization. Changes include establishing a respiratory
research group in Cambridge, Massachusetts, a proposal to close the
Horsham, UK, research site, a plan to exit from the Vienna, Austria
research site, consolidation of the US-based component of oncology
research from Emeryville, California to Cambridge, Massachusetts,
closure of the biotherapeutics development unit in La Jolla, California,
and a plan to exit research in topical applications for dermatology.
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In recognition of Novartis' significant on-going contributions to
malaria control and elimination, the company is honored with the
Global Corporate Citizenship Award at the Malaria No More
International Honors annual benefit.
Novartis announces a USD 5.0 billion share buyback. The buyback
begins on the date of the announcement and will be executed over two
years on the second trading line.
Novartis announces a definitive agreement to divest its blood
transfusion diagnostics unit to Grifols S.A. of Spain for USD 1.7
billion. This transaction was completed in January 2014.
The National Institute for Health and Care Excellence (NICE)
recommends Alcon’s Jetrea (ocriplasmin) as a clinically and costeffective treatment option for eligible patients suffering from
vitreomacular traction including when associated with macular hole.
With this final NICE guidance, Jetrea is now recommended for use
within the National Health Service (NHS) in England and Wales as the
first and only pharmacological treatment for this sight-threatening eye
condition.
October
New results from the Phase III ASTERIA I study show omalizumab is
effective and safe in the treatment of chronic spontaneous urticaria
(CSU), a chronic and debilitating form of hives. ASTERIA I is the final
pivotal registration study for omalizumab in CSU to be announced.
New data indicating that continued treatment with Gilenya
(fingolimod) led to a reduction in brain volume loss in patients with
relapsing forms of multiple sclerosis (MS), and was associated with a
higher proportion of patients remaining free of disability progression.
Results from the head-to-head Phase III FIXTURE study show
secukinumab (AIN457), an interleukin-17A (IL-17A) inhibitor, is
significantly superior to Enbrel® (etanercept) in moderate-to-severe
plaque psoriasis. Enbrel® is a current standard-of-care anti-TNF
medication approved to treat moderate-to-severe plaque psoriasis.
New clinical and real world data for Lucentis (ranibizumab) presented
at the EURETINA congress confirm its transformational and wellestablished safety profile in four retinal diseases. Designed for
intraocular use, Lucentis is an antibody fragment with a short
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systemic half-life and was first launched in Europe in 2007. Lucentis
is now indicated in many countries for the treatment of wet agerelated macular degeneration (wet AMD), for visual impairment due to
diabetic macular edema (DME), macular edema secondary to branchand central-retinal vein occlusion (BRVO and CRVO), and choroidal
neovascularization secondary to pathologic myopia (myopic CNV).
Novartis and Malaria No More announce the debut of the Power of
One (www.Po1.org) campaign, encouraging people around the world
to help end child deaths from malaria. Novartis will support the
campaign financially and donate up to three million Coartem
Dispersible treatments to match antimalarials funded by the public.
The company's commitment to Power of One aligns with its long
history in the fight against malaria; the Novartis Malaria Initiative is
one of the largest access-to-medicine programs in the healthcare
industry.
The European Commission approves once-daily Ultibro Breezhaler
(indacaterol 85 mcg/glycopyrronium 43 mcg) as a maintenance
bronchodilator treatment to relieve symptoms in adult patients with
chronic obstructive pulmonary disease (COPD), making it the first in
its class to gain approval. In addition, the Japanese Ministry of
Health, Labour and Welfare (MHLW) approves once-daily Ultibro
Inhalation Capsules (glycopyrronium 50 mcg/indacaterol 110 mcg),
delivered through the Breezhaler device, for relief of various
symptoms due to airway obstruction in COPD.
Novartis announces that it has entered into an exclusive global
licensing and research collaboration agreement with Regenerex LLC, a
biopharmaceutical company based in Louisville, Kentucky, for use of
the company's novel Facilitating Cell Therapy (FCRx) platform.
The European Commission approves the use of Ilaris (canakinumab)
in the treatment of active systemic juvenile idiopathic arthritis (SJIA)
in patients aged two years and older who have responded
inadequately to previous therapy with non-steroidal anti-inflammatory
drugs (NSAIDs) and systemic corticosteroids.
Results from a new analysis of the Phase III RELAX-AHF study
published in the European Heart Journal indicate that the
investigational medicine serelaxin (RLX030) consistently improves
symptoms and mortality across multiple subgroups of patients with
acute heart failure (AHF) assessed in the trial. If approved, RLX030
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has the potential to be the first treatment breakthrough for AHF
patients in 20 years.
Novartis receives FDA Breakthrough Therapy designation for BYM338
(bimagrumab) for sporadic inclusion body myositis (sIBM). If
approved, BYM338 has the potential to become the first treatment for
sIBM patients.
August
The Australian Therapeutic Goods Administration (TGA) adds Bexsero,
a multi-component Meningococcal B (MenB) vaccine (recombinant,
adsorbed) suspension for injection 0.5 ml pre-filled syringe, to the
Australian Register of Therapeutic Goods (ARTG) for use in individuals
from two months of age and older.
Novartis becomes the first company to earn the global CEO Cancer
Gold Standard accreditation from the non-profit organization CEO
Roundtable on Cancer, a group of cancer fighting CEOs from a variety
of industries, including healthcare. The designation recognizes the
company's efforts to provide support to Novartis associates in the
prevention, diagnosis and treatment of cancer.
Joerg Reinhardt, Ph.D., assumes role of Chairman of the Board of
Directors of Novartis AG on August 1.
The FDA approves Menveo (Meningococcal Group A, C, W-135 and Y
conjugate vaccine) for the prevention of meningococcal disease
caused by four strains of the bacterium Neisseria meningitidis (N.
meningitidis) in infants and toddlers from two months of age. With
this expanded indication, pediatricians in the US can now offer a
single vaccine for the protection of infants, children and adolescents
against four of the five most common serogroups that cause
meningococcal disease.
Novartis announces that the CHMP of the European Medicines Agency
(EMA) has adopted a positive opinion for the use of Ilaris
(canakinumab) in the treatment of active systemic juvenile idiopathic
arthritis (SJIA) in patients aged two years and older.
July
Novartis announces that the CHMP has adopted a positive opinion for
approval of once-daily Ultibro Breezhaler as a maintenance
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bronchodilator treatment to relieve symptoms in adult patients with
chronic obstructive pulmonary disease (COPD).
Novartis announces that it has entered into a development and
licensing agreement with Biological E Limited (BioE), a
biopharmaceutical company based in India, for two vaccines to
protect against typhoid and paratyphoid fevers. The agreement
advances the Novartis goal to deliver accessible and affordable
vaccines that address unmet medical need in endemic regions.
Novartis announces top-line results from the head-to-head Phase III
psoriasis study which showed the superiority of secukinumab
(AIN457) in clearing skin to Enbrel® (etanercept), an anti-tumor
necrosis factor (anti-TNF) therapy. In addition, secukinumab (AIN457)
met all primary and secondary endpoints.
The European Commission expands approval for Lucentis
(ranibizumab) to treat patients with visual impairment due to
choroidal neovascularization (CNV) secondary to pathologic myopia
(myopic CNV). This makes Lucentis, specifically designed for the eye
and proven to save sight, the first anti-VEGF therapy licensed for four
indications in the European Union.
The Novartis Board of Directors announces a final agreement with its
former Chairman, Dr. Daniel Vasella. From the date of the Annual
General Meeting held on February 22, 2013, until October 31, 2013,
Dr. Vasella provides certain transitional services, including select
Board mandates with subsidiaries of Novartis and support of the adinterim Chairman and the new Chairman. For his transitional services
during such period, Dr. Vasella will receive cash of CHF 2.7 million,
and 31,724 unrestricted shares as of October 31, 2013 (the market
value of the shares as of the date of the announcement was
approximately CHF 2.2 million). In addition, from November 1, 2013,
to December 31, 2016, Dr. Vasella will receive a minimum of USD
250,000 per annum in exchange for making himself available to
Novartis, at Novartis’ request and discretion, to provide specific
consulting services, such as the coaching of high-potential associates
of Novartis and speeches at key Novartis events at a daily fee rate of
USD 25,000, which will be offset against the USD 250,000 minimum
annual payment.
The FDA expands the approved indication for Exelon Patch
(rivastigmine transdermal system) to include the treatment of people
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with severe Alzheimer’s disease (AD) with Exelon Patch 13.3mg/24h.
Exelon Patch is now the first and only transdermal therapy approved
to treat patients with mild, moderate and severe AD.
Sandoz, the global leader in biosimilars, announces that it has
initiated a major Phase III clinical trial with its biosimilar version of
etanercept (Amgen’s Enbrel®). The global clinical trial will seek to
confirm biosimilarity with regard to safety, efficacy and
immunogenicity of the Sandoz product versus Enbrel® in patients
with moderate to severe chronic plaque-type psoriasis. The global
clinical program was developed in consultation with regulatory
authorities in the US and EU, and the results from this clinical trial
are expected to support regulatory submissions in both the US and
EU.
Novartis announces that the FDA has granted Breakthrough Therapy
designation status to RLX030 (serelaxin), an investigational treatment
for patients with acute heart failure (AHF). The FDA has concluded
that RLX030 qualifies for a Breakthrough Therapy designation after
considering the available clinical evidence which supports a
substantial improvement over currently available therapies for AHF, a
life-threatening illness.
Results from a Phase III three-year follow up study presented at the
Congress of European Hematology Association show Jakavi
(ruxolitinib) improved overall survival of myleofibrosis patients and
sustained reductions in spleen size compared to conventional
therapy. In a separate long-term exploratory analysis, Jakavi slowed
or stabilized the advancement of bone marrow fibrosis, one of the
underlying disease mechanisms and consequences of myleofibrosis,
an effect that has not been observed with conventional therapy in
advanced myleofibrosis patients.
Two new analyses from the Phase III TRANSFORMS study
demonstrated how Gilenya (fingolimod) was effective against all four
key measures of disease activity in multiple sclerosis: brain volume
loss, lesion activity, relapse rates and disability progression.
Improvements were seen in patients who switched from standard
interferon (interferon beta-1a) to Gilenya within 12 months of the
switch and up to the end of the 4.5 year extension study.
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Results of a pivotal Phase III trial in women with HER2 positive
(HER2+) advanced breast cancer show Afinitor (everolimus)
significantly extended progression-free survival (PFS) after prior
therapy when compared to treatment with placebo plus trastuzumab
and vinorelbine, The findings are the first to show potential benefit of
everolimus in HER2 positive advanced breast cancer, an aggressive
form of the disease.
Lucentis receives a positive opinion from the Committee for Medical
Products for Human Use (CHMP) for patients with myopic choroidal
neovascularization (CNV) showing vision gains with only two
injections. CNV is the most common vision-threatening complication
of high myopia. In patients with untreated myopic CNV the long-term
prognosis is poor with approximately 90% of affected patients
developing severe vision loss after five years.
May
New data reinforces strength of Novartis once-daily COPD portfolio in
improving lung function, shortness of breath and reducing rate of
exacerbations. Novartis presented 34 respiratory abstracts featuring
the latest findings from the IGNITE clinical trial program at the
American Thoracic Society International Conference. COPD is
projected to be the third leading cause of death worldwide by 2020.
GBCHealth, a coalition of more than 230 private sector companies
working to improve global health, awards Novartis with the Business
Action on Health Award for the company’s “Arogya Parivar” program.
The program makes affordable, high-quality medicines accessible to
underserved millions in India and expands access to health education
and consultations in remote villages. Since launching “Arogya Parivar”
in 2007, Novartis has trained more than 500 health educators and
supervisors and improved access to healthcare for 42 million patients
across 33,000 villages in India.
Ilaris (canakinumab) is approved by the FDA to treat active systemic
juvenile idiopathic arthritis (SJIA), a rare and disabling form of
childhood arthritis that can affect children as young as two and
continue into adulthood. SJIA affects five to 15 children per 100,000
in the United States and is the most severe subtype of juvenile
idiopathic arthritis. Ilaris is the first interleukin-1 beta (Il-1 beta)
inhibitor approved for SJIA.
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Novartis and Malaria No More, a leading global charity determined to
end malaria deaths, announce that they are joining forces on the
Power of One campaign to help close the treatment gap and
accelerate progress in the fight against malaria. Over the next three
years, Novartis will support the campaign financially and donate up to
three million full courses of its pediatric antimalarial drug to match
the treatments donated by the public, doubling the impact of these
donations.
April
Alcon announces the FDA approval of Simbrinza suspension, a new
beta blocker-free, fixed-combination therapy of brinzolamide 1.0%
and brimonidine tartrate 0.2% for glaucoma patients. Glaucoma
affects more than 2.2 million Americans and is the second-leading
cause of preventable blindness worldwide.
Alcon announces the EU approval of Jetrea (ocriplasmin), the first and
only eye drug to treat vitreomacular traction (VMT) including when
associated with macular hole of diameter less than or equal to 400
microns. VMT is often responsible for progressive sight-threatening
symptoms and irreversible vision loss and is estimated to affect
between 250,000 to 300,000 people in Europe alone.
March
Novartis compound LDK378 receives FDA Breakthrough Therapy
designation for the treatment of patients with anaplastic lymphoma
kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC).
There are limited treatment options for patients with ALK+ NSCLC.
Breakthrough Therapy designation is intended to expedite the
development and review of drugs that treat serious or life-threatening
conditions. Initial results from a Phase I study showed marked
responses in a majority of patients with ALK+ NSCLC.
The European Commission has approved Ilaris (canakinumab,
ACZ885) in the treatment of patients with acute gouty arthritis,
commonly referred to as gout, who suffer frequent attacks and whose
symptoms cannot or should not be managed with current treatment
options. Ilaris is the first biologic approved in the EU for symptomatic
pain relief in a gouty arthritis indication.
Novartis reports Phase III data showing omalizumab improved itch in
patients with moderate to severe refractory chronic idiopathic
uraticaria (CIU), a chronic form of hives, failed standard therapy.
While antihistamines are commonly used to treat CIU, there is still a
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February
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critical unmet need among patients, with more than 50% not
achieving relief with approved doses.
Zortress (everolimus) becomes the first drug in over a decade to be
approved by the FDA to prevent organ rejection in adult liver
transplant patients in the US. The approval was based on the largest
liver transplant study to date, which showed that Zortress plus
reduced tacrolimus led to comparable efficacy and higher renal
function as compared to standard tacrolimus at 12 months.
Novartis announces that the Novartis AG Board of Directors and Dr.
Vasella agreed to cancel his non-competition agreement and all
related conditional compensation. The agreement was to take effect
after Dr. Vasella stepped down as Chairman of the Board at the
Novartis Annual General Meeting on February 22, 2013.
Novartis receives EU approval for Bexsero, (Meningococcal Group B
Vaccine [rDNA, component, adsorbed]) the first vaccine to prevent the
leading cause of life-threatening meningitis across Europe. The
approval of Bexsero, for use in individuals two months of age or older,
underscores the unique leadership position of Novartis in the global
fight against devastating meningococcal disease.
January
Novartis announces that, at his own wish, Novartis AG Chairman of
the Board of Directors Dr. Daniel Vasella will not stand for re-election
as a member of the Board of Directors at the Annual General Meeting
to be held on February 22, 2013. The Board of Directors proposed the
election of, among others, Joerg Reinhardt, Ph.D., as a member of the
Board for a term of office beginning on August 1, 2013, and ending
on the day of the Annual General Meeting in 2016. The Board
announced its intention to elect Joerg Reinhardt as Chairman of the
Board of Directors as from August 1, 2013. The Board of Directors
further announced its intention to elect its current Vice-Chairman,
Ulrich Lehner, Ph.D., as Chairman of the Board of Directors for the
period from February 22, 2013, until the new Chairman took office.
Disclaimer
These materials contain forward-looking statements that can be identified by words such as “potential,” “expected,”
“will,” “planned,” or similar terms, or by express or implied discussions regarding potential new products, potential
new indications for existing products, or regarding potential future revenues from any such products; potential
shareholder returns or credit ratings; or regarding the potential completion of the announced transactions with GSK
and CSL, or regarding potential future sales or earnings of any of the businesses involved in the announced
January 2015 – Page 29 of 30
© Novartis AG 2015
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transactions with GSK, Lilly or CSL, and regarding any potential strategic benefits, synergies or opportunities as a
result of the announced transactions; or regarding potential future sales or earnings of the Novartis Group or any of its
divisions; or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these
statements. Such forward-looking statements are based on the current beliefs and expectations of management
regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more
of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements. There can be no guarantee that any new products
will be approved for sale in any market, or that any new indications will be approved for any existing products in any
market, or that any approvals which are obtained will be obtained at any particular time, or that any such products will
achieve any particular revenue levels. Nor can there be any guarantee that the announced transactions with GSK and
CSL will be completed in the expected form or within the expected time frame or at all. Neither can there be any
guarantee that Novartis will be able to realize any of the potential strategic benefits, synergies or opportunities as a
result of the transactions with GSK, Lilly or CSL. Neither can there be any guarantee that Novartis or any of the
businesses involved in the transactions will achieve any particular financial results in the future. Nor can there be any
guarantee that shareholders will achieve any particular level of shareholder returns. Neither can there be any
guarantee that the Novartis Group, or any of its divisions, will be commercially successful in the future, or achieve any
particular credit rating. In particular, management's expectations could be affected by, among other things,
unexpected regulatory actions or delays or government regulation generally, including an unexpected failure to obtain
necessary government approvals for the transactions, or unexpected delays in obtaining such approvals; the potential
that the strategic benefits, synergies or opportunities expected from the announced transactions, including the
divestment of our former Animal Health Division to Lilly, may not be realized or may take longer to realize than
expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties
inherent in research and development, including unexpected clinical trial results and additional analysis of existing
clinical data; the Company’s ability to obtain or maintain proprietary intellectual property protection, including the
ultimate extent of the impact on the Company of the loss of patent protection and exclusivity on key products which
commenced in prior years and will continue this year; unexpected manufacturing or quality issues; global trends
toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential
legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations
regarding sales and marketing practices, government investigations and intellectual property disputes; general
economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and
financial environment in many countries; uncertainties regarding future global exchange rates, including as a result of
recent changes in monetary policy by the Swiss National Bank; uncertainties regarding future demand for our
products; uncertainties involved in the development of new healthcare products; uncertainties regarding potential
significant breaches of data security or disruptions of the Company’s information technology systems; and other risks
and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission.
Novartis is providing the information in these materials as of this date and does not undertake any obligation to update
any forward-looking statements as a result of new information, future events or otherwise.
All product names appearing in italics are trademarks owned by or licensed to Novartis Group Companies.
January 2015 – Page 30 of 30
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