Eli Lilly 2015 Annual Report Download - page 185

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Pipeline of Molecules in Clinical Development
Including Select New Indications and Line Extensions (NILEX)
REGULATORY REVIEW
PHASE III
PHASE II
Empagliflozin*
cardiovascular
outcomes data
Abemaciclib
NSCLC
Solanezumab
preclinical
Alzheimer’s
disease
Abemaciclib
breast cancer
Baricitinib
diabetic
nephropathy
Edivoxetine
CNS disorder
Merestinib
cancer
Oxyntomodulin
peptide
diabetes
D1 potentiator
dementia
Pomaglumetad
methionil
schizophrenia
Blosozumab
osteoporosis
diabetes
Ixekizumab
psoriatic arthritis
Empagliflozin*
Type 1 diabetes
Ramucirumab
1st-line gastric
cancer
CGRP MAb
cluster headache
Abemaciclib
squamous NSCLC
BMP-6 MAb
anemia
PCSK9 MAb
cardiovascular
disease
PI3 kinase/mTOR
dual inhibitor
mesothelioma
BACE
inhibitor
Alzheimer’s
disease
VEGFR1 MAb
diabetic nephropathy
CXCR1/2L MAb
immunology
Ixekizumab
psoriasis
Tanezumab*
cancer pain
Tau imaging agent
Alzheimer’s disease
Chk1 inhibitor
cancer
FGF receptor
inhibitor
cancer
Ferroportin MAb
anemia
BAFF/IL-17
bispecific antibody
immunology
BTK inhibitor
immunology
IL-21 MAb
immunology
Linagliptin +
Metformin XR*
diabetes
Ramucirumab
2nd-line bladder
cancer
Nasal Glucagon
hypoglycemia
Baricitinib
psoriasis
Galunisertib
cancer
IL-23 MAb
ulcerative colitis
Emibetuzumab
cancer
CSF1R MAb
cancer
Pan-Raf inhibitor
cancer
Aß MAb Fab PEG
Alzheimer’s
disease
FGFR3-ADC
cancer
Baricitinib
rheumatoid
arthritis
CGRP MAb
migraine
Ramucirumab
2nd-line
hepatocellular cancer
Tanezumab*
osteoarthritic pain
CXCR4 peptide
inhibitor
cancer
Ralimetinib
cancer
Myostatin MAb
disuse atrophy
Florbenazine
Parkinson’s Disease
Imaging
diabetes
N3pG-Aß MAb
Alzheimer’s
disease
hypoglycemia
Empagliflozin +
Metformin XR*
diabetes
Olaratumab
sarcoma
Tanezumab*
chronic lower
back pain
Ramucirumab
1st-line NSCLC
Solanezumab
Alzheimer’s
disease
BACE - AZD3293*
Alzheimer’s
disease
Ultra-Rapid Insulin
diabetes
P70S6/AKT
dual inhibitor
cancer
NOTCH inhibitor
cancer
Angio 2 MAb
cancer
MET/EGFR
bispecific antibody
cancer
PHASE I
Information is current as of February 14, 2016. e search for new medicines is risky and uncertain, and there are no guarantees.
Remaining scientic, regulatory, or commercial hurdles may cause pipeline compounds to be delayed or to fail to reach the market.
Select NILEX
(Phase II or later)
New Chemical Entity
New Biological Entity
Diagnostic
* Commercial
collaboration
The Lilly pipeline currently
includes 48 new molecules in
clinical development including
nine molecules in Phase III or
regulatory review, 19 in Phase II
and 20 in Phase I. Since our last
annual report: eight molecules
advanced into Phase I testing,
five advanced into Phase II
testing, and four molecules
entered Phase III. These four
are: olaratumab, our antibody
that blocks PDGF receptor-α
being studied for the treatment
of advanced sarcoma; our CGRP
antibody being studied for cluster
headache and migraine; the
diagnostic Tau imaging agent;
and nasal glucagon licensed
from Locemia Solutions. Two
molecules were submitted for
regulatory approval: ixekizumab
for psoriasis and baricitinib
for rheumatoid arthritis. And
one new molecule, Portrazza
(necitumumab), was approved
for marketing. We terminated
development of 19 molecules,
including two in Phase III—basal
insulin peglispro and evacetrapib.
In addition, we are selectively
highlighting 17 molecules being
studied for new indications or
line extensions (NILEX) that have
advanced to Phase II testing
or later.
Additional information
and updates are available on
the Lilly Interactive Pipeline
at www.lilly.com.
In 2015, Elanco delivered 60
country-level approvals for 44
new products or projects. Three
important approvals in 2015
include Imrestor, for mastitis
in dairy cattle; Interceptor
Plus, a chewable treatment for
heartworm in dogs; and Osurnia,
a novel, more convenient
formulation to treat otitis externa
in dogs. As of December 2015,
the Elanco development pipeline
includes 39 molecules or unique
formulations, including 10 in
the final phase of development,
and 45 molecule expansion or
line extension projects, 24 of
which are in the final phase of
development.
Pipeline of Molecules in Clinical Development