Phase 1
Phase 2
Phase 3
Application
Therapeutic
area
Cardiovascular-
Metabolics
Oncology
Others

Edoxaban (JP)
(DU-176b / AF / FXa inhibitor)

Prasugrel (JP)
(CS-747 / Ischemic stroke / Anti-
platelet agent)

Esaxerenone (JP)
(CS-3150 / Hypertension /
MR antagonist)

Edoxaban (ASCA etc.)
(DU-176b / AF / FXa inhibitor)

Edoxaban (ASCA etc.)
(DU-176b / VTE / FXa inhibitor)

Tivantinib (US/EU)
(ARQ 197 / HCC / MET inhibitor)

Denosumab (JP)
(AMG 162 / Breast cancer adjuvant /
Anti-RANKL antibody)

Nimotuzumab (JP)
(DE-766 / Gastric cancer / Anti-EGFR
antibody)

Vemurafenib (US/EU)
(PLX4032 / Melanoma Adjuvant / BRAF
inhibitor)

Quizartinib (US/EU/Asia)
(AC220 / AML-2
nd
/ FLT3-ITD inhibitor)

Quizartinib (US/
EU/Asia
)
(AC220 / AML-1
st
/ FLT3-ITD inhibitor)

Pexidartinib (US/EU)
(PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD
inhibitor)

Laninamivir (US/EU)
(CS-8958 / Anti-influenza /
out-licensing with Biota)

Mirogabalin (US/EU)
(DS-5565 / Fibromyalgia / α2δ ligand)

Mirogabalin (JP/Asia)
(DS-5565 / DPNP/ α2δ ligand)

Mirogabalin (JP/Asia)
(DS-5565 / PHN / α2δ ligand)

Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid μ-
receptor regulator)

CHS-0214 (JP)
(Etanercept BS / Rheumatoid
arthritis / TNFα inhibitor)

VN-0105 (JP)
(DPT-IPV / Hib vaccine)

Esaxerenone (JP)
(CS-3150 / DM nephropathy / MR
antagonist)

DS-8500 (JP/US)
(Diabetes / GPR119 agonist)

Patritumab (EU)
(U3-1287 / Anti-HER3 antibody)

Pexidartinib (US)
(PLX3397 / CSF-1R/KIT/FLT3-ITD
inhibitor)

DS-1647 (JP)
(Glioblastoma / G47Δ virus)

DS-1040
(Acute ischemic stroke / TAFIa inhibitor)

DS-2330
(Hyperphosphatemia)

DS-9231/TS23
(Thrombosis / α2-PI inactivating antibody)

DS-9001
(Dyslipidemia / Anti-PCSK9 Anticalin-Albumod)

DS-3032 (US/JP)
(MDM2 inhibitor)

PLX7486 (US)
(FMS / TRK inhibitor)

PLX8394 (US)
(BRAF inhibitor)

DS-6051 (US/JP)
(NTRK/ROS1 inhibitor)

PLX9486 (US)
(KIT inhibitor)

DS-3201 (JP)
(EZH1/2 inhibitor)

PLX73086 (US)
(CSF-1R inhibitor)

PLX51107 (US)
(BRD4 inhibitor)

DS-1971
(Chronic pain)

DS-1501
(Osteoporosis / Anti-Siglec-15 antibody)

DS-7080 (US)
(AMD / Angiogenesis inhibitor)

DS-2969
(
Clostridium difficile
infection
/GyrB inhibitor)

DS-5141 (JP)
(DMD / ENA oligonucleotide)

VN-0102/JVC-001 (JP)
(MMR vaccine)

Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid μ-
receptor agonist)

CL-108 (US)
(Acute pain / Opioid μ-receptor
agonist)

Intradermal Seasonal
Influenza Vaccine (JP)
(VN-100 / prefilled i.d. vaccine for
seasonal flu)

VN-0107/MEDI3250 (JP)
(Nasal spray flu vaccine)

Denosumab (JP)
(AMG 162 / Rheumatoid arthritis /
Anti-RANKL antibody)
Major R&D Pipeline

DS-8895 (JP)
(Anti-EPHA2 antibody)

DS-8273 (US)
(Anti-DR5 antibody)

DS-5573 (JP)
(Anti-B7-H3 antibody)

DS-8201 (JP/
US
)
(Anti-HER2 ADC)

U3-1784 (EU)
(Anti-FGFR4 antibody)

DS-1123 (JP)
(Anti-FGFR2 antibody)

U3-1402 (JP)
(Anti-HER3 ADC)
As of October 2016
Red: Major changes after the FY2016 Q1 financial announcement on July 31, 2016
11. Major R&D Pipeline (Innovative pharmaceuticals
）
As of October 2016
◆
Filed
Class
Target indication
Opioid mu-receptor agonist
combination
Acute pain
Opioid mu-receptor agonist
Cancer pain
Denosumab
Anti-RANKL antibody
Rheumatoid arthritis
Intradermal influenza HA vaccine Prevention of seasonal Influenza
Live attenuated influenza vaccine Prevention of seasonal Influenza
Underline: change after FY2016 Q1 Financial Announcement in July 2016. Regarding edoxaban, the filing in Australia was withdrawn considering its business in total.
Edoxaban
Factor Xa inhibitor
Atrial fibrillation
（
AF
）
ASCA etc.
BR (14/6
*
), TH(15/7), CN(15/8), CA(15/8), TR(15/10)
* means June 2014, ditto
Venous thromboembolism (VTE)
ASCA etc.
BR (14/6), TH(15/7), CN(15/8), CA(15/8), TR(15/10)

The Vaccine is a pre-filled syringe type, intradermal influenza HA vaccine co-developed by four companies [Daiichi Sankyo, Terumo, Japan Vaccine and Kitasato Daiichi Sankyo Vaccine Co., Ltd.]. The intradermal injection device for this vaccine is
developed by Terumo. This device, which offers a more easy-to-use, surefire method to administer the vaccine than current methods. The device is also expected to ease patient hesitation to be injected and lower the risk of damaging peripheral
blood vessels and nerves within the subcutaneous tissue.
VN-0107/MEDI3250
JP
Submitted by Daiichi Sankyo in June 2016
Additional Indication, submitted in Sep 2016
Product Code Number/Generic Name
Region
Note, Filing year/month

Hydromorphone hydrochloride is an opiate, narcotic analgesic that has been available outside of Japan for over 80 years and it is the standard for pain management for cancer pain treatment according to WHO guidelines. Hydromorphone
hydrochloride is one of the agents publicly offered for development by the Review Committee on Unapproved Drugs and Indications with High Medical Needs. Daiichi Sankyo decided to develop the drug in 2012.
VN-100
JP
Submitted by Japan Vaccine in April 2015

The once daily oral anti coagulant (FXa inhibitor) discovered by Daiichi Sankyo. Edoxaban specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood.
CL-108
US
NDA was submitted in March 2016 by Charleston
Laboratories, Inc., licensor and co-development partner

CL-108 is novel hydrocodone combination products being developed by Charleston Lab and Daiichi Sankyo for the treatment of moderate to severe pain while preventing or reducing Opioid-Induced Nausea and Vomiting (OINV). The product expects
to reduce the unwanted side effects of opioid-induced nausea and vomiting.
Hydromorphone
JP
NDA of oral formulation (extended-release and
immediate-release formulations) was submitted in March
2016 by Daiichi Sankyo Propharma
JP

Denosumab is fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation, in-licensed from Amgen Inc. in 2007. Daiichi Sankyo began sales in Japan of a 60 mg preparation of denosumab as a therapeutic
agent for osteoporosis under the product name PRALIA subcutaneous injection 60mg syringe in June 2013. In addition, from April 2012 Daiichi Sankyo began sales of a 120 mg preparation of denosumab as a therapeutic agent to treat bone
complications stemming from multiple myeloma and bone metastases from solid tumors under the product name RANMARK subcutaneous injection 120 mg, and from May 2014, as a therapeutic agent to treat giant cell tumor of bone under the
product name RANMARK subcutaneous injection 120 mg. Daiichi Sankyo is also participating in global phase 3 clinical trials of denosumab as adjuvant treatment for women with breast cancer.

The US brand name of this vaccine is FluMist Quadrivalent that is a live attenuated influenza vaccine which is administered as a nasal spray and contains four protective strains.
◆
Under development (Phase1-3)
Class
Target indication
target FY for
approval/launch
basically for P3
Remarks
Anti-platelet agent
Ischemic stroke
JP
P3
2017 Additional indication
Edoxaban
Factor Xa inhibitor
Elderly patients with non-valvular atrial fibrillation
JP
P3
2021
Additional dosage and administration for elderly patients
Anti-RANKL antibody
Breast cancer adjuvant
JP
P3
2020 Additional indication
MET inhibitor
Hepatocellular cancer
US/EU P3
2018
Anti-EGFR antibody
Gastric cancer
JP
P3
2020
BRAF inhibitor
Melanoma adjuvant
US/EU P3
–
Additional indication.
Licensee Roche is conducting the study.
Submission in 2016 is planned.
US/EU/Asia
P3
2018 Relapsed and refractory AML patients
US/EU/Asia
P3
2021- Newly diagnosed AML patients
JP
P1
–
Tenosynovial Giant Cell Tumor (TGCT)
US/EU P3
2019 Including pigmented villonodular synovitis
Solid tumor
Asia
P1
– Including TGCT
Glioblastoma
US
P2
–
Melanoma
US
P2
–
Melanoma, solid tumor
US
P1/2
–
Combination with pembrolizumab
in collaboration with Merck
Hypertension
JP
P3
2019
Diabetic nephropathy
JP
P2b
–
Fibromyalgia
US/EU P3
2019
Diabetic peripheral neuropathic pain
JP/Asia P3
2018
Postherpetic neuralgia
JP/Asia P3
2018
Hydromorphone
Opioid mu-receptor agonist
Cancer pain
JP
P3
2018 Injection formulation
TNF
a
inhibitor
Rheumatoid arthritis
JP
P3
2017 Etanercept biosimilar
DPT-IPV/Hib vaccine
Prevention of pertussis, diphtheria, tetanus, poliomyelitis
and Hib
JP
P3
2019 Co-develop with Sanofi K.K.and KDSV
Patritumab
Anti-HER3 antibody
Head & neck cancer
EU
P2
–
G47
Δ
oncolytic virus
Glioblastoma
JP
P2
–
SAKIGAKE Designation granted
GPR119 agonist
Diabetes
JP/US
P2
–
US/EU P2
– Out-licensing with Biota
JP
P1
– Nebulizer formulation
Acute myeloid leukemia
Generic Name / Project Code Number
Stage
Prasugrel
Denosumab
Tivantinib
Nimotuzumab
Vemurafenib
Quizartinib
FLT3-ITD inhibitor
DS-1647
Pexidartinib/PLX3397
CSF-1R/KIT/FLT3-ITD inhibitor
Esaxerenone/CS-3150
MR antagonist
Mirogabalin
α2δ ligand
CHS-0214
VN-0105
DS-8500
Laninamivir
Neuraminidase inhibitor
Influenza
Underline: change after FY2016 Q1 Financial Announcement in July 2016
◆
Under development (Phase1-3)
Class
Target indication
target FY for
approval/launch
basically for P3
Remarks
Solid cancer, lymphoma
US/JP
P1
–
Leukemia
US
P1
–
FMS/TRK inhibitor
Solid cancer
US
P1
–
Anti-EPHA2 antibody
Solid cancer
JP
P1
–
Anti-DR5 antibody
Solid cancer
US
P1
–
BRAF inhibitor
Solid cancer, leukemia
US
P1
–
DS-6051
NTRK/ROS1 inhibitor
Solid cancer
US/JP
P1
–
DS-5573
Anti-B7-H3 antibody
Solid cancer
JP
P1
–
PLX9486
KIT inhibitor
Solid cancer
US
P1
–
DS-8201
Anti-HER2 antibody drug conjugate
Solid cancer
JP/US
P1
–
Anti-FGFR4 antibody
Solid cancer
EU
P1
–
Anti-FGFR2 antibody
Solid cancer
JP
P1
–
DS-3201
EZH1/2 inhibitor
Non-Hodgkin’s lymphoma
JP
P1
–
PLX73086/AC708
CSF-1R inhibitor
Tenosynovial Giant Cell Tumor (TGCT)
US
P1
–
PLX51107
BRD4 inhibitor
Hematologic malignancies
US
P1
–
Anti-HER3 antibody drug conjugate
Solid cancer
JP
P1
–
TAFIa inhibitor
Acute ischemic stroke, Acute pulmonary embolism
–
P1
–
Hyperphosphatemia treatment
Hyperphosphatemia in chronic kidney disease (CKD) –
P1
–
α2 plasmin inhibitor-inactivating
antibody
Thrombosis (cardiovascular diseases, ischemic stroke) –
P1
– In-licensed from Translational Sciences Inc.
Anti-PCSK9 Anticalin-Albumod
Dyslipidemia
–
P1
–
Analgesic agent
Chronic pain
–
P1
–
Anti-Siglec-15 antibody
Osteoporosis
US
P1
–
DS-7080
Angiogenesis inhibitor
Neovascular age-related macular degeneration (AMD) US
P1
–
DS-2969
GyrB inhibitor
Clostridium difficile infection (CDI)
–
P1
–
DS-5141
ENA oligonucleotide
Duchenne muscular dystrophy
JP
P1/2
–
Measles-Mumps-Rubela vaccine Prevention of Measles, Mumps and Rubela
JP
P1/2
2022
Japan vaccine company is conducting the
phase 1/2 study
DS-1123
U3-1402
DS-1971
DS-1501
Generic Name / Project code number
Stage
DS-3032
MDM2 inhibitor
PLX7486
DS-8895
DS-8273
PLX8394
U3-1784
DS-1040
DS-2330
DS-9231/TS23
DS-9001
VN-0102/JVC-001
◆
Stage-up (major changes from the FY2016 Q1 Financial Announcement in July 2016)
Class
Target indication
Remarks
FXa inhibitor
Elderly patients with non-valvular atrial fibrillation
JP
P3
Started phase 3 study for new dosage and
administration
FLT3-ITD inhibitor
Acute myeloid leukemia
EU/Asia
P3
Newly diagnosed AML patients. Started
phase 3 study in EU and Asia in addition to
US
MR antagonist
Hypertension
JP
P3
Started phase 3 study
Anti-HER2 antibody drug conjugate Solid cancer
US
P1
Started phase 1 study in US in addition to
Japan
Anti-HER3 antibody drug conjugate
Solid cancer
JP
P1
Started phase 1 study
Current stage
Denosumab
Anti-RANKL antibody
Rheumatoid arthritis
JP
Submitted
Generic Name / Project code number
U3-1402
DS-8201
Additional Indication, submitted in Sep 2016
Edoxaban
Quizartinib
Esaxerenone/CS-3150
Oncology
[ Project after Phase 2 ]
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Tivantinib
ARQ 197
Oral
MET inhibitor
– Hepatocellular cancer
ArQule
TBD
・
A phase 3 clinical study for HCC with MET high patients was started in Jan 2013.
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Nimotuzumab
DE-766 Injection
Anti-EGFR antibody – Gastric cancer
InnoCIMAb
TBD
・
Phase 3 in Japan for Gastric cancer started in April 2013.
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Quizartinib
AC220
Oral
FLT3-ITD inhibitor – Acute myeloid leukemia
Daiichi Sankyo
(Ambit)
TBD
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Patritumab
U3-1287 Injection
Anti-HER3 antibody – Head and neck cancer
Daiichi Sankyo
(U3 Pharma)
TBD
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Vemurafenib
PLX4032
Oral
BRAF inhibitor
– Melanoma adjuvant
Daiichi Sankyo
（
Plexxikon
）
Zelboraf
Kinase inhibitor against a receptor-type tyrosine kinase, FLT3.
Therapeutic effect for patients with acute myeloid leukemia harboring FLT3-ITD mutation is expected.

The fully human monoclonal antibody to target HER3, one of the Epidermal Growth Factor Receptor (EGFR) family of proteins. HER 3 is overexpressed in many tumors of epithelial origin and HER2/HER3 dimers and EGFR/HER3
dimers are more potent to induce tumor cell proliferation than homodimers of HER2 or EGFR.

The molecular-targeted agent to inhibit HGF(hepatocyte growth factor) receptor, MET which has multiple roles in intracellular signal transductions such as cancer cell proliferation, angiogenesis, invasion, and apoptosis induction.

The humanized monoclonal antibody to target Epidermal Growth Factor Receptor(EGFR). This antibody is expected to be a best in class EGFR, safety against the skin toxicity and the efficacy comparable to the other antibodies.

The molecular-targeted agent to inhibit BRAF V600E mutation. Launched since 2011 as personalized treatment for patients with unrespectable or metastatic melanoma. NDA for combination therapy with MEK inhibitor cobimetinib
was approved in US on November 11, 2015. A phase 1 study of a combination with anti PD-L1 monoclonal antibody atezolizumab and cobimetinib is being investigated by Genentech.
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Pexidartinib
PLX3397
Oral
CSF-1R/KIT/FLT3-ITD
inhibitor
– Tenosynovial Giant Cell Tumor
– Glioblastoma
– Melanoma
Daiichi Sankyo
（
Plexxikon
）
TBD
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
G47
Δ
DS-1647 Injection
Oncolytic Virus – Glioblastoma
Prof. Todo
Institute of
Medical Science
Univ. of Tokyo
TBD
The molecular-targeted agent to inhibit CSF-1R, KIT and FLT3-ITD. This agent is expected to reduce tumor cell proliferation and expansion of metastases.

A triple-mutated, replication-conditional herpes simplex virus type 1 (the third generation oncolytic herpes simplex virus type 1), designed to replicate only in cancer cells. This oncolytic virus therapy is expected better safety and
efficacy profile compare to existing oncolytic virus. This product received SAKIGAKE Designation from MHLW on February 10th ,2016. Phase 2 Investigator Initiated Study for Glioblastoma is on-going in Japan.

Cardiovascular-Metabolics
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Edoxaban
DU-176b
Oral
Factor Xa inhibitor
– Atrial fibrillation (AF)
– Venous thromboembolism (VTE)
Daiichi Sankyo
Lixiana (JP)
LIXIANA (EU, Asia)
SAVAYSA (US)
・
Top line results of Hokusai-VTE (VTE) phase 3 study was presented at ESC 2013.
・
Top line results of ENGAGE AF-TIMI 48 (AF) phase 3 study was presented at AHA 2013.
・
AF/VTE indication: Following the launch in Japan in Sep 2014 (Dec 2014 for 60 mg tablet), edoxaban has already been marketed in more than 10 countries.
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Prasugrel
CS-747
Oral
Anti-platelet agent
– Ischemic stroke
Daiichi Sankyo
Ube Industries
Effient (US, Asia)
Efient (JPN, EU)
・
Co-development with Eli Lilly in the US and EU, development by Daiichi Sankyo in Japan
.
・
[JP] Approved in Mar 2014 for the ischemic heart disease undergoing PCI and launched in May 2014. Phase 3 studies for ischemic stroke are completed.
・
[US] Phase 3 study in pediatric sickle cell disease patients was conducted. The patent exclusivity in US has been extended for 180 days based on the pediatric study completion.
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Esaxerenone
CS-3150
Oral
MR antagonist
– Hypertension
– Diabetic nephropathy
Exelixis
TBD
・
On January 2015, phase 2b studies of HTN and DN started.
・
On November 2015, phase 2b study in essential hypertension in Japan was completed.
・
In September 2016, phase 3 of HTN started.
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
–
DS-8500
Oral
GPR119 agonist
– Diabetes
Daiichi Sankyo
TBD

The once daily oral anti coagulant (FXa inhibitor). Edoxaban specifically, reversibly and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood. Launched in Japan in July 2011 as the prevention of venous
thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture surgery.

The oral antiplatelet agent. Prasugrel helps to keep blood platelets from clumping together and developing a blockage in an artery.

The agent inhibits aldosterone binding to Mineralocorticoid Receptor(MR) which stimulate the sodium absorption into kidney. This agent is expected antihypertensive and organ-protective effect.

The agent agonistically acts on GPR119 which is expressed in small intestine and spleen cells, stimulates insulin secretion, and lowers blood sugar concentration.
Others
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Intradermal Seasonal
Influenza Vaccine
VN-100
Injection
(prefilled
syringe)
Seasonal flu vaccine – Prevention of seasonal influenza
Daiichi Sankyo
（
KDSV
）
Terumo
TBD

Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Hydromorphone
DS-7113
Oral/
Injection
opioid mu-receptor
regulator
– Cancer pain
–
TBD
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Denosumab
AMG 162 Injection
Anti-RANKL antibody
– Breast cancer adjuvant
– Rheumatoid arthritis
Amgen
SRE, GCTB: Ranmark(JP)
Osteoporosis: Pralia(JP)
・
July 2007 In-licensed from Amgen.
・
Phase 3 : Breast cancer adjuvant
・
September 2016 sNDA submission for rheumatoid arthritis (additional indication)
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
–
CHS-0214 Injection
TNFα inhibitor
– Rheumatoid arthritis
Coherus
TBD
・
Phase 3 study for patients with rheumatoid arthritis in Japan was completed. In preparation for submission.
The Vaccine is a pre-filled syringe type, intradermal influenza HA vaccine co-developed by four companies [Daiichi Sankyo, Terumo, Japan Vaccine and Kitasato Daiichi Sankyo Vaccine Co., Ltd.]. The intradermal injection device
for this vaccine is developed by Terumo. This device, which offers a more easy-to-use, surefire method to administer the vaccine than current methods. The device is also expected to ease patient hesitation to be injected and
lower the risk of damaging peripheral blood vessels and nerves within the subcutaneous tissue.
・
NDA submission in Apr 2015 by Japan Vaccine

The opiate, narcotic analgesic that has been available outside of Japan for over 80 years and recommended in WHO guideline as a standard analgesia for cancer pain. It is designated as unapproved drug by "Study Group on
Unapproved and Off-label Drugs of High Medical Need."
・
NDA of oral formulations (extended-release and immediate-release formulations) were submitted in Mar 2016 by Daiichi Saknyo Propharma. Phase 2/3 studies for injection formulation are ongoing.

The fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation. Launched in Japan in April 2012 as treatment for bone complications stemming from multiple myeloma and bone
metastases from solid tumors, in June 2013 as treatment for osteoporosis, and in May 2014 as treatment for giant cell tumor of bone.

Biosimilar product for etanercept
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
–
CL-108
Oral
opioid mu-receptor
regulator
– Acute pain
Charleston Laboratories
TBD
NDA submission in Mar 2016 by Charleston Laboratories
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
Mirogabalin
DS-5565
Oral
α2δ ligand
– Fibromyalgia
– Diabetic peripheral neuropathic pain
– Postherpetic neuralgia
Daiichi Sankyo
TBD
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
–
VN-0107
MEDI3250
Nasal
spray
Seasonal flu vaccine
– Prevention of seasonal influenza
AZ/MedImmune
TBD
Generic Name
Project
code Number
Dosage
Form
Class
Target Indication
Origin
Brand Name
–
VN-0105
Injection
DPT-IPV/Hib vaccine
– Prevention of pertussis, diphtheria, tetanus, poliomyelitis and Hib
Daiichi Sankyo
(KDSV)
Sanofi Pasteur
TBD
The pain therapy agent to reduce the neurotransmitter release from nerve terminals. This agent is expected to show the good balanced efficacy and safety profile.

Combination product of immediate-release promethazine, hydrocodone and acetaminophen. Reduction of Opioid-Induced Nausea and Vomiting is expected.

A combination vaccine reconstituting Hib with precipitated and purified pertussis-diphtheria-tetanus-inactivated polio vaccine (Salk vaccine) vaccine previously licensed and launched in Japan, as 1st in the class of pentavalent
vaccine (DPT-IPV/Hib
）
.
・
Phase 3 study in Japan started in Oct 2014.
・
Phase 2 studies for diabetic peripheral neuropathic pain were completed.
・
Phase 3 studies for diabetic peripheral neuropathic pain and postherpetic neuralgia are in execution in JP/Asia.
・
Phase 3 studies for fibromyalgia are in execution in US/EU.

The US brand name of this vaccine is FluMist Quadrivalent that is a live attenuated influenza vaccine which is administered as a nasal spray and contains four protective strains. Phase 3 safety and efficacy studies were conducted
for FluMist Quadrivalent in Japanese children over the 2014-2015 influenza season and NDA was submitted in Japan in June 2016

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On 29 October 2016, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", stock code: 600196.SH, 02196.HK) reported in its A-share announcement that Shanghai Henlius Biotech Inc. ("Henlius"), a holding subsidiary under its control, and AbClon Inc. ("AbClon") from Korea entered into a license agreement for monoclonal antibody AC101 (Press release, Fosun Pharmaceutical, OCT 31, 2016, View Source [SID1234517344]).

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AC101, an innovative monoclonal antibody developed by AbClon targeting gastric cancer and breast cancer, is currently under pre-clinical trial studies. Under the agreement, Henlius is granted the exclusive rights to develop and commercialize AC101 across the Great China region. This cooperation will put into play techniques and advantages of Henlius as an existing monoclonal antibody development platform of Fosun Pharma in further diversifying its product lines to enhance its competitiveness in the anti-tumor therapeutic area.

AC101 is the first novel monoclonal antibody discovered using AbClon’s proprietary antibody development platform New Epitope Screening Technology (Nest). Currently there is no similar product in any market worldwide. According to statistics from Global Data, the gastric cancer treatment market is projected to reach US$4.4 billion globally by the year 2024, and the HER2-positive breast cancer treatment market to reach US$12.7 billion by the year 2023.

At present, AC101 is still under pre-clinical trial studies and it is uncertain that it will be able to start clinical trials. Any clinical trial, registration, manufacture and other matters in relation to it in the relevant region is subject to approval of relevant pharmaceutical authorities.

Dr. Scott Liu, President and CEO of Shanghai Henlius indicated that, "Shanghai Henlius’ mission is to provide high-quality, affordable and accessible healthcare products worldwide. We are very excited to add another promising antibody product to our expanding portfolio. We believe AC101 in combination with the proprietary recombinant humanized anti-HER2 monoclonal antibody injection (trastuzumab biosimilar) developed by Henlius will enhance the efficacy against gastric cancer and breast cancer." Phase I clinical study for the proprietary recombinant humanized anti-HER2 monoclonal antibody (trastuzumab biosimilar) developed by Henlius has been completed and the results show that the new drug is safe and has the same efficacy as the corresponding proprietary drug Herceptin. Phase III clinical trial for the new drug will commence within this year.

Dr. Jong-Seo Lee, CEO of AbClon, also expressed his delight in having a licensing deal with Henlius, one of the most prominent monoclonal antibody pharmaceutical companies in China, and he looked forward to more partnerships with premier biopharmaceutical companies such as Henlius.

On October 31, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of data from the ENGOT-OV16/NOVA trial of niraparib at the 2016 International Gynecologic Cancer Society (IGCS) Biennial Meeting in Lisbon, Portugal (Press release, TESARO, OCT 31, 2016, View Source [SID1234516235]). These data were presented on Sunday, October 30 during the Best Oral session by Dr. Ursula Matulonis, M.D., Medical Director of the Gynecologic Oncology Program at Dana-Farber Cancer Institute and principal investigator on the ENGOT-OV16/NOVA trial, during the Best Oral session. The results were previously published in the New England Journal of Medicine on October 8, 2016 and presented at the ESMO (Free ESMO Whitepaper) 2016 Congress.

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"Many women with recurrent ovarian cancer experience a fear of recurrence in between regimens of platinum-based chemotherapy. The availability of an oral maintenance treatment that could lengthen the progression free survival interval between rounds of platinum-based chemotherapy with a tolerable side effect profile could be very empowering for patients," said Dr. Matulonis. "The data from ENGOT-OV16/NOVA are extremely encouraging and demonstrate the potential of niraparib to offer a meaningful benefit for our patients with ovarian cancer."

"We are grateful for the patients, their families, and the caregivers that participated in the ENGOT-OV16/NOVA study, and we would like to thank our partners at ENGOT for their diligence in executing this trial," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We believe the results of this Phase 3 study demonstrated a meaningful benefit for women with platinum sensitive, recurrent ovarian cancer. We are pleased that the EMA recently accepted for review the MAA for niraparib, and we are on track to complete the rolling NDA submission imminently."

ENGOT-OV16/NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in response to their most recent platinum-based chemotherapy. This trial was designed to assess progression free survival (PFS) in a broad population of patients who were assigned to one of two cohorts based upon germline BRCA mutation status. The ENGOT-OV16/NOVA trial successfully achieved its primary endpoint in both cohorts, demonstrating that niraparib treatment significantly prolonged PFS compared to control in patients who were germline BRCA mutation (gBRCAmut) carriers and in patients who were not germline BRCA mutation (non-gBRCAmut) carriers. A high proportion of patients in both treatment groups in both cohorts had received three or more prior lines of chemotherapy.

The most common (≥10%) treatment-emergent grade 3/4 adverse events in the niraparib arm were thrombocytopenia (33.8%), anemia (25.3%), and neutropenia (19.6%) with treatment discontinuation for these events of 3.3%, 1.4% and 1.9%, respectively. Thrombocytopenia was not associated with grade 3/4 bleeding events. The majority of these hematological laboratory abnormalities occurred within the first three cycles; following dose modifications the incidence of these lab abnormalities decreased and thrombocytopenia and neutropenia were infrequent beyond cycle 3. The rates of MDS/AML in the niraparib (1.4%) and control (1.1%) arms were similar. There were no deaths among patients during study treatment.

About the Phase 3 ENGOT-OV16/NOVA Clinical Trial of Niraparib
ENGOT-OV16/NOVA is a double-blind, placebo-controlled, international Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy. Patients were enrolled into one of two independent cohorts based on germline BRCA mutation status. One cohort enrolled patients who were germline BRCA mutation carriers (gBRCAmut), and the second cohort enrolled patients who were not germline BRCA mutation carriers (non-gBRCAmut) and included patients with HRD-positive and HRD-negative tumors. Within each cohort, patients were randomized 2:1 to receive niraparib or placebo and were treated continuously with placebo or 300 milligrams of niraparib, dosed as three 100 milligram tablets once per day, until progression. The primary endpoint of this study was progression-free survival (PFS). Secondary endpoints include patient-reported outcomes, chemotherapy-free interval length, PFS 2, overall survival, and other measures of safety and tolerability. More information about this trial is available at View Source

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in four ongoing pivotal trials. TESARO is building a robust niraparib franchise by assessing activity across multiple tumor types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development program for niraparib includes a Phase 3 trial in patients with platinum-sensitive, recurrent ovarian cancer (the NOVA trial); a Phase 3 trial in patients with first-line ovarian cancer (the PRIMA trial); a registrational Phase 2 treatment trial in patients with ovarian cancer (the QUADRA trial); and a Phase 3 trial for the treatment of patients with BRCA-mutant breast cancer (the BRAVO trial). Several combination studies are also underway, including trials of niraparib plus pembrolizumab and niraparib plus bevacizumab. Janssen Biotech has licensed rights to develop and commercialize niraparib specifically for patients with prostate cancer worldwide, except in Japan.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter. The Marketing Authorization Application (MAA) for niraparib has been submitted to and accepted for review by the European Medicines Agency (EMA) for the maintenance treatment of patients with platinum-sensitive, recurrent ovarian cancer who are in response to platinum-based chemotherapy.

Niraparib is an investigational agent and, as such, has not been approved by the U.S. FDA, the European Medicines Agency (EMA), or any other regulatory agencies.

About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the United States, and more than 65,000 women are diagnosed annually in Europe. Ovarian cancer is the fifth most frequent cause of cancer death among women. Despite high response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85% of patients will experience recurrence within two years. If approved, niraparib may address the difficult "watchful waiting" periods experienced by patients with recurrent ovarian cancer in between cycles of platinum-based chemotherapy

On October 31, 2016 Novartis reported that it has been awarded the prestigious 2016 Prix Galien USA Award for Best Biotechnology Product for Cosentyx (secukinumab), as well as the Prix Galien Foundation "Discovery of the Decade" Award for Best Pharmaceutical Product for the drug Gleevec (imatinib mesylate) (Press release, Novartis, OCT 31, 2016, View Source [SID1234516146]). The awards were presented at a ceremony in New York City.

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"We are honored to receive these prestigious awards for Cosentyx and Gleevec, which not only have changed the practice of medicine for certain conditions, but also represent years of hard work by our scientists," said Joseph Jimenez, CEO of Novartis. "These wins underscore our commitment to addressing the unmet medical needs of patients through science-based innovation."

Cosentyx was the first fully human interleukin-17A (IL-17A) antagonist approved by the US Food and Drug Administration (FDA) in 2015 for the treatment of adults with moderate to severe plaque psoriasis[1]. Psoriasis affects an estimated 7.5 million people in the US[2]. It is a chronic immune-mediated disease characterized by thick and extensive skin lesions (plaques), which can cause itching, scaling, and pain[2]. Cosentyx was also approved for the treatment of active ankylosing spondylitis and psoriatic arthritis in 2016[1].

The discovery of Gleevec marked the first time in the history of cancer treatment that scientists were able to identify a chromosomal abnormality and then develop a drug that would target that specific protein. Gleevec, a molecularly targeted treatment, rapidly became a therapy of choice for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST)[3]. By showing that certain diseases can share a drug-sensitive target with seemingly unrelated ailments, and that molecular targeting can be medically and commercially successful, Gleevec helped establish a new paradigm for drug development.

About the Prix Galien Awards
Considered "the pharmaceutical industry’s Nobel Prize," the Prix Galien rewards excellence in scientific innovation that improves the state of human health. The award was first established in 1970 by French pharmacist Roland Mehl and was inaugurated in the United States in 2007 to recognize the technical, scientific and clinical research skills necessary to develop innovative medicines. Since 1970, Novartis has received more than 40 national Prix Galien awards in fifteen countries for innovative therapies such as Gleevec (imatinib mesylate), Rimactane (rifampin), Parlodel (bromocriptine mesylate), Sandimmune (cyclosporine), Sandostatin (octreotide acetate), Simulect (basiliximab) and Visudyne (verteporfin)[4].

The "Discovery of the Decade" is a special once-in-10-years recognition for distinguished industry achievement in medical innovation. The awards honor extraordinary human health impact in three categories – Best Pharmaceutical Product, Best Biotechnology Product, and Best Medical Technology. In addition to Gleevec (imatinib mesylate), two other Novartis products were nominated for "Discovery of the Decade," including Coartem (artemether/ lumefantrine) for Best Pharmaceutical Product and Promacta (eltrombopag olamine) for Best Biotechnology Product. Gleevec won the Prix Galien International Prize in 2002, and was recognized again in 2009 by the Prix Galien USA committee for "Best Pharmaceutical Product"[5].

About Cosentyx and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor[1].

Cosentyx is approved in more than 65 countries for the treatment of moderate to severe plaque psoriasis which includes the European Union countries, Japan, Switzerland, Australia, the U.S. and Canada[6]. In the U.S., Cosentyx is approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). Cosentyx is also approved in the US for adult patients with active ankylosing spondylitis and active psoriatic arthritis[1].

More than 10,000 patients have been treated with Cosentyx in clinical trial settings across multiple indications, and over 50,000 patients have been treated in the post-marketing setting worldwide[7].

About Gleevec (imatinib mesylate)
Gleevec (imatinib mesylate) tablets are indicated for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP). Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP after failure of interferon-alpha therapy.

Additionally, Gleevec is indicated for Patients with KIT(CD117)-positive gastrointestinal stromal tumors (GIST) that cannot be surgically removed and/or have spread to other parts of the body and for adult patients after surgery who have had their KIT (CD117)-positive GIST completely removed.

INDICATIONS
COSENTYX (secukinumab) is a prescription medicine used to treat adults:

with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light, alone or with systemic therapy)
with active psoriatic arthritis
with active ankylosing spondylitis
IMPORTANT SAFETY INFORMATION
Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

Infections
COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections.

Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.
If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection.
Before starting COSENTYX, tell your doctor if you:

are being treated for an infection
have an infection that does not go away or that keeps coming back
have TB or have been in close contact with someone with TB
think you have an infection or have symptoms of an infection such as:
fevers, sweats, or chills
warm, red, or painful skin or sores on your body
muscle aches
diarrhea or stomach pain
cough
burning when you urinate or urinate more often than normal
shortness of breath

blood in your phlegm

weight loss

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

Inflammatory Bowel Disease
New cases of inflammatory bowel disease or "flare-ups" can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Serious Allergic Reactions
Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; or skin rash. If you have a severe allergic reaction, do not give another injection of COSENTYX.

Before starting COSENTYX, tell your doctor if you:

have any of the conditions or symptoms listed above for infections
have inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
are allergic to latex. The needle caps contain latex.
have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines.
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.
are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

How should I use COSENTYX?
See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pens and prefilled syringes.

Use COSENTYX exactly as prescribed by your doctor.
If your doctor decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself, until you or your caregiver has been shown how to inject COSENTYX by your doctor or nurse.
The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch (link is external), or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information (link is external), including Medication Guide (link is external).

Gleevec Important Safety Information
Gleevec can cause fetal harm when administered to a pregnant woman. Women should not become pregnant, and should be advised of the potential risk to the unborn child.

Gleevec is often associated with edema (swelling) and serious fluid retention. Studies have shown that edema (swelling) tended to occur more often among patients who are 65 and older or those taking higher doses of Gleevec.

Cytopenias (reduction or lack of certain cell elements in blood circulation), such as anemia, have occurred. If the cytopenia is severe, your doctor may reduce your dose or temporarily stop your treatment with Gleevec.

Severe congestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors or history of renal failure will be monitored and treated for the condition.

Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of Gleevec.

Reactivation of hepatitis B can occur in patients who are chronic carriers of this virus after receiving TKI treatment.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with KIT+ GIST. GI tumor sites may be the cause of this bleeding; therefore, GI symptoms should be monitored at the start of treatment.

In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell) and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) have been associated with the initiation of Gleevec therapy.

Skin reactions, such as fluid-filled blisters, have been reported with the use of Gleevec.

Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement with Gleevec.

Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use.

GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported.

Growth retardation has been reported in children taking Gleevec. The long-term effects of extended treatment with Gleevec on growth in children are unknown.

Cases of tumor lysis syndrome (TLS), which refers to a metabolic and electrolyte disturbance caused by the breakdown of tumor cells, have been reported and can be life-threatening in some cases. Correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Gleevec.

Reports of motor vehicle accidents have been received in patients receiving Gleevec. Caution patients about driving a car or operating machinery.

Almost all patients treated with Gleevec experience side effects at some time. Some common side effects you may experience are fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.

Gleevec is sometimes associated with stomach or intestinal irritation. Gleevec should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including deaths, of stomach or intestinal perforation (a small hole or tear).

If you are experiencing any of the mentioned side effects, please be sure to speak with your doctor immediately.

Do not take any other medications without talking to your doctor or pharmacist first, including Tylenol (acetaminophen); herbal products (St. John’s wort, Hypericum perforatum); Coumadin (warfarin sodium); rifampin; erythromycin; metoprolol; ketoconazole; and Dilantin (phenytoin). Taking these with Gleevec may affect how they work, or affect how Gleevec works.

You should also tell your doctor if you are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods that may affect how Gleevec works.

Please see full Prescribing Information.

On October 31, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) and Sarah Cannon Research Institute (Sarah Cannon) reported a collaboration focused on advancing personalized medicine utilizing molecular information for patients across Sarah Cannon’s cancer programs in the United States (Press release, Foundation Medicine, OCT 31, 2016, View Source [SID1234516142]). The organizations will gather results from Foundation Medicine’s full suite of comprehensive genomic profiling (CGP) assays to personalize treatment options for patients and to ultimately support improved outcomes.

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Sarah Cannon is one of the world’s leading clinical research organizations conducting community-based clinical trials across a global network. Researchers can use Foundation Medicine’s CGP assays, FoundationOne for use with solid tumors, FoundationOne Heme for use with hematologic malignancies and FoundationACT for use as a liquid biopsy, to identify eligible patients for participation in Sarah Cannon’s clinical studies. Foundation Medicine’s CGP assays aid treating physicians and researchers to more effectively screen and match patients to early and late-phase clinical trials based on their genomic information. Sarah Cannon will also integrate Interactive Cancer Explorer, Foundation Medicine’s physician facing decision support portal, across its network to facilitate clinico-genomic knowledge among researchers and to enhance patient access to precision therapeutics.

Additionally, Sarah Cannon and Foundation Medicine have entered into a master research program agreement to collaborate on the development of research studies, as well as clinical programs designed to evaluate and establish the most appropriate use of Foundation Medicine’s assays into clinical care pathways.

"Our physicians are at the forefront of clinical research through our work with novel investigative therapies," said Howard A. "Skip" Burris, M.D., president, clinical operations and chief medical officer, Sarah Cannon. "Clinical trials, particularly those where patients can be molecularly matched to a study, are an integral part of effectively treating many types of cancers and accelerating patient access to novel therapies. We’re excited to collaborate with Foundation Medicine as we continue to enhance access to molecular information, which helps improve clinical care and inform research across our network."

Sarah Cannon and Foundation Medicine will also work together to develop training and educational programs that support the advancement of personalized medicine, including work with Sarah Cannon’s Nurse Navigator Program, a high-touch, personalized support program that enables nurses to comprehensively manage a patient’s experience with cancer.

"Precision medicine in cancer can be achieved by innovating new ideas that accelerate patient access to novel compounds in development," said Steven Kafka, president and chief operating officer for Foundation Medicine. "Together with Sarah Cannon, we believe we are in a unique position to eliminate roadblocks to patient access, to integrate genomics knowledge into clinical pathways and to extend that knowledge across the cancer care continuum to accelerate research and drive better outcomes for all patients."