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
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!