Kissei Performance
Kissei Performance
Kissei Performance
2
KISSEI’s Product Launch History
3
Operational Organization
◆ Sales Force: 10 Sales Branches
50 Offices
Headquarters
◆ Oversea Subsidiary:
Matsumoto Area Kissei America Inc.
◆ Headquarters (Fort Lee, NJ)
◆ Laboratories (3)
➢ Central Research Labs.
➢ Toxicological Labs. ◆ Joetsu Chemical Laboratory
➢ Pharmaceutical Labs.
Matsumoto Plant ◆ Manufacturing Site (2)
➢ Matsumoto and Shiojiri
Nihonbashi Office Koishikawa Office
Shiojiri Plant
4
Location of Kissei’s Laboratories
Mt. Jonen
Northern Alps
(Japanese Alps)
Toxicological
Labs.
5
Kissei’s Organization
Corporate Strategy
& Planning
Corporate Development
Research Strategic Alliance
Clinical Development
Quality, Safety and Regulatory Affairs
Pharmaceutical Manufacturing
Legal Affairs
Nutrition
Others
6
Kissei’s Areas of Strategic In-Licensing Focus
Urology
Nephrology
Gastrointestine
R&D and
Commercial Ophthalmology
7
Financial Highlights in FY2018
(April 2018 to March 2019; Non-consolidated)
FY2018 Mil. JPY Mil. USD
Net Sales 61,520 559.3
Operating Income 5,487 49.9
Net Income 5,064 46.0
R&D Expenditure※ 15,711 142.8
% on Net Sales 25.5 % ※consolidated
Net Sales Operating Income Net Income R&D Expenditure R&D rate (% on Net Sales)
Net Sales (Mil. USD) Income (Mil. USD) Expenditure (Mil. USD) R&D rate (%)
600 120 160 35
500 100 140 30
120 25
400 80 100 20
300 60 80
60 15
200 40 10
40
100 20 20 5
0 0 0 0
8
Global Product (Urology)
• URIEF® (Silodosin) in-house
– MoA: Selective 1A adrenoceptor antagonist
• Dysuria associated with benign prostatic hyperplasia (2006)
• Additional dosage form: Orally disintegrating tablet (2016)
– Co-marketing with Daiichi-Sankyo Co., Ltd. in Japan
• Daiichi Sankyo Espha Co., Ltd. launched authorized generic (2019)
– Launched in over 50 countries
As of March 2019 Silodosin Partners
Licensee Territory Brand name
US, Canada &
Allergan RAPAFLO®
Latin America
Europe & UROREC®,
Recordati Middle East, SILODYX®,
Australia SILOSIN®
JW Pharma Korea THRUPAS®
Synmosa Taiwan URIEF®
:Launched Daiichi-
China URIEF®
:Approved Sankyo
:NDA Eisai
ASEAN &
URIEF®
India
9 9
NEW Product (Urology)
• BEOVA® (Vibegron) in-licensed
– MoA: β3-adrenergic receptor agonist
• Overactive bladder (2018)
– Dosage form: Tablet
– Sublicensed from Kyorin Pharmaceutical Co., Ltd. 【Originator : MSD】
– Co-development and co-marketing with Kyorin Pharmaceutical Co., Ltd.
– Urovant Sciences Ltd. is developing in US and Europe for OAB.
10
NEW Product (Renal・Dialysis)
⚫ P-TOL® (Sucrofferic Oxyhydroxide) in-licensed
– MoA: Phosphate binder in gastrointestinal tract
• Hyperphosphatemia in dialysis patients (2015)
– Dosage form: Chewable tablet
• Additional dosage form: Granules (2018)
– Licensed from Vifor Fresenius Medical Care Renal Pharma Ltd.
– Known as Velphoro® in Europe and US
Chewable tablet
Granules
11
Development Pipeline 1
Therapeutic Product Code MoA/ Originator/ Available
Phase
Field Generic Name Indication Partner Territory
Genetically engineered Proaerolysin/
JP Sophiris/
PRX-302 Benign Prostatic Hyperplasia, -
Pre-IND Kissei
Prostate Cancer
Urology
Transient receptor potential cation channel
JP
KSP-0576 subfamily M member 8 (TRPM8) antagonist/ Kissei Global
Preclinical
Overactive bladder
JP Kappa opioid receptor agonist/ Cara/
MR13A9 -
Renal/ PII Uremic pruritus in dialysis Maruishi-Kissei
Dialysis JP Inhibitor of the complement C5a receptor/ ChemoCentryx/
Avacopan -
PIII ANCA-associated vasculitis VFMCRP/Kissei
US,EU PIIb
SGLT2 inhibitor/
(India
Type 2 diabetes Kissei/ Global
Launched)
Remogliflozin Avolynt (Global), (except
US Glenmark (India) India)
SGLT2 inhibitor/
Metabolism PII/III/IV
NASH
in Prep
KUX-1151 US PI
Inhibition of Xanthine Oxidase and URAT1/
& JP PIIa Kissei Global
Hyperuricemia, gout
KUX Back-Up (KUX-1151)
JP Oral GnRH antagonist/
Kissei
PII Endometriosis, Uterine fibroid
KLH-2109 US,EU Oral GnRH antagonist/
Ob/Gyn Asia
Linzagolix PIII Uterine fibroid Kissei/
US,EU Oral GnRH antagonist/ ObsEva (Global)
PIII Endometriosis 12
Development Pipeline 2
Therapeutic Product Code MoA/ Originator/ Available
Phase
Field Generic Name Indication Partner Territory
Ophthal- JP IgE trapping Fc-fusion protein/
KCE-210 Kissei Global
mology Preclinical Allergic Conjunctival Diseases
AJM300 JP Oral α4 integlin antagonist/ EA/
-
Carotegrast Methyl PIII Ulcerative colitis EA-Kissei
GI
KWA-0711 JP SGLT1 inhibitor/
Kissei Global
Mizagliflozin PII Chronic constipation
JP Dopamine agonist/
Neurology KDT-3594 Kissei Global
PII Parkinson's disease
JP PIII China
Spleen associated tyrosine kinase inhibitor/ Rigel/
Fostamatinib US Launch Korea
Immune Thrombocytopenia Kissei
EU Approved Taiwan
US,EU Selective β2 adrenoceptor agonist/
PII Acute exacerbation of asthma Kissei/
Others Bedradorine -
US Selective β2 adrenoceptor agonist/ MediciNova
PI COPD
P-TOL ®, Avacopan
RAPAFLO ® UROREC ®, SILODYX ® EPOETIN α BS
SILOSIN ® DARBEPOETIN α BS
ZOLADEX ®
FULSTAN ® FRAGMIN ®
THRUPAS ® URIEF ®,
GLUFAST ® GLUFAST ® URIEF ®
Wakamoto
RYSMON ® TG SAVENE ® AJM300, RECTABUL ®
URIEF ® GLUFAST ®
KPS-0373
BEOVA ®
GLUFAST ®
Maruishi
YS110 MR13A9 Fostamatinib PRX-302
Linzagolix Partners of other products
Remogliflozin Bedoradrine
MINIRIN MELT ® MARIZEV ®
15 15
Kissei Pharmaceutical Co., Ltd.
Corporate Development, Business Development
1-8-9 Nihonbashi Muromachi, Chuo-Ku, Tokyo
103-0022, Japan
<Tel> +81-(0)3-3279-2307
<Fax> +81-(0)3-3279-2541
<Web> https://www.kissei.co.jp/e_contents/
Kissei License & Alliance Organization
Dr. K. Akiyama, Senior Director Dr. Y. Takehana, Managing Director
17
Proportions of Sales by Therapeutic Areas
in FY2018
Sales to Partners & Royalty
Silodosin, Mitiglinide, etc
11.0% Urology
Others URIEF®
SALAGEN® BEOVA®
RIZABEN®
XANBON® 30.1%
DOMENAN®, etc
23.4%
Ophthalmology
RIZABEN® EYE DROP 1.7%
RYSMON® TG
18.5%
Ob/Gyn Renal/Dialysis
12.7%
UTEMERIN® 2.6% P-TOL®
ZOLADEX® Metabolism EPOETIN α BS
GLUFAST® FRAGMIN®
GLUBES® FULSTAN®
BEZATOL®
18
Net Sales of Kissei’s Main Products
19
Global Product (Metabolism)
• GLUFAST® (Mitiglinide) in-house
– MoA: Rapid-acting insulin secretagogue
• Type II diabetes
• Monotherapy (2004)
• α-GI combination use (2007)
• TZD combination use (2009)
• BG / DPP-4i combination use (2013)
• Additional dosage form: Orally disintegrating tablet (2016)
– Co-marketing with Takeda Pharmaceutical Co., Ltd.
– Launched in Asian countries
Mitiglinide Partners
Licensee Territory
JW Pharma Korea
20
NEW Product (GI)
• RECTABUL® (Budesonide Rectal Foam) in-licensed
– MoA: Glucocorticoid activity
• Ulcerative colitis (2017)
– Dosage form: Rectal foam
– Sublicensed from EA Pharma Co., Ltd. 【Originator : Dr. Falk Pharma】
– Co-marketing with EA Pharma Co., Ltd.
– Known as Budenofalk® /Ulceris® rectal foam in Europe and US
21
Products 1
Therapeutic Brand Name Sales MoA/
Licensor
Field Generic name (Mil. US$) Indication
URIEF® Selective α1A adrenoceptor antagonist/
161.9 In-house
Silodosin Benign prostatic hyperplasia (2006)
BEOVA® Selective β3 adrenoceptor agonist/ MSD/
Urology 6.4
Vibegron Overactive bladder (2018) Kyorin-Kissei
MINIRIN MELT® Vasopressin receptor agonist/ Ferring
-
Desmopressin Acetate Nocturia due to nocturnal polyuria (2019) (Co-Promotion)
Recombinant human erythropoietin/
EPOETIN α Biosimilar 54.7 JCR
Renal anemia on dialysis (2010)
DARBEPOETIN α Long-acting ESA/
- JCR
Biosimilar Renal anemia (2019)
P-TOL®
Phosphate binder in gastrointestinal tract/
Renal/ Sucrofferic 43.6 VFMCRP
Hyperphosphatemia in dialysis patients (2015)
Dialysis Oxyhydroxide
FULSTAN® Active vitamin D3/ Sumitomo
3.8
Falecalcitriol Secondary hyperparathyroidism (2001) Dainippon
Anticoagulant (low molecular weight heparin)/
FRAGMIN® Kabi Vitrum
1.3 Hemodialysis (1992)
Dalteparin (Pfizer)
Disseminated intravascular coagulation (DIC) (1994)
GLUBES® Mitiglinide & Voglibose combination product/
40.3 In-house
Mitiglinide + Voglibose Type II diabetes (2011)
BEZATOL® PPAR agonist/
15.5 Roche
Bezafibrate Hyperlipidemia (1991)
Metabolism
GLUFAST® Rapid-acting insulin secretagogue/
15.3 In-house
Mitiglinide Type II diabetes (2004)
MARIZEV® DPP4 inhibitor/
- MSD※
Omarigliptin Type 2 diabetes (2015)
※Transfer of distribution operation from April 2020.
22
Products 2
Therapeutic Brand Name Sales MoA/
Licensor
Field Generic name (Mil. US$) Indication
UTEMERIN® β2 adrenoceptor agonist/ Solvay
10.4
Ritodorine Premature labor (1986) (Mylan)
Ob/Gyn
ZOLADEX® GnRH agonist/
4.2 AstraZeneca
Goserelin Endometriosis (2000)
RIZABEN® EYE DROPS Inhibition of chemical mediators release from mast cells/
7.6 In-house
Ophthal- Tranilast Allergic conjunctivitis (1995)
mology RYSMON® TG β adrenoceptor antagonist/
2.0 Wakamoto
Timolol Glaucoma (1999), Ocular hypertension (1999)
RECTABUL® Budesonide rectal foam/ Dr. Falk/
GI 6.0
Budesonide Ulcerative colitis (2017) EA-Kissei
Muscarinic receptor (M3) agonist/
Xerostomia (dry mouth)
SALAGEN® MGI
14.7 Radiation therapy (head and neck cancer) (2005)
Pilocarpine (Eisai)
Sjögren syndrome (2007)
Additional dosage form: Granule form (2014)
Inhibition of thromboxane A2 synthetase/
XANBON®
3.7 Vasospasm after subarachnoid hemorrhage surgery (1988) In-house
Ozagrel Na
Acute cerebral thrombosis (1992)
Inhibition of chemical mediators release from mast cells
Others
Inhibition of synthesis of collagen in fibroblasts/
RIZABEN® Bronchial asthma (1982)
3.3 In-house
Tranilast Allergic rhinitis (1985)
Atopic dermatitis (1985)
Keloid, Hypertrophic scar (1993)
DOMENAN® Inhibition of thromboxane A2 synthetase
0.8 In-house
Ozagrel HCl Bronchial asthma (1992)
SAVENE® Catalytic inhibitor of topoisomerase II/
0.7 Clinigen
Dexrazoxane Antidote for anthracycline extravasation (2014) 23