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HYUNDAI PHARMCompany Profile
The information contained in this presentation shall not be shared or furnished without prior written consent by Hyundai Pharm
HYUNDAI PHARM GROUP
Chairman & CEO
Chairman : Lee, Han Koo
President : Yoon, Chang Hyun
Established in 1965
Headquarter located in Seoul, Korea
Total employees : over 510
Business area : Pharmaceutical products, Health
food drinks, and Medical equipment & Device
Total revenue in 2011 : 116M USD (1USD=1,000KRW)
Total three manufacturing facilities
Main therapeutic sales : Cardiovascular (40%),
Respiratory (22%), Dermatology (15%), etc.
RECENT EVENTSNov 2012 Received a gold award for Safety & Quality by the President for the first time
among the pharmaceutical companies in Korea.
Oct 2012 Signed on the marketing and sales agreement of TachoSil®
Jul 2012 Technology transfer agreement signed & in progress to Europe + 30 countries in Central South America & the Middle East & Africa & Asia
Jun 2012 Designated as ATC (Advanced Technology Center) by Ministry of Knowledge Economy for development of new pharmaceutical molecules.
Jun 2012 Selected as one of thirty innovative pharmaceutical companies by government recently, designation offered only to those pharmaceutical company investing in R&D
Oct 2011 Co-promotion agreement of Ocuvite with BauschLomb
Aug 2011 Co-marketing agreement of Tareg/Cotreg & Zilep/Zilep XL with Novartis
Jul 2011 Ella One(Emergency contraceptives) launched
Jun 2011 License-in agreement of Ruping eye drop (artificial tear) with Ophtecs corp, Japan
May 2011 Distribution right agreement of Surfolase in China with Polichem, Switzerland
Feb 2011 IND submission of Levotuss CR tablet
Dec 2010 Completed technology transfer of Galantamine SR to 20 countries including Spain, Portugal and Central & South America
Oct 2010 Exclusive distribution agreement for Natto Balance and Nasal Guard with Nitto Pharma
Jul 2009 IND approval of HD-003(NME)
This is the mark given by the government for se-lected innovative companies
ORGANIZATION
DOMESTIC BUSINESS AREA
Pharmaceu-tical Busi-
ness84%
PublicWel-fare1%
Health Food
Drinks 14%
Medical Equip-ment & Devices
1%
PHARMACEUTICAL BUSI-NESSTotal sales in FY 2011: 100 M.
USD
77.5%
22.5%
OTC
ETC
Others***
CNS
HEMOSTATICS**
OBGY
RESPIRATORY
CVM*
Sharein ETC
33.5%
23.6%
11.8%
11.4%
9.9%
9.8%
*CVM include CV & Endo products**HEMOSTATICS include disinfectants
***Others include GI, Pain, DERM, OPHTALMICs
Source: Internal Data
US$1=1,000won
ETC BUSINESS in FY 2011
Source: Internal Data
ProductSales (Mil.USD)
TC Originator Note
TENORMIN /TENORETIC
13.3 HYPERTENSION AstraZeneca No.1 B-blocker
TACHOCOMB 8.0 HEMOSTATIC Takeda No.1 Hemostatics
LEVOTUS 7.5 ANTITUSSIVES Dompe No.1 Rx antitussives in PED
SURFOLASE 5.7 EXPECTORANTS Policam No.2 Rx expectorants in IM
SYSCOR ER 4.7 HYPERTENSION Bayer Coat-core technology
ACTIQ 3.4NARCOTIC ANAL-GESICS
TevaOral transmucosal fentanyl citrate
RHINATHIOL 3.2 EXPECTORANTS In-house Long history product
NORLEVO-ONE
2.9 CONTRACEPT HRAFirst contracept after sex in Korea
UREMIN 2.6ANTIDIURETIC HORMONES
In-house First generic in Korea
SALAGEN 2.1 STOMATOLOGICALS EisaiOnly Radiation-Induced Xeros-tomia in Korea
TAMIRIN 2.0ALZHEIMER DIS-EASE
In-house First Galantamine SR in Korea
US$1=1,000won
OTC BUSINESS in FY 2011
ProductSales (Mil.USD)
TC Note
MINOXYL 8.5 Prevention of alopecia No.1 product in Korea
BUMOOL series 3.0 Antipruritics Long history product
MOOL PAS 1.3 Pain relief Long history product
SOLUFEN 1.4 NSAIDsFast pain killer product as soft capsule
DERMAWHITE 1.4 Whitening Topical No.1 whitening OTC
TONGEJON 1.1 NSAIDs TopicalAntiinflammatory analgesic drug
SINO series 0.6 Cold preparations Long history product
AIRPAS 0.4 Pain relief Spray pas
LIVER 0.4 Liver diseaseHigh contents ofsilymarin formulation
LUPING - Artificial tear New launched in 2012
Source: Internal Data
US$1=1,000won
PHARMACEUTICAL BUSI-NESS
•Co-development of innovative drugs
•Co-marketing/promo•Joint Ventures•Global clinical trials
•Out-license of in-house developed products ( NME / IMD )
•Technical licensing out of platform tech-nologies
• Global IP right se-curement
• Consulting services• Global research
center
• In-license, co- de-velopment product
• In-licensing of novel tech
In-li-cense R&D
Collabora-tion
Out-li-cense
Cross-license
GLOBAL NETWORK MAP
In-Licensing
Out-Licensing
GLOBAL NETWORK (In-Licens-ing)Partner Product
Action/Indica-tion
Takeda (Nycomed)
Tachocomb
Hemostatic
Mitsubishi Tanabe
Galan-tase
Dyspepsia caused by Chil-dren’s lactose In-tolerance
Novastan Hi
Thrombosis, Heparin Induced Thrombocytope-nia
Alegysal
Bronchial Asthma, Peren-nial Allergic Rhinitis
Kowa Hypadil Glaucoma, Ocular Hypertension
Eisai Salagen Radiation-In-duced Xerostomia
NittoNatto Balance
Intestinal Disor-ders
Ophtecs Ruping Eye Drop
Partner ProductAction/Indica-tion
Astra Zeneca
Tenormin Hypertension
Bausch & Lomb
Ocuvite Ophthalmological
Teva (Cephalon)
Actiq oral tab
Analgesic(Opiate agonist)
NovartisTareg /Co-tareg
CV (Valsartan etc)
Policam S.A
Surfolase in China
ExpectorantRespiratory
Dompe Levotuss Cough: Acute and Chronic Bronchitis
HRA Farma
EllaOne
Emergency contra-ceptives(Effective even af-ter 120hr)
Bayer Schering
Syscor ER Hypertension
GLOBAL NETWORK (Out-li-censing)
Product Country Current Status
Pramipexole SR
Europe +30 countriesin Central South America &the Middle East &Africa & Asia
Agreement signed &Technology transferin progress
Galantamine SR
20 countries includ-ing Spain, Portugal and Central & South America
Technology transfer completed
Pramipexole SR Australia
Under negotiation
Levetiracetam IR Indonesia
Telmisartan + HCTZ
Turkey, Indonesia
Ibandronate Indonesia
Tamsulosin CR / OD
Indonesia
Esomeprazole Indonesia
◆ Overseas technology transfer from 2010 to 2012◆ Domestic out-licensing from 2010 to 2012
Product Company
Iban-dronate
15 companies including Je-il
Lamotrig-ine
3 companies including Il-dong
Amlodipine + Valsar-tan
8 companies including Han-dok
Adefovir6 companies including Choong-wae
Lamivudine2 companies including Dong-koo
Olmesartan Kolon pharm
Olanzapine2 companies including Dong-wha
Pitavastatin11 companies including Whan-in
Telmisartan Kolmar Korea
Expected Growth Rate: 2012 – 7.4%2013 4.2%2014 5.3%2015 6.7%
2010 Korea Pharmaceutical market
$11 B with 10% GR
11th Largest Pharma market
4th largest economy in Asia
Among 10 new drug developers in the world
KOREAN PHARMACEUTICAL MARKET in 2012
Source: Data monitor international
Series10
20
40
60
80
100
SaleProfit
2010 2011 Exp.2012
2010.11Rebate Ban
2012.3New Drug
Pricing
2015.Q1USA-FTA
Profit squeezing & Reorganization of Pharma industry
%
Source: Hana investment security, Pharmaceutical industry report
INVESTMENT for R&D
◆ Reinforce GMP & information infra
◆ Excellent research ability
◆ Dedicate to NME & IMD
4.3
6.0 5.8 6.7
%: Against total revenueCurrency : US Dollar/ Unit : Mil-lion
4.3%5.6% 5.3%
5.5%
8.7%
'07 '08 '09 '10 '11
Annual Investment Growth:22%↑
Se-ries1
0.5 0.25 0.17
0.03 0.1
1.7
2.3
Se-ries1
0.42
10.75 0.75 0.75
0.58 0.6
1.2
'07 '08 '09 '10 '11
Research invest-ment
Facility invest-ment
NMEIMD
R&D CENTERS
R&D center (Seoul)
• Team : Project Planning Patent Planning DDS development Generics develop-ment Analysis
• Project : Generics, IMD* development, Pre-formulation of NCE
R&D center (Suwon)
• Team : Synthesis 1 Synthesis 2 Pharmacology Toxicology Pharmacokinetics
• Project : NCE* devel-opment
• IMD: Incrementally Modified Drug• NCE: New Chemical Entity
R&D center (Yong-In)
• Team : Safety and effi cacy test Animal test (rat, bea-gle) • Project : pre-clinical test
・ 2012. 06 Designated as ATC (Advanced Technology Center) by Ministry of Knowledge Economy for development of new pharmaceutical molecules.
PIPELINE
NoveltyCompeti-
tive advan-tage
Market Po-tential
Regulatory context
Few Ad-verse Ef-
fects
Better Compliance
Market Po-tential
Regulatory context
NewMolecularEntities
IMDs
PIPELINE_NME
Prod-uct
Indica-tion
DS PC
Clinical Trials
P I P II P III
HD003 Anti-
oxidant
Chronic
Renal
Failure
HOB04
6
11Beta
HSD1
in-
hibitor
Type 2
Dia-
betes
HOB04
7
GPR11
9 Ago-
nist
Type 2
Dia-
betes
* Added by Chinese source:S122 & B170 for Cancer, BPI 1500 for Anemia, TM135 for DB
Domestic Venture
Domestic Academy
International Venture
International Academy
PIPELINE_IMDs
CATERIA PRODUCTS ACTION INDICATION DEVELOPMENT STATUS
Aripiprazole IR AntipsychoticsAcute manic and mixedepisodes associatedwith bipolar disorder
Launch ready(expected in Feb, 2014)
Donepezil HCl SR AnticholinesterasesDementia fromAlzheimer’s disease
Finished the formulation study
Levetiracetam
SR
Antiepileptics Epilepsy
Finished the formulation study
IRLaunch ready(expected in Jan, 2013)
Mirtazapine IR TCA DepressionLaunch ready (expected in Dec, 2012)
Pramipexole HClSR
Dopamine agonists Parkinson’s Disease
Launch ready(expected in May, 2013)
IR BE ready
Choline alfoscerateSR
Parasympathomimetic Cognitive disorderPhase I ready
IR BE ready
Lacosamide SRvoltage-gated sodium channels
epilepsy Pre Clinical
Fentanyl citratetrans mu-
cosalPhenylpiperidine deri-vative
Narcotic analgesic In fomulation Study
Acebrophylline SR Muco-active Respiratory disease Phase I
Levodropropizine SRperipheral antitus-sive
Cough Launch ready
Oncology Imatinib mesylate Mini-tablettyrosine kinase in-hibitor
chronic myelogenous leukemia
In fomulation Study
PIPELINE_IMDs
CATERIA PRODUCTS ACTION INDICATION DEVELOPMENT STATUS
Ibandronate IR Bisphosphonate Osteoporosis Launched in August, 2012
Telmisartan + HCTZ COMAngiotensin II antago-nist
Hypertension Finished the formulation study
Valsartan + Amlodipine COMAngiotensin II antago-nist
HypertensionLaunch Ready(In process of product approval)
Tamsulosin CR / ODAlpha adrenoreceptor antagonist
BPH BE Ready
Dutasteride Weekly5-alpha-reductase inhibitor
Alopecia Pre Clinical
Ecabet + Ranitidine COMAntiulcerant Mucosal protection
Gastroduodenal Ulcer
Pre Clinical
Esomeprazole OD proton pump inhibitorgastro esophageal reflux disease
In fomulation Study
Clindamycin+Adapalene COM antibiotic+retinoidMild to moderate acne
Pre Clinical
HOB-060 TopicalSynthetic derivative ofthe amino acid
Whitening In fomulation Study