Transcript Business Development Updates

Business Development
Updates
8th – 9th April 2015
Regional Regulatory Affairs Conference
– Confidential –
Agenda/Content
 New Product Assessment Process
 Products assessed by Regional Regulatory in Sep 2014 to March 2015
 New Products in the Pipeline
 Roles and Responsibilities of “Strategic Regulatory Projects Director”
– Confidential –
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New Product Assessment
Process
New Products Assessment Process
Business Development
Business Intelligence, Regulatory &
Medical Assessment
New Product
Opportunities
Business Case Projection
1 to 2 years
NBEC Review
Term Sheet Negotiation
NBEC Review
Due Diligence Exercise
Contract Negotiation
Contract Execution
Starts Regulatory Activities
– Confidential –
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New Product Regulatory Assessment
Country /Product specific regulatory
requirements
Ingredients
List
Product Type
Local RA
inputs
Stability
Data
Manufacturer
Info (GMP status)
New Product
Regulatory
Assessment Report
Legal /Forensic
classification
Approval
Status in other
countries
Similar products
in market
Indications
Availability
and type of
dossier
Type of
Clinical Data
– Confidential –
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Products Assessed by Regional
Regulatory from
Sep 2014 to Mar 2015
Products Assessed by Regional Regulatory
 > 50 products
 Drug Products, Cosmetics , Medical Devices, Health Supplements
Company
Product
Berlin Chemie
Ironwood
Daewoong
Moberg
Sangui Biotech
Epirus
Polichem
Polichem
MEDA
Prostamol Uno
Linaclotide
Nabota (Botulinium Toxin)
Emtrix/Kerasal
Granulox
Infliximab Biosimilar
Kerid
Gynomunal Vaginal Gel
Kamillosan
Fulcare/Rejuvenail - ciclopirox 8%
Nail lacquer
Resminostat
Endwart
CB12 Range
Recover Acne Scar Serum
Ellanse Dermal Filler and
Silhoutte Sutures
Polichem
4SC
MEDA
MEDA
AMAP
Sinclair
Company
Moberg
Menarini Italy
AMAP
Pierre Fabre
Sinclair
Cell Therapies
LaboSuisse
Orion Pharma
Menarini Italy
Delife
Berlin Chemie
MITELOS
Boryoung
Boryoung
AMCO
– Confidential –
Product
MOB-15 (Topical Terbinafine for
Onychymosis)
Fasitibant
Dermatix Acne Scar
Permixon
BioTaches -5 SKUs
Cartistem Stem Cell Therapy
Crescina and Fillerina
Bufomix Easyhaler
Ibodutant
28 products
Prostamol Uno
VigilSleep - Melatonin Caffeine
and DHA
CINALONG (Cilnidipine) CCB
Stogar (Lafutidine) H2 Antagonist
TransAct Lat (Flurbiprofen Patch)
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Main reasons why new opportunities are
“killed off”
 Commercial viability
 Legal classification of the products in Asia Pacific Countries
 Current focus on consumer health markets
 Prohibitive cost of goods (COGS)
– Confidential –
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New Products in the Pipeline
Confirmed Deals in 2015
 SPEDRA (Avanafil 50, 100 & 200mg) – ID, HK, CN, TW
 Drug Product – erectile dysfunction
 Licencing agreement executed, pending finalization of supply agreement
 Registration preparation in progress
 ONY-TEC (Ciclopirox 8% nail lacquer) - TW
 Drug Product – onychomycosis
 MCH and BD’s backup plan in case Emtrix® registration rejected.
 Registration Agreement executed 12 March 2015. To commence registration
process ASAP
 CTC BIO TADALAFIL OSF (20mg, 10mg & 5mg) - KR
 Drug Product – Erectile Dysfunction
 Supply agreement executed in Dec 2014
 MA already obtained in KR for 20 mg
– Confidential –
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Confirmed Deals in 2015
 SKINFILL Derma Filler – TH
 Licensing and Supply contact executed in Nov 2014
 MAH transfer to Menarini (TH) after all 3 SKU have been registered
 To extend deal to rest of APAC in 2015
 PROSTAMOL (Serenoa Repens) – AU, SG, HK, MY, KR, TW, IN, VN, ID
 Health Supplement – General benefit if prostate well being
 Notified Food supplement in Italy in Mar 2015
 OTC Drug possibility to be explored in TW and KR
– Confidential –
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Near Confirmation Deals in 2015
 RESMINOSTAT – APAC
 Drug Product – Hepatocellular Carcinoma (HCC)
 Pending execution of licensing agreement
 Currently in Phase II clinical development, Asia Phase III study planned
in end 2015
 NDA filing expected 2019-2020
 KERASAL (9% Urea Nail Lacquer) – JP
 Cosmetics – Fungal Nail Renewal
 Pending contract finalization and execution to include Japan
 Launch estimated 3-4Q2015
– Confidential –
12
High Priority BD Projects in the Pipeline
 Bufomix Easyhaler ® - APAC
 Drug Product – Generic budesonide-formoterol inhaler for asthma and
COPD
 Business case forecast stage
 Atopiclair Hydra Cleanser - APAC
 Cosmetics – Sensitive, eczema prone skin to complement Atopiclair
range
 Selection and QA qualification of manufacturer
 Contract manufacturing in TH
 Business case forecast stage
 Bilastine – Korea
 Pending contract finalization with Faes
– Confidential –
13
High Priority BD Projects in the Pipeline
 Acne Scar Recover Serum
 Cosmetics – apple stem cell and snail secretion extract serum for mild
to moderate acne scar
 Business case forecast stage
 Kamillosan M Spray (Korea)
 Quasi drug – Herbal Sore Throat preparation
 Pending MEDA’s approval to source from TH manufacturer
 Promoitalia SkinFill and Happy Lift (APAC)
 Medical Devices – Dermal Filler and Lift Sutures
 Business case forecast stage
– Confidential –
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Roles and Responsibilities of
“Strategic Regulatory Projects
Director”
Strategic Regulatory Project Director
 New Business / Project assessment
 Regulatory Assessment
 Preliminary Medical Assessment, if required
 Regulatory Inputs into business case forecasts
 Alliance / Agency and Standalone Projects
 Regional regulatory contact with Alliance / Agency partners
 Ad-hoc support on regulatory issues
 Provide oversight and support to Compliance Activities in Regional Office
 Product complaints and recalls
 ISO 13485 certification
 GPMDS certification
Filina Tan,
Regional
 Other compliance issues
Regulatory
Compliance
Executive
– Confidential –
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