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TECHNICAL AGILITY.
RESPONSIVE SOLUTIONS.
January 31, 2017
COMPANY PRESENTATION
COMPANY OVERVIEW
3
SANECA PHARMA big pharma heritage
76 Years of History
Company formed as Slovak Alkaloids focused on
production of morphine
1941
2003 Merger with Czech Léčiva – Zentiva creation
2009
Acquisition by Wood Pharma Holding
Acquisition of Zentiva by Sanofi-Aventis
2013
1950 Creation of national company Slovakofarma
with broad capabilities
4
EXCELENT LOCATION
Located in Central European state Slovakia, European
Union member state
Slovakia = Current center of significant global
investment
Stable environment for business with EURO currency,
competitive cost of manufacture and low inflation
CZ
AT HU
SK
Vienna
Budapest
Prague
Saneca
in the heart of Europe
5
OUR CAPABILITIES CDMO for API's and finished dosage forms
Solid dosage forms
Semisolid dosage forms
Liquid dosage forms
Pharma
Synthesis
Multipurpose plants
Pilot plant & cGMP Kilolab
Opiates
Morphine extraction
Morphine & Thebaine based
opiates
Synthetic opiates
API
Preformulation and laboratory
development
Scale-up to pilot stage and
stability
Dossier preparation
Manage registration process
with authorities
Regulatory
and R&D
Warehousing
Distribution
Transport
Other
Services
6
QUALITY AND REGULATORY outstanding record of quality
years of the Quality systems,
based on EU GMP principles
Very Experienced Regulatory
affairs team
Frequent Customer Audits – 20x
in 2016 (+1 regulatory inspection
- Russia)
20
(starting from 1996,
the latest in 2007)
PIC/s member
state
Successful
GMP
Inspections
7
ACTIVE PHARMACEUTICAL INGREDIENTS expert support through technical ability
Portfolio of own IP based generic API´s
Wide range of opiate API´s for one-stop shopping
Backward integrated to farmers for opiate raw materials sourcing & supply
Flexible batch size range / reactor size
Lab scale -> Kilolab -> Pilot Plant -> Commercial Manufacturing Units
Long term experience and expertize in modifications of Particle Size Distribution profile
Full range of CDMO services in API field available
granted CEPs
Quality Systems approved recently with inspections by Korean MFDS and Japanese PMDA
16
8
FINISHED DOSAGE FORMS value through scope
Low humidity manufacture and packing
Pellet manufacture
Bi-layer tableting and D tooling
Solvent granulation
Extrusion spheronisation
Liquids, drops, syrups and suspensions
Soft gels capsules
Creams, ointments, body milks and gels (Medicines or Cosmetics)
Roller compactor for dry granulation
Sugar coating expertise
Blister packing PVC/PDVC /ALU, option ALU/ALU under Nitrogen,
plus Bottles and Tubes
Nasal sprays, non-sterile syrups
Backward and forward integration for handling controlled drugs
FDF clients
locations
+Canada
RU
SK CZ
PL GE
AT
IT
CH
GB
9
DEVELOPMENT/RA VALUE PROPOSITION Saneca's track record is one you can trust
Scale-up of product on one site from lab, pilot to routine production batches
Excellent formulation and analytical labs
Expertise to develop products with novel release mechanisms and innovative techniques,
including hot melt technology
R&
D t
ea
m
38 experts
PhD pharmacists and
chemists (2 ongoing)
patents and patents apps.
publications in professional
journals
presentations at
professional events
6
21 5
25 50 30
300
molecules (MRP/DCP)
Procedures (MRP/DCP)
molecules (NR)
procedures (NR)
variations
territories
x1000 15+
Re
gu
lato
ry t
ea
m
10
SANECA PHARMA SUMMARY technical agility, responsive solutions
Agile
experienced
technical work
force
Managing
complexity
so our
customers
do not have
to
Cost efficient
assurance of
EU quality
standards
supply
Agile
experienced
technical work
force
Turn key
supplier from
API to FDF.
Managing
complexity
so our
customers
do not have
to handle
Cost efficient
assurance of
EU quality
standards
supply
Agile
experienced
technical work
force
Agile and
experienced
technical work
force
Cost efficiency
assured.
EU quality
standards in
place.
API OVERVIEW
12
API KEY FACTS General introduction
More than 70 years of tradition in API manufacturing
Wide range of chemical and technological expertise from bio-mass extraction
to multi-step synthesis
30 active products are in portfolio:
23 Active Pharmaceutical Ingredients
5 API intermediates
2 pharmaceutical excipients (with cGMP certificate)
Backward integration, farm to pharmacy value chain
>70
13
API MARKET POSITION unparalleled expertise
Synthetic Morphine based Thebaine based
Alfentanil Apomorphine Buprenorphine
Dextromoramide Codeine Phosphate Butorphanol
Diphenoxylate Dihydrocodeine Levorphanol
Dipipanone Dihydromorphine Nalbuphine
Fentanyl Ethylmorphine Nalfurafine
Ketobemidone Heroin Nalmefene
Methadone Hydrocodone Naloxone
Methylnaltrexone Hydromorphone Naltrexone
Pethidine Morphine Sulfate Oxycodone
Piritramide Nicomorphine Oxymorphone
Propoxyphene Pholcodine Thebacon
Remifentanil
Sufentanil
Tapentadol
Opiate Molecules/APIs marketed worldwide as medicinal products Saneca has on average only 8 worldwide
and 3 central European competitors in
each product category
of synthetic opiate products covered
of morphine based opiate products
covered
of thebaine based opiate products
covered
estimated worldwide market share in
Pethidine
25%
64%
36%
23%
Commercially available or being developed by Saneca
PHARMA CONTRACT MANUFACTURING
15
FORMULATION PRODUCTION (1/2)
Solid
Liquid
Semi-
solid
Tablets
uncoated,
coated
(sugar/film)
bi-layered
Effervescent
cold & flu
formulations
Pellets
coated filled in
capsules,
compressed in
tablets
Nonsterile liquid production
solutions
suspensions
drops
syrups
Hard gel capsules
filled by powders,
granules,
pellets
Soft gel capsules
registered vitamins,
food supplements
Medical and cosmetic creams
gels, ointments, toothpastes, creams
value through scope
16
FORMULATION PRODUCTION (2/2) value through scope
Direct compression, dry, wet and fluid bed granulation,
(tablets ,film tablets, dragee, hard gel capsules) Immediate release
Orodispersible tablets, effervescent tablets, bi-layered Taste masking
Sustained release forms, delayed release forms Modified release
Layering technology and
extrusion/spheronisation technology Pelletization
Well accepted dosage form, potential in OTC products Soft gel capsules
Creams, ointments, gels, toothpaste, body milks Semisolids
Nonsterile liquids (solutions, drops, syrups) Liquids
17
CMO INSPECTION TRACK RECORD track record of successful audits
CMO INSPECTION TRACK RECORD
Latest local authority´s GMP inspection for API´s performed
by ŠÚKL (State Institute for Drug Control) in 05/2014
No critical observations
EU GMP Certificate valid until 05/2017
RU – inspected in 08/2016 , valid until 10/2019
Customer Audits in 2016 – 11x at CMO
All customer audits successful with no critical observations
DEVELOPMENT AND
REGULATORY
19
SANECA DIFFERENCE
results… through adaptability
Modern, systematic approach toward development, designing of experiments and in-vitro in-vivo
correlations
Scale-up your product on one site from lab through pilot to routine production (from tens of mg to ~
700 kg in the same/similar technology)
State of the art equipment enabling separation techniques and dissolution methods, including GIT
simulation (pH exchange, transit times)
Processes and safety knowledge to handle dosage forms for controlled drugs
Expertise to develop products with novel release mechanisms
Portfolio of innovative techniques such as taste making, oral disintegration, pelletisation and hot melt
technology
20
WHERE WE CAN HELP IN REGULATORY various structures of cooperation driven by client
Support of MAH in the dossiers compilation, registration procedures (DCP,MRP,NR) for both
non-EU region to EU countries.
Full support in the complex process (acting as an applicant/MAH) including contacts and
attorney on CZ and SK Regulatory Authorities.
DMF evaluation, compilation (restricted and applicants part), CEP.
Providing full service for variations in dossiers registered in EU and other countries.
21
combined support from screening to the registration
Formulation
and analytical
development
strategy
Reference
product
evaluation
Feasibility
study
Development
of dosage form
Development
of analytical
methods
Compatibility
study
Stability of
laboratory
batches
Production of
pilot batches
Analytical
validation
Process
validation
Stability study
Production
and release of
biobatch
Screening Clinical
phase Laboratory
phase
Pilot
phase
Dossier
preparation Registration
FULLY-FLEDGE SERVICES – R&D
22
combined support from screening to the registration
Regulatory
strategy
Strategic
sourcing,
DMF
evaluation
Market
access
support -
knowledge
of the Main
Policy
CRO
finding for
BES
Preparation
data for
BES
application
Dossier preparation
Module 1 (Application
forms and annexes, SPC,
PL, Labelling, Readability
test, Environmental risk
assessment,
Pharmacovigilance
system, Risk management
plan
Module 2 (External
experts cooperation)
Module 3
Module 4 + 5 (External
experts cooperation)
1.Registration in first territory
2. Market access support:
Knowledge of the Main Policy
Issues and Health care environment
Listing, pricing, reimbursement
Policy
Drug legislation
Local stakeholders
Competition environment evaluation
Market access evaluation from the
gross margin point of view
Screening Clinical
phase Laboratory
phase
Pilot
phase
Dossier
preparation Registration
FULLY-FLEDGE SERVICES – REGULATORY
23
KEY CONTACTS Saneca Pharma representatives
Ján Baťka
API Sales Director
Mob: +421 905 471 683
Katarzyna Ostrowicz-Pawelec
European Sales Manager
Mob: +48 504 987 020
API
CMO
TECHNICAL AGILITY. RESPONSIVE SOLUTIONS.
Saneca Pharmaceuticals, a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic
Phone: +421 33 736 1111
Email: [email protected]
Web: www.saneca.com
