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NerPharMa
Nerviano Contract Development & Manufacturing Organization
About NerPharMa
•
NerPharMa is a recently established company, operating since
January 2010. It was created as a spin-off from Nerviano Medical
Sciences (see ahead).
It is a fully owned subsidiary of Nerviano Medical Sciences.
•
NerPharMa operates as a CDMO (Contract Development and
Manufacturing Organization) and offers unparalleled expertise in
bringing highly potent compounds to the marketplace
Contents
• Overview of Nerviano Medical Sciences: facts and
figures
• Focus on NerPharMa
About Nerviano Medical Science (NMS)
Nerviano Medical Sciences is a research-based company dedicated to the
discovery and development of breakthrough new molecular entities for the
treatment of cancer
 Nerviano is the largest private pharmaceutical R&D center in Italy and
among the largest oncology-focused, integrated R&D sites in Europe.
 Our R&D organization includes all disciplines for the discovery and
development of cancer drugs from target validation to clinical proof of
concept
Farmitalia and
Carlo Erba merge
1965
Nerviano
Research Center
Founded
by Farmitalia
1980
Pharmacia and
Upjohn merge
1992
Farmitalia-Carlo Erba
acquired by Pharmacia
1995
Pfizer buys
Pharmacia
2000
2002
Pharmacia&Upjohn merge
with Monsanto/Searle
taking the name of
Pharmacia
NerPharMa & NerPharMa DS
span-off
2004
Spin-off from Pfizer:
NMS is born
2010 2012
Ownership to
Region Lombardy
NMS – Track Records
In the 70’s and 80’s Nerviano’ s center strongly contributed to the
definition of the foundamentals of chemotherapy through the discovery
of antracyclines, an antitumoral class including:



daunorubicin, in the treatment of hematological malignancies
doxorubicin and epirubicin, in solid tumors and hematological
malignancies
idarubicin, acute leukemia treatment
Outline of companies/entities within NMS
Discovery
Research core functions: Chemistry and Biology
Pre-clinical Development: toxicology, pharmacokinetics, safety
pharmacology, regulatory, IND packages, etc.
Clinical Development of Innovative Drugs from PC stage to Phase III
High Containment Manufacturing of Drug Substances and Drug
Products for clinical phases and market
Consorzio
Facility Management
One stop shop opportunity
Preclinal Phase
Target
Timelines
(years)
Discovery
HitID
1
H2L
1 / 1.5
Clinical Phase
LO
IND
PC
2 / 2.5
1
PH I PH II
3/4
PoC
Reg.
PH III PH IV
3
1
Core of the R&D process
Priority
HITS/LEADS
PC
Characterization
IND
Pack
Support to Clinical Development
Clinical Development of Innovative Drugs
from PC stage to PhaseIII.
High Contaiment Drug Substances Development and Manufacturing
on lab and pilot scale,
both for R&D Products and marketed drus
Formulation of the Drug Substance and Manufacturing of batches
in High Containment plants, on lab and pilot scale,
both for R&D producs and marketed products
NMS – The site
NerPharMa
Drug Product
NMS Discovery
Accelera
Drug Metabolism
Accelera
Toxicology
NerPharMa
Drug Substance
NMS MIO
Clinical Development
NerPharMa
DP Industrial Direction
DS Industrial Direction
NerPharMa - Profile
DP division
Mission
Type of
compound
Technology
assets
Services
offered
Headcount
HC Development and Manufacturing of
Drug Products for NMS and ext.
customers, from formulation to
packaging and distribution
Highly potent and non high potent
1 lab- scale lyophilizer
1 lyophilizer
1 sterile production suites
4 solid forms production suites
Analytic equipment: NMR, GC, HPLC Mass
Formulation identification and early development
Analytical Development
Formulation scale-up to pilot and commercial stages
Clinical trial supply and distribution
Commercial manufacturing and packaging
Full regulatory support
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DS division
HC Development and Manufacturing
of Drug Substances for NMS and ext.
customers, from lab stage to batches
for the market
Highly potent oncology only
4 suites for 0.5 – 5 kg API production
Multipurpose pilot plant (batch up to 30 Kg)
Low temperatures, hydrogenator
Chromatography (180 kg SiO2)
Special unit for hazard testing
State of the art analytic equipment: NMR,
GC, HPLC Mass. Prep HPLC
API process development and scale up
Analytical Development
Commercial manufacturing
Regulatory file preparation
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Manufacturing Authorizations
 NerPharMa DP plant has a GMP certificate and the
Authorization to manufacture and package Medicinal Products
issued by the Italian Regulatory Agency (AIFA).
The plant holds several FDA approvals for the production of
commercial products.
The plant is approved by PMDA for the production of a
commercial product.
 NerPharMa DS plant has a GMP certificate and the
Authorization to manufacture Active Pharmaceutical
Ingredients issued by the Italian Regulatory Agency (AIFA).
The plant holds the FDA approval for the production of a
commercial product.
Our Customers - geography
Territories
2013
75
14
11
USA
Europe
2012
61
32
2011
7
51
41
0%
20%
40%
% on turnover vs third parties
60%
8
80%
100%
ROW
Our projects - segmentation
Product mix
2013
66
30
4
NCE
2012
72
23
Generics
5
Clinical supply
2011
67
29
0%
20%
40%
60%
4
80%
100%
% on turnover vs third parties
Our projects - segmentation
Development phase
2013
75
25
marketed product
2012
64
under development
36
2011
56
44
0%
20%
40%
% on turnover vs third parties
60%
80%
100%
NerPharMa Services
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At NerPharMa we have expertise in all product life cycle phases and
we can assit our partners providing the following services:
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Dosage form development
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Manufacturing for clinical trials and commercial productions
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Analytical services
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Clinical supply management
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Documentation support services
Manufacturing capabilities
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NerPharMa can manufacture the following pharmaceutical forms both for
commercial and clinical trial purposes:
– Oral solid dose and semi-solid products:
- Tablets as direct compression, wet and dry granulation
- Hard Filled Capsules:direct mixing, wet and dry granulation, liquid and semisolid
– Sterile products:
- Bulk solutions and suspensions aseptically produced and terminally sterilized
in vials.
- Freeze-dried vials
– Both oral and sterile products can be produced using high
containment facilities
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Versatility and Flexibility: batch size as low as 50-200 g and as high as 250
L and 50 Kg for sterile and non sterile products, respectively
Clinical supply management
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•
•
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Packaging design
Primary & Secondary Packaging
Drug Supply Management and Worldwide Distribution
Study Randomization
Label Design and Generation
Domestic and International shipping
Study return management
Documentation support services
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Regulatory Guidance and Consulting
CMC Section support for IND, NDA filings (EU, US, Japan)
Post filing/post marketing support
Authorities inspections
 1996 FDA Dostinex (Cabergoline) PAI for commercial manufacturing
1996 FDA Idamycin and Idamycin PFS PAI for development activities
2003 Italian Ministry of Health: GMP inspection to be authorized to
manufacture Investigational Products and for commercialization
2005 AIFA.: periodic GMP inspection
2008 AIFA: periodic GMP inspection
2008 FDA: PAI for a Sterile Injectable Lyo product and relative diluent
2009 FDA: PAI for a Sterile Injectable Lyo product
2010 FDA: PAI for two products, one Sterile Injectable form and one Oral
2010 AIFA: periodic GMP inspection
2010 PMDA: PAI for a Sterile Injectable product
2012 FDA: PAI for two products, both Sterile Injectable forms
2013 AIFA.: periodic GMP inspection
2015 FDA: general GMP inspection
GMP Certificate
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AIFA manufacturing Authorization aM- 89/2014
Issued on June, 5th 2014
MANUFACTURING OPERATIONS FOR COMMERCIAL MEDICINAL
PRODUCTS
Sterile products:
Aseptically prepared:
Lyophilisates
Small volume liquids
Terminally sterilized:
Small volume liquids
Non-sterile Products:
Hard shell capsules
Tablets
GMP Certificate
MANUFACTURING OPERATIONS FOR INVESTIGATIONAL MEDICINAL
PRODUCTS
Sterile products:
Aseptically prepared:
Lyophilisates
Small volume liquids
Non-sterile Products:
Hard shell capsules
Other solid dosage forms
Tablets
SECONDARY PACKAGING
SPECIAL REQUIREMENTS:
CYTOTOXICS AND CYTOSTATICS
Contact Details
Address:
NerPharMa Viale Pasteur 10 – Casella postale n.11
20014 NERVIANO (MI)
ITALY
Contact Details
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Davide Taffurelli, CEO:
[email protected],
tel: +39 0331 581 672, mobile +39 348 89 04 435
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Germano D’Arasmo, Business and project manager:
[email protected],
tel +39 0331 581 259, mobile +39 335 13 02 967
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Ombretta DeCesare, Logistic and Customer manager:
[email protected]
tel +39 0331 581 152, mobile +39 348 570 12 00
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Attilio Tomasi, Industrial director & QP drug substance
[email protected]
tel +39 0331 581 619, mobile +39 348 890 49 70