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TABLE OF CONTENTSOUR MISSION AND VALUES
ABOUT THE COMPANY
ABOUT OUR PROJECTS
WHAT IS BIOCAD FRANCHISING
WHAT DOES FRANCHISEE GET
BIOSIMILAR PRODUCTS
MABNEXT INNOVATIVE PRODUCTS
PROJECT STAGES
OUR EXPERT TEAM
ADVANTAGES
CONDITIONS FOR PARTICIPATION IN OUR PROJECT
INVESTMENT
03
05
09
14
17
22
26
29
31
32
34
35
OUR MISSION AND VALUESBIOCAD is a full cycle innovative biopharmaceutical company.
WE’VE CREATED An international innovative biopharmaceutical company and
absorbed the best practices of cutting-edge research
and management.
THE CORE OF OUR BUSINESSIs creativity and professionalism in solving problems.
Patience and painstaking hard work is our formula for successfully
achieving our goals.
OUR MISSION AND VALUESBIOCAD is a full cycle innovative biopharmaceutical company.
OUR BUSINESS IS BASED ONThe accumulation of advanced knowledge which
enables us to unlock the revolutionary potential for creating
optimal conditions for patients to live happier lives.
ONE OF OUR MAIN GOALS Is to build a socially oriented business based on respect
for human rights and development of a positive social
environment.
ABOUT THE COMPANY– Extensive research capacities meeting GLP standards.
– Manufacturing in compliance with GMP standards.
The Company produces original and generic drug products in
the following areas:
- oncology
- autoimmune diseases
- chronic viral infections
Biocad is a leader among Russian pharmaceutical companies measured by number of clinical trials.
WE MEET
GOOD MANUFAC-TURING PRACTICE
WE MEET
GOOD LABORATORY PRACTICE
14 YEARSFounded in 2001,
BIOCAD is one of the
leading companies in
the Russian Federation.
ABOUT THE COMPANY
FOCUSThe Company is focused
on product development
and commercialization
in the Russian Federa-
tion, CIS states and other
countries.
LEADERAs of the end of
2011 and 2012
- leader in clinical trials
in Russia.
As of the end of 2013
- one of the leaders in
net profit ratio*.
* A
cco
rdin
g t
o w
ww
.rem
ed
ium
.ru
ABOUT THE COMPANY
30 PRODUCTSOur portfolio includes 30
products, 8 of them are
biotechnological products,
most of which are market-
leaders in Russia.
DEVELOPMENTCurrently over 40 products
under development.
EMPLOYEESPresently more than 860
employed with the company,
350 of whom are in R&D.
TURNOVEROver $200 million.
А 3 fold increase by
the close of 2014.
EXPANDING LIFE’S HORIZONS
We believe that these words must be reflected in action. That is why
we work day-by-day toward the development of drug products to
combat severe and socially significant diseases.
We create the conditions for optimal quality of life for patients.
PROJECT’SSLOGAN
ChemNext
PRODUCTION TECHNOLOGY FOR MONOCLONAL ANTIBODIES
MANUFACTURING FACILITY
Anti-IL-17Anti-IL-6RAnti-PD-1Anti-cMetAnti-Ang-2and other
RituximabBevacizumabTrastuzumabInfliximabAdalimumaband other
BIOCAD FRANCHISINGPARTNER
Generics
Biosimilar
ABOUT OUR PROJECTS
Be Easy Be Quick Be Smart
YOU CAN CHOOSE ANY FORM OF COOPERATION
WE MAKE DECISIONS EVERY DAY, AND THESE DECISIONS HAVE LASTING IMPACT.DECISIONS WE MAKE TODAY SHAPE OUR FUTURE.
FROM THE SIMPLEST TO HIGHEST-YIELDING BUSINESS MODELS.
Distribution of high-value, high-demand finished
dosage forms on your territory.
DURATION - FROM 1 YEAR
BE EASYCouldn’t be any simpler.
If you enjoy sales but don’t like manufacturing, this option is for you.
Finished drug productSales tools, marketing
Package of standards
This option is ideal for pharmaceutical companies that have their own finished dosage forms manufacturing. It is aimed at those who want to broaden their product portfolio and for those who want to leverage local fill&finish.
DURATION - FROM 2 YEARS
BE QUICKCouldn’t be any faster.
If you already have experience in pharmaceuticals and you want to follow your own path this option is for you.
Production
process for
finished drug
products
PACKAGEOF STANDARDS- QC
- staff training
- sales tools
- marketing
Support from
our experts
Is perfect for companies that want to produce local product from the scratch.
DURATION - FROM 3 YEARS
BE SMARTCouldn’t be any brighter.
If you possess the necessary resources and wish to build your own highly profitable business, this option is for you.
CONSTRUCTION TECHNOLOGY ADMINISTRATION LAUNCH PRODUCTS
WHAT IS BIOCAD FRANCHISING?
ATTRACTIVERETURNS
HIGH PROFITABILITY CUTTING-EDGEMEDICINALPRODUCTS
SHORT PAYBACKPERIOD
HOW CAN YOU ACHIEVE IT?WE HAVE A PLAN OF ACTION.
WHAT IS BIOCAD FRANCHISING?
IT IS EASY TO BUILD A PHARMA BUSINESS!
We share our experience, helping to avoid costly beginner’s
mistakes when launching a new product or line of business.
- Optimized technologies for manufacturing
MABNEXT Project and BIOSIMILARS products
- Staff training
- Full advisory support
- Powerful business practices
THERE IS MORE TO COME
WE GIVE YOUA VEHICLE AND TEACH HOWTO DRIVE IT
WHAT DOESFRANCHISEE GET?
WHAT DOESFRANCHISEE GET?
CONSTRUCTION
Assistance in construction of a mAb manufacturing facility.
TECHNOLOGYTraining in the manufacturing of biological products.
ADMINISTRATIONPackage of operational management standards.
LAUNCHExpertise that helps you at any launching stage.
WHAT DOESFRANCHISEE GET?
Production process and quality control at BIOCAD
is in accordance with European GMP
(Good Manufacturing Practice) standards.
WE MEET
THE COODMANUFACTURING PRACTICESTANDARDS
CONSTRUCTION
WHAT DOESFRANCHISEE GET?
Manufacturing is based on the profound knowledge obtained from
drug development with deployment of QbD (Quality by Design)
approach. Along with equipment qualification and process
validation this enable mitigation of quality risk for finished
products and superior management of occupational safety.
The use of disposable materials is our priority in manufacturing.
The safety and well-being of our patients and employees is
the Company’s core value.
INTERNATIONALCONFERENCE ON HARMONISATION
WE MEET THE
QUALITY BY DESIGNSTANDARDS
TECHNOLOGY
WE MEET THESTANDARTS OF THE
WHAT DOESFRANCHISEE GET?DESIGN OF MANUFACTURING FACILITYFacility is designed with the assistance of international consulting companies taking into account BIOCAD real-life experience.
CAPACITYCapacity and production processes have been emulated using
SuperPro Designer (USA).
EQUIPMENTModern biotech equipment with focus on the use of disposables.
MATERIAL SUPPLIESDelivery system & full specification list for raw materials,
equipment and consumables.
BIOSIMILAR PRODUCTS
Acellbia – the first Russian mAb
biosimilar prescribed to patients with
non-Hodgkin’s lymphoma and
chronic lymphocytic leukemia.
Launched in 2014.
The cost of treatment in Russia with the
original drug Mabthera starts from USD 20 000,
while cost of treatment using our product is 15% less.
RITUXIMABR
NON-HODGKIN’SLYMPHOMA IS ANNUALLY DIAGNOSED IN 358 741 PEOPLE WORLDWIDEIN RUSSIA THERE ARE7 715 NEW CASES PER YEAR
CHRONIC LYMPHOCYTIC LEUKEMIA IS ANUALLY DIAGNOSED IN 365 233 PEOPLE WORLDWIDEIN RUSSIA THERE ARE3 264 NEW CASES PER YEAR
358 741
365 233
R
BIOSIMILAR PRODUCTS
Avegra – the first Russian mAb biosimilar
prescribed to patients with lung cancer,
colorectal cancer, renal cell carcinoma, glio-
blastoma and epithelial ovarian cancer.
Launch in 2015.
The cost of treatment in Russia with
the original drug Avastin starts from USD 40 000,
while cost of treatment using our product is 15% less.
BEVACIZUMABR
LUNG CANCER ISANNUALLY DIAGNOSED IN 1.7 MILLION PEOPLE WORLDWIDEIN RUSSIA THERE ARE56 054 NEW CASESPER YEAR
COLORECTAL CANCER IS ANNUALLY DIAGNOSEDIN 1 MILLION PEOPLEWORLDWIDEIN RUSSIA THERE ARE34 729 NEW CASESPER YEAR
OVARIAN EPITHELIAL CANCER IS ANNUALLY DIAGNOSED IN 238 719 PEOPLE WORLDWIDEIN RUSSIA THERE ARE13 262 NEW CASESPER YEAR
1,7 М
1 М
238 719
R
Herticad – the first Russian
mAb biosimilar prescribed to patients
with breast cancer and advanced
stomach cancer.
Launch in 2016.
TRASTUZUMABR
BREAST CANCERIS ANNUALLY DIAGNOSED IN 1.7 MILLION PEOPLE WORLDWIDEIN RUSSIA THERE ARE60 717 NEW CASESPER YEAR
1,7 M
BIOSIMILAR PRODUCTS
The cost of treatment in Russia with
the original drug Herceptin
starts from USD 24 000, while cost
of treatment using our product is 15% less.
R
A major innovative project for development of drug products
using monoclonal antibodies.
- breast cancer
- lung cancer
- colorectal cancer
- pancreatic cancer
- head and neck cancer
- hepatic cancer
- rheumatoid arthritis
- psoriasis
- multiple sclerosis
- Crohn’s disease
- systemic lupus erythematosus
CLINICALLY VALIDATED TARGETSSerious and life-threatening diseases
ONCOLOGY AUTOIMMUNE DISEASES
THE MABNEXT INNOVATIVE PROJECT MABNEXT:
ORIGINAL PRODUCTS
- unique amino acid sequence
- absence of non-human sequences
- potential for further improvement of pharmacological
properties by modification of Fc fragments
THE MABNEXT INNOVATIVE PROJECT
ORIGINALPRODUCTS AREIN FINALDEVELOPMENT STAGES
8
MABNEXT:ORIGINAL PRODUCTS
THE MABNEXTINNOVATIVEPRODUCT
CLOUDBioinformatics support, in silico methods and statistical analysis.
HIGH-THROUGHPUTSCREENING
screening andoptimization of
candidate molecules
PHAGE DISPLAYCHOOSING THE TARGET
preparation of the target profile of the molecule
FUNCTIONALCHARACTERISTICS
selection of the final candidate
DEVELOPMENT OF UPSTREAM &DOWNSTREAM
PROCESSES
THE TECHNOLOGY PLATFORM FOR EFFECTIVE DEVELOPMENT OF MONOCLONAL ANTIBODY DRUGS.
PHARMACEUTICAL DEVELOPMENTAnti-
IL-17
enrichment of the library
with potentially functional molecules
CLINICAL TRIALS
DE
VE
LOM
EN
T O
F A
M
ON
OC
LON
AL
C
ELL L
INE
PRECLINICAL STUDIESAnti-
IL-6R
WHAT DOESFRANCHISEE GET?
BEST BUSINESS PRACTICES
QUALITY CONTROL
ADVANCED STAFF TRAINING
IMPROVED SALES TOOLS
THE PACKAGE OF OPERATIONALMANAGEMENT STANDARDS
1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q
Authorization of the drug product
Staff training at every stageof the project
Implementation of operationalmanagement standards
Transfer of analytical QC procedures for the finished drug
Transfer of analytical QCprocedures for API
Transfer of informationon drug manufacturing process,equipment and materials
Qualification/validationof manufacturing processat the partner’s premises
Registration of changesof drug production site
Staff training and skill evaluation
PROJECT STAGES
2 YEARS 3 YEARS1 YEAR
Be
Easy
Be
Qu
ick
DIS
TR
IBU
TIO
N O
F
DR
UG
PR
OD
UC
TS
M
AN
UFA
CT
UR
ED
BY
B
IOC
AD
DIS
TR
IBU
TIO
N O
F D
RU
G P
RO
DU
CT
S P
RO
DU
CE
DLO
CA
LLY
US
ING
AP
Is M
AN
UFA
CT
UR
ED
BY
BIO
CA
D
1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q
Preparation of project documentation
Production site constructionin compliance with GMP
Working cell bank transferfor API manufacturing
Transfer of informationon manufacturing process,equipment and materials for API
Registration of changesof API production site
Procurement of equipment
Equipment installation
Vendor qualificationand procurement of rawand auxiliary materials
API manufacturing process validation
Be
Sm
art
DIS
TR
IBU
TIO
N O
F T
HE
DR
UG
PR
OD
UC
ED
US
ING
AP
I T
HA
T W
AS
M
AN
UFA
CT
UR
ED
AT
OU
R P
AR
TN
ER
’S P
RE
MIS
ES
- Distribution of finished drugs manufactured by BIOCAD.- Distribution of finished drugs produced locally using APIs manufactured by BIOCAD.- Distribution of drugs produced locally using APIs manufactured at our partner’s premises.
Step 1Step 2
Step 3
Be EasyBe Quick
Be Smart
2 YEARS 3 YEARS1 YEAR
OUR EXPERT TEAM
DMITRY MOROZOV PRESIDENT OF BIOCAD
ALEXANDER GRACHEV VICE PRESIDENT MANUFACTURING
ROMAN IVANOVVICE PRESIDENT
R&D AND INTERNATIONAL BUSINESS DEVELOPMENT
ALEXANDRA GLAZKOVAVICE PRESIDENT
HR, PR AND CORPORATE MARKETING
ADVANTAGES
We lower the barrier to entry in the mAbs business by mitigating
risk and shortening time to break-even.
WE ENJOY AND ARE PROUD OF WHAT WE DO
We will support you at all stages of building a new business
You will receive the right to use BIOCAD’s brand-name
This enabled us to enter high-value, knowledge-based business enjoy our work and are proud of our achievements
Products that are vital
– finished drug product
– package of standards
Be Easy Be Quick Be Smart
ADVANTAGESFREEDOM OF CHOICE
You can choose to enter at any stage, or to skip one:
sales tools, marketing
– manufacturing
technology
– package of standards
– assistance of
our experts
– full-cycle company
YOU DON’T NEED MUCH TO BECOMEA FRANCHISEE!
MODESTINVESTMENT
PROFESSIONALEXPERTISE
BURNING DESIRE TO SUCCEED
HOW MUCH FUNDS DO YOU NEED?
INVESTMENTSFROM $X MILLION TO $Y MILLION
DEDICATION - 3 YEARS
PAYBACK PERIOD - 3 YEARS
WWW.BIOCAD.RU
THANK YOUFOR BEINGWITH US!