brochure

TABLE OF CONTENTS
03
OUR MISSION AND VALUES
05
ABOUT THE COMPANY
09
ABOUT OUR PROJECTS
14
WHAT IS BIOCAD FRANCHISING
17
WHAT DOES FRANCHISEE GET
22
BIOSIMILAR PRODUCTS
26
MABNEXT INNOVATIVE PRODUCTS
29
PROJECT STAGES
31
OUR EXPERT TEAM
32
ADVANTAGES
34
CONDITIONS FOR PARTICIPATION IN OUR PROJECT
35
INVESTMENT
OUR MISSION AND
VALUES
BIOCAD 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 BUSINESS
Is creativity and professionalism in solving problems.
Patience and painstaking hard work is our formula for successfully
achieving our goals.
OUR MISSION AND
VALUES
BIOCAD is a full cycle innovative biopharmaceutical company.
OUR BUSINESS IS BASED ON
The 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.
WE MEET
GOOD MANUFACTURING PRACTICE
The Company produces original and generic drug products in
the following areas:
- oncology
- autoimmune diseases
- chronic viral infections
WE MEET
GOOD LABORATORY
PRACTICE
Biocad is a leader among Russian pharmaceutical companies
measured by number of clinical trials.
14 YEARS
FOCUS
LEADER
Founded in 2001,
The Company is focused
As of the end of
BIOCAD is one of the
on product development
2011 and 2012
leading companies in
and commercialization
- leader in clinical trials
the Russian Federation.
in the Russian Federa-
in Russia.
tion, CIS states and other
As of the end of 2013
countries.
- one of the leaders in
net profit ratio*.
* According to www.remedium.ru
ABOUT THE COMPANY
ABOUT THE COMPANY
30 PRODUCTS DEVELOPMENT TURNOVER
Our portfolio includes 30
Currently over 40 products
Over $200 million.
products, 8 of them are
under development.
А 3 fold increase by
biotechnological products,
EMPLOYEES
the close of 2014.
most of which are marketleaders in Russia.
Presently more than 860
employed with the company,
350 of whom are in R&D.
PROJECT’S
SLOGAN
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.
ABOUT OUR PROJECTS
Generics
ChemNext
Biosimilar
PRODUCTION TECHNOLOGY FOR MONOCLONAL ANTIBODIES
Anti-IL-17
Anti-IL-6R
Anti-PD-1
Anti-cMet
Anti-Ang-2
and other
Rituximab
Bevacizumab
Trastuzumab
Infliximab
Adalimumab
and other
MANUFACTURING FACILITY
PARTNER
BIOCAD FRANCHISING
WE MAKE DECISIONS EVERY DAY, AND THESE DECISIONS
HAVE LASTING IMPACT.
DECISIONS WE MAKE TODAY SHAPE OUR FUTURE.
YOU CAN CHOOSE ANY FORM OF COOPERATION
Be Easy
Be Quick
Be Smart
FROM THE SIMPLEST TO HIGHEST-YIELDING BUSINESS MODELS.
BE EASY
Couldn’t be any simpler.
Distribution of high-value, high-demand finished
dosage forms on your territory.
DURATION - FROM 1 YEAR
Finished drug product
Package of standards
Sales tools, marketing
If you enjoy sales but don’t like manufacturing, this option is for you.
BE QUICK
Couldn’t be any faster.
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
Production
process for
finished drug
products
PACKAGE
OF STANDARDS
-
Support from
our experts
QC
staff training
sales tools
marketing
If you already have experience in pharmaceuticals and you want to
follow your own path this option is for you.
BE SMART
Couldn’t be any brighter.
Is perfect for companies that want to produce local product from
the scratch.
DURATION - FROM 3 YEARS
CONSTRUCTION
TECHNOLOGY
ADMINISTRATION
LAUNCH
PRODUCTS
If you possess the necessary resources and wish to build your own
highly profitable business, this option is for you.
WHAT IS BIOCAD
FRANCHISING?
ATTRACTIVE
RETURNS
HIGH PROFITABILITY
CUTTING-EDGE
MEDICINAL
PRODUCTS
SHORT PAYBACK
PERIOD
HOW CAN YOU ACHIEVE IT?
WE HAVE A PLAN OF ACTION.
WHAT IS BIOCAD
FRANCHISING?
We share our experience, helping to avoid costly beginner’s
mistakes when launching a new product or line of business.
THERE IS MORE
TO COME
- Optimized technologies for manufacturing
MABNEXT Project and BIOSIMILARS products
- Staff training
- Full advisory support
- Powerful business practices
IT IS EASY
TO BUILD A PHARMA BUSINESS!
WE GIVE YOU
A VEHICLE AND
TEACH HOW
TO DRIVE IT
WHAT DOES
FRANCHISEE GET?
WHAT DOES
FRANCHISEE GET?
CONSTRUCTION
Assistance in construction of a mAb manufacturing facility.
TECHNOLOGY
Training in the manufacturing of biological products.
ADMINISTRATION
Package of operational management standards.
LAUNCH
Expertise that helps you at any launching stage.
WHAT DOES
FRANCHISEE GET?
CONSTRUCTION
WE MEET
THE COOD
MANUFACTURING
PRACTICE
STANDARDS
Production process and quality control at BIOCAD
is in accordance with European GMP
(Good Manufacturing Practice) standards.
WHAT DOES
FRANCHISEE GET?
TECHNOLOGY
WE MEET THE
STANDARTS OF THE
INTERNATIONAL
CONFERENCE ON
HARMONISATION
WE MEET THE
QUALITY BY DESIGN
STANDARDS
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.
WHAT DOES
FRANCHISEE GET?
DESIGN OF MANUFACTURING FACILITY
Facility is designed with the assistance of international consulting
companies taking into account BIOCAD real-life experience.
CAPACITY
Capacity and production processes have been emulated using
SuperPro Designer (USA).
EQUIPMENT
Modern biotech equipment with focus on the use of disposables.
MATERIAL SUPPLIES
Delivery system & full specification list for raw materials,
equipment and consumables.
BIOSIMILAR PRODUCTS
358 741
NON-HODGKIN’S
LYMPHOMA IS ANNUALLY
DIAGNOSED IN 358 741
PEOPLE WORLDWIDE
IN RUSSIA THERE ARE
7 715 NEW CASES PER YEAR
RITUXIMAB
R
Acellbia – the first Russian mAb
biosimilar prescribed to patients with
non-Hodgkin’s lymphoma and
chronic lymphocytic leukemia.
Launched in 2014.
365 233
CHRONIC LYMPHOCYTIC
LEUKEMIA IS ANUALLY
DIAGNOSED IN 365 233
PEOPLE WORLDWIDE
IN RUSSIA THERE ARE
3 264 NEW CASES PER YEAR
The cost of treatment in Russia with the
R
original drug Mabthera starts from USD 20 000,
while cost of treatment using our product is 15% less.
1,7 М
LUNG CANCER IS
ANNUALLY DIAGNOSED
IN 1.7 MILLION PEOPLE
WORLDWIDE
IN RUSSIA THERE ARE
56 054 NEW CASES
PER YEAR
1М
COLORECTAL CANCER IS
ANNUALLY DIAGNOSED
IN 1 MILLION PEOPLE
WORLDWIDE
IN RUSSIA THERE ARE
34 729 NEW CASES
PER YEAR
BIOSIMILAR PRODUCTS
BEVACIZUMAB
R
Avegra – the first Russian mAb biosimilar
prescribed to patients with lung cancer,
colorectal cancer, renal cell carcinoma, glioblastoma and epithelial ovarian cancer.
Launch in 2015.
238 719
OVARIAN EPITHELIAL
CANCER IS ANNUALLY
DIAGNOSED IN 238 719
PEOPLE WORLDWIDE
IN RUSSIA THERE ARE
13 262 NEW CASES
PER YEAR
The cost of treatment in Russia with
R
the original drug Avastin starts from USD 40 000,
while cost of treatment using our product is 15% less.
BIOSIMILAR PRODUCTS
1,7 M
TRASTUZUMAB
BREAST CANCER
IS ANNUALLY DIAGNOSED
IN 1.7 MILLION PEOPLE
WORLDWIDE
IN RUSSIA THERE ARE
60 717 NEW CASES
PER YEAR
Herticad – the first Russian
mAb biosimilar prescribed to patients
with breast cancer and advanced
stomach cancer.
Launch in 2016.
R
The cost of treatment in Russia with
R
the original drug Herceptin
starts from USD 24 000, while cost
of treatment using our product is 15% less.
THE MABNEXT
INNOVATIVE
PROJECT
MABNEXT:
ORIGINAL PRODUCTS
A major innovative project for development of drug products
using monoclonal antibodies.
CLINICALLY VALIDATED TARGETS
Serious and life-threatening diseases
ONCOLOGY
AUTOIMMUNE DISEASES
-
- rheumatoid arthritis
- psoriasis
- multiple sclerosis
- Crohn’s disease
- systemic lupus erythematosus
breast cancer
lung cancer
colorectal cancer
pancreatic cancer
head and neck cancer
hepatic cancer
THE MABNEXT
INNOVATIVE
PROJECT
8
ORIGINAL
PRODUCTS ARE
IN FINAL
DEVELOPMENT
STAGES
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
PRODUCT
THE TECHNOLOGY PLATFORM FOR EFFECTIVE DEVELOPMENT
OF MONOCLONAL ANTIBODY DRUGS.
CHOOSING THE TARGET
preparation of the target
profile of the molecule
AntiIL-17
PRECLINICAL
STUDIES
HIGH-THROUGHPUT
SCREENING
FUNCTIONAL
CHARACTERISTICS
screening and
optimization of
candidate molecules
selection
of the final candidate
PHARMACEUTICAL
DEVELOPMENT
CLOUD
Bioinformatics support, in silico methods and statistical analysis.
DEVELOMENT OF A
MONOCLONAL
CELL LINE
AntiIL-6R
CLINICAL TRIALS
PHAGE DISPLAY
enrichment of
the library
with potentially
functional molecules
DEVELOPMENT
OF UPSTREAM &
DOWNSTREAM
PROCESSES
WHAT DOES
FRANCHISEE GET?
THE PACKAGE OF OPERATIONAL
MANAGEMENT STANDARDS
BEST BUSINESS PRACTICES
QUALITY CONTROL
ADVANCED STAFF TRAINING
IMPROVED SALES TOOLS
PROJECT STAGES
Be Easy
Authorization of the drug product
Staff training at every stage
of the project
Implementation of operational
management standards
Transfer of analytical QC procedures
for the finished drug
Transfer of analytical QC
procedures for API
Be Quick
Transfer of information
on drug manufacturing process,
equipment and materials
Qualification/validation
of manufacturing process
at the partner’s premises
Registration of changes
of drug production site
Staff training and skill evaluation
2Q
3Q
4Q
1Q
DISTRIBUTION OF
DRUG PRODUCTS
MANUFACTURED BY
BIOCAD
1Q
2 YEARS
2Q
3Q
3 YEARS
4Q
1Q
DISTRIBUTION OF DRUG PRODUCTS PRODUCED
LOCALLY USING APIs MANUFACTURED BY BIOCAD
1 YEAR
2Q
3Q
4Q
1Q
2Q
3Q
2 YEARS
4Q
1Q
2Q
3Q
3 YEARS
4Q
1Q
2Q
Production site construction
in compliance with GMP
Preparation of project documentation
Procurement of equipment
Be Smart
Equipment installation
Transfer of information
on manufacturing process,
equipment and materials for API
Working cell bank transfer
for API manufacturing
Vendor qualification
and procurement of raw
and auxiliary materials
API manufacturing process validation
Registration of changes
of API production site
Step 1 Be Easy - Distribution of finished drugs manufactured by BIOCAD.
Step 2 Be Quick - Distribution of finished drugs produced locally using APIs
manufactured by BIOCAD.
Step 3 Be Smart - Distribution of drugs produced locally using APIs manufactured at
our partner’s premises.
3Q
4Q
DISTRIBUTION OF THE DRUG PRODUCED USING API THAT WAS
MANUFACTURED AT OUR PARTNER’S PREMISES
1 YEAR
OUR EXPERT TEAM
DMITRY MOROZOV
PRESIDENT OF BIOCAD
ALEXANDER GRACHEV
VICE PRESIDENT MANUFACTURING
ROMAN IVANOV
VICE PRESIDENT
R&D AND INTERNATIONAL
BUSINESS DEVELOPMENT
ALEXANDRA GLAZKOVA
VICE PRESIDENT
HR, PR AND
CORPORATE MARKETING
ADVANTAGES
WE ENJOY AND ARE PROUD OF WHAT WE DO
Products that are vital
This enabled us to enter high-value, knowledge-based business
enjoy our work and are proud of our achievements
We lower the barrier to entry in the mAbs business by mitigating
risk and shortening time to break-even.
We will support you at all stages of building a new business
You will receive the right to use BIOCAD’s brand-name
ADVANTAGES
FREEDOM OF CHOICE
You can choose to enter at any stage, or to skip one:
Be Easy
– finished drug product
– package of standards
sales tools, marketing
Be Quick
– manufacturing
technology
– package of standards
– assistance of
our experts
Be Smart
– full-cycle company
YOU DON’T NEED
MUCH TO BECOME
A FRANCHISEE!
MODEST
INVESTMENT
PROFESSIONAL
EXPERTISE
BURNING DESIRE
TO SUCCEED
HOW MUCH FUNDS
DO YOU NEED?
INVESTMENTS
FROM $X MILLION TO $Y MILLION
DEDICATION - 3 YEARS
PAYBACK PERIOD - 3 YEARS
THANK YOU
FOR BEING
WITH US!
WWW.BIOCAD.RU