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TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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Page 1: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products
Page 2: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 3: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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.

Page 4: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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.

Page 5: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 6: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 7: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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.

Page 8: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 9: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 10: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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.

Page 11: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 12: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 13: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 14: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

WHAT IS BIOCAD FRANCHISING?

ATTRACTIVERETURNS

HIGH PROFITABILITY CUTTING-EDGEMEDICINALPRODUCTS

SHORT PAYBACKPERIOD

HOW CAN YOU ACHIEVE IT?WE HAVE A PLAN OF ACTION.

Page 15: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 16: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

WE GIVE YOUA VEHICLE AND TEACH HOWTO DRIVE IT

Page 17: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

WHAT DOESFRANCHISEE GET?

Page 18: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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.

Page 19: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 20: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 21: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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.

Page 22: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 23: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 24: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 25: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 26: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar 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

Page 27: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar 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

Page 28: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

WHAT DOESFRANCHISEE GET?

BEST BUSINESS PRACTICES

QUALITY CONTROL

ADVANCED STAFF TRAINING

IMPROVED SALES TOOLS

THE PACKAGE OF OPERATIONALMANAGEMENT STANDARDS

Page 29: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 30: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 31: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 32: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

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

Page 33: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

– 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

Page 34: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

YOU DON’T NEED MUCH TO BECOMEA FRANCHISEE!

MODESTINVESTMENT

PROFESSIONALEXPERTISE

BURNING DESIRE TO SUCCEED

Page 35: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

HOW MUCH FUNDS DO YOU NEED?

INVESTMENTSFROM $X MILLION TO $Y MILLION

DEDICATION - 3 YEARS

PAYBACK PERIOD - 3 YEARS

Page 36: TABLE OF CONTENTS - · PDF filetable of contents our mission and values about the company about our projects what is biocad franchising what does franchisee get biosimilar products

WWW.BIOCAD.RU

THANK YOUFOR BEINGWITH US!