All or part of the information contained in this document should be treated as the

confidential property of Preclinical Study Centre. It cannot be published or divulged for

whatever purpose to unauthorized persons, or third parties, in any form without the

prior written consent of Preclinical Study Centre.

Pushchino, 2017

Disclaimer

Contract Development

Manufacturing

Organization

«Pushchino»

Production of more than 20 names of drugs, including

• monoclonal Ab - Ekulizumab, Natalizumab, Adalimumab, etanercept, Tocilizumab,

Bevacizumab, Cetuximab, Ranibizumab, Palivizumab, Trastuzumab, Ustekinumab and others.

• Recombinant and fusion proteins and enzymes– Alteplase, Dornase alpha,

Darbepoetin alfa, Imatinib, Sunitinib, Interferons, etc..

Invented name (proprietary

name)

Price for 1 pack,

Rur

IP expiry US IP expiry EU

Adalimumab (Humira) 0,8 ml –80000 Rur Dec. 16 Apr. 18

Infliximab (Remicade) 20 ml – 50000 Rur. Feb.15 Sep. 18

Etanercept (Enbrel) 50 ml – 50000 Rur. Feb. 15 Nov. 28

Darbepoetin alfa (Aranesp) 0,5 мг – 80000 Rur Jul. 16 May. 24

Rituximab (MabThera)

500мг/50мл –

40000 Rur Nov. 13 Sep 16

Biosimilar market behavior

0

200

400

600

800

1000

1200

Humira (AbbVie Inc.) Exemptia (Cadila, India) Adfrar (TorrentPharmaceuticals, India)

Price for 1 pack, EU

0

0,5

1

1,5

2

2015г., млдр.$ 2016г., млрд.$

Biosimilar and Original ratio

Inflectra, Pfizer Inc. Remicade, Johnson & Johnson

Biosimilars are able to actively generate incomes on markets occupied with existing blockbusters

World biosimilar market, bln $ Biotech medicinal substancesmarket of RF, import ~ 70%

2015 2016 Import in 2016

Other82%

Biological Drugs18%

monoclonal Ab24%

peptide hormones, steroid

13%

biological antibiotics10%Insulins / glucagon

9%

factors8%

enzymes / antienzymes8%

immunoglobulins5%

synthetic proteins5%

erythropoietins3%

others15%

State import substitution programme analysis according to Ministry of Industry and Trade of the Russian Federation Federal Law #656 as of 31 Mar 2015

of them

020406080

100

Adalimumab Rituximab Sunitib Darbepoetin alfa

2015/ thsnd packages 2016/ thsnd packages

Dynamics of Government Biological Drugs Procurement Market - Target product line

+550%

+216% +350%

0102030405060

Leaders of the growth in absolute terms

2015 / bln rubles 2016 / bln rubles

+1978%

+60%

+350% +2350%

+2365%+216% +113%

+550%+550%

Company dynamics

Prospects for the development

Full GxP testings

International Accreditation

0

2

4

6

8

10

2015 2016

revenue/ mln rubles

contracts

Preclinical Study Centre, LLC

Distinctiveness, Novelty and Attributes

Biotechnological GMP grade industry zone 2000 m2

3 fermentation plants

6 pharmaceutical substances production lines

Value Proposition

50 l 200 l 10 l 100 l 100 l 100 l

Up to 5 kg API/ year

Eukaryotes reactors Prokaryotes reactors Yeast reactors

Up to 13 kg API/ year Up to 23 kg API/ year

Thank you for kind attention!

Ilya N. Chistyakov, MD, PhDchistyakov@preclinical.ru

+7 (916) 226 25 48

“Preclinical Study Centre" LLC.

of. 409, 3 Nauki av., Pushchino Moscow Region, 142290, Russia

e-mail: request@preclinical.ru

Development of a new drug product progress

Basic research Disease study Drug study Preclinical studies Clinical trials ph. I, II, III Marketing study ph. IV

Bioanalysis and bio analytics

Research and Development Preclinical and Clinical studies Post marketing and PV

Clinical Laboratories

Development of products and

processes

Small-scale production for pre-commercial batches

Data Transfer and Up Scaling Commercial manufacture

GLP GCP

GMP GDP, GSP, GVP

Manufacturing and Expertise Laboratories

Bioanalysis and bio analytics Post marketing and PV

IP

1

2

3

1 – Pushchino Scientific Center RAS activities

2 – Pharmaceutical Valley Cluster activities

3 – Demanded CDMO activities

Project localization infrastructure

In vitro

microbiology

Institute of Biochemistry and

Physiology of Microorganisms

Toxicocinetics

bioanalytical and clinical chemistry

Moscow Institute of Physics & Technology

In vivo

non-HP toxicology

Institute of Medical Primatology

Bioeq and Phase I-III

Clinical trials

Pushchino Scientific Center Clinic

Moscow State University of

Fine Chemical Technologies

Moscow State University

Science Park I.M. Sechenov First

Moscow State Medical University

Pushchino State Naturally Institute of Science

In vivo

rodent toxicology

Laboratory of Biological Testing

IBCh, RAS

Pharmaceutical

ValleyCluster

Stages and terms of project implementation

Year

quarter I II III IV I II III IV I II III IV

Pre-feasibility study

Bankable Feasibility Study

Tender for FEED

Front-end engineering design, feasibility analysis, conceptual planning

and design

Detailed design, grid connection, equipment delivery, operation,

installation, commissioning and start-up

Staff training, validation of processes and equipment, handover to

production

` - complete

2017 2018 2019

` - commencement of operations

` - completion of work

Conclusive statement

Of current concern

The market is growing rapidly.

The project is of high interest for the government, the investors and the producers.

The competitors contract 100% of their production capacity at the building phase.

«At the right time and place» (the fundamental grounding for successful implementation)

Historically established scientific and human capacities of Pushchino.

Personnel training programs developed in Pushchino State Naturally Institute of Science in cooperation with Moscow State University of Fine Chemical

Technologies, Moscow State University and the Science Park of I.M. Sechenov First Moscow State Medical University.

70% of orders portfolio is already formed

Achieving the strategic objective

Creating a powerful tool to provide the National biological security

Increasing the competitiveness of the domestic biopharmaceutical industry

Import substitution of thigh-tech products

Increasing federal and local tax payments and creating jobs