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Corporate Overview

Global Footprint

Innovation Infrastructure

Vaccines

Key Business Highlights

Portfolio & Pipeline

Manufacturing Infrastructure for Vaccines, Biosimilars & mAbs

Pharmaceuticals

Key Business Highlights

NCEs

NDDS & Generic Products

Manufacturing Infrastructure (Pharma)

Pipeline Overview

Collaborations

Panacea Bioec in the region

Barriers for doing business

Some suggestions 2

Contents

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• Pharmaceuticals

• Vaccines

• Biotherapeutics (Biosimilars, mAbs & Peptides) Business Lines

• 2nd Largest Vaccine Producer in India

• Ranked 48th amongst Pharmaceutical Companies in India (ORG-IMS, 2012) Ranking

• Four Research & Development Centers

• Established Sales & Distribution Network in India, 50 branded products

• Direct presence in Germany for specialty hospital products segment

• Presence in 55 ROW and Emerging Markets

• cGMP Manufacturing Facilities

Infrastructure

• 3,800 Human Resource

• 275 in R&D

• 1,200 in Sales and Marketing Manpower

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Corporate Overview

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Serbia Bosnia

Germany

Kazakhstan

Belarus

Ukraine

Russia

Syria

Vietnam Thailand

Sri-lanka

Kenya

US

Australia

New Zealand

Philippines

Myanmar

Uganda Nigeria

Tanzania

Mongolia

Cambodia

Singapore

Hong Kong Algeria

Morocco

India

Brazil

Switzerland

Turkey

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Global Footprint

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Drug Discovery: Small Molecules • Target identification to development of pre-

clinical candidate • Focus areas : Metabolic disorders, Anti-

infectives, CNS

Laksh, Mohali OneStream, New Delhi

Drug Discovery: Novel Biologicals • Target identification to development of pre-

clinical candidate • Focus areas for Novel Peptides: Metabolic

Disorders • Vaccines & Biosimilars

GRAND, Navi Mumbai Sampann, Lalru

NDDS Product Development • Platform NDDS technologies :

Nanoparticles, Liposomes, Micro-particles, Depot Injections, SPORT, Oral films etc.

• High barrier to entry generics

Difficult to Develop Products • High barrier to entry generics • NDDS technologies: Depot Injections, Oral

modified release, SMEDDS in Softgels, MD tablets, Critical dose drugs

• Vaccine Formulation & Bio-therapeutics Development

Innovation Infrastructure

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Vaccines

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• Established presence of over 25 years vaccines

• Reliable partner to WHO, UNICEF: has been largest supplier of vaccines to UNICEF from

India

• First Indian Company to launch innovative branded combination vaccine – Easyfive

(DTP/Hep B/Hib) & other combination vaccines (Easyfour, Ecovac)

• One of the 3 Companies chosen by Govt. of India to develop Flu vaccine (Pandemic Flu)

Vaccine Business – Key Highlights

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• Easyfive (DTwPPTB-HepBPE-Hib-CRM NVD)

• Easyfour (DTwPPTB-Hib-CRMNVD)

• Novohib (HibPE-TTPTB)

• Polprotec (IPVNVI)

• Enivac HB (Hep BPE)

• Ecovac - 4 (DTwPPTB-HepBPE)

• Primopol (tOPVPTB)

• mOPV 1 SP, PTB

• bOPV (type 1 & 3) sp,PTB

# Combination vaccines in Green

• PTB - PT BioFarma • SP - Sanofi Pasture • PE - PanEra Biotec Pvt Ltd • NVD - Novartis Vaccines and Diagnostics • NVI - Netherlands Vaccin Institut

Marketed Vaccine Products

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Expertise in Combination Vaccines

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• Easyfour-Pol (DTwPPE-Hib-TTPE-- IPVNVI)

• Easysix (DTwPPE-HepBPE-Hib-TTPE- IPVNVI)

• Hapy3 (DTaPPE)

• Hapyfive (DTaPPE-Hib-TTPE- IPVNVI)

• Hapysix (DTaPPE-Hib-TTPE-HepBPE- IPVNVI)

• Dengue (Chimeric Recombinant Tetravalent )

• Japanese Encephalitis (Inactivated cell culture based viral vaccine)

• Pneumococcal Conjugate CRM (10v Phase I;

• 15v conjugate

• Universal Flu (Recombinant viral vectored)

• Seasonal Flu (Quadrivalent seasonal Vaccine)

• Meningococcal (Tetravalent conjugate vaccine

PE : PanEra Biotec Pvt Ltd NVI: Netherlands Vaccin Institut now called as Bilthoven Biologicals

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Vaccine Pipeline

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Manufacturing Infrastructure Vaccines & Biosimilars

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Mammalian Cell Culture Products • MAbs • Biosimilars

• Low pressure Chromatography

Gel Filtration Chromatography

Ion exchange chromatography

• Tangential flow filtration (TFF)

Concentration / Diafiltration

• HPLC

• Centrifugation

• Sterile filtration

• Purification High Pressure Chromatography Medium Pressure Chromatography

System

• Fermentation Capacity at

Production Level

Pre inoculum preparation - 1 x 5 L

Inoculum Preparation - 1 x 50 L

Production fermentation - 2 x 500 L

Harvesting - Microfiltration (TFF)

Bio-therapeutics: Manufacturing Capabilities

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Indigenous & fully integrated bulk antigen manufacturing facilities

Location Bulk Antigen Facilities Built Up Area

Recombinant Vaccines

Bacterial Vaccines

Tetanus Vaccine

Cell Culture Vaccines

Lalru

~ 40,000 sq. ft

~ 18,000 sq. ft

~ 20,000 sq. ft

~ 30,000 sq. ft

(US-FDA / UK-MHRA compliant)

• Licensed Bulk Antigens – Diphtheria Toxoid • Tetanus Toxoid • Whole cell / acellular Pertussis Haemophilus influenzae type b conjugate • Recombinant Hepatitis B Inactivated H1N1 split viron influenza vaccine bulk (egg based technology)

• Facility has provision for production of Bulk Antigens which are under development Vaccines : Dengue Vaccine, Japanese Encephalitis, Sabin IPV, egg based seasonal flu

vaccine, Yellow Fever vaccine Bio therapeutics : Viral proteins, non-viral recombinant bio molecules on cell culture in

both conventional & disposable formats

Vaccine - Manufacturing Capabilities

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Formulation Capacity of 1.6 billion doses p.a. (Includes Vials & PFS)

Location Formulation Facilities Capacities (mn doses/yr ) Built Up Area

Delhi 1 line for Oral vaccines 800 ~ 50,000 sq ft

Baddi 3 lines. 2 for Vials , 1 for PFS PFS-16

Single dose -39 20 Dose -800

~ 129,167 sq ft

Facility Location: Baddi, Himachal Pradesh

Vaccine - Manufacturing Capabilities

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Key Business Highlights Pharma

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Market Key Achievements Pipeline

ROW

Latin America: Brazil, Other Latin America

CIS: Russia, Serbia, Srspska & Bosnia, Kazakhstan, Ukraine, Uzbekistan, Belarus

Asia: Vietnam , Cambodia, Myanmar, Mongolia, Philippines, Sri Lanka

Middle East: Syria, Jordan

Africa: Kenya, Uganda, Tanzania, Nigeria

• Commercialized over 50 brands in more than

20 countries

• Major brands: Alhpadol, Dolzero, Fosbait, Glizid

Range, Livoluk, Mycept, Nimulid Range, Ocimix,

Pangraf, Panimun, Sitcom, Thank OD, Toff MD & Toff

Plus

• 20 Branded Generics

• 3 NDDS

Pipeline Products available for out licensing:

• 40 Branded Generics

• 7 NDDS

TACROFORT

Pharmaceutical Business – ROW

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Major Therapeutic Areas

Key Brands Key Achievements Future Pipeline

Organ

Transplantation,

Renal Disease

Pangraf, Panimun Bioral, Mycept, Fosbait , Epotrust

• Leadership in organ transplant market with 30% market share in respective segment

• Pangraf and Fosbait ranked 1st in respective segment

• Panimum Bioral and Mycept ranked 2nd in respective segment

• 2 NDDS products • 3 Branded generic products

Oncology PacliALL

• 1st to introduce Albumin bound formulation of Paclitaxel in India

• PacliALL ranked 2nd in the respective segment

• 1 Nanoparticle based product • 2 Liposomal products • 2 Depot injections • 7 Branded generic products

Diabetes ,

Cardiovascular

Glizid , Glizid –M, Glizid MR, Glizid Total

• Glizid ranked 1st among Gliclazide and Gliclazide combination market with ~ 20% market share

• 1 NDDS product • 4 Branded generic products

Pain

Management

Willgo, Nimulid MD, Nimulid SP, Nimulid MR

• Nimulid Group ranked Number 3 amongst the Nimesulide and Nimesulide combinations market

• 1 NDDS product • 1 Branded generic product

Pharmaceutical Business – India

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Pharma Formulation Facility, Baddi

• State-of-the-art cGMP facility approved by US FDA, EU agencies, ANVISA, and TGA amongst others

• 161 Product Approvals from 14 countries

• Maintain high standards of manufacturing by using state of art GMP compliant machines

Production Lines Annual Capacity (in Millions)

Anticancer (Cytotoxic Products)

Liquid and Lyophilized Injectables

1.2

Tablets & Capsules 50

Other Dosage Forms

Tablets 3,000

Hard Gelatin Caps 650

Soft Gelatin Caps 150

Ointments & Gels 42

Liquid Orals 24

Dietary Supplements 300

Pharmaceutical - Manufacturing Capabilities

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Difficult to

develop

Generics

NCE Biosimilars,

Peptides,

Vaccines

Pipeline

Generics

NCE & Peptides

• 4 Best in Class NCE

• 1 Atypical NCE

• 2 Novel Peptides

Biosimilars, Peptides, Vaccines • 4 Biosimilars in

development • 4 Peptides in

development • 10 Innovative

vaccines in development

ICH Region:

• 1 Generic Launched in US

• 2 ANDAs under review in US

• 2 MAA granted in Europe

• 29 ANDAs in development

NDDS

NDDS

• 7 best in class NDDS products in development (Scientific advice from US / European agencies has been taken for 5 products)

Pipeline Overview

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Marketing Partnership in US

Major Collaborations

RIVM, Netherlands

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PBL

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Panacea Biotec in the region

• With Binnopharm

• Intially HiB Vaccine, other pipeline products in due course

RUSSIA

• Global Alliance with Osmotica

• Advanced R&D and product marketing

HUNGARY

• With Alymore Corporation

• Products Easyfive, Polprotec KAZAKHSTAN

• With Uzbiopharma

• Products Easyfive, Polprotec UZBEKISTAN

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Barriers for doing business

Secured Banking

Language

Monopolistic Market

domination

High Entry

Barriers

Transparency

High Cost of

Operation

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Some suggestions

Reduce registration timelines

Single Window agency : for enhanced interface with Local companies & fast track approval

Set clear SOPS for the Bio technology Industry as well as allied products : Local initiative

National level support to Local manufacturing companies – hence, increased need to collaborate for “localising” the operations

Partnering in Govt programmes – Pharma 2020

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For more information, please visit our website at

www.panaceabiotec.com

Dr. Goutam Ghosh

Panacea Biotec Ltd. B-1 Extn./G-3, Mohan Co-op. Indl. Estate, Mathura Road,

New Delhi-110 044, INDIA

Phone : +91 11 4167 9012

Fax : +91 11 4167 9068

Email : goutamghosh@panaceabiotec.com

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