PIRAMAL DISCOVERY SOLUTIONS

Pharma Solutions

products and services

We are an integral part of Piramal Enterprises Ltd., a leading business group in India with multiple business interests. As a Group, we are committed to achieving excellence and leadership by practicing our core values of knowledge, action and care. We adhere to innovative, value-driven practices in our diverse business initiatives, ranging from healthcare and glass manufacturing to real-estate. Our beginning in the Healthcare business goes back to the year 1988 when we acquired Nicholas Laboratories. Since then we have grown into a

Our roots

leading pharmaceutical company in India and a dominant player on a global level.

With the changing dynamics of the pharmaceutical industry worldwide, innovation and cost have emerged as key challenges for pharmaceutical companies worldwide. We enable our customers to address these challenges by offering cost effective and reliable delivery solutions across the product lifecycle.

We are the Contract Development & Manufacturing arm of Piramal Healthcare, a part of Piramal Enterprises Ltd. Our capability as an integrated solutions provider enables us to serve Innovator and Generic companies worldwide.

Our customers can avail a comprehensive range of services across all phases of the drug lifecycle which includes Drug Discovery & Development,

Manufacturing and Packaging of Clinical Trial Supplies, Delivering Commercial Volumes of APIs as well as Finished Dosage products. To provide flexibility and scalability of operations, we have invested in a network of contract development and manufacturing facilities located in North America, Europe and Asia.

Delivering Globally Integrated

Solutions across the drug lifecycle

Canada

Toronto

U.S.A

Boston

India

Ahmedabad

|

Ennore

Pithampur

|

Digwal

|

Mumbai

China

Shanghai

United Kingdom

Grangemouth

|

Morpeth

Cambridge

Global

Network

Consistent

Track

Record

Integrated

Solutions

Financial

Stability

People &

Science

Hallmark

of Quality

& Safety

our global network of assets spread across Europe, North America and Asia. Our network enables us to deliver benefits by strategically placing projects to take advantage of low costs, local supply chains and s p e c i f i c c u s t o m e r / m a r k e t requirements.

Our R&D team is led by scientists with experience of working with pharma companies across the globe and hold expertise across various chemistries and range of formulation types.

We are a pioneer in the Contract Development and Manufacturing Services market and have an experience of over two decades. We have advanced manufacturing facilities approved by leading regulatory agencies including the US-FDA and MHRA. We are a trusted supplier to more than 100 pharma companies across the US, Europe and Japan including all major Big Pharma and large Generic companies.

We believe that the best can be delivered if only there is an internal focus on quality. Stringent quality and safety norms are followed across our facilities worldwide. With capabilities across drug

discovery, development, scale-up and manufacturing of APIs as well as Formulations, we are well positioned to address customers’ needs across the entire drug lifecycle. Our specialization in Antibody Drug Conjugation, Clinical Trial Supplies, Packaging and Biocatalysis enables us to provide differentiated services to our customers.

Piramal Enterprises Ltd., currently valued at more than 1 billion USD, is amongst the largest business conglomerates in India. We embrace a rich legacy of over 20 years in the business of healthcare.

PIRAMAL DISCOVERY

SOLUTIONS

We, Piramal Discovery Solutions (formerly known as O2h) are an integral part of Piramal Pharma Solutions and deliver early stage drug discovery services to Pharma companies, Biotech companies and Academic institutions.

Our 10,000 m² (100,000+ ft²) greenfield campus is located in a Special Economic Zone (SEZ), which is a government sponsored industrial park with specialized infrastructure to encourage export and industrialization. Our campus benefits from on-site customs clearance, central waste and power management and secure buildings with access control points.

Our modern and advanced facility hosts 28 lab units (12 fume-hood reconfigurable modules), a write-up area and research campus that accommodates over 300 scientists. Our specialized areas are

- Medicinal and Synthetic Chemistry - In vitro and in vivo Pharmacology - Integrated Drug Discovery

MEDICINAL AND

SYNTHETIC CHEMISTRY

We are a reputed service provider of discovery chemistry. We have partnered with a range of well known pharmaceutical and biotechnology companies from Europe, USA and Japan. Our specialized team at PDS has a wide array of experience in preparing small molecule NCEs with the requisite high quality specifications. Our medicinal chemistry expertise includes hit expansion, hit to lead optimisation, lead generation and lead optimisation. All of these can be accessed as stand-alone offerings or as a part of an integrated drug discovery project.

Our demonstrated expertise lies in the following chemistries

• Complex / multi-stage synthesis • Heterocyclic • Chiral • Carbohydrate • Peptide • Aliphatic • Nucleoside • Natural product

Our techniques include • Microwave chemistry • High pressure chemistry • Cryogenic chemistry • Parallel synthesis

Our capabilities include

• Synthesis of small molecules on mg to kg scale (non-GMP) with the required high quality specifications, using diverse synthetic methodologies

• Modular custom-built lab units accommodating 12 FTE chemists each

• Lab units can be tailored to customer requirement, with key-card access and IP / IP security • Supported with latest equipment - NMR, LC-MS / MS, microwave, combiflashes and access to literature (journals, patents etc.)

• Typical projects undertaken by us include: design and synthesis of discrete or series of compounds, as well as synthesis of focused libraries for SAR / SPR optimization

Our specificities include

• Cambridge (UK) project office providing logistical, communications and objective project management support

• We have perfected clear templates which enable the systematic day-to-day reporting and measurement of scientific progress in the most effective manner

• Performance and productivity metrics are represented in a graphical form and shared internally as well as with the client

• Communications with clients range from direct communication to secure space on our intranet site for depositing documents and data arising during the projects

• Our dedicated team of personnel includes purchasing officers, store/stock managers as well as in-house customs liaising officer for efficient sourcing of starting materials

• Our IP (Intellectual Property) security model is designed to protect the IP of the clients during the project lifecycle and beyond

• Our scientists at are supported by a 360º _{support system which aims at maximising their time}

to focus on their projects

• We value integrity in communication and action; social responsibility with respect to waste management and making a contribution to the community

IN VITRO & IN VIVO

PHARMACOLOGY

Our biology facilities have been developed to provide faster decision-making points for our chemistry clients. Since 2008, we have doubled both our capacity as well as capability to include a range of pharmacology services to evaluate activity and/or potential liability of compounds. Currently, we are executing biology studies for several of our clients whose medicinal chemistry work is also being carried out by us; thus reducing the iterative cycle time of drug discovery and helping clients progress their compounds faster through the discovery stage. The biology work is available on a stand-alone basis as well as part of an integrated drug discovery project.

I. In vitro assays

• ADME: solubility, permeability, CYP inhibition / induction, plasma stability (across different species), microsomal / S9 stability (across different species), plasma protein binding

• Target-based: enzymatic / kinase assays, binding assays,

GPCR assays

• Cell-based: ELISA, proliferation, apoptosis, phosphorylation status, insulin sensitizer assays, cytokine production assays using hPBMCs, signal transduction assays

II. In vivo assays

• Collagen-induced arthritis • Adjuvant-induced arthritis • DSS-induced colitis • TNBS-induced colitis

• PMA-induced psoriasis / atopic dermatitis • IMQ-induced psoriasis / atopic dermatitis • Diet-induced obesity model

• Fat tolerance test • Glucose tolerance test • STZ-induced diabetes • Cytokine release

• Single / repeat dose acute toxicity

• Oral bioavailability / tissue distribution studies

Our capabilities

• Purpose-built labs include industry standard formats of fluorescence, luminescence and absorbance to help develop and optimize biochemical and / or cellular assays in a range of therapeutic areas

• In-depth expertise in pathophysiologically relevant experimental models for multiple therapeutic indications

• For in vivo studies, the macroscopic observations can be corroborated with a range of different techniques including but not limited to histopathological analysis, estimation of haematological and / or biochemical parameters etc

• Currently, the in vivo studies are performed only with rodents (e.g. mice, rats) • Customization of assays based on client’s requirement(s)

INTEGRATED

DRUG DISCOVERY

Our highly skilled team of scientists deliver services in Integrated Drug Discovery (IDD) projects incorporating medicinal chemistry (lead generation, hit-to-lead and lead optimisation), and in vitro and in vivo pharmacology. We offer expertise in multiple therapeutic indications.

We consider the ultimate metric to measure the success of an IDD project is the capacity to create intellectual property and value to our customers. Our goal of IDD is to afford our clients access to specialized skills without incurring their own fixed costs and operating in a dynamic, flexible manner that suits the competitive commercial environment of drug discovery.

Successful IDD projects rely on efficient integration of various disciplines

- Medicinal chemistry

- In vitro & in vivo discovery biology / pharmacology - ADMET

- Computer-Aided Drug Discovery - Operational excellence and expertise

Each of the varied modules of the drug discovery process is available as a unique point of entry individually as a subset of services or as the traditional drug discovery pathway from hit identification through to lead generation and beyond. Our expertise includes medicinal chemistry: hit expansion, hit to lead, lead generation/ optimization, computational chemistry, in vitro enzymatic and cell-based screening, DMPK and in vivo models in multiple therapeutic areas.

Our Core Values

Our Intellectual Property Policy

The cornerstone of our philosophy on intellectual property rights (IPR) is built on upholding the IP generated by the company and all its associates. In order to achieve this objective, we have set up various systems which ensure that we:

We value the relationships we have built with our customers. We believe that ‘Customer Centricity’ is the driver behind all our actions. Our performance is measured on the value delivered to our customers. We partner with our customers in developing and delivering solutions.

We function as an environmental-friendly organization and our practices have enabled us to • Pursue continuous improvement: Periodic audits and gap analysis are conducted

by Corporate EHS and cross functional teams

• Implementing EHS best practices through: ISO: 14001 and OHSAS: 18001

• Aim towards the goal of Sustainable Development by targeting the triple bottom line growth in the fields of Economics, Environment and Society

• Ensuring continuity of the business processes through Business Continuity Plans • Execute Process safety by implementing safety systems at all sites

• Enhance awareness, knowledge and skills of employees towards a safe, clean, greener and healthier work place

Customer

Centricity

All our manufacturing sites have been approved by leading global regulatory agencies. All major sites have been approved by the US-FDA without any 483s

Our aspiration is to be the best in class in global standards. Our process has evolved through the stages of:

• Create robust quality base

• Strengthen and implement system • Quality culture across the organization • Execute best in class standards

• Respect the IPR of all its clients, partners and competitors

• Do not infringe any process or product knowingly and / or unknowingly • Protect and enforce the IPR of the Company, our clients and partners • Introduce measures to reduce IPR infringement related risks

• Promote a culture of IPR compliance within the organization • Conduct periodic Intellectual Property Audits for effective IPR management and monitoring

Win Awards and Recognition

• Safety Award from National Safety Council of India, 2004 and 2005 • Runners-up at the ‘NE Business Awards Corporate Responsibility

& Environment’, 2009

• CII-National Award for Energy Efficient Operations, 2009 • Winner of State’s ‘Environment Award’, 2010

• Golden Peacock Award for Occupational Health & Safety, 2012 • Frost and Sullivan’s Green Manufacturing Excellence award, 2012

Respect

for IP

Environment

Quality

For further details on Piramal Discovery Solutions

contact us at

Frédéric Somny, Ph.D.

Head-Business Development

Email: [email protected]

Mobile: +33 683 359 372

www.piramaldiscoverysolutions.com

Our other services

• API Services

• API Generics

• Formulation Services

• Antibody Drug Conjugation

Drug Discov_{ery S}

ervic_es Ea rly _P ha se _A P_I E ar ly P ha se _F or_m ul_at io ns La te Pha se A PI La te P hase For mul atio ns Off pa tent API Cl in ica l T ria l S up plie s An tib od y D ru g C on ju ga te s Pa ck ag in g B io ca ta ly sis Pre-clinical Phase I Phase II Phase III Launch On-patent Off-patent Discovery DRUG LIFECYCLE Pre-clinical Phase I Phase II Phase III Launch On-patent Off-patent Discovery DRUG LIFECYCLE

Drug Discov_{ery S}

ervic_es Ea rly _P ha se A_P I E ar ly P ha se _F or_m ul_at io ns La te Pha se A PI La te P hase For mul atio ns Off pa tent API Cl in ica l T ria l S up plie s An tib od y D ru g C on ju ga te s Pa ck ag in g B io ca ta ly sis Pre-clinical Phase I Phase II Phase III Launch On-patent Off-patent Discovery DRUG LIFECYCLE Pre-clinical Phase I Phase II Phase III Launch On-patent Off-patent Discovery DRUG LIFECYCLE

Products & Services across the drug lifecycle

Core Services

Drug Lifecycle

Special Services

Piramal Enterprises Limited

247 Business Park, A - Wing, 6th floor,

LBS Marg, Vikhroli (W), Mumbai – 400 083. India. Phone: +91 22 3095 6666 Fax: +91 22 3095 6665

Email: [email protected] PPS/PDS/OC