NUVISAN GROUP

Our Philosophy

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EARLY DEVELOPMENT

Introduction to Nuvisan

Fully integrated Contract Research Organisation headquarted in Neu-Ulm,

southern part of Germany.

Nuvisan - Early Development• Headquartered in Neu Ulm, Germany, with more than 30 years of

successful business operations offers services in Bioanalytics, Pharmaceutical Analytics, Phase I/IIa, Clinical Trial Supplies, CDM & Biometrics, Regulatory Affairs.

Nuvisan –Oncology

• Headquartered in Paris, France, is a global group of experiencedprofessionals in Clinical Research and Development in Oncology, a core competency of Nuvisan Pharma Services.

Nuvisan - Clinical Development Solutions

• Headquartered in Madrid, Spain, offers all Clinical Services in Phase II-IV.

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NUVISAN GROUP

The Nuvisan Group is established through three Business Units

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EARLY DEVELOPMENT

Pharmaceutical Development

• 20 years of Formulation Development experience

• Proven expertise in Phase I Development

• Rapid Phase I approach / Quick proof of concept

• Unique development campus with all disciplines under one roof

• Dosage forms:capsules, tablets, OPCs (oral powders for constitution) plus liquid vehicles, powder blends, wet granulation, sachets, fluid bed coating

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EARLY DEVELOPMENT

Clinical Trial Supplies - Services

CTS Packaging and Logistics

• Primary Packaging: Blisters, bottles, sachets, tubes

• Secondary Packaging: Blister cards, wallets, patientkits

• Label Printing: Randomised, double blind, multilingual

• International Clinical Distribution incl. Depot Network

• Import / QP Release

Manufacturing

• Capsules

• Over-encapsulation

• Tablets

30+ professional staff

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EARLY DEVELOPMENT

Pharmaceutical Analytical Services

• ICH Stability Testing (API, Formulations)

• CTS Comparator Stability Studies

• Method Development

• Method Validation

• Cleaning Validation

• Pharmaceutical Batch Control

• Batch Release CTS

• Raw Material Testing and Release

• Special tasks (e.g. infusion compatibility etc.)

• 30+ professional staff

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EARLY DEVELOPMENT

Bioanalytics

• One of the largest bioanalytical laboratories in Europe

• 2500 m² arranged over four laboratories

• 60+ Professional staff

• Analysis of drugs and their metabolites in biological matrices

• Method Development and Validation (more than 500 non-proprietary assays)

• Method Adaptation and Revalidation

• Method Transfer

• Cross Validation

• Biomarkers / Protein-Binding

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EARLY DEVELOPMENT

Bioanalytics / Quality

• GLP certified since 1994

• Last FDA Inspection 2009

• LC-MS/MS incl. 2x Sciex API 5000

• GC-MS

• ICP- MS (PE Elan)

• HPLC Units (detectors: UV, ECD, F)

• Immunoassay Lab / Clinical Chemistry

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EARLY DEVELOPMENT

Phase I Clinical Pharmacology

• Strategic Planning & Project Management

• Phase I – IIa (healthy volunteers and patients)

• 80 beds, 12 bed ‘Intensive Care’ unit

• First in Man

• BA/BE

• Interaction studies (drug / drug & food)

• Special Populations

• 35+ professional staff including 8 MD‘s

• PK/PD expertise

• On site clinical chemistry and bioanalysis

• Pharmacy, QP release and on-site IMP support

• On site catering - special diets

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ONCOLOGY

Oncology drug development and clinical trial management

Our expertise resides in:

• Support for product development for cancer therapy

• Clinical optimization of single agent and combination therapies, notably for first-in-man molecules

• Exploration of treatments for targeted populations with unmet needs

• Implementation of the trials necessary to achieve successful registration

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ONCOLOGY

We have assisted various companies in early product developmentthrough MTD definition

• PK analysis and recommendation of Phase II/III strategies

• Solid experience in performing international Phase I, II and Phase III studies for registration purposes

• Our experience covers a wide range of solid tumors, hematological diseases, and a variety of cancer therapies.

• Our involvement results in pertinent and well executed trials with expedited approval for marketing and rapid adoption of new cancer treatments.

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ONCOLOGY

Medical oncology input at every step:

• Unique protocol design by our medical oncologists with medical and scientific input to ensure feasibility

• Real-time data evaluation in Phase I studies to optimize the dose andschedule, and maximize patient safety

• Targeted Phase II-III study design (eligibility criteria, endpoints, appropriate controls, etc.)

• On-site medical source review by oncologists

• Medical involvement throughout all stages of clinical development, from Phase I to Phase III

• Access to a global network of experienced investigators

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ONCOLOGY

Clinical operations expertise:

• Rigorous project management by experienced staff ensuring timely and seamless study implementation

• Quality clinical monitoring with oncology-specific training, GCP/ICH compliance, up-to-date in the field, e-CRF experience

• Medically-driven data management (MedDRA, WHO-DRUG, NCI-CTCAE, etc.) and statistical analyses, using validated systems (SAS®/SPSS®/Oracle Clinical ®- FDA 21 CFR Part 11, Clintrial™ )

• Medical writing: protocols, clinical study reports, peer-reviewed publications (preclinical/clinical), IBs, IMPDs, abstracts, posters, clinical summaries, etc.

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ONCOLOGY

Clinical operations expertise:

• Pharmacovigilance: SAE reporting, narratives, Competent Authority reporting, Oracle AERS, following FDA, ICH, EMEA PV guidelines

• Regulatory Affairs: Ethics Committees, Competent Authorities, regulatory submission

• Quality Assurance: global SOPs, audit plan, site audits

• Database cleaning

• Training in oncology tailored to the Sponsor’s needs

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Clinical Solutions

Clinical Trial Services (Ph II – IV)

• 60 experienced Professionals across Western/Eastern Europe

• Strategic planning & project management

• Feasibility & Site selection

• Preparation of essential documents

• Submission to EC and CA

• Clinical monitoring

• Pharmacovigilance – QP trained

• Data management & statistical analysis, PK/PD

• Medical writing

• IMP manufacturing, packaging, labelling & distribution

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ADCURAM GROUP

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Organigram

ADCURAM GROUP

Nuvisan is Part of a Family-Owned International Industry Group

• ADCURAM is a family-owned international group that invests in companies with good substance and significant growth potential.

• Led by entrepreneurs, ADCURAM develops its businesses with a long-term approach.

• Hence, ADCURAM provides its group companies with financial resources and expert teams to invest in operational improvement,research and development, growth, and complementary acquisitions.

• ADCURAM is based in Munich, Germany, and currently employs ~ 2500 highly qualified and motivated employees worldwide. ADCURAM group companies have subsidiaries in all major regions, including USA and Canada, South America, Western and Eastern Europe, Russia, and China. ADCURAM expects to grow strongly in the coming years.

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NUVISAN HEADQUARTERS

Contact

NUVISANNUVISANNUVISANNUVISANPharma Services

Wegenerstrasse 1389231 Neu-UlmGermany

HeadquartersHeadquartersHeadquartersHeadquartersTel +49 731 - 9 84 0 – 0Fax +49 731 - 9 84 0 - 280

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