Early Clinical Study in Cancer Patients Paris Region Paris 22, 23 February 2007

Early Clinical Study in Cancer Patients

Paris Region

Paris 22, 23 February 2007

France, world leader in development of new anti-cancer agents

Evidence for the efficacy of many anti cancer drugs was first provided in France.

CPT-11 CPT-11 was synthesized by Yakulto Honsha (Japan) Marketing approval in January 1994 in Japan, for the treatments

of non-small cell and small cell lung cancers, cervical cancers, and ovarian cancers.

Marketing approval in France in May, 1995, for the treatment of advanced colon cancers. (Rhone-Poulenc Rorer )

Licensed in Japan in September 1995 for the treatment of patients with colorectal cancer

Marketing approval in the USA in June 1996 for the treatment of patients with colorectal cancer

Oxaliplatin

Invented in 1976 by Dr. Kidani (Japan) Marketing approval with the indication of colorectal

cancer in France in 1996 Marketing approval in the USA in 2002 with same

indication Marketing approval with the same indication in Japan

in March, 2005

Taxotere

Discovered by Pierre Potier (CNRS, France) 1994 received the first marketing authorizations from Mexico

and South Africa for the treatment of advanced breast cancer in patients

1995: the first oncology drug to complete the European Union's new centralized review procedure and receive regulatory clearance in all 15 member countries in the treatments of patients with advanced stage breast cancer

1996 Market approval for the US

Navelbine (Vinorelbine)

Discovered by Pierre Potier (CNRS, France ) in 1978 First Marketing approval in France in 1989 in NSCLC by Pierre

Fabre the American FDA in 1994 in NSCLC

France, world leader in development of new anti-cancer agents

Eight anti-cancer drugs are manufactured in France for the rest of the world.

The Eli Lilly laboratories’ site for the worldwide supply of Alimta is in Alsace Ipsen produces Decapeptyl and Somatuline in France for the rest of the

world Exolatine is packaged in France for about fifty countries. Aventis Pharma has a production factory Taxotere for the rest of the world The same is true for Fasturtec, Gemzar and Vinorelbine.

France, world leader in development of new anti-cancer agents

12,000 people work in the field of cancer in the pharmaceutical industry in France

More than 230 clinical trials/year over the period 1998-2000

France, the second biggest market in Europe for oncology product

1.420 billion dollars in 2002 and a study by Datamonitor predicts an increase of 22% by 2005

France, one of the countries with the highest speed to market for drugs

France is the only country in Europe having a procedure for pre-market approval (ATU)

ATU procedure is an exceptional measure for marketing drugs available that do not have marketing approval.

The aim is to enable early access to new treatments when they are to be used for treating patients with serious disease and when there is no therapeutically alternative.

ATU is issued by the AFSSAPS( the French National Drug Agency)

France, the most active region in cancer clinical research

For exemple In 2002, 6241 patients participated into clinical studies organized

by EORTC (European Organization for Research and Treatment of Cancer, the biggest European cancer research network.

The highest number of patients included into studies were: France 1262 The Netherlands: 1261 The United Kingdom: 716 Germany: 426

Paris Region (Île de France)a structured and dynamic region for drug’s development

High population and patient concentration: 11 million inhabitants

High concentration of medical resources: 42,000 physicians/ 50,000 beds

High concentration of public/private establishments: 42% of biomedical research 20% of the healthcare market supply in Oncology

Paris Region (Île de France)a structured and dynamic region for drug’s development

The biggest French and international laboratories are present

50% of biotechnology companies are located 90% of CROs The large consultancies specialized in regulatory affairs The headquarters of the AFSSAPS, the French National

Drug Agency

France has launched its national plan to fight cancer on 23th March 2003

A national cancer institute and 7 Cancéropôle cancer centers have been set up to bring together the major research bodies

The Paris Region Cancéropôle Cancer Centre (Cancéropôle île de France) presided by Prof. Claude Huriet

Being the head of the French Cancéropôle network Its mission is o federate skills and research capabilities in

cancer research in the Paris Region through 7 Areas

Seven areas inside of Cancéropôle île de France

Tumor identify cards From tumor biology to innovative cancer treatments Host-tumor relationship: immune responses, angiogenesis Targeted screening and specific prevention of cancer Functional imaging of cancer New clinical research with novel tolls for the definition and

evaluation of clinical trials Human and social science

Area 6: Clinical Research

Its principal goal is to ensure the new and effective treatments will be available more readily to patients

The bureau of Phase I/II oncology study inside of Area 6

Represented by Jiali LI, Chief Manager, MD, PhD Karine Buffard, Assistant Manager, Pharm.D Hôpital Saint-Louis 1 Ave. Claude Vellefaux 75010 Paris, FRANCE Tel. 33-1-4803-7244

[email protected] karine. [email protected]

Executive committee constituted by Top French Authorities

Pierre BEY (Institut Curie) Véronique DIERAS (Institut Curie) Fabien CALVO (AP-HP) Michel MARTY (AP-HP) Olivier RIXE (AP-HP) Jean Nicolas MUNCK (Centre René Huguenin) Eric Angevin (Institut Gustave Roussy) Gilles VASSAL (Institut Gustave Roussy)

Members of Executive committee

Pierre BEY, Professor of Oncology Radiotherapy

Responsible person for Area 6 Director of Curie Institute’s Hospital Former Director of Regional anti cancer center (Lorraine-Centre

Alexis Vautrin),1991/2001 Former General Secretary of French Federation against cancer

(FNCLCC)

Members of Executive committee

Michel MARTY, Professor of Medical Oncology

Top authority of French National Drug Agency (AFSSAPS) since 1993: Member, drug approval commission Expert, transparency commission Chairman, anti-neoplastic agents working group/approval commission

President of Scientific Committee, French League against Cancer Expert of Commission for Proprietary, Medicinal Products, EMEA President of EuroCancer Author of more than 450 publications

Members of Executive committee

Gilles Vassal, Professor of Pediatric Oncology

Chairman of the European Consortium for Innovative Therapies for Children with Cancer

Expert of pediatric oncology, at EMEA and AFSSAPS Director of clinical and translational research at the IGR Author of more than 300 publications

Facilities for clinical cancer research in Cancéropôle île de France

2 main French and European reference cancer centers : Gustave Roussy Institute, Curie Institute

A third French cancer center, the René Huguenin center

The biggest hospital network in Europe: the AP-HP (Assistance Publique-Hôpitaux de Paris) including 14 establishments in Oncology

The Gustave Roussy Institute Established in 1921, the leading European anticancer centre 2,500 employees Fifteen departments with 400 beds 30,000 patients attend its clinics and 42,000 patients treated and

11,000 new patients per year More than 400 researchers working in 11 research units Technology platform: tumor biology, host-tumor interaction,

functional/metabolic imaging, epidemiology, healthcare economics Almost 20 years experience in conducting Phase I/II studies 12 Phase I trials, 14 Phase I/II trials and 47 phase II have been

conducted in the Institute during the year of 2004

Curie Institute

Established in 1921 by Marie Curie and Claudius Regaud

>1,700 people employees >650 researchers working in 12 research units 227-bed with 27 departments 8,000 new patients are treated each year Technology platform: Genomics, bioinformatics,

pharmacology, immunology; functional imaging More than 100 clinical trials including studies

sponsored by the Institute are conducted each year during the last 4 years

The René Huguenin Center

Founded in 1959 2500 new cases of cancer each year including

>1000 breast cancer Established in 1959 650 employees 150 beds Technology Platform: tumor bank/serum bank;

genomics, pharmacokinetics; host-tumor relationships; Oncogenetics, metabolic/functional imaging

Long experience for conducting phase I/II studies of new anti cancer agents

Assistance Publique-Hôpitaux de Paris (AP-HP) Biggest hospital network in Europe

39 establishments with >25,000 beds With 32% of hospital admissions in oncology in the

Paris Region (40 800 new patients a year) 16 of them have particularly well-developed

oncology 6 sites are highly specialized in oncology practice

and clinical study

Settling in the Paris Region

Guarantees successful entry

into the European market