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Pierre Fabre : Expertise in oncology and dermatology based on natural and biological sources
Bertrand Parmentier Chief Execu+ve Officer, Pierre Fabre
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FROM HEALTH TO BEAUTY
• Pharmaceu+cal laboratory founded by Pierre Fabre, French pharmacist in the early 60’s
• €2.0 billion net sales – 10 000 in house employees
• Structured in 2 divisions around 3 complementary ac+vi+es: Prescrip+on drugs, Healthcare, Dermo-‐cosme+cs (cosmetology)
• France’s 3rd-‐leading pharmaceu+cal laboratory
• Europe’s leading dermo-‐cosme+cs laboratory
• R&D exper+se in natural and biological ac+ve ingredients
Mr. Pierre Fabre 1926 • 2013
PIERRE FABRE LABORATORIES
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Pierre Fabre Laboratories belong to a public interest founda+on whose mission is to improve access to quality medica+on and care in the least developed countries (Africa / South-‐East Asia)
• The Pierre Fabre Founda+on is the Group’s main shareholder (86 %) through its affiliate Pierre Fabre Par+cipa+ons
• The remaining 14% are split between employees and Treasury stock
• The profits made by the company each year are primarily reinvested in R & D
• The vast majority of the dividends will be paid to the Founda+on, so that it can pursue its public interest mission
GOVERNANCE SHAREHOLDING CONTROL STRUCTURE
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NET SALES* OF € 910M IN 2013
PRESCRIPTION DRUGS : 70% - OTC DRUGS : 30%
PHARMACEUTICALS
7 MAIN FRANCHISES
ORAL CARE
NATURAL HEALTH
OTHER THERAPEUTIC FIELDS
ONCOLOGY
FAMILY HEALTH
NEUROPSYCHIATRY
WOMEN’S HEALTH
DERMATOLOGY
* Excluding dermatology commercialized by the Dermo-‐cosme+cs division
p 55
NET SALES OF € 1089M* IN 2013
AVENE : MARKET LEADER IN EUROPE AND ASIA
DERMO-COSMETICS
9 INTERNATIONAL BRANDS
AVENE
KLORANE
DUCRAY
A-‐DERMA
RENE FURTERER
GALENIC ELANCYL OTHERS
* Including prescrip+on drugs in dermatology
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GLOBAL REACH…
…LOCAL ROOTS
p 57
R & D EXPERTISE
R&D annual expenditure : € 210 million • Pharmaceu+cals : 17% of sales • Dermo-‐cosme+cs : 5% of sales
3 priority areas • Oncology • Neuropsychiatry • Dermatology
7 main research centers 1,400 employees
Ac+ve network of academic partners (CNRS, INSERM, etc.)
Oncology Cytotoxic
Oncology An+bodies
Neuropsychiatry
Dermatology Dermo-‐cosmeMcs
Skin clinical research
Avène Spring water Marine acMve substances
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Venous insufficiency Breast, Bladder & Lung Cancers
Benign prosta+c hypertrophy
Serenoa repens Tropical periwinkles
(Catharanthus roseus)
Ruscus Aculeatus
BOTANICAL EXPERTISE PIERRE FABRE PRESCRIPTION DRUGS & HEALTHCARE
Rhealba® oat
Skin care
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A CULTURE OF PARTNERSHIPS IN R&D
INSERM CNRS
University Paris VI Shiseido
Otsuka University Of Bordeaux
Maruho Merck
Roche Forest
p 60
DEVELOPING OUR PRESENCE IN CHINA
SINCE 1996
• 1996 Launch of Navelbine® IV drug (breast and lung cancers)
• 2003 Launch of Avène in dermo-‐cosme+cs
• 2008 Partnership with the Chinese Dermatology Associa+on (CDA) • 2010 Crea+on of the Atopic Derma++s Founda+on (with CDA)
• 2012 Agreement with China Resources Guokang Pharmaceu+cal for the distribu+on of Navelbine® Oral
• 2013 Kick-‐off of Javlor® (vinflumine) clinical trial (breast cancer)
Laurent Audoly Global Head of Drug Development
at Pierre Fabre Laboratories
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ONCOLOGY PIPELINE
Javlor® (vinflunine, iv) Bladder cancer
Javlor® (vinflunine, iv) Breast cancer
F14512 (targeted topo II inh.) AML
F50067 (CXCR4 mAb) AML+ MM
W014A (PD1 Decoy)
F50085 (ADC)
Javlor® (vinflunine, iv) Head & Neck cancer
MulMple
NON CLINICAL DEV
PHASE I PHASE II PHASE III RESEARCH LAUNCHED
Busilvex® (busulfan, iv) Bone marrow transplant (adult & pediatric)
Navelbine® (vinorelbine iv & oral) Breast, Lung & Prostate cancers
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DRUG DEVELOPMENT IN CHINA: JAVLOR® (VINFLUNINE, IV) IN BREAST CANCER
BREAST CANCER TRIAL:
An open label, mul+center, randomized, phase III study of vinflunine + capecitabine versus capecitabine alone in pa+ents with Advanced Breast Cancer previously treated with an anthracycline and a taxane.
• First Pa+ent In : Oct 2013 / Last Pa+ent In: Apr 2015 • 334 pa+ents / 30 sites in China
Objec+ves:
• Primary: Progression Free Survival (Apr 2016)
• Secondary: Response Rate, Disease Control Rate and Dura+on, Overall Survival, and Safety
p 64
DRUG DEVELOPMENT IN CHINA: NAVELBINE® (VINORELBINE, ORAL)
IN BREAST AND LUNG CANCER BREAST CANCER TRIAL:
An open label, randomized mul+centre, phase II trial of oral vinorelbine + epirubicin vs intravenous vinorelbine + epirubicin as first-‐line chemotherapy in pa+ents (133 pts) with Advanced Breast Cancer (ABC)
LUNG CANCER TRIAL:
An open-‐label, randomized mul+centre, phase II trial of oral vinorelbine + cispla+n or intravenous vinorelbine + cispla+n in pa+ents (132pts) with advanced Non Small Cell Lung Cancer (NSCLC)
Primary objec+ves for each trial: • Response Rate
Secondary objec+ves for each trial:
• Progression Free Survival and Overall Survival • Safety and tolerability • Pharmacokine+cs of intravenous and oral vinorelbine
p 65
NAVELBINE® DRUG DEVELOPMENT CLINICAL TRIAL SITES
Shenyang
Beijing
Tianjin
Wuhan Chengdu
Nanning
Guangzhou
Fuzhou
Hangzhou
Shanghai Nanjing
13 Breast Cancer sites 6 Lung Cancer sites
p 66
SAFETY AND EFFICACY: ORAL VS. IV NAVELBINE® IN ASIAN PATIENTS
• Oral vinorelbine in combina+on with either epirubicin in first line ABC or cispla+n in first line NSCLC is an ac+ve regimen.
• Clinical performance and pharmacokine+cs are similar to those reported with iv vinorelbine in combina+on with either epirubicin in ABC or cispla+n in NSCLC.
• Hematological toxici+es are the most frequent dose-‐limi+ng events with both formula+ons, mainly related to the close monitoring performed on D8 administra+ons:
• Despite the high incidence of neutropenia, febrile neutropenia was <10% with both formula+ons in the trials performed in Chinese ABC and NSCLC pa+ents
• Gastrointes+nal events as nausea, diarrhoea, and cons+pa+on can be easily managed by oral 5-‐HT3 inhibitors, and dietary educa+on.
• Currently under review with Chinese regulatory authori+es
Yi-Long Wu Vice-‐President of the Guangdong General Hospital & Guangdong Academy of Medical Sciences and director of the Guangdong Lung Cancer Ins+tute
p 68
CONTENTS
CURRENT SITUATION OF LUNG CANCER IN CHINA 01
INTRODUCTION OF CSCO (CHINESE SOCIETY OF CLINICAL ONCOLOGY)
ORAL CHEMOTHERAPY BENEFITS TO PATIENTS
COLLABORATE ON INNOVATIVE DRUGS TO FASTEN CHINESE PATIENTS BENEFIT FROM NEW THERAPEUTIC METHOD
02
03
04
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THE INCIDENCE OF LUNG CANCER (NON SMALL CELLS LUNG CANCER) IN CHINA
• The incidence of lung cancer in China has increased over the last three decades, linked to environmental pollu+on and smoking habits
• According to 2009 Chinese lung cancer sta+s+cs1: • crude incidence rate 53.57 per 100,000 • mortality rate 45.57 per 100,000
• Around 600,000 people die of lung cancer in China each year2
• NSCLC is es+mated to account for up to 90% of lung cancers3 65% of Chinese NSCLC pa+ents present with late stage disease
1. Hao J et al., [Chinese Cancer Registry Annual Report 2012]. Beijing: Military Medical Science Press; 2013; 2. She J et al., Chest 2013;143:1117–26; 3. Yang P et al.,Chest 2005;128:452–62. 3. NSCLC: non-‐small cell lung cancer
p 70
CHALLENGES TO EFFECTIVE CANCER CONTROL IN CHINA, INDIA AND RUSSIA
The most common causes of cancer-‐associated disability-‐adjusted life-‐years lost in China in 2010 were lung and liver cancer.
Lancet Oncol 2014; 15: 489–538
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CONTENTS
CURRENT SITUATION OF LUNG CANCER IN CHINA 01
INTRODUCTION OF CSCO (CHINESE SOCIETY OF CLINICAL ONCOLOGY)
ORAL CHEMOTHERAPY BENEFITS TO PATIENTS
COLLABORATE ON INNOVATIVE DRUGS TO FASTEN CHINESE PATIENTS BENEFIT FROM NEW THERAPEUTIC METHOD
02
03
04
p 72
THE DEVELOPMENT OF CSCO (CHINESE SOCIETY OF CLINICAL ONCOLOGY)
• Established in 1997, Beijing
• Membership: Individual & Group member
• The Science and Educa+on Fund • non-‐profit social charitable grants • for CSCO member
• since October 2002
YEAR INDIVIDUAL ONCOLOGIST GROUP MEMBER
2004 over 4,200 39
2014 over 12,000 80
p 73
GLOBAL PERSPECTIVE
Closer friendship with naMonal socieMes
p 74
CSCO 2014 INTERNATIONAL TRACK
• Interna+onal collabora+on with Na+onal Socie+es • Language: English • Another interna+onal joint symposium on Lymphoma is a one-‐day mee+ng on Day 1, Sep.18, 2014
DAY 1, SEP.18 DAY 2, SEP. 19 DAY 3, SEP.20
AM ASCO-‐CSCO joint symposium on Breast Cancer
ESMO-‐CSCO joint symposium on Colorectal Cancer
JSMO-‐CSCO joint symposium on Gastric Cancer
PM IASLC-‐CSCO joint symposium on Lung Cancer
Plenary SITC-‐CAHON-‐US CACA-‐CSCO joint symposium on Immunotherapy
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CONTENTS
CURRENT SITUATION OF LUNG CANCER IN CHINA 01
INTRODUCTION OF CSCO (CHINESE SOCIETY OF CLINICAL ONCOLOGY)
ORAL CHEMOTHERAPY BENEFITS TO PATIENTS
COLLABORATE ON INNOVATIVE DRUGS TO FASTEN CHINESE PATIENTS BENEFIT FROM NEW THERAPEUTIC METHOD
02
03
04
p 76
ORAL CHEMOTHERAPY
PaMents’ preference for oral versus i.v. chemotherapy has been demonstrated in two studies
A QUESTIONNAIRE-‐BASED STUDY 1
• Major reasons for preference for oral therapy included
• Convenience • problems with i.v. access or needles
• bexer environment for chemotherapy administra+on
• However, 70% of pa+ents were unwilling to sacrifice efficacy to retain their original preference
THE PATIENTS’ CHOICE
89% of pa+ents preferred oral chemotherapy
1Liu G et al. J Clin Oncol 1997;15:110–15
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ORAL CHEMOTHERAPY
A RANDOMIZED, CROSSOVER STUDY (I.V. VERSUS ORAL THERAPY) A QUESTIONNAIRE-‐BASED STUDY1
• The majority (84%) of pa+ents preferred oral therapy Order of treatment did not influence pa+ent preference
• Most frequent reasons for preferring oral therapy were that
• treatment was a pill
• therapy could be administered at home*
• QoL is significantly (p=0.001) reduced in pa+ents receiving chemotherapy in hospital versus at home2
THE PATIENTS’ CHOICE
1 Borner MM et al. Eur J Cancer 2002;38:349–58 2 Payne SA et al. Soc Sci Med 1992;35:1505–9
p 78
ORAL CHEMOTHERAPY
• Engender much saving for Hospital admission, Hospital Stay, dura+on of remission (and, in some cases, also survival) while maintaining the quality of life of pa+ents.
• Reduce medical ins+tu+ons overload by large number of pa+ents in China.
THE PAYERS’ CHOICE
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CONTENTS
CURRENT SITUATION OF LUNG CANCER IN CHINA 01
INTRODUCTION OF CSCO (CHINESE SOCIETY OF CLINICAL ONCOLOGY)
ORAL CHEMOTHERAPY BENEFITS TO PATIENTS
COLLABORATE ON INNOVATIVE DRUGS TO FASTEN CHINESE PATIENTS BENEFIT FROM NEW THERAPEUTIC METHOD
02
03
04
p 80
FASTEN INNOVATION FOR PATIENTS
CHINA NATIONAL POLICIES: • Encourage innova+on in the pharmaceu+cal fields, • Encourage the global synchronized development of innova+ve drugs for the
early benefit of pa+ents.
SOCIAL RESPONSIBILITY: • Public demand: meet all the needs of public demand for the latest
treatment, • NaMonal strategy: adapt to na+onal innova+on and development strategy • Development of the industry: innova+on, the introduc+on of advanced
conversion concepts, models and treatments • InternaMonal compeMMon: early involvement in the development of
innova+ve drugs may also help Chinese experts to learn the fron+ers of knowledge in the concerned areas.
TO ENSURE CANCER PATIENTS’ ACCESS TO INNOVATIVE DRUGS THROUGH COLLABORATION BETWEEN THE WEST AND CHINA
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Thanks!
