SANOFI. A global healthcare leader, focused on patients needs CEPiA

Transcription

1 SANOFI A global healthcare leader, focused on patients needs CEPiA

2 CONTENTS OUR GROUP INDUSTRIAL AFFAIRS CEPIA CEPiA Contract Manufacturing CEPiA API Supply (BU per BU) CEPiA Offer in Russia & CIS

3 SANOFI AT A GLANCE We are a global healthcare company engaged more than employees present in more than 100 countries 112 Industrial sites in 41 countries A diversified offer of pharmaceuticals, vaccines and innovative therapeutic solutions R&D A major biopharmacy player 45% of revenues generated by biologics 80% of development projects are biologics

4 INDUSTRIAL AFFAIRS DIVISION

5 INDUSTRIAL AFFAIRS AT A GLANCE

6 CEPiA YOUR INDUSTRIAL PARTNER

7 CEPiA, your Industrial Partner Within the Industrial Affairs of Sanofi, CEPiA (Commercial & External Partnership, Industrial Affairs) covers third party activities, including Sales and Sub-contracting activities

8 DEDICATED SUPPORT TEAMS CEPiA, an expertise-oriented organization API SALES Opiates Corticosteroids Sythesis Biotech Prostaglandins Pharma Contract Manufacturing Injectables Inhaled Solids Semi Solids Liquids Custom Synthesis & API Coontract Manufacturing Monoclonal Antibodies Therapeutic proteins Viral vectors Peptides & Oligonucleotides Highly Active Ingredients Oligosaccharides Multi-step Chemistry DEDICATED COMMERCIAL TEAM IN KEY MARKETS

9 CEPiA, a worldwide organization 16 Chemicals & Biotech sites Located in 6 countries (mainly in Europe). 38 Pharmaceutical sites located in 25 countries. All our sites are regularly inspected by international health authorities full time industrial professionals for your project.

10 CEPiA Sales activity Drug Product Contract Manufacturing

11 CEPiA contract manufacturing An offer tailored to support your needs Quality Support Sanofi quality standards Quality: a core value of our company Customer Service Supply Chain reliability Oriented Customer Satisfaction Various & Efficient packaging to protect products A Dedicated Team Regulatory Support Ensure regulatory compliance Coordinate regulatory registration files Commercial Relationship Respect & Confidentiality Focusing on your needs Customized product grade

12 CEPiA contract manufacturing Pharma sites network UK GERMANY FRANCE ITALY SPAIN TURKEY CZECH REPUBLIC ROMANIA POLAND HUNGARY 12 CANADA USA MEXICO VENEZUELA COLOMBIA BRAZIL ARGENTINA MOROCCO TUNISIA EGYPT SENEGAL SOUTH AFRICA PAKISTAN INDIA VIETNAM CHINA JAPAN INDONESIA AUSTRALIA

13 CEPiA contract manufacturing Focus: Prague site - Production Capabilities SOLID DOSAGE FORMS SEMI-SOLID DOSAGE FORMS LIQUID DOSAGE FORMS Tablets Film coated tablets Sugar coated tablets Hard gelatine capsules Non sterile - ointments, creams, gels Sterile ointments, creams Suppositories Sterile Liquid Ampoules Vials Solution Non Sterile Liquid High Potential Products (Hormons) Tablets Film coated tablets Syrups Drops Suspensions 13

14 API Sales

15 CEPiA SALES at a glance More than 200 APIs on catalogue More than 80 countries invoiced 200 Collaborators close to you Dedicated teams for: Commercial support Quality Assurance & Regulatory Affairs Technical support and Development Customer Service

16 Sanofi CEPiA Moscow office your One-Stop-Shop close to your needs One-Stop-Shop: API supply API Registration Quality monitoring Customer support Sanofi expertize for your product development

17 BU Biotech CEPiA Sales activity

18 BU Biotech Our historical expertise in biochemical APIs Large scale fermentation has been since long one of our reference technology used to produce complex APIs over the time: Vitamin B12 derivates Antibiotics Rifamycins & Rifampicin (1959) Cyanocobalamin Roussel Uclaf 1960 Rhône Poulenc 1966 Hydroxocobalamins Roussel Uclaf Glycopeptides / Teicoplanin (1976) Lepetit - HMR Macrolides / Spiramycin (1952) Rhône Poulenc Aminoglycosides / Framycetin Roussel Uclaf

19 BU Biotech Our industrial footprint 2 French sites for vitamin B12 & derivates Elbeuf Aramon 2 major poles dedicated to integrated productions of traditional compounds 1 pole focused on specific biotech projects 2 sites for biotech projects Aramon / France Garessio / Italy 1 site in Italy for antibiotics Brindisi

20 BU Biotech Our Product List World leading manufacturer Soon Registered Originator Originator Originator Originator

21 BU Biotech Elbeuf : Largest fermentation site in Europe 310 people, 17 ha area Cyanocobalamin (vitamin B12) Only European producer Certifications: Kosher, Halal, injectable grade Plant exclusively dedicated to API manufacturing with dedicated fermentors and separate building for downstream processes Total fermentation capacity of 6000 m 3 (vessels of 147 m 3, 225 m 3 or 320 m 3 ) Automatized fermentation and extraction processes Regulatory approvals and certifications: FDA, PMDA, ANSM/GMP, ISO 14001

22 BU Biotech Brindisi : Biochemistry dedicated to antibiotics 210 people, sqm Antituberculosis APIs (originator) Rifampicin (RIFADIN, RIFATER, RIFINAH ) Rifamycin SV Na (RIFOCIN ) Other main APIs (originator) Teicoplanin (TARGOCID ) Spiramycin base (ROVAMICIN, RODOGYL, BIRODOGYL ) Regulatory approvals and certifications: FDA, AIFA/GMP, ANVISA, KFDA, ISO 14001, OHSAS 18001

23 BU Biotech From traditional fermentations to biotech Sanofi, the European supplier to propose a complete and fully integrated offer for traditional fermentation APIs, excluding use of intermediates from varied and distant origins. Sanofi, a leader in Biomanufacturing with expertise and capacities to produce high-tech APIs through recombinant technologies, cell cultures, protein engineering

24 BU Synthesis CEPiA Sales activity

25 BU Synthesis Chemical Synthesis within Sanofi: long history and rich tradition since 1880s Metamizol Mass production started in 1922 (Novalgin ) Articaine First synthesized by Rusching in 1969 and brought to the market in Germany by Hoechst AG in 1976 as Ultracaine Frankfurt 1880 Vitry 1908 Ketoprofen Discovered in 1967 (Profenid,orudis ) Phenothiazines 1947: start of Promethazine (Phénergan ) manufacturing 1950: discovery of Chlorpromazine (Largactil ) Sisteron 1917

26 BU Synthesis Chemical Synthesis within Sanofi A long history means : Excellent knowledge on manufacturing process Excellent product knowledge (on both side API and DP) Regulatory expertise Continuous process improvements

27 BU Synthesis A large & diversified product portfolio from a large industrial network More than 60 API coming from 11 manufacturing plants

28 BU Synthesis: A large & diversified product portfolio from a large industrial network Analgesics & anestetics Ketoprofen DL Lysine acetyl salicylate* DL Lysine acetyl salicylate + glycine* Carbasalate calcium Metamizol Na & Mg Articaine HCl Soon Registered Soon Registered Soon Registered * Under conditions/restricted Access

29 BU Synthesis: A large & diversified product portfolio from a large industrial network Central Nervous Systems Phenothiazines & derivatives Chlorpromazine HCl Registered Clorazepate di potassium* Levomepromazine Maleate and HCl Promethazine HCl Registered Benzodiazepines & derivatives Clobazam* Ethyl loflazepate Loprazolam methanesulfonate Zolpidem tartrate* Zopiclone* Others Amisulpride* Riluzole* Sulpiride Trimipramine maleate Valproic acid* Valproate Na* * Under conditions/restricted Access

30 BU Synthesis: A large & diversified product portfolio from a large industrial network Internal medicine Systemic & Cardiovascular Acebutolol Betaxolol HCl* Altizide Amiodarone HCl* Disopyramide phosphate* Furosemide Molsidomine* Piretanide* Ramipril (powder & coated) Ticlopidine HCl* Pentoxifylline Metabolic disorders Glimepiride* Ciprofibrate* Soon Registered Anti-allergic Alimemazine tartrate Sodium Cromoglycates Fexofenadine HCl* Dermatology Ciclopirox acid powder* Ciclopirox olamine powder* Prednicarbate HCl* Registered Others Busereline acetate* Hydroxychloroquine* Leflunomide* Noradrenaline hydrogenotartrate & Hcl* Oxybutynin HCl* Tiaprofenic acid *Under conditions/restricted Access

31 BU Corticosteroids & Hormones CEPiA Sales activity

32 BU Corticos & Hormones Our strong corticosteroid know-how Over the years, Corticotherapy has become the reference treatment for allergies and inflammation. More recently, corticosteroids have been used in combination for treatment of cancer. The 1950 s were the starting point for the development and commercialization of the principal corticosteroids: Prednisone in 1955 with Cortancyl by ROUSSEL UCLAF Prednisolone in 1956 Registered Dexamethasone in 1959 Registered Methylprednisolone in the 1960s. Soon Registered ROUSSEL UCLAF (Sanofi Group) continues to be a world corticosteroids market supplier. Today Sanofi offers a large product portfolio of around 30 corticosteroids manufactured on a ton scale.

33 BU Corticos & Hormones A large portfolio of around 30 APIs ANTI INFLAMMATORY Non fluorinated glucocorticoids and derivatives: Hydrocortisone, prednisone, prednisolone, methyprednisolone to treat: inflammatory diseases, allergy and asthma. Soon Registered Fluorinated glucocorticoids and derivatives: Dexamethasone, triamcinolone, fluorometholone for the same indication at lower dosage and with a longer onset of action. For various formulations: creams, tablets, injectables, nasal sprays and inhalers. ANTI-HYPERTENSIVES Soon Registered Mineralocorticoids: Spironolactone, canrenone and potassium canrenoate used as diuretics and blood pressure regulators

34 BU Corticos & Hormones Vertolaye Sanofi Main Corticosteroids Production site Over 700 people experienced in corticosteroids production More than 70 different APIs Chemical synthesis duration between 15 days and 16 months 86 different final dosage forms 500 chemical steps made Chemical synthesis From 2 to 40 consecutives steps Equipment volume About 300 vessels (reactors, spin dryers ) Between 150 and liters Regulatory requirements Certifications ANSM, FDA ISO certified GMP certificate for all active ingredients manufactured on site Last agency s audit on the site: FDA in April 2012, no remark on the 483 form, GMP Compliance

35 Jet milling expertise Center of expertise and industrialization for Sanofi Group A various range of particules size distributions from one micrometer to hundred micrometers

36 CEPiA Sales activity BU Prostaglandin - Chinoin

37 Development, Production, Sales 30 years experience CHINOIN, HUNGARY launched its first prostaglandin (PG) development project as early as the 1970s. The Prostaglandin business was so successful that a dedicated Business Unit was established in the 1990s to manage the increasing demands and activities. PG BU has successfully developed and industrialized several synthesis routes for natural and modified prostaglandins. Carboprost Beraprost Na Limaprost Chinoin was founded on the fundamentals of the timehonored Hungarian tradition and knowledge of chemical and pharmaceutical academic sciences. Due to highly experienced professionals, Chinoin has always been a fountain of innovation and provided partners with high-tech solutions. Soon Registered As a result of the high level of expertise and diverse portfolio, we are now supplying high quality Prostaglandin APIs in 65 countries, in partnership with more than 50 companies Dinoprostone Latanoprost Alprostadil

38 CEPiA Prostaglandin Business Unit Offer Flexible supply of broad range of natural and modified Prostaglandins from our regular manufacturing Equipment sizes from 2 L up to 3000 L Multi-purpose production lines, batch sizes up to 10 Kg API High-level service for specific customer needs by tailor-made solutions Flexible contractual relations: custom synthesis, exclusive agreements, capacity contracts Development with high-speed and flexibility Chemical Development specialized in experimental synthesis and scale-up Analytical Department specialized in method development, validation and stability studies Process development and scale-up of new chemical entities Quality service and Regulatory support Constant high quality, in-house specifications above monograph levels Supply of impurities, related substances, degradation products, working standards DMF file preparation and submission

39 CEPiA Sales activity FRANCOPIA The opiate expert CEPiA offer

40 FRANCOPIA AT A GLANCE N 1 in codeine exports 30 years of export expertise 40 years of industrial Scale poppy cultivation in France 50 years opiates prodution in the same manufacturing french site Present in 80 Countries over the 5 continents N 1 in naloxone sales 80 Years of Alkaloid extraction Source: INCB & IMS 40

41 OPIATE ACTIVITY Opium is obtained from papaver somniferum, a variety from poppy family Opiate : term generally used to designate drugs derived from opium and their chemically related derivatives, such as the semi-synthetic alkaloids Opioid : a more general term for both natural and synthetic drugs with morphine-like actions, although the chemical structure may differ from that of morphine Principal opiates naturally occuring in opium poppy : Morphine Codeine Thebaine PRESENTATION

42 A FULLY INTEGRATED ACTIVITY FROM POPPY SEEDS TO API PRODUCTION 1 - RESEARCH & DEVELOPMENT Development of varieties with high content of alkaloids 2 - AGRICULTURAL PRODUCTION More than Ha of poppy fields cultivated in France 3 - INDUSTRIAL PRODUCTION Manufacturing close to 20 API & intermediates. France Aramon & Germany Frankfurt 4 - GLOBAL COMMERCIAL & CUSTOMER CARE NETWORKS Exportation of narcotic materials to over 80 countries. PRESENTATION

43 A VERY SPECIFIC KNOW-HOW 2 manufacturing plants 2 range of products Aramon, France Continuous extraction process Over 50 years of expertise 8500 tons of granules processed resulting in +140 tons of active ingredients Frankfurt, Germany Long history in production of analgesic and synthetic narcotic API production i.e. the discovery and manufacture of Pethidine since 1930 s. Morphine/Codeine derivatives 1st generation APIs used as analgesic and cough suppressant. Codeine and its salts Morphine and its salts Thebaine derivatives 2nd generation APIs used as analgesics, gastro-intestinal disorders, treatment & prevention of addiction to opioids and alcohol, antidote to morphine/opiates. Naloxone HCL (not controlled) Nalbuphine HCL (not controlled) Naltrexone HCL (not controlled) Buprenorphine HCL Oxycodone HCL PRESENTATION

44 A DIVERSIFIED PORTFOLIO FOR A PAIN FREE WORLD A CHOICE OF 20 ACTIVE INGREDIENTS AND INTERMEDIATES Pain management Other treatments Moderate pain Level 2* Severe pain Level 3* MORPHINE DERIVATIVES Codeine, Dihydrocodeine, Ethylmorphine Morphine, Hydromorphone Apomorphine (Parkinson s disease/ Erectile dysfunction) THEBAINE DERIVATIVES Buprenorphine, Nalbuphine Oxycodone Naloxone, Naltrexone (antidote, management of alcohol dependence) SYNTHETIC OPIOIDS Pethidine Methadone, * World health Organization pain ladder PRESENTATION

45 A COMPLETE RANGE OF 20 ACTIVE INGREDIENTS AND INTERMEDIATES Product Name CEP EDMF (ASMF) USDMF JMF OTHERS* Apomorphine hydrochloride Buprenorphine hydrochloride Codeine base Codeine Camphosulfonate Codeine phosphate hemihydrate Concentrate of poppy straw (morphine) Concentrate of poppy straw (thebaine) Dihydrocodeine hydrogen tartrate Ethylmorphine hydrochloride Hydromorphone hydrochloride * Other DMF types or technical information DIFFERENT PARTICLE SIZE SPECIFICATIONS AVAILABLE ON DEMAND PRESENTATION

46 A COMPLETE RANGE OF 20 ACTIVE INGREDIENTS AND INTERMEDIATES Product Name Methadone hydrochloride Morphine base CEP EDMF (ASMF) USDMF JMF OTHERS* Morphine hydrochloride Morphine sulfate Nalbuphine hydrochloride Naloxone hydrochloride Naltrexone hydrochloride Oxycodone hydrochloride Pethidine hydrochloride Thebaine base * Other DMF types or technical information DIFFERENT PARTICLE SIZE SPECIFICATIONS AVAILABLE ON DEMAND PRESENTATION

47 CEPiA offer for Russia & CIS

48 Why choosing Sanofi CEPiA? Direct supply from the manufacturer Day to Day contact with your regional office Direct contact with the regulatory teams; CEPiA takes care of the API registration in the country (one dedicated manager in Moscow); One quality, the same API as in Sanofi drug products Reliable commercial partner for long partnership Benefit from Sanofi expertize for your product development

49 Sanofi CEPiA offer in Russia & CIS To increase supply of API to domestic manufacturers To perform API registration according to your needs and projects To support you with the development and registration of your product with Sanofi API API registered in Russia: -Dexamethasone sodium phosphate -Prednisolone sodium phosphate -Prednisolone sodium metasulfobenzoate -Chlorpromazine hydrochloride -Promethazine hydrochloride Soon to be registered in Russia: -Pentoxifylline -Articaine hydrochloride -Metamizol Sodium -Ketoprofen -Spironolactone -Latanoprost -Methylprednisolone micronized -Rifampicin

50 Thank you for your attention Our websites: + dedicated CEPiA page on Sanofi Russia : See «Наша деятельность» «Поставка субстанций» CEPiA Moscow regional office: