Sanofi-Aventis - Business



About

- Synthélabo: Created in 1970 and purchased in 1973 by L'Oréal (World's cosmetic leader).
- Sanofi Group: Merger in 1973 of a number of cosmetic, health care, and animal nutrition firms into a corporate subsidiary of the French state-owned Elf Aquitaine oil company (Total).
- Sanofi Bio-industries: Biotechnological center of all Elf Aquitaine's activities.
- Merial = Merger of Merck & Co. Inc. (MSD AgVet) and Sanofi-Aventis (Rhone Mérieux) in 1997.
- Sanofi-Synthélabo = Merger of Sanofi and Synthélabo in 1999.
- Hoechst Marion Roussel = Merger of Hoechst AG with Roussel Uclaf and Marion Merrell Dow.
- Aventis = Merger of Rhône-Poulenc S.A. and Hoechst Marion Roussel in 1999.
- Aventis CropScience = Merger of AgrEvo and Rhône-Poulenc Agro in 2000.
- 2004: Sanofi-Synthélabo acquires Aventis by friendly bid of €54.5 billion.
- 2009: Merck sells its 50% of Merial for $4 billion in cash.
- 2010: Equally-owned Joint Venture with Merck by combining Merial (entreprise value fixed at $8 billion) with Intervet/Schering-Plough (entreprise value fixed at $8.5 billion), leading to true-up payment of $250 million to Merck to establish a 50/50 joint venture, and an additional $750 million.
- Full member of the European Federation of Pharmaceutical Industries and Associations.


Business

2009
- Acquisitions: Zentiva N.V., company with leading positions in the pharmaceutical markets in the Czech Republic, Slovakia, Romania, and Turkey and growing rapidly in Poland, Russia, Bulgaria, Hungary, the Ukraine and the Baltic States; Laboratorios Kendrick in Mexico; Medley, 3rd largest pharmaceutical company and 1st generic company in Brazil; BiPar Sciences Inc., US biopharmaceutical company, developing novel tumorselective approaches for treatment of different types of cancers, leading in the emerging field of DNA repair using Poly ADP-Ribose Polymerase inhibitors; Chattem Inc. for approximately $1.9 billion; Fovea Pharmaceuticals S.A., French research and development biopharmaceutical company focused on ocular diseases; Laboratoire Oenobiol, French leader in nutritional, health and beauty supplements.
- New vaccine manufacturing facility in France with an investment of 350 million euros to produce 100 million doses of novel vaccine against dengue fever under development.
- Partnership with the Chinese Diabetes Society to undertake in China the world's largest diabetes genotyping project and new investment to locally produce Lantus SoloSTAR.
- New manufacturing base in Hangzhou (China).
- Donation of medical equipment to Zundao Community Hospital (China).
- Conversion of Vitry-sur-Seine Industrial Facility to Biotechnologies, BIOLAUNCH project.
- Collaboration and licensing agreement with Kyowa Hakko Kirin Co. Ltd. on an anti LIGHT fully human monoclonal antibody. Exclusive rights to develop the product worldwide, except in Japan and Asian countries where both parties will co-develop the product.
- Collaboration agreement with Drugs of Neglected Diseases iniciative on a new drug for sleeping sickness, fexinidazole.
- Exclusive Global Alliance with biotechnology company Exelixis Inc. for novel targeted oncology therapies. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including Bristol-Myers Squibb, GlaxoSmithKline, Genentech, Wyeth Pharmaceuticals and Daiichi-Sankyo.
- Sanofi-Aventis purchases from Pfizer the Diabel manufacturing plant in Frankfurt-Höchst, Germany, one of the largest state-of-the-art insulin manufacturing plants in the world.
- Launch of major insulin research program in partnership with the international scientific community.
- Exclusive global collaboration and licensing agreement with Merrimack Pharmaceuticals Inc. on MM-121, a first-in-class, fully human monoclonal antibody designed to block signaling of the ErbB3 (also known as HER3) receptor, for the management of solid malignancies.
- Launch of the RealiseAF registry (Real Life global Survey Evaluating patients with Atrial Fibrillation), international, cross-sectional, observational registry to be conducted in patients with atrial fibrillation.
- Global licensing agreement with Wellstat Therapeutics Corporation on PN2034, a novel oral first-in-class, insulin sensitizer, for the treatment of Type II Diabetes.
- Global collaboration and license agreement with Micromet Inc. to develop a BiTE antibody against an antigen present at the surface of carcinoma cells. BiTE antibodies are novel therapeutic antibodies that activate patients' T cells to seek out and destroy cancer cells.
- Agreements with Regeneron Pharmaceuticals Inc. to expand and extend their existing global collaboration to discover, develop, and commercialize fully-human therapeutic monoclonal antibodies. Annual funding commitment of $160 million (2010-2017) to advance an average of 4 to 5 antibodies into clinical development each year.
- Agreement with Medicines for Malaria Venture to launch the largest safety and efficacy study of an antimalarial drug. Field-monitoring program on ASAQ, only fixed-dose combination of artesunate and amodiaquine prequalified by WHO in the treatment of Plasmodium falciparum uncomplicated malaria.
- Memorandum of Understanding with Prominvest, fully owned subsidiary of the Russian State Corporation Rostekhnologii, confirming intent to participate in the "Pharmpolis Project" using the new modern Sanofi-aventis insulin factory located in Russia as a pilot initiative.
- Exclusive global licensing agreement with The Rockefeller University concerning a novel monoclonal antibody, targeting certain specific forms of the Amyloid Beta parenchymal plaque for the treatment of Alzheimer's disease.
- Strategic research alliance agreement with the California Institute of Technology.
- Sanofi-aventis doubles syringe production capacity and diversifies vaccine production at the Le Trait Manufacturing Plant. The site manufactures the seasonal flu vaccine Vaxigrip, packages an infant meningitis vaccine for the Japanese market, and produces the intradermal flu vaccine Intanza.
- Collaboration agreement with Alopexx Pharmaceuticals and option for a license on a first-in-class human monoclonal antibody for the prevention and treatment of S. aureus, S. epidermidis, E. coli, Y. pestis (the bacterium that causes plague) and other serious infections.

2008
- Antibody agreements with Dyax for the fully human monoclonal antibody DX-2240 and "Phage Display Technology".
- Partnership with OneWorld Health and Amyris Biotechnologies for the development of semisynthetic artemisinin, a key ingredient in first-line malaria treatments. OneWorld Health, UC Berkeley, and Amyris have been working together as the Artemisinin Project since late 2004 to develop a new, low-cost technology platform to produce artemisinin, a project funded by the Bill & Melinda Gates Foundation.
- Partnership with Drugs for Neglected Diseases initiative Foundation to co-develop an innovative pharmaceutical formulation for malaria.
- New formulation and filling facility in France.
- Collaboration agreement with The Johns Hopkins University School of Medicine to find new therapies for respiratory & immuno-allergic diseases.
- Termination of development and commercialization agreement for S-1 with Taiho Pharmaceutical.
- Binding agreement with Primary Health Care Limited to acquire Symbion CP Holdings Pty Limited. Symbion Consumer manufactures, markets and distributes nutraceuticals (vitamins & mineral supplements) and over the counter brands throughout Australia and New Zealand and has a strong portfolio of premium brands including Natures Own, Cenovis, Bio-organics, Golden Glow and Microgenics.
- Inauguration of the Sanofi-Aventis Central Anti-Counterfeit Laboratory in Tours.
- Collaboration agreement with RainDance Technologies and Louis Pasteur University to launch dScreen Consortium within "Alsace BioValley" Cluster.
- Collaboration agreement with the Global Alliance for TB Drug Development to accelerate the discovery, development and clinical use of drugs against tuberculosis.
- Expansion of R&D facility in Shanghai, new establishment of a state-of-the-art Biometrics Center in Beijing, and partnership agreement with Shanghai Institutes for Biological Sciences for discovery of breakthrough drugs for neurological diseases, diabetes and cancer.
- Joint agreement with Medicines for Malaria Venture to speed up the research and development of new treatments for malaria.
- "China Charity Award" by the Ministry of Civil Affairs of the People's Republic of China.
- Global licensing and collaboration agreement with Novozymes for the development and marketing of a potential new antibiotic.

2007
- New, once-a-day fixed-dose combination against malaria available throughout sub-Saharan Africa in partnership with Drugs for Neglected Diseases initiative Foundation.
- Exclusive global license agreement with Oxford BioMedica, established in 1995 as a spin out from Oxford University, to develop and commercialise TroVax for the treatment and prevention of cancers.
- Transfer of all commercial rights for Panaldine (ticlopidine hydrochloride) in Japan from Daiichi Sankyo Company Ltd.
- Collaboration agreement with the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China, recommended by the Central Chinese Authorities, in order to capitalize on the increasing evidence of the role of cancerstem cells.
- Major global collaboration with Regeneron to develop and commercialize fully-human therapeutic antibodies and increased its stake in Regeneron to 19%.
- Restructuration of the joint venture activities in Japan with Astellas Pharma Inc.
- First Asian pharmaceutical development centre in Goa, India.
- Strategic collaboration with Dyax that grants an exclusive worldwide license for the development and commercialization of the fully human monoclonal antibody SAR161578 as well as a license to Dyax’s proprietary antibody phage display technology.
- Research collaboration with the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China, to generate therapeutic antibodies directed to acute myeloid leukemia stem cells.

2005
- Reaffirmation of development commitment with Regeneron Pharmaceuticals.
- Creation of the Sanofi-Aventis European Works Council.
- Sanofi-Aventis concludes €10 billion in medium-term credit agreements with its banks to refinance the Aventis acquisition.
- Collaborative agreement with DNDi Foundation to develop new easy-to-use malaria drug.
- Join forces with World Heart Federation to encourage prevention of cardiovascular disease.
- Partnership and transfer of all commercial rights of Plavix in Japan from Daiichi Pharmaceutical Co. Ltd.
- Subsidiary Hoeghst AG sells its interests in Wacker-Chemie GmbH to an affiliate of the Wacker family.
- Distribution and supply agreement with Prasco Laboratories to market generic versions of ALLEGRA (fexofenadine HCl) in the U.S.
- Expansion of VEGF Trap oncology collaboration with Regeneron Pharmaceuticals Inc. to Japan.

2004
- Sanofi-Synthelabo acquires all interests in Arixtra, idraparinux and other oligosaccharides from Organon.
- Partnership with Drugs for Neglected Diseases initiative to jointly develop non-patented fixed-dose combination of artesunate and amodiaquine.
- Agreement with Procter & Gamble to maintaian the collaboration on Actonel (risedronate sodium tablets), 3rd-generation bisphophonate indicated for prevention and treatment of osteoporosis in postmenopausal women.
- Sanofi-Synthelabo acquires all of Taisho Pharmaceutical Co. Ltd.'s 49% interest in the joint venture company for commercial exploitation of the anti-arrhythmic preparation Ancaron.
- Sanofi-Synthelabo sells to GlaxoSmithKline Arixtra, Fraxiparine and Notre Dame de Bondeville plant.
- Sanofi-Synthelabo and Pfizer conclude an agreement on the divestment of Campto.

Before Sanofi-Aventis
- 1895: Creation of Societe Chimique des Usines du Rhone in Lyon.
- 1896: Creation of the Mérieux Biological Institute by Marcel Mérieux.
- 1928: Association to the Poulenc Freres Company to form Societe des Usines Chimiques Rhone-Poulenc.
- 1947: Creation of French Foot-and-Mouth Disease Institute and start of new industrial revolution large-scale Foot-and-Mouth Disease vaccine production.
- 1968: First production of rabies inactivated vaccines; Acquisition of 51% of Mérieux Institute shares by Rhone-Poulenc; Acquisition of Institut de Sérothérapie de Toulouse.
- 1983: Creation of Rhone Mérieux from the merger of the veterinary activities of the Rhone-Poulenc Group (Mérieux Institute, Institut de Sérothérapie de Toulouse, Specia, and Roger Bellon).
- 1994: Rhone-Poulenc acquires 100% of Rhone Mérieux and its subsidiaries, including Institut de Sélection Avicole (poultry breeding); First launch of Frontline, external antiparasiticide for cats and dogs.
- 1996: Rhone Mérieux ranks Nº4 on the world animal health market and Nº1 in veterinary biology (vaccines and sera).
- 1998: Alliance with Pfizer to jointly develop, manufacture and market inhaled insulin Exubera.
- 2001: Agreement with Altana to jointly develop and market Alvesco in the U.S.

Sanofi Group
- 1980: Merger with the Clin-Midy division of CM Industries, manufacturer of pharmaceuticals, veterinary, chemical, medical-surgical and food products.
- 1981: Joint subsidiaries with the U.S. based American Home Products Company and the Japanese groups Meiji-Seika-Kaisha and Taisho.
- 1983: Inauguration of the largest biotechnology center of its kind in France, and acquisitions of Choay, pharmaceutical company specializing in the area of venous thrombosis, and a minority interest in Entremont, dairy products firm engaged in researching biotechnological applications, for Entremont's investigation into the production of milk compounds through biotechnology.
- 1984: Sanofi merges with Rousselot, gelatine, protein, and glue producer in which Elf Aquitaine formerly held a majority interest, first step in creating Sanofi Elf Bio Industries, Elf Aquitaine's stake in Sanofi increases to 62%.
- 1985: Annual sales figure of FFr15 billion; Acquisitions of Brazilian subsidiary of Revlon, 50% interest in a South Korean company, and two U.S. companies with successful biotechnology programs, Dairyland Food Laboratories, a Wisconsin dairy company, and Dahlgren, a large crop seed producer.
- 1986: 35% bid for Barberet & Blanc, plant and genetic technologies; FDA approval of Cordarone, major anti-arrhythmic drug, marketed through joint venture with American Home Products.
- Principal Subsidiaries: Centre Pharmaceutique Europe; Centre de Recherches Clin-Midy; Diagnostics Pasteur; Diphac; Distrithera; Farmadis; Francis SpA (Italy); Francopia; Labaz GmbH (West Germany); Labaz-Sanofi NV (Belgium); Laboratoires Choay; Laboratoires Clin-Midy; Laboratoires Labaz; Laboratoires Lafarge; Laboratoires Millot-Solac; Laboratoires Pharmygine; Laboratoires Robilliart; Laboratoires Roland-Marie; Laboratoires Sauba, Laboratoires Labaz (Spain); Midy Arzneimittel GmbH (West Germany); Midyfarm; Midy SpA (Italy); Moehs (Spain); Opiaramon; Parcor; Produits Dentaires Pierre Rolland; Prophac; Sapchim; Sempa Chimie; Sintebras (Brazil); Ceva Laboratories Inc. (USA); Cie Rousselot; C.M. Aromatics Inc. (USA); Dairyland Food Laboratories Inc. (USA); Dahlgren (USA); Eurogat; Fondoirs de la Moselle; MéroRousselot-Satia; Rousselot Bénélux (Belgium); Rousselot Ltd (UK); Sanofi Elf Bio Industries; Société Anonyme de Récupération Industrielle & Agricole; Création et Diffusion Internationale de Parfumerie; Omnium de la Parfumerie de Luxe (Parfums Van Cleef & Arpels); Parfums Charles Jourdan; Parfums de Molyneux; Roger & Gallet; Sanofi Beauté; Secta Laboratoires de Cosmetologie Yves Rocher; Stendhal.
- Other countries: Brazil, Mexico, Netherlands, Switzerland and the United Kingdom.


Products

Earnings Guidance
- Net Sales: €28,052 million in 2007; €28,373 million in 2006.
- Net Income: €7,110million in 2007.
- Gross Profit: €21,636 million in 2007.
- Operating Income: €9,617 million in 2007.
- Operating Cash Flow: €7,917 million in 2007.
- Prescription Medicines Sales: €22,943 million in 2008.
- Sales Growth in 2008: Plavix (+10.5%); Lovenox (+10.6%); Lantus (+27.7%); Taxorete (+13.2%); Aprovel (+14.2%).

2009
- Multaq approved in U.S. and Canada for patients with atrial fibrillation or atrial flutter.
- Donation of approximately $1.3 million in pharmaceutical therapies Taxotere (docetaxel), Eloxatin (oxaliplatin) and Lovenox (enoxaparin sodium), over the course of one year, for ongoing use in clinical trials and other therapeutic treatments at the National Institutes of Health Clinical Center, the largest hospital in the United States entirely devoted to clinical research.
- Regulatory approval in European Union and Canada of ClikSTAR, a new reusable insulin pen, for administration of the 24-hour insulin analog.
Lantus (insulin glargine rDNA injection) or/and the rapid acting insulin analog Apidra (insulin glulisine rDNA origin injection).
- European Commission grants marketing authorization for Multaq (dronedarone, 400mg Tablets) in all 27 European member states.

2008
- European Commission approves APIDRA for Treatment of Children and Adolescents with Diabetes.
- Clexane/Lovenox and "Taxotere Injection" (docetaxel hydrate), for the treatment of prostate cancer, approved in Japan.
- FDA approves XYZAL (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria; Nasacort AQ nasal spray for children aged 2-5 years old; and Rapid-Acting Insulin Apidra for treatment of children with diabetes.

2007
- LANTUS SoloSTAR and APIDRA SoloSTAR approved by European Commission.
- FDA approves SoloSTAR, a new prefilled disposable insulin pen for oncedaily 24-hour insulin LANTUS (insulin glargine) for the treatment of hyperglycemia in people with type 1 or type 2 diabetes; supplemental New Drug Application for the anticoagulant Lovenox (enoxaparin sodium injection) for the treatment of patients with acute ST-segment elevation myocardial infarction; XYZAL tablets for the treatment of seasonal and year round allergies, and chronic urticaria; Taxotere (docetaxel) Injection Concentrate in combination with cisplatin and 5-fluorouracil (TPF regimen), for induction therapy of locally advanced Squamous Cell Carcinoma of the Head and Neck before patients undergo chemoradiotherapy and surgery; and Menactra meningococcal conjugate vaccine for use in children 2 years through 10 years of age.
- Approval of Acomplia (rimonabant) in Brazil and Switzerland for the treatment of obese patients, or overweight patients with associated risk factors, such as type 2 diabetes or dyslipidemia.

2005
- Taxotere (docetaxel) receives 2 new European approvals for treatment of breast cancer.
- FDA approval for new Eloxatin formulation; AMBIEN CR (zolpidem tartrate extended release) and AMBIEN CR (zolpidem tartrate extended-release tablets) Civ for the treatment of insomnia; ADACEL vaccine for combined protection against tetanus, diphtheria and pertussis; Allegra-D 24 hour Extended Release Tablets availabled for seasonal allergy sufferers; and Actonel with Calcium.

2004
- FDA approves Eloxatin (oxaliplatin for injection) for the first line treatment of metastatic colorectal cancer; Alvesco (ciclesodine) for treatment of persistent asthma (regardless of severity) in adults, adolescents and children 4 years of age and older; and Eloxatin (oxaliplatin for injection) for the treatment of colon cancer following surgery (adjuvant treatment).
- European Union approval for Taxotere (docetaxel) in Prostate Cancer.

Eloxatin
- 2002: FDA approval for 2nd line treatment of patients with metastatic carcinoma of colon or rectum.
- 1999: Approval in major European countries for 1st line treatment of metastatic colorectal cancer.
- 1998: Approval in France for 1st line treatment of metastatic colorectal cancer.
- 1996: Approval in France for 2nd line treatment of metastatic carcinoma of colon or rectum.



About
- Present in more than 150 countries.
- Sales: About $2.2 billion in 2006; More than $2.6 billion in 2008.

2001
- Two collaborative vaccine development programmes with Microscience Limited.
- Collaborative research and development agreement with Remedyne, a US vaccine biotechnology company.

2002
- Exclusive license and supply agreement with Bioject Medical Technologies Inc., a leading developer of needle-free drug delivery systems.

2003
- Agreement with Vivalis covering the test of Vivalis cell lines for the production of vaccines.
- Hubbard ISA, the world's foremost poultry breeder and a division of Merial, the world's leading animal health company, and Vivalis, one of the world specialists in avian and mammalian stem cells, sign a research agreement covering joint research in the field of avian embryonic stem cells.
- Long-term strategic alliance with Boehringer Ingelheim Vetmedica Inc. for their animal health business in the United States.
- Research collaboration with SomaLogic, a privately held Boulder, CO-based proteomics company, to develop aptamer-based diagnostics for bovine spongiform encephalopathy, also known as BSE or "mad cow disease".
- Global Development and Distribution Agreement with AspenBio Inc.
- Strategic partnership with Boehringer Ingelheim Shionogi Vetmedica Co. Ltd., a joint venture between Nippon Boehringer Ingelheim and Shionogi & Co. Ltd., in companion animal business to market METACAM (meloxicam) in Japan.
- Global Marketing Agreement with Quantum Genetics Inc.
- Acquisition of the assets of QIAGEN's Pecura business acquired and developed by QIAGEN.
- New IVOMEC plant in Brazil.

2004
- Second license and supply agreement with Bioject Medical Technologies Inc.
- Collaboration with Transgene to develop products for animal health indications providing research and development support regarding vector-based expression of certain genes selected by Merial. Merial conducts feasibility studies of different recombinant viruses in veterinary target species, and has the right to execute an exclusive worldwide license for products originating from the research process.

2005
- Launch of new H5N1 avian influenza vaccine. GALLIMUNE Flu H5N9, inactivated vaccine, joins TROVAC AIV H5 as Merial's second major introduction of avian influenza vaccines. TROVAC AIV H5 is the only USDA licensed avian influenza vaccine for administration to chickens at one day of age. More than one billion doses of TROVAC AIV H5 vaccine sold in Mexico and Central America since (1998-2005).
- Strategic alliance with PR Pharmaceuticals Inc., global biopharmaceutical company, for the development of animal health products.
- Frontline Plus, number one animal health product in the World to control fleas and ticks, produces one billionth dose after only a decade on market.
- Aviagen purchases Merial's subsidiary B.U.T., one of the world's leading Turkey Breeding Companies.

2006
- Manufactured and delivered 2.5 million doses of Aftovaxpur foot-and-mouth vaccine to check an outbreak in Turkey. Order from the European Commission one month before, concerned at the threat to European Union countries. Vaccines made from a 33 million dose stock of foot-and-mouth antigens bank (pre-formulation vaccines) held on behalf of the European Commission at Lyon (France). Banks are also held by Merial on behalf of 26 countries from various parts of the world. As well as responding to previous Turkish outbreaks in 2000 and 2003, Merial has also drawn on its banks for outbreaks in South Korea in 2002; Belgium, the Germany, Hungary and Czech Republic in 2001; and South Korea and Japan in 2000.
- Avian business launches Vaxxitek HVT+IBD, poultry industry's first one-dose, hatchery vaccination specifically designed to protect against Classic, Variant or vvIBD strains of Infectious Bursal Disease. First approval for sale and use in Brazil.

2007
- Sale of St. Louis blending facility and rights to certain anticoccidial products to Huvepharma Inc.
- Acquisition of Ancare, New Zealand animal health products company.

2008
- More than 650,000 doses of ProteqFlu vaccine supplied to Australia as part of the country's government-coordinated Emergency Response Plan to contain and eradicate the severe outbreak of Equine Influenza.
- Imugene Limited and Merial begin a Strategic Alliance whereby, Merial was granted exclusivity to the Imugene platform technologies and vaccines in return for Alliance fees and other fees & royalties payable as vaccines are commercialized.

2009
- Exclusive distributor and technical service provider of the innovative in ovo injection systems of AviTech's IntelliJect and ManualJect.
- $70 million investment in the facility in Nanchang to double production capacity of poultry vaccines for the domestic Chinese market.