Sanofi-Aventis – Business & Products

About

– 2004: Sanofi-Synthélabo acquires Aventis by friendly bid of €54.5 bn.
Merial = Merger of Merck & Co. Inc. and Sanofi-Aventis in 1997. Merck sells its 50% to Sanofi-Aventis for $4 billion in cash in 2009.
Aventis = Merger of Rhône-Poulenc S.A. and Hoechst AG in 1999.
Aventis CropScience = Merger of AgrEvo and Rhône-Poulenc Agro in 2000.
Sanofi-Synthélabo = Merger of Sanofi and Synthélabo in 1999.
Sanofi: former subsidiary of Total, one of the six “Supermajor” oil companies in the world.
Synthélabo: created in 1970 and purchased in 1973 by L’Oréal (world’s cosmetic leader).
– 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; Mérieux Alliance‘s French subsidiary ShanH (550 million euros), which owns a majority stake in vaccine company Shantha Biotechnics based in Hyderabad, India.
– 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.
– Sanofi-aventis launches 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.
– Signing of a 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 a non-patented fixed-dose combination of artesunate and amodiaquine.
– Agreement with Procter & Gamble to maintaian the collaboration on Actonel (risedronate sodium tablets), a third-generation bisphophonate indicated for the 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 2004
– 2001: Agreement with Altana to jointly develop and market Alvesco in the U.S.
– 1998: Alliance with Pfizer to jointly develop, manufacture and market inhaled insulin Exubera.

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%).

Products

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 EU 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.

Before 2004
– 2002: U.S. FDA approves Eloxatin for second line treatment of patients with metastatic carcinoma of the colon or rectum.
– 1999: Approval of Eloxatin in major European countries for the first line treatment of metastatic colorectal cancer.
– 1998: Approval of Eloxatin in France for the first line treatment of metastatic colorectal cancer.
– 1996: Approval of Eloxatin in France for second line treatment of patients with metastatic carcinoma of the colon or rectum.

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