Novartis – Business

About

– Novartis = Merger of Ciba-Geigy Ltd. and Sandoz Laboratories in 1996.
Ciba-Geigy = Merger of J. R. Geigy Ltd. and Ciba in 1970.
– Revenues: $53 billion in 2008.
– Net sales: $41.5 billion in 2008 ; $39.8 billion in 2007 ; $37 billion in 2006.
– Net income: $8.2 billion in 2008 ; $12.0 billion in 2007 ; $7.2 billion in 2006.
– Full member of the European Federation of Pharmaceutical Industries and Associations.

Business

2009
– Approvals in Japan of Tasigna, for the treatment of a life-threatening form of leukemia; Xolair, for severe asthma; Co-Dio, for high blood pressure; Lucentis, for wet age-related macular degeneration; and Rasilez, first-in-class direct renin inhibitor for treatment of high blood pressure.
– Launch of Extavia, new version of the standard-of-care for relapsing forms of multiple sclerosis.
– Novartis and Medicines for Malaria Venture announce the launch of Coartem Dispersible, a new pediatric formulation of Coartem (artemether/lumefantrine 20 mg/120 mg), for the treatment of uncomplicated malaria in infants and children.
– Novartis and Gen-Probe agree to extend and expand blood screening collaboration to protect the world’s supply of donated blood from infectious diseases until 2025, continued expansion into new global markets and development of innovative new products, including next-generation PANTHER instrument, and exploratory collaboration in pharmacogenomics.
– Ixiaro vaccine receives Marketing Authorization in Europe and U.S. for the prevention of Japanese Encephalitis.
– Glivec approved in E.U. as first post-surgery therapy to reduce risk of cancer returning in patients with aggressive gastrointestinal tumors.
– Restructuring of global collaboration with Schering-Plough to develop fixed-dose combination respiratory therapies.
– Agreement with the Takeda Pharmaceutical Company in Japan for the distribution of the Novartis Vaxem-Hib vaccine for the prevention of infection caused by Haemophilus influenzae type B.
Novartis Vaccines Institute for Global Health awarded a grant from the Wellcome Trust to develop a bivalent vaccine for Typhoid fever.
FDA approves Ilaris (canakinumab) for the treatment of children and adults with cryopyrin-associated periodic syndrome; Reclast, to prevent postmenopausal osteoporosis for 2 years with a single dose; Prevacid 24HR, as first and only OTC proton pump inhibitor in original prescription formulation; Exforge HCT, the only high blood pressure treatment to combine three medications in a single pill; Coartem, first artemisinin-based combination treatment for malaria in the U.S.; Afinitor (everolimus) tablets, for patients with advanced renal cell carcinoma; Tekturna HCT (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals; Valturna, a single-pill combination of valsartan and aliskiren, to treat high blood pressure; and Extavia (interferon beta-1b) for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations.
– Once-yearly Aclasta approved in E.U. to treat osteoporosis caused by steroid treatment in men and postmenopausal women.
– Novartis delivers 250,000,000th Coartem treatment and becomes first healthcare company to join United Against Malaria partnership. Extends tuberculosis drug donation to Tanzania delivering another 250,000 treatments over the next 3 to 4 years.
– Approval in E.U. for Xolair to treat children age 6 to 11 years suffering from severe persistent allergic asthma, and Afinitor (everolimus) tablets for the treatment of patients with advanced renal cell carcinoma.
– Agreement with Paratek Pharmaceuticals and exclusive worldwide rights to market PTK 0796, potentially the first once-daily broad-spectrum antibiotic that can be given by intravenous infusion or oral tablet to treat a wide variety of life-threatening infections, including those caused by highly resistant bacteria such as methicillin-resistant Staphylococcus aureus and multi-drug resistant Streptococcus pneumoniae.
– Agreement with Vanda Pharmaceuticals Inc. for exclusive US and Canadian rights to Fanapt (iloperidone), a new oral medication approved by the FDA for the acute treatment of adults with schizophrenia.

2008
FDA approves Tekturna HCT as a single-tablet combination of 2 high blood pressure medicines.
– New Novartis Research Institute to focus on innovative vaccines for the developing world.
– Approval in the E.U. of Extavia for treatment of multiple sclerosis; Galvus, a new treatment for patients with type 2 diabetes; and Eucreas, an oral tablet combining Galvus (vildagliptin) and metformin, as a new treatment for patients with type 2 diabetes.
– Novartis acquires Protez Pharmaceuticals.
– 5-year research collaboration with the Global Alliance for TB Drug Development designed to yield new medicines for TB.
– Novartis acquires Alcon Inc. from Nestlé S.A.
– Novartis acquires Speedel Holding Ltd., Swiss biopharmaceutical company and world leader in developing renin inhibition.
– Strategic partnership with Lonza to accelerate growth of biologics pipeline.
– Single-pill combinations Diovan HCT and Exforge approved in U.S. as first-line treatments for high blood pressure.
– Omnitrope Pen 10 with liquid cartridge, a somatropin, is approved in the U.S. for long-term treatment of pediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.
– Once-yearly Aclasta approved in E.U. to treat osteoporosis in men and to reduce risk of new fractures following hip fracture both in men and postmenopausal women.
– Novartis acquires Nektar Therapeutics‘ pulmonary business unit for $115 million in cash.
– Rasilez HCT, single-pill combination of Rasilez and diuretic, receives Swiss approval for the treatment of high blood pressure.
– Glivec receives U.S. approval as first treatment to reduce risk of cancer returning in patients with gastrointestinal stromal tumors.
– Exclusive agreement to license AlphaVax‘ investigational Cytomegalovirus vaccine program.

2007
FDA grants additional 6 months marketing exclusivity for the high blood pressure in children and adolescents medicine Diovan.
– Reclast receives U.S. regulatory approval as first and only once-yearly treatment for women with postmenopausal osteoporosis.
– Sale of Gerber baby foods business to Nestlé for $5.5 billion.
– Agreement with Bayer Schering Pharma AG related to various rights for the multiple sclerosis treatment Betaseron.
– Long-term research collaboration with the Massachusetts Institute of Technology aimed at transforming pharmaceutical manufacturing.
– European approval of Aclasta, as first once-yearly treatment for postmenopausal osteoporosis; Galvus, as new treatment for type 2 diabetes with broad range of indications; Exelon, as the first skin patch therapy to treat Alzheimer’s disease; Cubicin, to expand use to treating two additional types of life-threatening hospital infections; Rasilez, the first major innovation in high blood pressure treatment for more than a decade.
– Voltaren Gel receives U.S. regulatory approval as the first approved topical prescription treatment for pain associated with osteoarthritis.
– Tasigna gains U.S. and European approval for patients with a life-threatening form of leukemia who are resistant or intolerant to existing therapies.
– Expanded collaboration with German biotechnology company MorphoSys to focus on the discovery and development of antibody-based biologic therapies.

2006
– Creation of a strategic biomedical R&D center in Shanghai, China.
– Partnership with the WHO to provide anti-malaria treatment Coartem in developing countries.
Novartis Vaccines obtains from Intercell worldwide marketing and distribution rights to the Ixiaro vaccine with the exception of Australia, Korea, Japan and certain other Asian markets.

2005
– Novartis acquires Hexal AG, a leading generics company based in Germany, and Eon Labs, an American generics company, making Sandoz a world leader in generic pharmaceuticals.
– Aclasta gains regulatory approval in Europe as a treatment for Paget’s disease of the bone.
– Novartis acquires the North American OTC brand portafolio of Bristol-Myers Squibb.
– Novartis acquires Chiron Corporation.
– Alliance with Alnylam Pharmaceuticals Inc. focused on discovering innovate therapies based on RNA interference.
– E.U and U.S approval of Exjade (deferasirox), breakthrough once-daily oral iron chelator for the treatment of chronic iron overload due to blood transfusion in adults and children.
– E.U. approval of Xolair (omalizumab) for the treatment of allergic asthma.

2004
– The Novartis Institute for Tropical Deaease opens in Singapore with a focus on biomedical research for denge fever and drug-resistant tuberculosis.
– Novartis acquires 2 generics companies: the Danish firm Durasacan A/S from AstraZeneca, and Sabex Holdings Ltd. of Canada.
– Joint project with the Broad Institute of MIT and Harvard to research the generic causes of type 2 diabetes.
– Several Novartis generic pharmaceutical business are unified under Sandoz and the unit is named as a division of the Novartis Group.

2003
– Novartis acquires the worldwide adult medical nutrition business of Mead Johnson and Company, a subsidiary of Bristol-Myers Squibb.
– Novartis acquires Idenix Pharmaceuticals Inc., a U.S. based biotech company focused on antiviral and anti-infective therapies.

2002
– Novartis increases investment in Roche Holding AG to just under one-third of Roche‘s voting shares.
Associated British Foods acquires the Food and Berverage Business Unit as part of a decision by Novartis to divest the Health and Functional Food business.
– Creation of the Novartis Institutes for BioMedical Research in the U.S.

1996-2001
– Collaboration with Gen-Probe in 1998.
– The Novartis Research Fundation establishes the Novartis Institute for Functional Genomics in 1999.
Syngenta = Merger of the agribusiness units of Novartis and AstraZeneca in 2000.
– Novartis spins out the chemicals activities as Ciba Specialty Chemicals, now part of BASF
– Novartis acquires Merck‘s crop protection business.
– The antiviral products Famvir and Vectavir/Denavir are acquired from SmithKline Beecham.

Influenza Vaccine

2009
– The U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority, awards Novartis Vaccines a contract for up to $486 million over 8 years to support the design, construction, validation, and licensing of U.S. cell-based influenza vaccine manufacturing facilities in Holly Springs, North Carolina, to provide a pre-pandemic supply of influenza vaccine and to provide the capacity to manufacture 150 million doses of pandemic vaccine within 6 months of declaration of an influenza pandemic. The contract also requires Novartis to provide 2 commercial-scale annual lots of pre-pandemic vaccine for a minimum of 3 years. In addition, HHS has the right to exercise options to purchase additional influenza vaccine over 17 years.
– Completed the production of the first batch of influenza A(H1N1) vaccine. Requested supply of influenza A(H1N1) vaccine ingredients by more than 30 governments.
– Delivered Fluvirin influenza virus vaccine to U.S. healthcare facilities. Approximately 30 million doses indicated for patients 4 years and older.
– Two contracts by the U.S. government totaling $979 million for purchase of H1N1 bulk vaccine and the MF59 adjuvant. Contracts also signed with other countries including France, the Netherlands and Switzerland.
– 27 million doses of Fluvirin influenza virus vaccine shipped to US market.

2008
– Shipment to U.S. of Fluvirin Influenza Virus Vaccine with 3 new strains for the influenza season.
– Partnership with Parent Teacher Association and Flu Busters, an on-site vaccinations provider, for a nationwide influenza vaccination campaign.

2007
– U.S. shipment of Fluvirin, influenza vaccine.
– European approval of Optaflu, innovative flu vaccine, and Focetria, pandemic influenza vaccine.

2006
– $200 million contract from the U.S. Department of Health and Human Services to build a cell culture-based influenza vaccine production plant in the U.S.
– Contract valued at $40.95 million to supply to the U.S. government a pre-pandemic influenza vaccine against the H5N1 avian influenza strain.

Current Alliances

Abbott/Boston Scientific: Drug elutingstents ; Ablynx: Nanobodies as therapeutics ; Ajinomoto: Starlix ; Alnylam: RNA interference-based compounds ; Antisoma: Vascular Disrupting Agent ; Applied Pharma Research: Development of new Voltaren formulations ; Arrow: RSV604 in respiratory syncytial virus infections ; Astellas: Foradil ; Astex: Novel cell cycle control drug for cancer treatment ; Avalon Pharma: Pathways ; Avanir: MIF inhibitors in inflammatory diseases ; Bayer-Schering: PTK787 on oncologyand ophthaindications NVF233 (Extavia) ; Biotec Thailand: Natural products ; Biozentrum Basel: Nuclear magnetic resonance technology ; Broad Institute: Oncology research ; Bruin Pharma: APL018 in atherosclerosis ; Celgene: Focalin ; Cell Therapeutics Inc.: Opaxioand Pixantrone ; Cytopia: Jack3 inhibitors ; Cytos: Immuno drug Alzheimer’s Disease (CAD106) and NIC002A (Nicotin vaccine) ; Cubist: Cubicin ; Dana-Farber Cancer Institute: Oncology, signal transduction ; Eisai: Rufinamide ; Elan: RitalinLA and FocalinXR ; Emisphere: Oral calcitonin, oral PTH, oral hGH ; Genelabs Technologies: HCV ; Genentech: Lucentis and Xolair ; Human Genome Sciences: Albuferon, Hepatitis C ; Idenix: Hepatitis B and C ; Idera: HYP2093 for treatment of asthma ; Jubilant Biosys: Bioinformatics ; KaloBios: Antibody therapeutics ; Kyorin: KRP-203 in autoimmune diseases ; Lohmann LTS: Exelon TDS ; 3M: MDI HFA ; Massachusetts General Hospital and Massachusetts Institute of Technology: Huntington’s disease ; Mediolanum: SOMXL, Lucentis BOE ; MicroDose: Electronic Respiratory Device ; Mitsubishi: FTY720 in multiple sclerosis ; MIP: Octreother ; MorphoSys: Therapeutic antibodies ; Neuroscience Center Zürich: Neuroscience ; NexMed: Lamisil topical ; Nordic Bioscience: Oral calcitonin ; Noven: HRT Patches/Novosync ; Ono: Exelon TDS Japan ; Orion: Comtan & Stalevo in Parkinson’s disease ; Pharmachemie: Miflonide ; Procter & Gamble: Enablex US ; QLT: Visudyne ; Schering-Plough: Combinations of Foradil, QAB and mometasone for asthma & COPD ; Scripps Research Institute: Broad-based research ; Sebo: Oral phosphate binder for hyperphosphatemia ; Senju: RKI983 in glaucoma ; Servier: Agomelatine ; Shanghai Institute of Materia Medica: Natural products from Traditional Chinese Medicine ; Sosei/Vectura: NVA237 & QVA149 in COPD ; Synosia: Rufinamidein anxiety & bipolar disorder ; Syngene: Chemistry services ; Unigene: Oral calcitonin ; Vernalis: Cancer research ; Xenon Pharmaceuticals: Metabolic syndrome ; Xenogen: Oncology, imaging technology ; Xoma: CD40 antigen AB & Prolactin Receptor.

Sandoz

History
– 1886: The chemical company Kern & Sandoz is founded.
– 1917: The pharmaceutical deparment is created.
– 1921: Gynergen is introduced.
– 1929: Calcium Sandoz, a breakthrough product that lays the fundation for modern calcium therapy, is introduced. The chemicals deparment is created producing chemicals for textiles, paper and leather.
– 1938: LSD is introduced, later marketing as psychiatric drug under the trade name Delysid.
– 1939: First steps into agribusiness producing agricultural chemicals.
– 1943: Discovered psychedelic effects of LSD.
– 1947: LSD marketed under the name Delysid as a psychiatric drug, thought useful for treating a wide variety of mental ailments, from alcoholism to sexual deviancy.
– 1958: The neuroleptic drug Melleril (thioridazine HCI) is introduced.
– 1963: Sandoz acquires Biochemie GmbH.
– Mid 1960s: LSD withdrawal from the market.
– 1967: Sandoz merges with Warder Ltd.
– 1975: Sandoz acquires Rogers Seed Co.
– 1976: Sandoz acquires Northrup King.
– 1977: Sandoz acquires Wasa, Swidesh crisp bread producer. Anti-allergic drug Zaditen (ketotifen) is introduced.
– 1982: Immunosuppressant Sandimmun (cyclosporine) is introduced.
– 1994: Sandoz acquires baby food company Gerber. Immunosuppressant Neoral (cyclosporine) is introduced.
– 1995: Sandoz spins off its speciality chemicals business to form Clariant.
– 1997: Clariant merges with the speciality chemicals business that was spun off from Hoechst AG in Germany.
– 2002: Sandoz acquires Lek Pharmaceuticals, a Slovenian generic pharmaceuticals company for $900 million.
– 2006: European Commission approval for Omnitrope.
– 2007: European Commission approval for biosimilar epoetin alfa.
– 2008: Launch of Omnitrope Pen 5 with liquid cartridge.

2009
– Sandoz acquires for $1.3 billion EBEWE Pharma specialty generics business, improving access for patients worldwide to injectable cancer drugs.
European Commission approval for biosimilar filgrastim for the treatment of neutropenia.
– Marketing authorization for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin.
– Introduction of tacrolimus capsules, a generic equivalent of Prograf, in the US.
– 1.3 billion acquisition of EBEWE Pharma‘s specialty generic injectables business, paving the way for the creation of a global center of excellence in generic oncology injectables.
– Launch of recombinant human growth hormone somatropin in Japan, marketed as Omnitrope in the EU, the US, Australia and elsewhere.

Ciba-Geigy

History
– 1900: Ciba produces its first pharmaceutical substances: Vioform, an antiseptic, and Salen, a antirheumatic agent.
– 1908: Ciba acquires production site in Monthey, Switzerland.
– 1911: Ciba‘s first factories in England and Italy.
– 1915: Ciba‘s production expands to Russia and Germany.
– 1924: Coramine, a circulatory drug, is first produced in Ciba laboratories.
– 1928: Ciba takes over Geigy‘s production of textile auxiliaries.
– 1935: Geigy begins producing insecticides.
– 1954: Ciba begins producing insecticides.
– 1956: First triazine-based herbicides Simazine and Atrazine are introduced.
– 1958: Psychotropic drug Tofranil (imipramine) is introduced.
– 1959: First long-lasting diuretic, Hygroton (chlorthalidone), for the treatment of high blood presure, is introduced.
– 1963: Antiepileptic Tegretol (carbamacepine) is introduced. Desferal, a breakthrough product for the treatment of iron and aluminum overload is introduced.
– 1973: Antirheumatic drug Voltaren (diclofenac sodium) is launched.
– 1974: Acquisition of the U.S. based Funk Seeds International.
– 1978: Joint venture with the American firm ALZA Corp. to develop transdermal therapeutic systems. Systemal fungicide Rimodil is introduced.
– 1980: Creation of a biotechnology unit.
– 1981: First transdermal delivery system Scopoderm TTS is introduced for travel sickness.
– 1987: CIBA Vision is organized as a business unit of Ciba-Geigy.
– 1994: Strategic partnership with biotechnology company Chiron.

Etiquetas: ,


A %d blogueros les gusta esto: