Archive for 30 noviembre 2009

GlaxoSmithKline – Business



– Sales: £24.3 billion in 2008; £22.7 billion in 2007; £23.2 billion in 2006; £21.7 billion in 2005.
– Profit: £7.8 billion in 2008, 2007, 2006; £6.7 billion in 2005.
– Free Cash Flow: £4785 million in 2008; £3857 million in 2007; £4.7 billion in 2005.
GSK Biologicals S.A. distributed 1.1 billion doses of vaccines to 169 countries, 3 million doses a day, in 2007; and more than 1.2 billion doses of vaccines to 165 countries, more than 3 million doses per day, with £1.1 billion investment in 2005.
– GlaxoSmithKline is a corporate member of the Council on Foreign Relations.


– GSK’s wholly-owned subsidiary Gemstone Acquisition Corporation merges Genelabs Technologies to increase focus on novel small molecule therapies for Hepatitis C.
– GSK acquires UCB S.A. current marketed product portfolio across certain territories in Africa, the Middle East, Asia Pacific and Latin America, for €515 million.
– Worldwide license agreement with Idenix Pharmaceuticals for IDX899, a novel NNRTI for the treatment of HIV.
– Innovative agreement with Pfizer (15%) to create a new world-leading HIV company focused solely on research, development and commercialisation of HIV medicines.
– GSK acquires Stiefel Laboratories Inc., the world’s largest independent dermatology company, for $3.6 billion.
– Agreement to divest full commercial rights to Wellbutrin XL in the United States to Biovail International Laboratories SRL, a subsidiary of Biovail Corporation, for $510 million.
– Agreement to extend strategic relationship with Aspen Pharmacare Holdings Limited and to acquire a 16% shareholding in the South African based pharmaceuticals company.
– Collaboration with Concert Pharmaceuticals to develop and commercialise deuterium-containing medicines.
– Strategic alliance with Dr. Reddy’s Laboratories Ltd to develop and market selected products across an extensive number of emerging markets, excluding India.
– Collaboration with Chroma Therapeutics Ltd to develop novel macrophage-targeted drugs
– GSK acquires the branded generics business of Bristol Myers Squibb in Lebanon, Jordan, Syria, Libya and Yemen for a cash consideration of $23.2m.
– GSK acquires Stiefel Laboratories Inc. for a cash consideration of $2.9 billion, $0.4 billion of net debt and additional cash payments of up to $0.3 billion depending on the future performance of the business. New world-leading specialist dermatology business with revenues of approximately $1.5 billion.
– Unique partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil. New research and development collaboration programme at Fiocruz to develop a vaccine for dengue fever. GSK also provides Fiocruz with access to the technology behind its 10-valent conjugate vaccine for paediatric pneumococcal disease, Synflorix, incorporated by the Brazilian government into its national immunisation programme.
– Cooperation agreement with Jiangsu Walvax Biotech Company to form a long-term Joint Venture to develop and manufacture paediatric vaccines for use in China. New manufacturing facility for GSK’s paediatric vaccine Priorix and supply to China’s public vaccine market.
– Unique partnership with the UK Government, The Wellcome Trust and the East of England Development Agency to develop an innovative new biotechnology science park located at GSK’s site at Stevenage. The project aims to create a world-leading hub for early-stage biotechnology companies.
– Exclusive worldwide collaboration with Prosensa, Dutch based biopharmaceutical company focusing on RNA modulating therapeutics, for the development and commercialisation of RNA based therapeutics for Duchenne Muscular Dystrophy, severely debilitating childhood neuromuscular disease.
– World’s most clinically advanced malaria vaccine candidate underway in 7 African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. Trial expected to involve up to 16,000 children on schedule.
GlaxoSmithKline Biologicals S.A. and Nabi Biopharmaceuticals announce exclusive worldwide option and licensing agreement for a nicotine conjugate candidate vaccine (NicVAX), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.
– Completed the extension of strategic relationship with Aspen Pharmacare Holdings Limited and the acquisition of a minority shareholding in the South African based pharmaceuticals company. Part of a wide ranging agreement which includes combining commercial activities in Sub-Saharan Africa and the divestment of several assets to Aspen.
– The London Organising Committee of the Olympic Games and Paralympic Games announces GlaxoSmithKline as its Official Laboratory Services Provider in a Tier Three deal. GSK provides facilities and equipment to enable Kings College London to operate a World Anti-Doping Agency accredited satellite laboratory at Games-time.

– New collaboration with Medicines for Malaria Venture to identify novel drugs for the treatment of malaria.
– Renewed joint research programme with the Global Alliance for TB Drug Development to improve the treatment of tuberculosis.
– Creation of a jointly funded programme seeking with the Medical Research Council to identify and validate genes associated with common human diseases.
– Expansion of the Horizon programme with Theravance Inc. into development of a next-generation combination treatment for chronic obstructive pulmonary disorder.
– Worldwide strategic alliance with Regulus Therapeutics LLC (joint venture between Alnylam Pharmaceuticals Inc. and Isis Pharmaceuticals Inc.) to discover, develop and market novel microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease.
– GSK’s wholly-owned subsidiary Fountain Acquisition Corporation acquires Sirtris Pharmaceuticals Inc. for approximately $720 million.
– 5 year collaboration worth $25 million with Boston’s Immune Disease Institute, corporation academically affiliated with Harvard Medical School, to build a unique partnership in immunoinflammation research.
– Worldwide strategic alliance with Mpex Pharmaceuticals for the discovery, development and commercialisation of novel medicines for bacterial diseases.
– First agreement with the University of Cambridge to develop a novel centrally-acting agent with therapeutic potential for obesity and addictive disorders.
– Licensing collaboration with South African based pharmaceuticals company, Aspen, and its joint venture partner, Strides Arcolab Ltd. to significantly extend pharmaceutical portfolio in emerging markets.
– Five-year, $25 million-plus collaborative agreement with Harvard Stem Cell Institute to build a unique alliance in stem cell science, leading to the development of new medicines.
– Exclusive worldwide collaboration agreement with Valeant Pharmaceuticals International for the investigational drug retigabine, a first in class neuronal potassium channel opener for treatment of adult epilepsy patients with refractory partial onset seizures.
– Worldwide strategic alliance with Cellzome Inc. to discover, develop and market novel kinase-targeted therapeutics to treat inflammatory diseases.
– GSK acquires Egyptian mature products business of Bristol Myers Squibb for $210 million.
– Exclusive licence and option agreement with AFFiRiS GmbH for therapeutic Alzheimer’s disease candidate vaccines.
– Agreement with AstraZeneca to acquire the company AZ Tika for approximately £146 million and a number of leading over-the-counter medicines predominantly sold in Sweden, including analgesic treatment Alvedon.
– One-billionth Albendazole tablet and $250,000 grant donation to The Carter Center. The Carter Center has assisted the Ministry of Health of Nigeria with providing over 22 million treatments for Lymphatic Filariasis since 2000. The Global Program to Eliminate Lymphatic Filariasis (since 1998) relies on the donation of the drugs GSK’s Albendazole and Merck‘s Mectizan in partnership with the World Health Organization.
– Worldwide strategic alliance with Dynavax Technologies Corporation to discover, develop and commercialise novel inhibitors of endosomal Toll-like Receptors for the treatment of immuno-inflammatory diseases.
– GSK acquires Bristol-Myers Squibb Pakistan Ltd. and certain associated trademarks for approximately $36.5 million.
– Worldwide strategic alliance with Archemix Corp. (merged with NitroMed Inc.) to discover, develop and commercialise aptamer therapeutics to treat inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease.

– GSK’s wholly-owned subsidiary Pilgrim Acquisition Corporation acquires Praecis Pharmaceuticals Inc., a biopharmaceuticals company.
– Exclusive worldwide agreement with Fabre-Kramer Pharmaceuticals Inc. for new treatment of major depressive disorder.
– Exclusive agreement with XenoPort Inc. to co-develop and commercialise late-stage compound for Restless Legs Syndrome and neuropathic pain.
– GSK commends $1.5 billion advance market funding from governments of Canada, Italy, Norway and the U.K., as well as the World Bank, to establish a pilot Advance Market Commitment to purchase and distribute new pneumococcal vaccines, including AIDS, malaria and TB.
– Worldwide strategic alliance with Anacor Pharmaceuticals for the discovery, development and commercialisation of novel medicines for viral and bacterial diseases.
– Multi-year strategic alliance with Galapagos NV to develop novel anti-infective drug candidates.
– Collaboration with The Wellcome Trust to develop a new class of antibacterial to combat the rise of certain drug-resistant hospital-acquired infections.
– GSK launches Chinese R&D centre with appointment of head in Shanghai.
– GSK, Imperial College London, and The Medical Research Council officially open the UK’s world-leading Clinical Imaging Centre.
– Strategic alliance with Targacept Inc. to discover, develop and market novel therapeutics that selectively target specified neuronal nicotinic receptors.
– Strategic alliance with OncoMed Pharmaceuticals to develop cancer stem cell antibody therapeutics.
– GSK acquires Reliant Pharmaceuticals, a producer of cardiovascular medicines.
– Worldwide strategic alliance with Santaris Pharma for the discovery, development and commercialisation of novel medicines against viral diseases.

– GSK acquires PLIVA‘s Research Institute.
– Pulmonary arterial hypertension partnership with Myogen Inc.
– GSK joins a coordinated effort with the White House, US State Department, other pharmaceutical companies, UNICEF and UNAIDS to reduce barriers to treatment for children with AIDS in developing countries.
– GSK’s CEO appointed to Chancellor Gordon Brown’s International Business Advisory Council.
– New drug discovery and development alliance with Pharmacopeia.
– Exclusive multi-year strategic alliance with Sirna Therapeutics Inc., wholly owned subsidiary of Merck & Co. Inc., focused on discovery, development and commercialisation of novel RNA interference (RNAi)-based therapeutics for respiratory diseases.
– Completion of enrolment of pivotal clinical studies of Entereg (alvimopan) with Adolor Corporation.
– GSK licenses cancer antigen portfolio from Ludwig Institute for Cancer Research.
PATH launches a five-year effort to make sure that new cervical cancer vaccines reach women in the developing world. With a $27.8 million grant from the Bill & Melinda Gates Foundation, PATH will conduct program research in India, Peru, Uganda, and Vietnam to gather the evidence countries need to make informed decisions about how to introduce the vaccine. PATH collaborate with international agencies and government officials in the four countries, and with industry partners Merck & Co. Inc. and GlaxoSmithKline Biologicals.
– Worldwide, multi-year, multi-programme drug discovery and development alliance with Galapagos NV in the field of osteoarthritis.
– Worldwide multi-target strategic alliance with ChemoCentryx Inc. to discover, develop and market novel medicines targeting four chemokine and chemoattractant receptors for the treatment of a variety of inflammatory disorders.
– Investment of more than €500m in vaccine manufacturing plant in St-Amand-Les-Eaux, France, to increase production capacity in formulation, filling, freeze-drying and packaging, to meet growing worldwide demand for paediatric and adult vaccines.
– GSK pledges more than $200,000 in support of the HIV Medicine Association‘s Minority Clinical Fellowship Program.
– GSK and NeuroSearch expand the scope of strategic alliance.
– GSK acquires Domantis Ltd., a leader in developing the next generation of antibody therapies, for ₤230 million in cash.
– Worldwide multi-target strategic collaboration with EPIX Pharmaceuticals to discover, develop and market novel medicines targeting four G-protein coupled receptors for the treatment of a variety of diseases, including EPIX’s novel 5-HT4 partial agonist programme, PRX-03140, in early-stage clinical development for the treatment of Alzheimer’s disease.
– GSK acquires CNS Inc., producers of the Breathe Right nasal dilator strips and FiberChoice dietary fibre supplements.

– Licensing agreement with Gilead Sciences Inc. under which GSK receives exclusive rights to Hepsera (adefovir dipivoxil), Gilead‘s first hepatitis B treatment, in various territories including China, Japan, South Korea and Taiwan, as well as the right to commercialise tenofovir for the treatment of chronic hepatitis B under certain circumstances.

– Broad strategic alliance with Cytokinetics Inc. to discover, develop and commercialize novel small molecule therapeutics targeting mitotic kinesins for applications in the treatment of cancer and other diseases.

Influenza: Pandemic and Vaccines

Governments & H1N1 Influenza Vaccine (2009)
UK Government: 60 million doses.
French Government: 50 million doses.
Government of Belgium: 12.6 million doses (total population).
Government of Finland: 5.3 million doses, expected to be used in conjunction with government’s existing stockpile of GSK’s adjuvant system.
US Government: A(H1N1) influenza antigen and proprietary adjuvant system AS03, 7.6 million doses of unadjuvanted H1N1 pandemic vaccine, produced in multi-dose vials from bulk vaccine manufactured at facility in Quebec, 250 million doses of pandemic (H1N1) adjuvanted vaccine, and pandemic products worth $250 million.
– 9 government contracts for a further 96 million doses.
– 22 government orders agreed to supply a further 149 million doses.
– Total number of doses ordered for pandemic vaccines: 440 million.
– Discussions with governments for further supplies.

– The UK Government purchases 18 million treatment courses of antivirals and 10.6 million treatment courses of Relenza (zanamivir) for use in an influenza pandemic. The UK becomes the second European country, alongside France, to hold a treatment stockpile sufficient to treat 50% of their population. Zanamivir constitutes approximately a third of the UK’s current antiviral stockpile. Since 2003, Relenza has been supplied to 26 governments for the purposes of pandemic stockpiling and on average the product constituted 13% of these stockpiles. Production levels for Relenza increased to produce between 50-60 million treatment packs of Relenza per year.
– New alliance with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. to develop and manufacture influenza vaccines in China.
– Worldwide agreements with Enigma Diagnostics Limited to develop and supply the first point-of-care diagnostic influenza tests to identify specific influenza virus strains using its real-time Polymerase Chain Reaction technology platform, the Enigma ML (Mini Laboratory).
– Relenza Rotacaps, alternative Relenza treatment, granted temporary approval by Swedish regulators, as part of an application submitted under the European mutual recognition procedure for distribution during a pandemic. In discussions with regulatory authorities around the world to secure further approvals.
– Contracts in place to supply Relenza to over 60 governments.
– Allocated 10% of new Relenza production capacity for developing countries and intended donation of 2 million doses of Relenza to the WHO.
– Tiered-pricing policy for Relenza, again based on World Bank classification of countries.
– Donation to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new candidate A (H1N1) adjuvanted influenza vaccine and supply to developing countries under a tiered-pricing policy based on World Bank classifications and GAVI eligibility.
– Worldwide collaboration and license agreement with Vivalis devoted to developing a new way of producing both seasonal and pandemic human influenza vaccines. Milestones included the designing of a manufacturing process capable of obtaining a high level of virus productivity compatible with industrial development and an important step in the characterization of the sanitary status of the EB66 cell line.
– Agreement with Kaketsuken to co-develop influenza vaccines, including pandemic influenza vaccines, produced using EB66 cell-culture technology in Japan.
– GSK expects to increase annual production capacity of Relenza to 190 million treatment courses by the end of 2009.
European Commission grants marketing authorisation of pandemic (H1N1) adjuvanted vaccine Pandemrix for pandemic H1N1 2009 influenza.
– Agreement with the World Health Organization to donate 50 million doses of adjuvanted pandemic H1N1 influenza vaccine to WHO for distribution to developing countries most in need.
FDA approves supplemental biologics license application for unadjuvanted influenza A (H1N1) pandemic vaccine.
Health Canada approves adjuvant-free H1N1 vaccine for pregnant women and healthy individuals aged 10 to 64.
– 172,000 doses of Arepanrix, distributed to almost half of the country, recalled after 6 Canadians experienced severe allergic reaction called anaphylaxis, which causes breathing problems, low blood pressure and swelling of the tongue, lips and eyes. Confirmed 24 cases including one person who died after getting vaccinated.
World Health Organization awards prequalification for global use of Arepanrix, adjuvanted H1N1 pandemic vaccine manufactured in Canada.

– European licence for Pandemrix, a “mock-up” pandemic vaccine, and first company to obtain a European licence for a pre-pandemic vaccine, Prepandrix, designed to raise immune protection against several strains of the H5N1 virus.
– Exclusive Cooperation Agreement with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. as a preliminary step in forming a Joint Venture company to co-develop seasonal influenza vaccines and pre-pandemic/pandemic influenza vaccines, firstly targeting against strains of the virus specific to China, Hong Kong and Macau.

– Contract from the U.S. Department of Health and Human Services for the development of pre-pandemic and pandemic flu vaccines.
– Donation of 50 million doses of H5N1 adjuvanted pre-pandemic influenza vaccine to the World Health Organization in support of stockpile initiative.
– Second task order for 22.5 million doses of 15µg H5N1 bulk vaccine antigen from the U.S. Department of Health and Human Services.
– Agreement with the U.K. Government to provide pandemic influenza vaccine in the event of a flu pandemic.
– Agreement with Vivalis to develop and commercialise new human influenza vaccines based on Vivalis‘ proprietary EBx cell line technology. Under this worldwide collaboration and license agreement, Vivalis participates in the vaccine process development, and GlaxoSmithKline Biologicals is entitled to use Vivalis‘ avian embryonic stem cell derived EBx cell lines and related technologies to produce seasonal and pandemic human flu vaccines.
– New generation H5N1 split antigen pre-pandemic influenza vaccine accepted for review by the Committee for Medicinal Products for Human Use in Europe.

– GSK produces over 10 million packs of anti-flu treatment Relenza in one year.
– International clinical human trial programme to test two pandemic vaccines against the H5N1 strain of the avian influenza virus in humans.
– Award of $274 million contract from the U.S. Department of Health and Human Services to speed the development of new cell culture-based seasonal and pandemic influenza vaccines and to scale-up cell culture manufacturing capability at its Marietta, PA facility.
– Daronrix, first generation alum-adjuvanted inactivated whole virus candidate flu vaccine for use once a pandemic has officially been declared by the WHO/E.U., receives positive opinion from Europe’s Committee for Medicinal Products for Human Use. This is a first step in the preparation against a possible H5N1 pandemic.
– Task order for 5 million doses of H5N1 clade 2 bulk antigen at 15µg HA/dose from the U.S. Department of Health and Human Services.
– Shipping of 25 million doses of Fluarix and FluLaval (influenza virus vaccines) to U.S.
– Supply contract with the Swiss Federal Office of Public Health for 8 million doses of H5N1 antigen influenza vaccine and its proprietary adjuvant for pre-pandemic use.
– The FDA approves FluLaval (Influenza Virus Vaccine) for the active immunization of adults 18 years and older against influenza disease.
– Licensing agreement with Simcere Pharmaceutical Group of Nanjing, China, granting Simcere the right to manufacture and sell the anti-viral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnam and all Least Developed Countries.
– Approval in the E.U. of anti-viral Relenza (zanamivir for inhalation) in the prevention (prophylaxis) of influenza A and B in adults and children 5 years of age and above.
– Agreement with the U.S. Government to provide the anti-viral Relenza (zanamivir for inhalation) as they prepare for a potential influenza pandemic.

– GSK’s acquisitions: a major influenza vaccine manufacturer, ID Biomedical Corporation; a vaccine manufacturing site in Marietta, Pennsylvania, for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity.
FDA approves Fluarix, an influenza virus vaccine.
– GSK CEO JP Garnier meets U.S. President Bush to discuss pandemic flu planning.