About
- GlaxoWellcome = Merger of Burroughs Wellcome & Co. and Glaxo Laboratories in 1995.
- SmithKline Beecham = Merger of Beecham and SmithKline in 1989.
- 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.
- Corporate member of the Council on Foreign Relations.
Origins
GlaxoWellcome
- 1878: Silas Mainville Burroughs travels to London as an agent for John Wyeth & Bro (Wyeth Pharmaceuticals) and founds Burroughs & Co., which imported American drugs into the UK.
- 1880: Silas Mainville Burroughs's friend Henry Wellcome joins the company and the name is changed into Burroughs Wellcome & Company.
- 1904: Glaxo is founded in Bunnythorpe, New Zealand, as a baby food manufacturer processing local milk into a baby food.
- 1935: Glaxo becomes Glaxo Laboratories and opens new units in London.
- 1947: Glaxo Laboratories buys Joseph Nathan.
- 1958: Glaxo Laboratories buys Allen & Hanburys.
- 1959: The Wellcome Company buys McDougall & Robertson Inc. to become more active in animal health.
- 1978: Glaxo Laboratories buys Meyer Laboratories Inc.
- 1987: The AIDS treatment Retrovir (zidovudine) is launched by Wellcome. Glaxo introduces the oral antibiotic Zinnat (cefuroxime axetil).
- 1991: Glaxo launches novel treatment for migraine, Imigran (sumatriptan), Lacipil (lacidipine) for high blood pressure, and Cutivate (fluticasone propionate) in the U.S. for skin diseases.
- 1992: Mepron (atovaquone) for AIDS-related pneumonia is introduced by Burroughs Wellcome in the U.S.
- 1993: Glaxo introduces Flixotide (fluticasone propionate) for bronchial conditions.
- 1995: Glaxo and Wellcome merge to form Glaxo Wellcome. Glaxo Wellcome acquires California-based Affymax, a leader in the field of combinatorial chemistry. The Queen opens Glaxo Wellcome's Medicines Research Centre at Stevenage in England. Valtrex (valaciclovir) is launched as an anti-herpes successor to Zovirax (acyclovir).
- 1998: GlaxoWellcome buys Polfa Poznan Company in Poland.
SmithKline Beecham
- 1830: John K. Smith and his brother-in-law John Gilbert open a drugstore in Philadelphia.
- 1841: John Gilbert withdraws and Smith is joined by his younger brother George to form John K Smith & Co.
- 1842: Thomas Beecham launches his Beecham's Pills laxative in England giving birth to the Beecham Group.
- 1859: Beecham opens the world's first factory to be built solely for making medicines at St Helens in England.
- 1865: Mahlon Kline joins John K Smith & Co.
- 1875: Mahlon K Smith & Co is renamed Smith, Kline and Co.
- 1891: Merges with French, Richard & Co.
- 1929: Smith, Kline & French Co is renamed Smith Kline & French Laboratories and becomes more focused on research.
- 1930's: Smith Kline & French Laboratories buys Norden Laboratories, a business doing research into animal health.
- 1938: Beecham acquires Macleans Ltd and Eno's Proprietaries Ltd.
- 1939: Beecham acquires County Perfumery Co Ltd, manufacturers of Brylcreem, a men's hair application.
- 1943: Beecham Research Laboratories is formed with the mission to focus exclusively on basic pharmaceutical research.
- 1945: Beecham Group Ltd is established, replacing Beecham Pills Ltd and Beecham Estates Ltd, later known as Beecham Group plc, and incorporates Beecham Research Laboratories.
- 1949: Beecham Group Ltd acquires C L Bencard Ltd, a company specialising in allergy vaccines.
- 1963: Smith Kline & French Laboratories buys Recherche et Industrie Thérapeutiques (Belgium) to order to focus on vaccines.
- 1969: Smith Kline & French Laboratories buys 7 laboratories in Canada and the U.S.
- 1982: Smith Kline & French Laboratories buys Allergan, a manufacturer of eye and skincare products, and merges with Beckman Inc. changing its name to SmithKline Beckman.
- 1986: Beecham acquires Norcliff Thayer.
- 1988: SmithKline BioScience Laboratories buys its biggest competitor, International Clinical Laboratories Inc.
- 1989: SmithKline Beckman and The Beecham Group plc merge to form SmithKline Beecham plc.
- 1991: Seroxat/Paxil (paroxetine hydrochloride) is launched in the UK.
- 1992: Havrix hepatitis A vaccine, inactivated, the world's first hepatitis A vaccine, is launched in 6 European markets.
- 1993: SmithKline Beecham and Human Genome Sciences negotiate a multi-million-dollar research collaboration agreement.
- 1994: SmithKline Beecham sells its animal health business and purchases Diversified Pharmaceutical Services Inc., a pharmaceutical benefits manager, and Sterling Health, becoming the third-largest over-the-counter medicines company in the world and number one in Europe and the international markets.
- 1995: SmithKline Beecham acquires Sterling Winthrop's site in Upper Providence, Pennsylvania.
- 1997: SmithKline Beecham and Incyte Pharmaceuticals create diaDexus, a joint venture to discover and market novel molecular diagnostics based on the use of genomics.
Business
2010
- Haiti: Approximately £250,000 to the British Red Cross. Donations of mainly oral and topical antibiotics, including Bactroban, Zovirax, Augmentin, Ceftin, Zinacef and Zantac provided from stocks held in warehouses of non-profit partners, such as AmeriCares, Direct Relief International, Health Partners International of Canada and International Medical Assistance.
- Series of new initiatives targeted at further transforming the approach to diseases that disproportionately affect the world's poorest countries.
- Formation of new standalone unit specialising in the development and commercialisation of medicines for rare diseases.
- Unique agreement with the GAVI Alliance to supply up to 300 million doses of Synflorix vaccine, for invasive pneumococcal disease, over a 10 year period. Agreement is funded by ground-breaking mechanism called an Advance Market Commitment and is the result of years of planning by GAVI Alliance, UNICEF, the World Bank and major donors, who recognised the potential of vaccines to prevent diseases in developing countries. The mechanism is backed by the G8 and was officially launched by the Advance Market Commitment partners and donors on June 2009. The agreement for supply of pneumococcal vaccines has been financed by GAVI Alliance, 5 donor countries (UK, Canada, Russia, Norway and Italy) and the Bill & Melinda Gates Foundation.
- New production facility at Nashik site in India to manufacture albendazole, part of combination treatment used within the WHO Global Programme to Eliminate Lymphatic Filariasis. Since the programme began in 2000, more than 1.9 billion treatments have been given to over 570 million people in 48 countries. Investment of $330,000 to deliver additional 300 million treatments of albendazole per year, largest drug donation programme in the history of the global pharmaceutical industry.
- New strategic alliance with Isis Pharmaceuticals Inc. to collaborate on RNA therapeutics for rare and infectious diseases. Isis Pharmaceuticals Inc. will be eligible to receive license fees and milestone payments, totaling nearly $1.5 billion, in the event all 6 programmes are successfully developed for one or more indications and commercialised through to pre-agreed sales targets. In addition Isis Pharmaceuticals Inc. will receive up to double-digit royalties on sales, from any product that is successfully commercialised.
- Strategic alliance with Dong-A Pharmaceuticals Co. Ltd., number one pharmaceutical and OTC Company in South Korea. As part of the transaction, GSK acquires 9.9% minority equity shareholding for £73.9 million.
- Acquisitions of Laboratorios Phoenix, leading Argentine pharmaceutical business, for cash consideration of approximately $253 million.
- Agreement for Aptuit Inc. to acquire operations at Medicines Research Centre in Verona, Italy.
- GSK and Singapore Economic Development Board, government agency responsible for economic growth and development, $35 million funding for 8 research projects based in Singapore aimed at growing local capabilities and talent in green and sustainable manufacturing.
- Galapagos acquires GSK's state-of-the art research centre in Zagreb, Croatia.
- Partnership with the Bone and Joint Decade (endorsed by WHO) to develop the global programme that provides information on practical and clinically proven techniques that people can use to self-manage their joint pain.
- 18% minority equity stake in Convergence Pharmaceuticals Limited, new biotechnology company that focus on the development of new analgesic compounds.
- New 5 year commitment to expand donation of medicine albendazole to treat children at risk of intestinal worms, known as soil-transmitted helminths. Increase production capacity of albendazole through new investments in factories in South Africa and India provide additional 400 million treatments per year, representing major new contribution to United Nations's strategy.
- New strategic alliance with Fondazione Telethon and Fondazione San Raffaele to research and develop novel treatments to address rare genetic disorders, using gene therapy carried out on stem cells taken from the patient's bone marrow (ex vivo), at the San Raffaele Telethon Institute for Gene Therapy.
- New agreement under which Lonza supports ongoing development of GSK's biopharmaceutical pipeline by supplying manufacturing capacity for 5 early stage monoclonal antibodies.
- Unique collaboration with Oswald Cruz Foundation to research and develop new and innovative medicines to treat diseases which disproportionately affect people living in the world’s poorest countries. This new collaborative framework, builds on a long-standing relationship established in 1985 to manufacture vaccines for public health priorities in Brazil including polio, Haemophilus influenzae type b, measles, mumps, rubella, rotavirus and pneumococcal disease.
- Vaccine production alliance in Russia with JSC Binnopharm.
- Stock purchase agreement to purchase 5,750,000 shares of Theravance Inc. common stock at a price of $22.50 per share, for a total investment of $129,375,000. Following the purchase, GSK owns 15,151,499 shares of common stock and Class A common stock, which represent approximately 19% of the total outstanding capital stock.
- Acquisition of Nanjing MeiRui Pharma Co. Ltd., chinese pharmaceutical company specializing in manufacturing urology and allergy medicines (China operating entity of Pagoda Pharma Group Inc., privately owned company registered in the British Virgin Islands), for cash consideration of approximately $70 million (90% from Pagoda Pharmaceuticals Limited and 10% from Allergon AB).
- Acquisition of Maxinutrition, UK company that manufactures protein-enhanced functional nutrition products (Europe's number one sports nutrition company by market share), from Darwin Private Equity, for cash consideration of approximately £162 million including the repayment of outstanding debt.
2009
- GSK's wholly-owned subsidiary Gemstone Acquisition Corporation merges Genelabs Technologies to increase focus on novel small molecule therapies for Hepatitis C.
- Acquisition of 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.
- Acquisition of Stiefel Laboratories Inc., 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.
- Extension of strategic relationship with Aspen Pharmacare Holdings and acquisition of 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
- Acquisition of branded generics business of Bristol Myers Squibb in Lebanon, Jordan, Syria, Libya and Yemen for cash consideration of $23.2 million.
- Acquisition of 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.
- Agreement with JCR Pharmaceuticals, Japanese developer and manufacturer of bioactive products, obtaining global rights to a number of enzyme replacement therapies that could, upon approval, be used to treat orphan diseases such as Hunter syndrome, Fabry disease and Gaucher 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.
- Official Laboratory Services Provider in a Tier Three deal with the London Organising Committee of the Olympic Games and Paralympic Games. GSK provides facilities and equipment to enable Kings College London to operate a World Anti-Doping Agency accredited satellite laboratory at Games-time.
2008
- 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.
- 5 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.
- 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.
- Acquisitions of Bristol-Myers Squibb Pakistan Ltd. and certain associated trademarks for approximately $36.5 million, and Egyptian mature products business of Bristol Myers Squibb for $210 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.
- Sponsor deployment of British Red Cross Mass Sanitation Unit to Zimbabwe in response to cholera outbreak.
2007
- 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.
- $1.5 billion advance market funding from governments of Canada, Italy, Norway, UK, and the World Bank, to establish a pilot Advance Market Commitment to purchase and distribute new pneumococcal vaccines, including AIDS, malaria and tuberculosis.
- 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.
- Launch of 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.
2006
- Acquisition of 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 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.
- More than $200,000 in support of the HIV Medicine Association's Minority Clinical Fellowship Program.
- Expand scope of strategic alliance with NeuroSearch.
- Acquisitions of Domantis Ltd., leader in developing next generation of antibody therapies, for ₤230 million in cash, and CNS Inc., producers of the Breathe Right nasal dilator strips and FiberChoice dietary fibre supplements.
- 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.
2004
- Strategic alliance to license exclusive development and commercialization rights to product candidates from all of Theravance Inc.'s full drug discovery programmes initiated prior to September 2007, on pre-determined terms and on an exclusive, worldwide basis.
2002
- Licensing agreement with Gilead Sciences Inc. for exclusive rights to Hepsera (adefovir dipivoxil), hepatitis B treatment, in various territories including China, Japan, South Korea and Taiwan, and the right to commercialise tenofovir for the treatment of chronic hepatitis B under certain circumstances.
- Long-acting beta agonist collaboration with Theravance Inc. to develop and commercialize a once-daily product candidate as part of a new combination medicine with an inhaled corticosteroid for the treatment of asthma and/or a long-acting muscarinic antagonist for chronic obstructive pulmonary disease and as a single-agent new medicine.
2001
- 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.
Products
2010
- Obtained from ChemoCentryx Inc. exclusive license for further development and worldwide commercialization of Traficet-EN (CCX282-B), a specific CCR9 antagonist with the potential to offer a new approach for the treatment of inflammatory bowel diseases, including Crohn's disease.
- FDA accelerated approval for new combination regimen using TYKERB (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.
- GSK Consumer Healthcare warns consumers of potential health risks associated with long-term excessive use of zinc-containing denture adhesives.
- European Commission grants marketing authorisation for Revolade (eltrombopag), discovered as result of research collaboration with Ligand Pharmaceuticals, for oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura.
- Swiss regulatory authority grants approval for Duodart, fixed dose combination of dutasteride (0.5mg) and tamsulosin (0.4mg).
- Duodart, fixed dose combination of dutasteride (0.5mg), and tamsulosin (0.4mg) receive approval in Europe via the Decentralised Procedure with Germany acting as Reference Member State.
- GSK and Genmab A/S confirme European Commission conditional marketing authorisation for Arzerra (ofatumumab) for the treatment of refractory chronic lymphocytic leukaemia.
- FDA approval of Jalyn, single-capsule combination of dutasteride (0.5 mg) and tamsulosin (0.4 mg) to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.
- European Commission grants conditional marketing authorisation for Votrient (pazopanib) for the first-line treatment of advanced Renal Cell Carcinoma and for patients who have received prior cytokine therapy for advanced disease.
- Exclusive agreement with Medivir for the commercialisation of cold sore treatment Xerclear (acyclovir and hydrocortisone) for non-prescription use in key global markets, including Europe, Russia, Japan, India, Australia and New Zealand, and excluding North and South America, China, South Korea and Israel.
- Variation to the conditional marketing authorization for Tyverb (lapatinib) in the European Union for a new therapeutic indication.
- Amendment to the ofatumumab co-development and commercialisation agreement: GSK takes responsibility for developing ofatumumab in autoimmune indications whilst continuing to jointly develop ofatumumab with Genmab A/S in oncology indications; Genmab A/S receives upfront payment of £90 million, future funding commitment for the development of ofatumumab in oncology indications capped at a total of £145 million, including a yearly spending cap of £17 million for each of the next 6 years starting with 2010.
- GSK exercises option on Anacor Pharmaceuticals novel antibiotic for the treatment of gram-negative infections.
- Refocus development programme with Genmab A/S for ofatumumab in autoimmune indications.
- The European Medicines Agency suspends marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim). In the US, all rosiglitazone-containing medicines (Avandia, Avandamet and Avandaryl) remain available with additional safety labelling and restrictions for use. Total sales of Avandia products in the first half of 2010 were £321m (-18%); US £164m (-23%); Europe £72m (-17%); Emerging Markets £37m (-5%); RoW £48m (-6%).
- Fondaparinux 2.5 mg is additionally approved in the EU for the treatment of unstable angina or non-ST segment elevation myocardial infarction and for the treatment of ST segment elevation myocardial infarction, and 5mg, 7.5mg and 10mg are approved for initial treatment of acute deep vein thrombosis and pulmonary embolism. 1.5 and 2.5 mg currently approved for prevention of venous thromboembolic events.
- Definitive agreement with Amicus Therapeutics to develop and commercialise Amigal (migalastat HCl), for the treatment of Fabry disease, a rare inherited disorder.
- Approval from the Ministry of Health, Labour and Welfare in Japan for Revolade (eltrombopag), for the treatment of the blood disorder, chronic idiopathic thrombocytopenic purpura, and for Xyzal (levocetirizine dihydrochloride), first new anti-histamine to be made available in Japan for 8 years.
- Agreement with Impax Pharmaceuticals (brand products division of Impax Laboratories Inc.) for the development and commercialisation of IPX066, novel extended release carbidopa-levodopa product, outside the United States and Taiwan.
2009
- European Commission's approvals: Synflorix, paediatric pneumococcal vaccine for meningitis and bacteraemic pneumonia, and middle ear infections; Alli (orlistat 60mg), first non-prescription product for weight loss.
- World Health Organization global prequalification to Rotarix, vaccine against rotavirus, necessary for UN agencies and the GAVI Alliance to purchase rotavirus vaccines on behalf of developing countries. The WHO's Strategic Advisory Group of Experts also recommends that rotavirus vaccination be included in all national immunisation programmes. Opens the door to making rotavirus vaccines available to children worldwide, accelerates access to the vaccine in Asia and Africa and expands on the WHO decision taken in 2007 to prequalify the vaccine for Europe and the Americas.
- WHO prequalification to Cervarix, cervical cancer vaccine, necessary for UN agencies and the GAVI Alliance to purchase the vaccine in partnership with developing countries and help speed access globally.
- The 10-valent pneumococcal conjugate vaccine Synflorix approved by Brazilian regulatory authorities.
- Collaboration with Amgen to share commercialization of monoclonal antibody denosumab for postmenopausal osteoporosis in Europe, Australia, New Zealand and Mexico. Amgen to commercialize the drug for PMO and oncology in the U.S. and Canada and for all oncology indications in Europe and specified markets.
- Actiprotect, disposable respirator mask specifically designed with a coating with antiviral effectiveness, approved in Europe and certain international markets, and for occupational use in the USA.
- Withdraw the Marketing Authorisation Application in the European Union for mepolizumab for the treatment of hypereosinophilic syndrome.
- Exclusive agreement with President Trading Co. Ltd, a wholly-owned trading arm of Uni-President China Holdings Ltd, one of the leading food and beverage companies in China, to launch GSK's Lucozade drinks franchise across China.
- FDA approvals: Votrient (pazopanib), to treat patients with advanced renal cell carcinoma, a form of kidney cancer; Cervarix (Human papillomavirus bivalent types 16 and 18 vaccine, recombinant), for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus types 16 and 18 for use in girls and young women (aged 10-25).
- Cervarix becomes the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare. Cervarix, formulated with innovative AS04 adjuvant system, licensed for the prevention of pre-cancerous lesions (cervical intraepithelial neoplasia 2 and 3) and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by human papillomavirus types 16 and 18, in girls and women aged 10 and above. This landmark approval is the 99th licence obtained to date around the world. These include the 27 member states of the European Union, Australia, Brazil, South Korea, Mexico and Taiwan.
- GSK and Genmab A/S announce accelerated approval of Arzerra (ofatumumab) from the FDA for use in patients with chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab.
- World Health Organization prequalification for global use of Synflorix, GlaxoSmithKline Biologicals' pneumococcal conjugate vaccine. The WHO prequalification allows UN agencies to purchase vaccines on behalf of developing countries and will accelerate global access to Synflorix.
- Licensing agreement with Gilead Sciences Inc. to commercialise Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B infection in adults in five countries in Asia. Gilead's exclusive rights for commercialisation in Hong Kong, Singapore, South Korea and Taiwan. GSK's exclusive commercialisation rights and registration responsibilities in China. Each company will pay royalties to the other on sales in their respective Asian territories. Companies working to expand this agreement to include Japan and other countries.
- Exclusive licensing agreement with NanoBio Corporation in the United States and Canada for the over-the-counter use of NB-001, a novel, patented compound representing the next advance in the treatment of cold sores.
2008
- European Commission's approvals: Once-daily Avamys (fluticasone furoate) nasal spray for the treatment of the symptoms of allergic rhinitis in adults, adolescents and children; Volibris (ambrisentan) for the treatment of Functional Class II and III Pulmonary Arterial Hypertension; Avodart (dutasteride) with tamsulosin for the treatment of benign prostatic hyperplasia.
- FDA's approvals: Promacta (eltrombopag), the first oral medication to increase platelet production for people with serious blood disorder; Requip XL (ropinirole extended-release tablets) for the treatment of the signs and symptoms of idiopathic Parkinson's disease; Rotarix (Rotavirus Vaccine, live, oral) for the prevention of rotavirus gastroenteritis in infants (by 4 months of age); Advair 250/50 for the reduction of exacerbations in patients with chronic obstructive pulmonary disease; Tyverb (lapatinib), the first oral targeted therapy for ErbB2-positive breast cancer.
- GSK and Synta Pharmaceuticals Corp. announce orphan drug designation by the FDA to Elesclomol (STA-4783) for the treatment of patients with metastatic melanoma.
- GSK and POZEN Inc. announce FDA's approval of Treximet (sumatriptan and naproxen sodium) tablets for acute treatment of migraine.
- Worldwide exclusive agreement with Amira Pharmaceuticals to develop, manufacture and commercialise FLAP (5-Lipoxygenase Activating Protein) inhibitors for the treatment of respiratory and cardiovascular disease.
- Cervical cancer vaccine, Cervarix, confirmed by the Netherlands Vaccine Institute as the cervical cancer vaccine for the Dutch National Immunisation Programme to vaccinate all 12 year old girls.
- Agreed to sell Eltroxin, Lanoxin, Imuran and Zyloric to a subsidiary of the South African based pharmaceuticals group, Aspen Global Inc. for £170 million.
- Agreement with Laclede to purchase the leading Dry Mouth brand Biotene for $170 million.
- Cervical cancer vaccine, Cervarix, confirmed as the UK Department of Health's vaccine of choice for its national human papillomavirus immunisation programme to vaccinate girls aged 12 to 13 each year.
- Exclusive worldwide collaboration (excluding Japan) with Actelion Ltd. to realise the full potential of Almorexant in sleep disorders and beyond.
- Donation of 600 million treatments for lymphatic filariasis.
2007
- European Commission's approvals: new scored-tablet formulations of HIV fixed-dose combination medicines Combivir, Epivir (lamivudine/3TC) and Ziagen (abacavir) for use in children weighing more than 14kg; Wellbutrin XR, first once-daily noradrenaline dopamine reuptake inhibitor for the treatment of Major Depressive Disorder; cervical cancer vaccine, Cervarix; new indication for its once-daily anticoagulant ARIXTRA 2.5 mg (fondaparinux sodium) for the treatment of specific acute coronary syndromes; Atriance (nelarabine), for the treatment of difficult-to-treat leukaemias and lymphomas; novel topical antibacterial ALTARGO (retapamulin ointment, 1%) for the treatment of impetigo and infected small lacerations, abrasions or sutured wounds.
- FDA's approvals: the once-daily anticoagulant ARIXTRA (fondaparinux sodium) Injection; the weight-loss product orlistat 60 mg capsules; the New Drug Application for Requip (ropinirole) XL Extended-Release Tablets for the treatment of the signs and symptoms of idiopathic Parkinson's disease; oral Hycamtin (topotecan) capsules for the treatment of relapsed small cell lung cancer; once-daily Veramyst (fluticasone furoate) Nasal Spray for treatment of seasonal and year-round allergy symptoms in adults and children as young as 2 years; antibacterial Altabax for the topical treatment of impetigo; Twinrix (Hepatitis A Vaccine Inactivated and Hepatitis B Recombinant Vaccine), for an accelerated dosing schedule that consists of 3 doses given within 3 weeks followed by a booster dose at 12 months; Coreg CR (carvedilol phosphate) extended-release capsules, a once-a-day beta-blocker to treat three cardiovascular conditions; Tykerb (lapatinib), in combination with Xeloda (capecitabine), for the treatment of advanced or metastatic breast cancer.
- The Ministry of Health, Labour and Welfare in Japan approves Seretide/Advair Diskus (salmeterol and fluticasone proprionate combination) and Arixtra (fondaparinux sodium).
- Swiss approval of Tyverb, a new oral treatment for advanced breast cancer.
- Cervarix approved in Australia for use in females aged 10 to 45 years old. Approved in more than 80 countries including the European Union, Mexico, Singapore and the Philippines.
- GSK and Adolor Corporation provide an update on the alvimopan (Entereg/Entrareg) development programme.
- GSK acquires from Roche Group exclusive rights to the weight-loss medicine, Orlistat, for over-the-counter use in markets outside the U.S., excluding Japan.
- GSK, via its Centre Of Excellence for External Drug Discovery, exercises options to further develop and commercialise Exelixis Inc.'s anti-cancer C-Met inhibitior XL880.
- Rotarix, first rotavirus vaccine to obtain the prequalification status by WHO.
- Prometheus Laboratories Inc. acquires exclusive rights in the U.S. to GSK's Lotronex (alosetron hydrochloride) Tablets, only prescription drug approved by the FDA for use in adult female patients with severe diarrhea-predominant irritable bowel syndrome.
- Global collaboration agreement with Synta Pharmaceuticals Corp. for the joint development and commercialisation of STA-4783 in oncology.
- Worldwide alliance with Tolerx Inc. to develop and commercialise otelixizumab (TRX4), a novel humanised anti-CD3 monoclonal antibody. Collaboration focuses on type 1 diabetes and other autoimmune indications.
- Agreement with Merck for over-the-counter marketing rights for Mevacor in the U.S.
- Agreement with Sepracor Inc. for the commercialisation of eszopiclone product, treatment of insomnia, worldwide (excluding the U.S., Canada, Mexico and Japan).
2006
- European Commission's approvals: Hycamtin, as treatment for relapsed small cell lung cancer; Rotarix, allowing active vaccination of infants from the age of 6 weeks; quarterly intravenous injection of the osteoporosis medication Bonviva; Adartrel (ropinirole), for the treatment of moderate to severe idiopathic restless legs syndrome.
- FDA's approvals: Avandaryl (rosiglitazone maleate and glimepiride), a new fixed-dose combination product for type 2 diabetes; a new formulation of Imitrex (sumatriptan succinate) injection; Flovent HFA (fluticasone propionate hfa) Inhalation Aerosol in children 4 to 11 years of age with asthma; Altabax (retapamulin ointment), 1%, for the treatment of secondarily-infected traumatic lesions; new use of the anti-seizure medicine Lamictal (lamotrigine) Tablets for the treatment of one of the most serious forms of epilepsy; Wellbutrin XL, for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.
- Roche and GSK announce FDA's approval of Boniva (ibandronate sodium) Injection, 1st intravenous medication for the treatment of postmenopausal osteoporosis.
- GSK begins distribution of Trizivir (HIV medicine) tagged with radio frequency identification (RFID) technology by IBM.
- Licence agreement with Simcere Pharmaceuticals to manufacture and sell products containing Zanamivir, in China and other countries, including all 50 of the world's Least Developed Countries.
- Worldwide agreement with Genmab to co-develop and commercialize Arzerra and HuMax-CD20 (ofatumumab), fully human monoclonal antibody.
- GSK and Adolor Corporation announce FDA's approval of Entereg (alvimopan 12mg) for the management of post operative ileus.
- GSK and Flamel Technologies announce FDA's approval of once-a-day Coreg CR (carvedilol phosphate) extended-release capsules for the treatment of 3 key cardiovascular conditions.
- Agreement with the Russian Government to supply anti-retroviral medicines, for the treatment of HIV/AIDS, at discounted prices.
2005-2000
- 2005: FDA approves once-monthly Boniva as the first once-a-month tablet for postmenopausal osteoporosis; Launch of Rotarix, vaccine against rotavirus.
- 2004: GSK ships 33 million tablets of preferentially-priced Combivir (HIV treatment) to Africa.
- 2003: 10 million people in Sri Lanka receive free doses of Albendazole to help prevent the transmission of lymphatic filariasis; Launch of Wellbutrin XL, anti-depressant medicine, in the U.S.
- 2002: 1st 100 million Albendazole tablets donation for lymphatic filariasis; Avandia reaches 20 million prescriptions milestone in the U.S.; 15th anniversary of AZT, first medicine used to treat HIV/AIDS.
- 2001: Twinrix, the first combination vaccine to prevent hepatitis A and B is approved by the FDA; Launch of Advair, anti-asthma medicine, in the U.S. and acquisition of the Sensodyne range of oral care products; Launch of the African Malaria Partnership.
- 2000: Avandia passes 1 million retail prescriptions in the U.S.
Consumer Brands
- Dermatological: Abreva, Eumovate, Hinds, Lactacyd, Zovirax.
- Vitamins and naturals: Abtei, Alluna, Beano, Cetebe, Feosol, Geritol, Granufink, Medacalm, Os-cal, Rutinoscorbin, Scott's Emulsion, Valda, Viva, Vivarin.
- Weight loss: alli.
- Oral healthcare: Aquafresh, Astringosol, Binaca, Biotene, Chlorhexamed, Corega, Corsodyl, Dequadin, Dr. Best, Gly-Oxide, Macleans, Odol, Odol-med3, Parodontax, Polident, Polident 5 Minute, Poligrip Ultra, Sensodyne, Shumitect, Super Poligrip, Super Wernet's, Synthol, Targon.
- Pain relief: BC Powder, Goody's Powder, Iodex, Mejoral, Stanback.
- Allergy treatment: Beconase Allergy and Hayfever.
- Cold and flu treatment: Beechams, Coldrex, Iodosan.
- Respiratory: Breathe Right.
- Lip care: Chap-et.
- Analgesics and respiratory tract: Cholinex, Contac, Cortal, Crocin, Ecotrin, Fenbid, Panadeine, Panadol, Solpadeine.
- Analgesic/triptan: Formigran, Imigran Recovery.
- Gastrointestinal: Citrucel, Eno, FiberChoice, Gaviscon, Tagamet, Tums, Zantac.
- Smoking cessation treatment: Commit Lozenge.
- Nicotine replacement therapy: Committed Quitters, NiQuitin CQ/Nicoderm CQ/Nicabate, Nicorette.
- Ear care: Debrox.
- Eye care: Insto.
- Allergy treatment: Flixonase Allergy, Piriton.
- Anti-inflammatory: Hibitane.
- Nutritional healthcare: Horlicks, Lucozade, Maltova, Ribena.
- Nasal congestion: Libenar.
- Feminine hygiene: Massengill.
- Sleep aid: Nytol, Sominex.
- Gas: Phazyme.
Prescription Medicines
- A: Adartrel (ropinirole hydrochloride), Advair (salmeterol, fluticasone propionate), Albenza (albendazole), Alkeran (melphalan), Altabax (retapamulin ointment), Altargo (retapamulin), Amerge (naratriptan), Amoxil (amoxicillin), Andropatch (testosterone), Anectine (suxamethonium chloride), Argatroban (argatroban), Arixtra (fondaparinux sodium), Arranon (nelarabine), Arzerra (ofatumumab), Atriance (nelarabine), Augmentin (amoxicillin/clavulanate potassium), Avamys (fluticasone furoate), Avandamet (rosiglitazone/metformin HCl), Avandaryl (rosiglitazone maleate and glimepiride), Avandia (rosiglitazone maleate), Avodart (dutasteride), Axid (nizatidine).
- B: Bactroban (mupirocin), Becodisks (beclomethasone dipropionate), Beconase Aqueous Nasal Spray (beclomethasone dipropionate), Betnovate (betamethasone valerate), Bexxar (tositumomab), Boniva (ibandronate sodium).
- C: Ceftin (cefuroxime axetil), Coreg (carvedilol), Coreg CR (carvedilol phosphate), Cutivate (fluticasone propionate).
- D: Daraprim (pyrimethamine), Dermovate (clobetasol propionate), Dexedrine (dextroamphetamine sulfate), Digibind (digoxin antibody fab fragments), Doralese Tiltabs (indoramin hydrochloride), Dyazide (hydrochlorothiazide/triamterene), DynaCirc CR (isradipine).
- E: Efcortelan (hydrocortisone), Entereg (alvimopan), Eumovate (clobetasone butyrate).
- F: Flixonase (fluticasone propionate), Flixotide (fluticasone propionate), Flolan (epoprostenol), Flonase (fluticasone propionate), Flovent (fluticasone propionate), Fortaz (ceftazidime), Fortum (ceftazidime).
- H: Hycamtin (topotecan).
- I: Imigran (sumatriptan succinate), Imitrex (sumatriptan succinate), Imuran (azathioprine), Innopran XL (propranolol hydrochloride), Integrilin (eftifibatide).
- K: Kemadrin tablets (procyclidine hydrochloride).
- L: Lamictal (lamotrigine), Lanoxin (digoxin), Lanvis (tioguanine), Leukeran (chlorambucil), Liskonum (lithium carbonate), Lovaza (omega-3-acid ethyl esters).
- M: Malarone (atovaquone and proguanil hydrochloride), Mepron (atovaquone), Mivacron (mivacurium chloride), Myleran (busulfan).
- N: Naramig (naratriptan hydrochloride), Nimbex (cisatracurium besilate).
- O: Otosporin ear drops (polymyxin B sulphate, neomycin sulphate, hydrocortisone).
- P: Parnate (tranylcypromine sulfate), Paxil (paroxetine hydrochloride), Pentostam (sodium stibogluconate), Promacta (eltrombopag), Puri-Nethol (mercaptopurine).
- R: Relenza (zanamivir), Requip (ropinirole hydrochloride), Respontin nebules (ipratropium bromide), Rupafin (rupatadine fumarate), Rythmol (propafenone hydrochloride), Rythmol SR (propafenone hydrochloride).
- S: Septrin (co-trimoxazole), Seretide (salmeterol xinofoate, fluticasone propionate), Serevent (salmeterol xinafoate), Seroxat (paroxetine hydrochloride).
- T: Tabloid (thioguanine), Tagamet (cimetidine), Timentin (ticarcillin disodium / potassium clavulanate), Tracrium (atracurium besilate), Treximet (sumatriptan and naproxen sodium), Trimovate (clobetasone butyrate), Tykerb (lapatinib), Tyverb (lapatinib).
- U: Ultiva (remifentanil hydrochloride).
- V: Valtrex (valaciclovir hydrochloride), Ventolin (salbutamol sulphate), Ventolin HFA (albuterol), Veramyst (fluticasone furoate), Volibris (ambrisentan), Volmax (salbutamol sulphate), Votrient (pazopanib).
- W: Wellbutrin (bupropion hydrochloride), Wellvone (atovaquone).
- Z: Zantac (ranitidine hydrochloride), Zeffix (lamivudine), Zinacef (cefuroxime), Zinnat (cefuroxime axetil), Zofran (ondansetron hydrochloride), Zovirax (aciclovir), Zyban (bupropion hydrochloride), Zyloric (allopurinol).
CBS - Bad Medicine, The Glaxo Case (2010)