Key Developments: GlaxoSmithKline PLC (GSK)
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24 May 2013
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Latest Key Developments (Source: Significant Developments)
U.S. Government Taps Glaxosmithkline Plc For New Antibiotics-Reuters
Reuters reported that the U.S. government has signed an antibiotics development deal worth up to $200 million with GlaxoSmithKline to tackle the dual threats of drug resistance and bioterrorism. The collaboration, the first of kind between Washington and a drug company, will allow funding to move around GSK's antibiotics portfolio rather than focusing on a single drug candidate. The collaboration between GSK and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, will study potential new drugs to treat conventional pathogens and those that might be developed as bioterrorism weapons. Britain's drugmaker said on May 22, 2013, it would receive $40 million for an initial 18 months and up to a total of $200 million if the agreement is renewed over five years. Full Article
Elan Corporation PLC Strikes $1 Billion GlaxoSmithKline Plc Royalty Deal With Theravance Inc-Reuters
Reuters reported that Elan Corporation PLC stepped up its bid to keep its independence by agreeing a $1 billion deal to buy 21% of the royalty that U.S. company Theravance Inc receives from GlaxoSmithKline Plc for its respiratory drugs. Full Article
FDA Approves Glaxosmithkline Plc's Breo Ellipta To Treat Lung Disease Jointly Developed With Theravance Inc-DJ
Dow Jones reported that the U.S. Food and Drug Administration approved a new drug that will be marketed by GlaxoSmithKline PLC to treat chronic obstructive pulmonary disease, or COPD. The drug, Breo Ellipta, is administered once-daily with an inhaler. The FDA's approval was expected after a federal advisory panel endorsed the product last month. Breo was developed by Theravance Inc. and GlaxoSmithKline. It has the potential to be a successor to Glaxo's Advair, which should be taken twice daily. Breo Ellipta combines the corticosteroid fluticasone with vilanterol, a new active ingredient. The FDA said the product isn't approved to treat asthma. Full Article
Impax Laboratories Inc's Impax Pharmaceuticals And Glaxosmithkline Plc Terminate Collaboration On IPX066 (RYTARYTM)
Impax Laboratories Inc's Impax Pharmaceuticals and Glaxosmithkline Plc announced that they are terminating their collaboration for the development and commercialization of IPX066 outside the United States (U.S.) and Taiwan. IPX066 (known as RYTARY in the U.S.) is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson's disease and is not approved anywhere in the world. Under the terms of the agreement entered into in December 2010, GSK's right to develop and commercialize IPX066 outside the U.S. and Taiwan will transfer back to Impax effective at the end of July 2013. The decision has been reached because of delays in the anticipated regulatory approval and launch dates in countries in which GSK has rights to commercialize the product. Impax intends to initiate activities to find a partner or partners for markets outside the U.S. looking to grow their non-US neurology franchise. Full Article
Glaxosmithkline Plc Opts To Sell Off Lucozade And Ribena Drink Brands-Reuters
Reuters reported that Glaxosmithkline Plc has decided to sell its soft drink brands Lucozade and Ribena in a disposal that analysts believe could bring in more than GBP1 billion ($1.5 billion). Full Article
Glaxosmithkline Plc Reaffirms FY 2013 Guidance; Declares First Interim Dividend
Glaxosmithkline Plc announced for fiscal 2013, it expects sales growth of approximately 1% and core EPS growth 3-4% unchanged (both at CER). The Company reported revenue of $42.025 billion and EPS of $3.53 in fiscal 2012. The Company also announced that the Board has declared a first interim dividend of 18 pence per share (first quarter of 2012: 17 pence per share). The equivalent interim dividend receivable by ADR holders is 55.0224 cents per ADS based on an exchange rate of GBP1/$1.5284. The ex-dividend date will be May 08, 2013, with a record date of May 10, 2013 and a payment date of July 11, 2013. Full Article
Glaxosmithkline Plc To Partner With Venture Capital Firm For Drug Discovery-Reuters
Reuters reported that Glaxosmithkline Plc (GSK) said it will partner with venture capitalists Avalon Ventures in a deal worth up to $495 million to fund as many as 10 drug-discovery startup companies over the next three years. GSK will provide financing and technical support to startups established by Avalon Ventures and will have first rights on buying each new company, GSK spokeswoman Melinda Stubbee said. Avalon will contribute up to $30 million to the collaboration, and Glaxo will provide as much as $465 million in initial funding and development milestone payments, Stubbee said. Full Article
US FDA Advisory Panel Backs Glaxosmithkline Plc And Theravance, Inc. Lung Drug-Reuters
Reuters reported that an advisory panel to the U.S. Food and Drug Administration has recommended that the agency approve an experimental treatment for smoking-related lung damage made by GlaxoSmithKline Plc and Theravance Inc. The drug, Breo Ellipta, is a once daily inhaled treatment for chronic obstructive pulmonary disease (COPD), a condition that includes emphysema, chronic bronchitis or both. Breo consists of a corticosteroid, fluticasone furoate, which reduces inflammation and a novel long-acting beta-agonist, or LABA, called vilanterol, which is designed to open the airways. The product is inhaled through a palm-sized device called Ellipta. Full Article
Genmab A/S Announces Final US Court Judgment in Favor of Arzerra and GlaxoSmithKline Plc in Patent Infringement Lawsuit
Genmab A/S announced that the United States (US) Court of Appeals for the Federal Circuit has upheld the US District Court’s judgment in favor of GlaxoSmithKline Plc (GSK) in a patent infringement case involving Genmab's Arzerra brought against GSK by Genentech and Biogen Idec. The two companies appealed the court order on the patent claim construction which led to the judgment in favor of GSK in December 2011. The US Court of Appeals for the Federal Circuit has upheld the District Court’s original decision and the lawsuit is now over unless Genentech and Biogen Idec are granted further review by the Federal Circuit or the Supreme Court. Genentech and Biogen Idec originally filed the lawsuit in 2010 with the US District Court for the Southern District of California claiming Arzerra infringed US Patent No. 7,682,612 covering methods of treating Chronic Lymphocytic Leukemia (CLL) with CD20 antibodies. GSK denied infringement and claimed the patent was invalid and unenforceable. Arzerra, Genmab’s CD20 antibody, is partnered with GSK and is marketed in the US and Europe as well as other territories. Full Article
Vivalis SA Announces New EB66 Cell Line Services and License Option Agreement with Glaxosmithkline Plc
Vivalis SA announced that it has signed an EB66 cell line research services and license option agreement with Glaxosmithkline Plc to establish the feasibility of producing a new viral vaccine against an important viral disease using EB66 with an option to license EB66 cell line for similar viruses of the same family. Financial terms of the agreement were not disclosed. Full Article
U.S. government taps GlaxoSmithKline for new antibiotics
LONDON - The U.S. government has signed an antibiotics development deal worth up to $200 million with GlaxoSmithKline to tackle the dual threats of drug resistance and bioterrorism.
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