GlaxoSmithKline

Upfront and potential consideration of over $500 million

16 November 2009, London UK, Rockville US -- GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals (Nabi) today announced an 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.    » read more »

10 November 2009, London UK & Philadelphia US -- GlaxoSmithKline (GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The approval of the sBLA, which was filed as a strain change supplement to GSK’s FluLaval seasonal flu vaccine, allows the company to manufacture a flu vaccine for use in adults to prevent influenza caused by the 2009 pandemic H1N1 influenza A strain.    » read more »

10 November 2009, London, UK -- GlaxoSmithKline (GSK) today announced that it has signed an agreement with the World Health Organization (WHO) to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to WHO for distribution to developing countries most in need. GSK is working with WHO and health authorities to prepare for initial shipments of the vaccine to developing countries by the end of November.    » read more »

Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®)

09 November 2009, London UK -- GlaxoSmithKline (GSK) today announced the results from the clinical trial assessing Pandemrix™, GSK’s adjuvanted H1N1 pandemic influenza vaccine, administered at the same time as the annual seasonal influenza vaccine, Fluarix ® . The trial showed that co-administration of one dose of both vaccines in separate arms, induced a strong response in adults for both the H1N1 pandemic vaccine as well as the seasonal vaccine. The trial involves 168 adults aged over 60 years of age, and was designed to evaluate the tolerability and immunogenicity of the co-administration of Pandemrix and Fluarix.    » read more »

Pivotal testing of RTS,S is on track for target enrollment of 16,000 children

NAIROBI, KENYA November 3, 2009 -- A pivotal efficacy trial of RTS,S, the world’s most clinically advanced malaria vaccine candidate, is now underway in seven African countries: Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique and Tanzania. The trial, which is expected to involve up to 16,000 children, is on schedule, with more than 5,000 children already enrolled, researchers announced Tuesday at the 5th Multilateral Initiative on Malaria Pan-African Malaria Conference.    » read more »

Oct. 19, 2009 -- GlaxoSmithKline [NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved Votrient™ (pazopanib) to treat patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. Approximately 57,700 people in the U.S. will be diagnosed with kidney cancer this year, and 13,000 people will die from this disease.    » read more »

Results confirm immune response and tolerability

16 October 2009, London, UK -- GlaxoSmithKline (GSK) today announced results from a second clinical trial of its pandemic (H1N1) adjuvanted vaccine, which demonstrate that one dose of the vaccine can provide a strong immune response which exceeds criteria as defined by international licensing authorities using the lowest dose of antigen available in pandemic vaccines. The data from GSK’s H1N1 trials announced to date demonstrate the vaccine is generally well tolerated. The vaccine in this trial contains 3.75 µg of H1N1 antigen, which is the EMEA approved final formulation.    » read more »

16 October 2009, London UK -- GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved 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 (HPV) types 16 and 18 for use in girls and young women (aged 10-25).    » read more »

06 October 2009, London, UK -- GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain.

The company today provided an update on orders received for its pandemic (H1N1) adjuvanted vaccine.

On the 4th August, GSK confirmed that it had contracts in place to supply 291 million doses of the vaccine and had a variety of agreements in place with the US Government to supply pandemic products worth $250 million.

Since that date, 22 government orders have been agreed to supply a further 149 million doses of the vaccine. This now brings the total number of doses ordered for GSK’s pandemic vaccines to 440 million. Discussions continue with governments for further supplies.    » read more »

First company to join the pool since creation in March 2009

8 July 2009, Cambridge, Massachusetts and London UK -- GlaxoSmithKline (GSK) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced today that Alnylam will contribute more than 1500 issued or pending patents on its RNA interference (RNAi) technology patent estate to the patent pool established by GSK earlier this year.    » read more »

WHO grants prequalification to Cervarix®: GSK’s vaccine to help combat cervical cancer in developing nations

9 July 2009, London, UK -- The World Health Organization (WHO) has awarded prequalification to Cervarix®, GlaxoSmithKline’s cervical cancer vaccine. The WHO decision is necessary for UN agencies and the GAVI Alliance to purchase the vaccine in partnership with developing countries and will help speed access to Cervarix globally.

More than 80 percent of the 280,000 cervical cancer deaths a year occur in resource-poor nations.[i] Cervical cancer affects poor women in the least developed countries more often and more aggressively due to a lack of available screening services and the high prevalence of other serious health conditions such as HIV/AIDS. [ii], [iii]    » read more »

23 June 2009, London UK -- GlaxoSmithKline (LSE: GSK) and Chroma Therapeutics Limited announced today a collaboration to develop macrophage-targeted compounds using Chroma’s proprietary esterase-sensitive motif (ESM) technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process.    » read more »

WHO raises influenza pandemic alert to phase 6

June 12, 2009, London, UK -- The World Health Organisation (WHO) has announced it has raised the current level of influenza pandemic alert from phase 5 to phase 6. As stated by the WHO, phase 6 indicates that there now is a pandemic ongoing caused by the new A (H1N1) influenza virus. The WHO has stated in their current assessment of the situation that this pandemic is currently of a moderate severity.

In addition to increasing production and supply of the anti-viral medication, Relenza (zanamivir), the company continues to focus efforts on the development of a candidate A (H1N1) adjuvanted influenza vaccine.    » read more »

June 0, 2009, London UK -- GlaxoSmithKline plc (GSK) today announced it has entered into a definitive agreement to form a new Joint Venture with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd (Shenzhen Neptunus) focused on developing and manufacturing influenza vaccines for the Chinese market.    » read more »

June 7, 2009, London UK -- New Phase II data presented today at the American Diabetes Association 69th Scientific Sessions in New Orleans show that the investigational type 2 diabetes treatment Syncria® (albiglutide) significantly reduced blood glucose levels and provided weight loss across weekly, biweekly and monthly dosing.1 Reducing blood sugar is a key part of managing type 2 diabetes, a disease that affects over 250 million people worldwide.2    » read more »