GlaxoSmithKline

Glaxo wins European contract for Cervarix

John Carroll — Thu, 20 Nov 2008 08:30:59 -0500

GlaxoSmithKline has won another European contract for the cervical cancer vaccine Cervarix. The Dutch government selected Cervarix for a new program to vaccinate all girls aged 12 with a catch-up program for girls aged 13 to 16 in the second half of 2009. In the first year some 350,000 Dutch girls will get the jab.

Cervarix won out over Merck's Gardasil in the Netherlands, but has yet to be approved in the United States. That makes European market penetration vital for Glaxo. Glaxo markets Cervarix in Europe under a joint venture with Sanofi-Aventis.

"We are delighted with this decision and the fact that since Cervarix received European approval it has been selected as the cervical cancer vaccine for more than half of eligible tenders across Europe," said Eddie Gray, president of Pharmaceuticals Europe for GSK. "We look forward to working with the Netherlands Vaccine Institute." Globally, cervical cancer is the second leading cause of cancer death among women.

- check out GSK's release

GSK kickstarts global trial for seasonal flu vax

Calisha Myers — Mon, 10 Nov 2008 14:47:00 -0500

GlaxoSmithKline announced that it has started a worldwide clinical efficacy trial to evaluate a new seasonal flu vaccine. With over 43,000 volunteers, this Phase III clinical trial is one of the largest influenza efficacy trials ever undertaken for seasonal flu. The trial will be conducted over a two-year period and will involve adults aged 65 and older in 15 countries, including Belgium, France, United Kingdom, Germany, Russia, Mexico, United States, Taiwan and Canada.

"With this large clinical trial in seasonal influenza, we are building on the leading role GlaxoSmithKline Biologicals has already played in the development of pandemic protection. This new seasonal vaccine contains an adjuvant similar to the one pioneered for the only influenza pre-pandemic vaccine approved in Europe, Prepandrix, and the pandemic vaccine Pandemrix," said Jean Stéphenne, President and General Manager GSK Biologicals. "We are looking to develop a superior influenza vaccine that will provide those at risk of influenza with better protection."

- check out the GlaxoSmithKline release

ALSO: GSK has teamed up the PATH Malaria Vaccine Initiative, an anti-malaria organization funded by the Bill & Melinda Gates Foundation, and clinics and research centers in Africa to develop the world's first malaria vaccine. The massive clinical trial will include 16,000 children and is expected to begin as early as next month. Article

Glaxo snags Alzheimer's vax rights in €452.5M deal

John Carroll — Thu, 23 Oct 2008 08:05:34 -0400

GlaxoSmithKline has put down €22.5 million and promised up to €430 million more to license the rights to two early-stage Alzheimer's disease vaccines from Austria's AFFiRiS. Glaxo picks up exclusive rights to two vaccines in Phase I testing and an option on preclinical candidates.

The deal is an endorsement of AFFiRiS' technology. The biotech boasts of being able to design proteins that have very specific binding abilities, a key feature for anyone creating a vaccine that can attack the beta-amyloid associated with Alzheimer's.

The deal is heavily weighted to the back end of the development process, with the biggest payoff coming as researchers have a chance to pour through clinical trial data. Alzheimer's therapies offer a potential source of enormous wealth for drug companies, but have also proved to be extraordinarily risky as scientists try to under stand the causes and potential cures for the disease. For Glaxo, the deal also underscores its intention to get deeper and deeper into the biotech sphere of drug development.

"We are impressed with the AFFiRiS technology--combined with our expertise in innovative adjuvant systems--this collaboration will improve our chance of success in the discovery of new treatments against this major disease," said Jean Stephenne (photo), president and general manager of GlaxoSmithKline Biologicals.

- check out the GlaxoSmithKline release

Combo vaccines endorsed by federal advisory panel

John Carroll — Thu, 03 Jul 2008 08:19:23 -0400

In a move that should make it easier for millions of children in the U.S. to get their recommended vaccinations, a federal vaccine advisory panel has endorsed two new combination vaccinations. GlaxoSmithKline won a thumb's up from the advisory panel for a four-in-one shot that guards against diphtheria, tetanus, pertussis and polio at a cost of $45. Sanofi Pasteur won an endorsement of its five-in-one shot for diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b, or HiB. That jab costs $69. The vaccine advisory panel's decision helps clear the way for 36 million children to receive the vaccines through the Vaccines for Children program. Both vaccines have been approved by the FDA.

The new combination vaccines don't change the number of vaccinations that children are expected to receive. But it should make it easier for parents to keep track of which vaccinations have been completed.

- read the report in the Baltimore Sun

Glaxo ready to wait for late-stage Cervarix data

John Carroll — Thu, 03 Jul 2008 08:18:12 -0400

GlaxoSmithKline now says it will wait for the completion of a late-stage trial of its cervical cancer vaccine Cervarix before answering the FDA's questions about the therapy. That will push back any approval of Cervarix until 2010, at the earliest. And it confirms some of the worst fears of market analysts, who see Merck's Gardasil gobbling up the market long before Cervarix arrives on the scene.

The long-term efficacy trial that GSK is waiting on tracks the real-world experiences of girls and young women who have been vaccinated. The cancer vaccine is on sale in 67 countries.

- read the report in the Financial Times

Glaxo touts effectiveness of pediatric vaccine candidate

John Carroll — Thu, 12 Jun 2008 08:05:41 -0400

GlaxoSmithKline is touting new, late-stage data that demonstrates how its experimental pediatric vaccine Synflorix effectively protects children from pneumococcal disease. Glaxo filed Synflorix for review by the EMEA at the beginning of the year. The new data illustrates its protection against 10 strains of streptococcus pneumoniae, which includes bacteria that causes meningitis, pneumonia and ear infections. If Glaxo prevails in its quest for regulatory approval, Synflorix will go up against Wyeth's Prevnar, which targets seven of the 10 strains.

"The data presented today are extremely encouraging and represent a major step forward to a pneumococcal conjugate vaccine formulation, specifically designed to address the global epidemiology of pneumococcal disease in both developed and developing countries," says Jean Stéphenne, president of GlaxoSmithKline Biologicals

- check out GSK's release
- read the Dow Jones report

Cervarix data demonstrates prolonged protection

Thu, 15 May 2008 06:59:56 -0400

GlaxoSmithKline has released new Cervarix data that demonstrates the vaccine's ability to generate a high and sustained level of antibodies to neutralize the two most prevalent strains of cervical cancer for up to 6.4 years. That's the longest duration yet observed. The new follow-up data from ongoing trials also shows that the vaccine triggered antibody levels 11 times higher than a natural infection would induce over that period of time.

"We designed our cervical cancer vaccine with our proprietary Adjuvant System, AS04, to deliver high and sustained levels of neutralizing antibodies to prevent cervical cancer over the long-term," said Philippe Monteyne, Senior Vice President, GSK Biologicals. "With nearly six and a half years of data, the vaccine has already been shown to provide the longest duration of protection of any cervical cancer vaccine to date. The high and sustained neutralizing antibody levels we observe over this same period give us confidence that the vaccine will continue to protect for even longer. This is why we are extending the study follow-up in a sub-set of women for up to 9.5 years, the longest follow-up period for any cervical cancer vaccine."

- read the Cervarix release for more
- read the story from RTT News

GSK bird flu vaccine provides more positive data

Thu, 06 Mar 2008 06:59:58 -0500

New trial data on GlaxoSmithKline's experimental bird flu vaccine indicates that the drug works against a variety of subsets of the virus. A trial that recruited volunteers in Hong Kong, Taiwan, Thailand and Singapore showed that the vaccine spurred antibodies that neutralized both the Indonesian and Vietnamese strains of the virus. Earlier trial data for the adjuvanted vaccine, which is nearing official European approval, demonstrated efficacy against Chinese and Turkish strains.

The vaccine uses very low doses of antigens, relying on adjuvants to boost its ability to protect people from H5N1. But despite rapid progress in the field to develop new bird flu vaccines to head off any potential outbreaks, researchers are acutely aware that they're running the risk of being blindsided by a completely new strain of the virus. That possibility has led some experts, including Albert Osterhaus, head of virology at the Erasmus Medical Centre in the Netherlands, to conclude that antigens and adjuvants could be stockpiled separately, so that a new, customized mixture could be swiftly developed to protect populations from a disease that could threaten millions of lives.

"If a pandemic breaks out in Indonesia or Thailand, the virus could be in Singapore within two days," said Dr. Helen Oh, who was in charge of the Singapore trials.

- check out the report from the Sydney Morning Herald

Related Article:
GSK wins EMEA approval for pandemic vaccine. Report

GSK's secret vaccine adjuvant draws attention

Thu, 28 Feb 2008 06:59:56 -0500

GlaxoSmithKline's success advancing two pandemic vaccines--Prepandrix and Pandemrix--relies on a secret formula that drives efficacy of a low antigen dose in these adjuvated products. According to In Vivo, Glaxo has been careful to keep the proprietary adjuvant secret throughout the approval process. As Glaxo has noted, a pandemic would require massive quantities of vaccine for any effective campaign to protect populations--and adjuvants are considered a key to making sure that vaccine stocks can be spread far and wide enough to prevent an outbreak. At some point, In Vivo notes, Glaxo will have to either unveil the adjuvant to European or U.S. regulatory officials.

- read the feature in In Vivo

Related Articles:
GSK pre-pandemic vaccine shows promise. Report
GSK wins EMEA approval for pandemic vaccine. Report
HHS awards H5N1 contracts. Report