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J&J joins amazing race
October 2013
by Lori Lesko  |  Email the author


LONDON—Johnson & Johnson (J&J) has entered the race to become the first company to discover, develop and market an effective vaccine to treat Dengue fever—the world's fastest-spreading tropical disease, infecting up to 100 million people worldwide this year. Teaming up with academic researchers at the University of Leuven (KU Leaven) in Belgium and the London-based Wellcome Trust medical charity, J&J believes it has the inside track to a cure—despite competition from Paris-based Sanofi Pasteur and Japan-based Takeda.  
Spread by the Aedes aegypti mosquito, dengue has grown rapidly along with urbanization and globalization because it thrives in tropical megacities and is easily spread in goods containing small puddles of water. The World Health Organization (WHO) estimates that 50 million to 100 million infections occur each year. The incidence has increased sharply in the last 40 years, and the disease now affects more than 100 countries. In 2009, the Florida Keys had its first cases in decades. Last year, Europe experienced its first sustained transmission of dengue fever since the 1920s with around 2,000 people infected in the Portuguese archipelago of Madeira.
Ratcheting up the statistics, experts estimated in April that there may be as many as 390 million dengue infections around the world each year, although not all patients get seriously sick. Current approaches to treating the condition are focused on alleviating symptoms, rather than attacking the cause. There is currently no drug treatment or vaccine for the mosquito-borne viral disease that is also known as "breakbone fever" because of the severe pain it can cause the joints and muscles. Severe cases can involve bleeding and shock and can be fatal, particularly for children.
The collaboration of J&J's Janssen unit, researchers at the KU Leuven and financial backing from Wellcome Trust will build on the discovery of a series of chemical compounds that are highly potent in preventing the replication of dengue virus. The compounds, which have yet to be tested in clinical trials, are active against all four types of the virus and have been shown to work in animal tests. Under the terms of the agreement, J&J made an undisclosed upfront payment and will make future milestone payments to KU Leuven based upon the achievement of development, regulatory and sales goals.
Daniel De Schryver, global communications leader of infectious diseases and vaccines for Janssen J&J, says the collaborative project will build on an existing three-year drug discovery program at the Rega Institute and the Centre for Drug Design and Discovery at KU Leuven, supported by a Wellcome Trust Seeding Drug Discovery Award.
"There are several published mouse models for dengue virus infection which allow evaluation of antiviral test compounds," De Schryver tells DDNews. "The chemical series involved in this collaboration have shown promising activity in such models."
J&J is realizing this race for a cure is more of a marathon than a sprint. Earlier this year, Sanofi suffered a setback when an experimental shot from its latest dengue vaccine proved less effective in a mid-stage clinical trial in Thailand. Still, the study marked a milestone in the 70-year quest to develop such a vaccine, demonstrating that a safe and effective inoculation against dengue is feasible. While previous trials were meant to discover if a dengue vaccine was safe or could spur an immune response, the Sanofi trial was the first to test whether a vaccine could actually prevent the disease.
If Phase III clinical trial results fulfill Sanofi's hopes, the company will be poised to launch in 2015 and hit the ground running to meet the massive global demand for dengue vaccine. It will also be comfortably ahead of competitors with pipeline candidates, such as GlaxoSmithKline, Merck & Co., Takeda/Inviragen—and now J&J.

Sanofi comes close in chase for vaccine  
Sanofi's clinical trial results for a dengue fever vaccine are "the first ever demonstration that dengue vaccine is possible, and that's huge," says Dr. Nadia G. Tornieporth, head of global clinical research and development at Sanofi Pasteur, and co-author of a study the company published in The Lancet. But in a commentary published in The Lancet, Dr. Scott B. Halstead, a senior scientific adviser to the Dengue Vaccine Initiative, called the results "a complete surprise" and disappointing due to the "enormous expectation."
The trial, conducted by Sanofi and Thailand's Mahidol University, involved 4,000 school-aged children ages 4 to 11, in Thailand's Ratchaburi Province. Two-thirds of the children received three injections of the vaccine over the course of a year, while the other third received three injections either of a rabies vaccine or a placebo. Among children who got all three doses of either the vaccine or the control, there were 45 cases in the vaccinated group, representing 1.8 percent of that group, and 32 cases, or 2.6 percent, in the control group. The difference was not statistically significant.  
The main problem was that there are four types of dengue virus and the vaccine failed to protect against one of them, known as serotype 2. Unfortunately, it turned out that serotype 2 was the prevalent type in that region at the time of the study, accounting for more than half of the infections in the trial, researchers reported.  
It is unclear why the vaccine did not protect against serotype 2, especially since the vaccine did spur an immune response to that serotype. The good news is, the trial showed that the vaccine was safe and could help dispel a theoretical concern that a vaccine could actually make the disease worse.
Sanofi is already testing the vaccine in large Phase III trials involving more than 30,000 people in 10 countries, with results expected in 2014. The dengue vaccine, which is made of live, attenuated viruses, is one of the most important products in Sanofi's pipeline, with some analysts expecting sales to exceed $1 billion a year. Sanofi spent about $450 million in 2009 to build a new factory near Lyon, France, to make the vaccine. The plant has a design capacity of 100 million doses of the vaccine, tetravalent CYD-TDV, annually, according to Antoine Quin, manager of the site in Neuville-sur-Saone, France. In the meantime, Phase III trials are now underway in Asia and Latin America, with results expected next year.
Code: E101310



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