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A gut check for Big Pharma
July 2013
by Jim Cirigliano  |  Email the author


SAN DIEGO—Microbiome specialist biotech company Second Genome has announced an agreement with Janssen Biotech Inc., one of the Janssen Pharmaceutical companies of Johnson & Johnson. The agreement focuses on microbiome drug discovery in ulcerative colitis, with the goal of advancing novel drug targets, as well as discovering and understanding therapeutic mechanisms mediated by the bacterial ecosystem living within the human gut.
Under the terms of the agreement, Second Genome will receive an upfront payment and support for research activities conducted in collaboration with Janssen. Second Genome will also be eligible to receive potential payments upon the achievement of certain research milestones. Janssen will provide a guidance role, and the funding will come through the Johnson & Johnson Innovation Center and the Immunology Therapeutic Area within Janssen Research & Development LLC.  
The partnership's first goal will be gaining an understanding of or discovering a mechanistic role the microbiome plays in ulcerative colitis. Then, the researchers will attempt to identify novel targets based on these discoveries.  
According to Dr. Miguel Barbosa, vice president and head of Immunology Research & Scientific Partnership Strategy at Janssen Research & Development, the field of microbiome research is on the cusp of moving from pointing to associations between certain microbiota and disease states to defining causative relationships or identifying predisposing factors related to disease.
The microbiome is the bacterial ecosystem living within the human gut, as well as in the mouth, skin and elsewhere in and on the body. It is estimated that the human microbiome consists of more than 100 trillion microorganisms that form a complex community of bacterial species that play vital roles in human health, including food digestion, synthesizing vitamins and nutrients and preventing disease-causing bacteria from entering the body.  
"A breakdown in the normal relationship between the human immune system and the bacterial communities that reside in the gut appears to play an important role in development of the hallmark chronic inflammation of ulcerative colitis," said Dr. Susan Lynch, scientific advisor to Second Genome, director of the Colitis and Crohn's Disease Microbiome Research Core and associate professor of gastroenterology at University of California, San Francisco, in a media statement about the agreement.    Prior to announcing their agreement, both partners had recognized the swell of interest in microbiome research in the past 12 to 18 months, and the strong growth of scientific literature connecting the microbiome to a number of disease areas.  
"We saw a lot of compelling data, and an explosion of more and more labs publishing in this area related to human disease and potential mechanisms," says Barbosa.
"The question on the table has been the relevance of the microbiome for pharmaceutical drug discovery, " says Peter DiLaura, president and CEO of Second Genome. "The Janssen-Second Genome collaboration is the first pharma-biotech deal in the space, and we believe it provides a strong validation that the microbiome is increasingly understood to be relevant to Big Pharma."  
Second Genome has developed a powerful proprietary platform for mining the microbiome for potential targets. It is able to broadly profile microbiota associated with specific samples and analyze vast amount of data collected this way using advanced computational tools. Janssen was attracted to Second Genome because it had the right combination of these factors and a mature platform seen as one of the leaders in the field. Barbosa says this agreement with Second Genome plays into Janssen's broader strategy of proactively entering areas of emerging science and investing in collaborations with companies and labs at the forefront in those areas.
"I see our engagement with this area of emerging science as a reflection of Janssen's R&D commitment to treatment of autoimmune disease, not just looking at current approaches but also identifying disease mechanisms that could allow us to transform the way we treat illness," says Barbosa.
"We're excited to be the first company to take this important step in translating microbiome science into therapeutics applications," says DiLaura.  
Aside from applications in inflammation (and in ulcerative colitis within this broad category), microbiome research and development also holds promise in metabolic disease, particularly in type 2 diabetes.
Code: E071326



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