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Summit, Seeking Asian Toehold, Inks Zebrafish Tox Deal With J&J

Summit this week announced that it has signed a non-exclusive research agreement with Johnson & Johnson to develop zebrafish screening assays for use in drug discovery and development.
Under the terms of the agreement, which is the second of its kind between the partners, Summit will receive an undisclosed amount from J&J over the course of three years to support the development of new assays using Summit’s zebrafish platform. The assays will screen drug candidates, including those in J&J’s pipeline, for a variety of toxicity and other safety issues.
Financial terms of the deal were not disclosed.
The screening will take place at Summit’s new zebrafish facility in Singapore, which UK-based Summit will establish and maintain. According to a Summit official, the Singapore facility will allow Summit to establish a foothold in the Asian market.   
The facility, which Summit anticipates being operational by mid-2009, “has come about from the investment that we are receiving from J&J,” said Richard Pye, investor relations for Summit.
J&J is currently working in Singapore and wanted to reinvest money into the area, said Pye. He added that the drug giant is looking for new technologies, and since Summit has been working with J&J, the company decided to invest in its zebrafish platform.
“The facility itself will not have a full aquaculture facility like we have in the UK,” Pye said. Summit will buy embryos from zebrafish researchers located in Singapore on an as-needed basis to keep the overhead low, compared to Summit’s facility in the UK, he said.
It will also be a smaller facility than the one that makes up its UK headquarters. “We are initially looking to employ about three people, likely a site manager and several technicians,” said Pye. That headcount will grow within the first year or so of the agreement, to perhaps five people, he said.

If zebrafish screening “is very successful, it could be used routinely following cell-based screens, [though] it is not likely to replace existing mammalian screens; it could be a bridge between cell-based and mammalian screens.”

“One of the ambitions for this center will be for it to offer people beyond J&J access to our zebrafish-screening technology and assays,” including drug makers in Asia, Pye said.  
The location will be “quite exciting,” said Pye, and will give Summit an opportunity to target the Asian market, something that the company has not had a lot of exposure to yet.
“If we start getting a lot of fee-for-service work, we will grow the number of employees accordingly, so it is going to be a very flexible setup,” said Pye. However, initially the Singapore site will focus on the J&J research.
Pye said that approximately two-thirds of Summit’s zebrafish clients are located in Europe, and a third are located in the US.
“From our experience with our current clients, people take comfort in the fact that our facility is close by,” he said. “So for Far Eastern clients, the Singapore location will inspire them to want to work with us” and give Summit a foothold in Asia.
“We have already earmarked lab space within Singapore, and the recruitment process is already underway as well,” said Pye. “I think we are looking to get people in place by the end of this year or early 2009.”
Pye said he did not have the exact size of the Singapore lab space yet.
The dollar value of the Asian market to Summit’s business is difficult to estimate, said Pye. “At this point it is more important for the industry to understand the potential that zebrafish can have in the drug-discovery process,” he said. “We just want to get people excited about the benefits that it can bring.”
A Continued Collaboration
Summit has had a working relationship with J&J for several years. In July, 2007, Summit, then known as VASTOx, announced that it had entered into a series of pilot-screening agreements with Merck KGaA, Servier, and J&J (see CBA News, 7/6/07). As part of those studies, the company used its zebrafish-screening platform to blind-screen various known compounds to validate its ability to predict adverse effects.
Pye said that Summit shared the results with its pharma collaborators “so that they could understand how the zebrafish worked, and the information that it provides.” That initial work grew into a larger collaboration between J&J and Summit, resulting in this week’s announcement.
“Now they are, through this agreement, making an investment in the development of the platform, and the development of new assays to enhance the technology,” said Pye.
When Summit initially announced its pilot studies with Merck, Servier, and J&J, Summit CEO Steven Lee said that the company was seeing a trajectory of exponential growth from pharma and biotech companies for zebrafish screening.
For instance, in its 2004/2005 fiscal year, the company pulled in £100,000 ($173,000) in revenue from its services business, including zebrafish services, which rose to £500,000 the following year, and generated £1 million in its 2006/2007 fiscal year. For the 2007/2008 fiscal year, which ended Jan. 31, 2008, the company generated £1 million from fish services and £2 million from carbohydrate services.
“Based on our discussion with pharmaceutical companies, using the zebrafish as a model organism for drug-toxicity assessments is becoming a major initiative,” Eric Sandberg, then a scientist with Zygogen, an Atlanta-based zebrafish technology company, told CBA News in July, 2007.
“It’s clearly an emerging trend,” Sandberg said, because researchers can assess the effect of the drug in a whole organism, the fish are inexpensive, and their organ systems develop within five days of fertilization. Also, zebrafish offer a higher throughput vertebrate model for toxicity assessment, and give scientists the advantage of physiological relevance.
“In my experience, a lot of big pharmas have shown interest in zebrafish for toxicity and safety studies,” Stephane Berghmans, director of drug discovery for Znomics, a zebrafish company based in Portland, Ore., told CBA News in an e-mail this week. The best examples are the recent publications of collaborative work between Summit and Pfizer or AstraZeneca in the July-August 2008 issue of the Journal of Pharmacological and Toxicological Methods.
AstraZeneca has also been evaluating zebrafish larval locomotor activity for safety, and published findings in the September-October issue of the Journal of Pharmacological and Toxicological Methods. Pfizer and AstraZeneca also shared their experience with zebrafish in a review article published in the September-October issue of the Journal of Pharmacological and Toxicological Methods.
“Zebrafish allows us to bring a first in vivo evaluation much earlier in the drug-discovery process. When most tox/safety assessments are still performed in vitro, zebrafish permits us to obtain early in vivo data because of its scalability, low compound requirement, and predictivity,” Berghmans said
Virginia Herndon, vice president for business development for Zygogen, told CBA News this week that if zebrafish screening “is very successful, it could be used routinely following cell-based screens. Although it is not likely to replace existing mammalian screens, it could be a bridge between cell-based and mammalian screens.”      
The advantages of zebrafish for safety, toxicity, and efficacy testing are compelling, said Patricia McGrath, president and CEO of Phylonix, in an e-mail to CBA News this week. Cambridge Health Associates estimates that more than $2 billion is currently spent on toxicity testing.
McGrath went on to say that several pharmaceutical companies have combined pre-clinical testing and toxicology groups, and there is a discernable trend toward earlier toxicity assessment, especially for developmental toxicity, which was previously performed only after some human clinical data was available.

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