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Clinical Data Adds Diverse Icoria Technology To Genaissance Assets; Plans Service, Dxs

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Icoria shareholders this week approved the company's acquisition by Clinical Data, which plans to use Icoria's technology to support its pharmacogenomic service offerings and its nascent molecular diagnostics effort.

The $11 million all-stock acquisition follows on the heels of Clinical Data's $56 million acquisition of New Haven, Conn.-based Genaissance in October, and ends Icoria's long search for its identity in the genomics market.

"The core Clinical Data business is rather different, at least at this stage, from the molecular services and diagnostics businesses that we're acquiring through Genaissance and Icoria," Drew Fromkin, Clinical Data vice president and chief marketing officer, told Pharmacogenomics Reporter this week. "The genomics or molecular services side of our business is where the Icoria components fit most immediately," he said.

Icoria's assets include its biomarker discovery, metabolomics, and gene-expression technologies. These complement Genaissance's capabilities in sequencing, genotyping, and biobanking to enable a broad service offering that Clinical Data hopes to provide to pharma, biotech, and academia, Fromkin said. The service business should "effectively strengthen and solidify the foundation for our molecular diagnostics business in the testing area," he said.

So far, Clinical Data has yet to produce a molecular diagnostic of its own, but it provides Genaissance's Familion test for predicting the risk of Long-QT Syndrome, and it has also inherited from that firm the thiopurine S-methyltransferase intellectual property licensed to Prometheus Labs. Clinical Data also has "other tests" in the molecular diagnostics pipeline, including a schizophrenia-related test that should be available in "mid-to-late 2006," Fromkin said.


"The core Clinical Data business is rather different, at least at this stage, from the molecular services and diagnostics businesses that we're acquiring through Genaissance and Icoria."

The company also inherited from Genaissance a Merck KGaA selective serotonin inhibitor known as vilazodone that twice failed clinical trials, and which Genaissance committed to pass through clinical trials through the use of its haplotyping technology. Fromkin said Clinical Data has no plans to enter into similar agreements.

Although Clinical Data and Genaissance both have experience in producing products for cardiovascular medicine, "I don't think that's where the most immediate synergies are," said Fromkin, naming instead the parent company's experience navigating reimbursement and other non-molecular product-development issues. He declined to specify which diagnostic areas would receive most of the company's attention. "I think we're only months away from having more open discussions about those things," Fromkin said.

And Icoria Makes Three

The technology Icoria brings to its new Clinical Data family result from its long search for a special niche in the molecular biology market.

Under the name of Paradigm Genetics, Icoria began in 1998 as an agricultural functional genomics firm with bioinformatics expertise that it employed in developing of herbicide, pesticide, and fungicide targets, as well as seed improvement.

Through 1999, Paradigm leaned heavily on its bioinformatics capabilities, including a collaboration with PE Informatics — a division of PE Biosystems, later known as Applied Biosystems — and expanded its facilities to include a new Center for Functional Genomics Research.

By 2000, Paradigm had begun to move more decisively toward metabolomics. Around the same time as it formed an alliance with Germany-based bioinformatics company Lion Bioscience, it first announced it would use its functional genomics program to investigate human health and nutrition, in addition to agricultural work. Later that year, Paradigm formed a specialized metabolomic profiling group, and soon thereafter, expanded its alliance with Lion to explicitly pursue human drug targets, and licensed Rosetta Biosoftware's Resolver gene-expression analysis system.

The company's focus remained largely confined to agricultural genomics through 2001, but it expanded its metabolomic database agreement with Lion to include profiling data mostly from human cells, fluids, and tissues. The firm also acquired Celera's AgGen plant genomics and genotyping business in late 2001, a move that John Ryals, then Paradigm's CEO, said would give his company the ability to provide genomics services "from gene sequencing, genotyping, and marker-assisted breeding to gene function discovery, gene expression analysis, phenotypic analysis and biochemical profiling."

Early in 2002, at a JPMorgan H&Q Healthcare Conference, Ryals said that the firm was working to commercialize mass spec equipment and bioinformatics technology being developed with Thermo Finnigan and Lion Bioscience, respectively, and that it planned to enter the healthcare sector. At the same time, the company brought its first medical scientist onto the board of directors: Lee Hood, director of the Institute for Systems Biology.

One month later, in February, Paradigm announced a cardiovascular drug discovery deal with Duke University, while the board of directors sacked Ryals. Two months after that, the company laid off about 20 percent of its staff and split its research division into two distinct units, agriculture and healthcare.

By late 2002, Paradigm began to explore toxicogenomics with Agilent gene-expression chips and a $24 million grant from the US National Institute of Environmental Health. About five months later, in March 2003, the firm began a microarray services business as the preferred provider of Agilent microarrays, and won an additional $8.4 million from the NIEHS for toxicogenomics research in April. By October, it added Affymetrix arrays to its services offerings.

The early 2004 acquisition of the pathology-software company TissueInformatics furthered Paradigm's entrée into biomarker and target-discovery, and it inherited a portfolio of drug targets and diagnostics products in diabetes, obesity, and aging. Later that year, NIEHS expanded its toxicogenomics collaboration with Paradigm to include the study of RNAi.

The acquisition of TissueInformatics triggered Paradigm's name change to Icoria in August 2004, which was meant to reflect its shift from agricultural genomics to systems biology for human healthcare. By October of 2004, the company began offering analysis services for miRNA arrays from Rosetta Genomics.

The shift continued into this year, and Icoria eventually sold its agricultural business in March to Monsanto for $6.8 million. On June 30, Icoria lost its small-cap listing on the Nasdaq exchange. Three months later, Clinical Data announced that it planned to acquire the company for $12.5 million.

Fromkin did not indicate which of Icoria's wide spectrum of technologies would prove the most valuable in the short term to Clinical Data's molecular diagnostics strategy.

— Chris Womack ([email protected])

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