With an investment of about $1.5 million, Nanogen has acquired around 20 percent of Finland-based Jurilab, and gained access to a wealth of genotyping data to complement its cardiovascular diagnostic offerings — along with Jurilab's drug-metabolizing enzyme microarray.
Nanogen said it expects its investment in Jurilab to be followed "within six months" by an investment of equal size. The company also retains the right to buy the Finnish firm at a fixed, but undisclosed price, according to Robert Saltmarsh, Nanogen CFO.
Saltmarsh told Pharmacogenomics Reporter that the investment will give Nanogen access to intellectual property that "really fits in" with a congestive heart-failure diagnostic under development at its SynX subsidiary, "but we're also working [with Jurilab] in the pharmacogenetic area as well."
The fruit of an acquisition that closed last April, SynX's congestive heart-failure diagnostic has seen its share of stops and starts, but Jurilab's deep database of population-specific genotyping data could give Nanogen a jumping-off point to follow up with a few more diagnostic products.
"All the data has been submitted to the FDA now, and they seem to be happy."
In pharmacogenomics, Jurilab said that Nanogen will now be distributing its DrugMet drug-metabolizing enzyme microarray, according to Kari Paukkeri, Jurilab's CEO. Jurilab is the third company to aim for US Food and Drug Administration 510(k) clearance for such a drug metabolizing enzyme microarray. Should Nanogen follow through with its option to buy Jurilab, it will stand to become a competitor to Roche Diagnostics' FDA-cleared CYP450 AmpliChip and ParAllele's DME-T, which will belong to Affymetrix after it acquires the firm in a deal expected to close this quarter. (Affymetrix also produces the FDA-cleared GeneChip microarray reader.)
Asked whether Nanogen will be the distributor of Jurilab's chip, Saltmarsh was coy. "We certainly could be. We'll be working with them very, very closely in all kinds of priorities," he said.
Jurilab's DrugMet microarray is similar to Roche's CYP450 AmpliChip, but "it's a little bit broader in content," Paukkeri told Pharmacogenomics Reporter. "The same customers are interested," he said, adding that those customers are largely satisfied with the research-use-only strictures of the not-yet-cleared DrugMet, because "there is no true clinical market for the product." Although there is a small market for clinical use of the drug-metabolizing enzyme arrays, the market for these diagnostics won't really pick up until the FDA requires the use of such a test on the label of a drug, Paukkeri said.
Of the three drug-metabolism arrays, only Roche's and Jurilab's have filed for FDA approval, but the DrugMet chip may be cleared by the FDA around the same time as ParAllele's MegAllele DME-T assay, which will also target drug metabolism. "We will be getting a CE [mark] in September, and we're looking at FDA 510(k) approval in the first quarter of 2006," said Paukkeri. In a March interview, Aaron Solomon, ParAllele's vice president of business development, said his company's chip could be cleared within 12 months.
But the research-only limitation of the yet-to-be cleared DrugMet chip doesn't really impact its potential market, said Paukkeri. "There is no true clinical market for the product, so we're not in that much of a hurry [for clearance]," he said. While doctors in some countries have begun requesting drug-metabolizing enzyme testing for their patients, such as in Germany, the market for these arrays in clinical trials and research far outweighs the demand in clinical diagnostics, he added.
But Jurilab apparently doesn't expect things to remain that way. "We have LabCorp testing the product — they actually finished testing the product a few months back — and all the data has been submitted to the FDA now, and they seem to be happy," Paukkeri said.
DrugMet includes 27 SNPs in 8 genes coding for major drug-metabolizing enzymes, and samples are separately tested for the presence of a CYP2D6 duplication and deletion, according to Jurilab. ParAllele's current DME-T chip interrogates about 170 SNPs in "roughly" 29 genes, but the company will develop a smaller assay when it pursues FDA clearance to market the device as a consumer testing product, Solomon said. Roche's CYP450 AmpliChip can detect 31 polymorphisms and mutations, including gene deletions and duplications, in the 2C19 and 2D6 CYP450-family genes, the company said.
It's Cardio Time; Work it
There are several cardiovascular disease-predisposition products in which Jurilab's IP will aid Nanogen's development, said Paukkeri. Jurilab has about 20 years' worth of clinical data on an East Finland founder population of about 3,000 people, and it has matched this information with genotypes related largely to cardiovascular and metabolic diseases. "We think [Jurilab's database] can potentially support about 30 disease states," said Saltmarsh.
Jurilab and Nanogen representatives declined to specify what area of cardiovascular disease seemed most promising for a new clinical test, but the agreement between the two companies gives Nanogen the right to develop diagnostics using certain genes and other markers belonging to Jurilab. The next cardiovascular diagnostic may or may not work together with SynX's CHF test, which checks plasma for N-terminal pro-hormone brain natriuretic peptide, a sign of congestive heart failure. But Nanogen will be scouring Jurilab's database for diagnostically useful information for its own microarray platform, in any case, Saltmarsh said.
The company is working on potential assays to run on its upcoming NanoChip-400 platform, "so this could be a way to either supplement that information, or give us some unique markers, or come up with some completely novel tests that our customers can use," Saltmarsh said.
Nanogen is not planning any FDA submissions at the moment, said Saltmarsh. "We may eventually, but at this stage, one step at a time," he said. The company would prefer to release the platform with attendant assays, but it has none yet, he added. The 400-site microarray-based diagnostics platform will be aimed at the research and clinical diagnostic markets, and was originally due mid-year.
Nanogen is displaying the system at scientific conferences, and plans its launch to occur in September, said Pam Lord, a spokesperson for the company.
The cardiovascular-disease area is already "huge," said Paukkeri, although he declined to estimate the size of the market for diagnostic products that might come out of the collaboration.
David Ludvigson, Nanogen's chief operating officer, told investors during a late-February conference call that that the SynX CHF test would play in an estimated $300 million market.
Any diagnostic products stemming from the collaboration will sell largely to Nanogen's existing customer base, while the drug targets Jurilab produces will continue to sell to big pharma and downstream-development companies, he said. Current big-pharma customers for DrugMet include Aventis, Wyeth, and Chiron, he added.
Nanogen will become a worldwide distributor of Jurilab's products and services, including IP that Jurilab licenses to drug makers, said Saltmarsh. Nanogen will also support the company's business-development and sales-and-marketing efforts, he added.
But plans regarding Nanogen's distribution of Jurilab's founder database remain indistinct. "It really depends on what kind of resources Nanogen can offer us in the long term," said Paukkeri. "The deal is [an] investment, and all the contracts we're negotiating now are at arm's length, so we're not talking about combining the two companies yet, at all," he said.
"We're going to go into planning in just a few weeks, and after that, we'll also decide how to communicate these things," said Paukkeri. The planning phase should take "no more than a month or two" to finish up, he said.
— Chris Womack ([email protected])