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Innogenetics Preps New 4-MAT Assays for CE Mark as It Considers GenProbe, Solvay Bids

Belgian biotechnology company Innogenetics may be in a “season of bidding,” but it is moving forward with plans to introduce two new microarray-based assays that will complement a human leukocyte antigen-testing service the company introduced earlier this year.
Filip Goossens, Innogenetics’ head of investor relations, told BioArray News this week that the company expects to obtain CE Marks for its HLA-B and HLA-DRB1 assays by the end of the year.
Innogenetics received a CE Mark for an HLA-A typing test in March. All three assays are designed to test for rejection risk in patients scheduled to undergo allogeneic organ transplantation. They run on Innogenetics’ 4-MAT system, which is based on PamGene’s bioarray technology. Innogenetics licensed PamGene’s technology in 2004 to augment its internally developed line-probe assays that allow up to 38 genes to be tested on one strip (see BAN 3/28/2006).
“These assays are targeting the same market,” Goossens said. “When physicians or specialists want to perform a transplant, they need as much info as possible to ensure there will be a good match between the donor and recipient to minimize the risk of rejection. These additional applications will focus on other alleles that complement the first product, the HLA-A test.”
The 4-MAT system, which enables physicians to evaluate up to 400 genes, “generates more data, so it was decided to go for a market we knew and, secondly, a market that we knew was looking for more info that can be provided in a single test,” Goossens explained.
Friendly Bids
Innogenetics’ introduction of array-based assays comes as the company entertains two separate acquisition offers. Last week, Gen-Probe offered to buy Innogenetics for €215 million ($334 million) in cash, or €6.10 a share. The bid came two months after Solvay Pharmaceuticals offered to pay €178 million, or €5.75 a share, to buy the company.
Gen-Probe’s offer is roughly 4.3 times the approximately €51 million Innogenetics made in 2007 in revenue from its diagnostics business. The San Diego-based company said in a statement that Innogenetics would give it a strong manufacturing, marketing, and distribution presence in Europe, and that it would expand the company’s product range.
Brussels-based Solvay, meantime, said that it intends to preserve the autonomy of Innogenetics’ diagnostics programs while combining the firms’ R&D efforts to accelerate the development of biomarkers, diagnostics, and companion diagnostics. Solvay has not said whether it will try to match Gen-Probe’s bid.

“Both companies that are bidding are serious about what they want to do with the diagnostics side of Innogenetics.”

Goossens said that Innogenetics has currently entered a “season of bidding,” and that only the firm’s board of directors can make official statements about the offers.
PamGene CEO Tim Kievits told BioArray News this week that if Innogenetics opts to sell itself to either company, it is unlikely that PamGene’s relationship with Innogenetics will be negatively affected.
“I think 4-MAT is of extreme importance for the development of their diagnostics,” Kievits said of Innogenetics. “Both companies that are bidding are serious about what they want to do with the diagnostics side” of Innogenetics, he said. “It might actually be a good opportunity for us.”
PamGene’s relationship with Innogenetics goes back at least four years, when it licensed to the company the right to offer certain tests on the 4-MAT system, which Kievits said is a customized version of PamGene’s PamStation 12. The PS-12 enables users to design and run up to 12 arrays simultaneously, which means that Innogenetics manufactures the arrays that run on its system. PamGene, for its part, receives undisclosed monthly royalty payments from Innogenetics.
Kievits noted that Gen-Probe and Solvay have different plans for Innogenetics, referring to statements made by both of the companies regarding their bids. Gen-Probe, a molecular diagnostics company, envisions turning the Belgian firm into a European manufacturing and marketing hub, while Solvay is more focused on biomarker discovery work.
“I think we can work with both directions,” Kievits said. “Both make a lot of sense.”
Companion Diagnostics
While Innogenetics considers the offers, Kievits said that PamGene is looking at other opportunities in the diagnostics space.
According to Kievits, PamGene closed an undisclosed round of venture-capital financing in March that will help the company develop companion diagnostics with an emphasis on monitoring kinase activity.
“This is PamGene’s future,” he said. “It differentiates us from other companies because we are testing clinical samples for enzymatic activity; we are looking for kinases and the effect of inhibitors on kinases in patients. Other companies are looking at DNA or presence of proteins.”
PamGene has already commercialized a number of different arrays for kinase studies. In January, it inked a deal with Invitrogen to co-market Invitrogen's nuclear hormone receptor proteins and LanthaScreen assay technology with PamGene’s portfolio of microarray-based nuclear hormone receptor screening tools (see BAN 1/15/2008).
While PamGene is focused on screening kinase activity at the moment, Kievits said that the company also has programs to develop companion diagnostics for breast cancer, lung cancer, and renal cancer.

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