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Ipsogen Files European IPO, Plans to Launch Two New Assays by Year-End

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French diagnostics firm Ipsogen this week filed for an initial public offering that could be worth around €9.6 million ($14.8 million). The IPO coincides with the launch of the company’s array-based breast cancer diagnostic MapQuantDx and a time of intensive commercial outreach for the company.
 
The offering of up to 1.2 million shares at a price range between €7.2 and €8 per share is being managed by Paris’ Bryan, Garnier, & Co. Ipsogen intends to begin trading on the Alternext market, a sub-market of the global NYSE Euronext market geared towards smaller to mid-sized companies, under the symbol ALIPS by June 16. 
 
According to Jean-Marc Le Doussal, director of Ipsogen’s breast cancer program, the proceeds of the IPO will enable the Marseilles-based company to make strategic investments in sales and marketing to support the roll-out of up to three tests related to breast cancer this year. It will also support sales of the firm’s leukemia-monitoring assays
 
“This money will be obviously used for extending our marketing force in the US and Europe,” Le Doussal told BioArray News this week. “We will invest in a direct sales force and look to increase our work with cancer research centers to perform economic studies,” he said.  The company currently employs 40 people in France and the US. It is unclear how large the firm’s existing sales and marketing force is.
 
Last week, Ipsogen launched MapQuant Dx Genomic Grade, a molecular diagnostic that runs on Affymetrix’s GeneChip platform and uses a gene signature of 97 genes from biopsy samples to measure tumor grade — a consensus indicator of tumor proliferation, risk of metastasis, and response to chemotherapy.
 
For example, patients with grade 1 tumors are often not treated with chemotherapy because of their relatively good prognosis, while patients with grade 3 tumors are often selected for chemotherapy. However, patients with intermediate, grade 2 tumors typically raise questions for clinicians with regards to treatment. Ipsogen claims that MapQuant Dx can stratify grade 2 patients into either the grade 1 or grade 3 categories in 80 percent of cases.
 
Ipsogen is not alone in targeting the market for breast cancer diagnostics. Agendia, based in the Netherlands, offers its array-based MammaPrint test for breast cancer recurrence. Genomic Health, located in Redwood City, Calif., offers Oncotype DX, an RT-PCR based assay that assesses breast cancer patients for possible recurrence and chemotherapy benefit.
 
Le Doussal said that one competitive advantage of the MapQuant Dx is that it uses a grading index for tumors that is already commonly used by pathologists. ”We believe that [the grade] needs to be well measured, and that is what we do,” he said.
 
A Service Model
 
Ipsogen plans to offer MapQuant Dx as a service through its labs in Marseilles as well as through external laboratories in Europe. For example, this week Gosselies, Belgium-based DNAVision announced that it will be the first European lab to offer MapQuant Dx as a service.
 
In this scenario, clinicians will send their samples to DNAVision, who will run the assay in their labs and use a secure server to transmit the results to Ipsogen, who, in turn, will grade the samples and provide the diagnosis back to the clinician.
 

“This money will be obviously used for extending our marketing force in the US and Europe.”

Le Doussal said that Ipsogen plans to use this service model with other European laboratories, as well as potential laboratories in the US, when it launches the test, hopefully sometime next year. Ipsogen currently maintains a subsidiary in New Haven, Conn., and Le Doussal said that the company is preparing talks with the US Food and Drug Administration to develop a roadmap to the eventual 510(k) clearance of MapQuant Dx.
 
“In the US, we plan a launch in 2009 and we are in the process of discussing this issue with the FDA. We have a grading test, and there is a strong precedent with histological grading,” he said. “We don’t know what the FDA will ask, but we already have a lot of data.”
 
According to BioArray News sister publication Pharmacogenomics Reporter, two studies related to Ipsogen’s test were presented at the American Society of Clinical Oncology meeting in Chicago last week (see PGx Reporter 5/28/2008).
 
The first study, conducted by MD Anderson Cancer Center in Houston, Tex., and the Institut Bordet in Brussels, discusses whether the Genomic Grade index is a predictive marker for chemotherapy response in HER2-normal breast cancer.
 
In the study, 229 patients with HER2-normal breast cancer were treated with the commonly used regimen T/FAC — paclitaxel, 5-fluoruracil, doxorubicin, and cyclophosphamide — followed by surgery. The researchers collected gene-expression data using Affymetrix GeneChip technology.
 
Researchers concluded that ER-positive and ER-negative patients who measured higher on the Genomic Grade index were more sensitive to T/FAC, and thus responded better to the regimen, than women who ranked lower on the scale.
 
A second study, also conducted at MD Anderson, combined the Genomic Grade index with the 200-gene endocrine-sensitivity index to predict both chemotherapy response and hormone therapy response in breast cancer.
 
With the help of the Genomic Grade index and the endocrine sensitivity index, researchers concluded that those patients predicted to be at low risk for recurrence are mainly sensitive to endocrine therapy. However, approximately 12 percent of patients in the study may also be sensitive to chemotherapy and between 40 percent and 50 percent of high-risk patients are predicted to be insensitive to existing therapies.
 
Le Doussal said that Ipsogen’s breast cancer assay is “an ideal platform to develop other tests to derive new signatures from the same tumor” and that companion diagnostics to MapQuant Dx to assess HER2 and endocrine response could become available by as soon as the end of this year.
 
“With these three signatures, you have essentially complete classification of breast cancer that will be quite robust,” said Le Doussal. “We have projects to complement this classification with specific predictive signatures, too.” He declined to further discuss other breast cancer-related diagnostics in the company’s pipeline.
 
IPO Details
 
Ipsogen’s move into breast cancer diagnostics complements its existing presence in the leukemia testing space. The firm offers a line of RT-PCR-based leukemia-monitoring assays, and sales generated from leukemia tests comprise the bulk of Ipsogen’s revenues.
 
According to the firm’s prospectus filed with NYSE Euronext, Ipsogen earned €2.6 million in 2007, a 63 percent increase compared to the €1.6 million it posted in 2006, of which roughly €2 million was related to product sales and €480,000 was related to services.
 
During the past two years, the company has typically sold between 55 percent and 58 percent of its products and services in Europe, 25 percent and 28 percent in North America, and 17 percent and 18 percent in other regional markets.
 
At the same time, research and development costs doubled last year to €1.2 million, while Ipsogen’s net loss widened to €1.3 million from €587,000 in the year prior.
 
As of December 31, 2007, the company held €3 million in cash and cash equivalents.

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