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Agendia CEO Says $34M Investment Will Drive MammaPrint Sales and ColoPrint Development

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Dutch microarray diagnostics firm Agendia last week said that it has raised €25 million ($34 million) in a fourth financing round.
 
Bank-insurer ING became a shareholder, though Agendia did not disclose the amount it invested.
 
Also participating in the round were current investors Van Herk Biotech, Gilde Healthcare Partners, and Global Life Science Ventures.
 
According to CEO Bernhard Sixt, the investment will allow the firm to invest more significantly in commercializing its expression signature-based tests — most prominently MammaPrint, which was cleared by the US Food and Drug Administration in February, but also CupPrint for cancer-of-unknown-primary identification and a colorectal test called ColoPrint that is still being validated.
 
In an e-mail to BioArray News this week, Sixt declined to discuss how much money Agendia has raised to date, but called the $34 million investment a “reasonably significant sum” for Agendia. Sixt also said that the firm’s success with MammaPrint enabled it to generate the kind of financing that will support the commercialization of the test and eventually guide the four-year-old company to profitability.
 
Since its launch, MammaPrint, a multi-gene breast cancer recurrence prognostic, has helped drive Agendia’s success. The company was first spun out from the Netherlands’ Cancer Institute in 2003, and gained a CE Mark for the test in 2005 followed by 510(k) clearance by the FDA in February (see BAN 2/13/2007).
 
While the FDA’s OK meant that Agendia could begin selling MammaPrint to customers in the US as of February, the firm had long offered the test through a service model under which clinicians sent their samples to Amsterdam for analysis and then Agendia distributed the results back to the clinicians to help them better guide therapy for patients recovering from breast cancer.
 
Earlier this summer, the FDA cleared Agendia’s RNARetain solution, shipping procedures, and service methodology, which Sixt expects to boost sales globally as well as to draw more funding from investors.
 
“The funds were raised as we believe we ticked all the right boxes with MammaPrint to start serious marketing efforts,” he wrote, adding that these “boxes” include “peer-reviewed high level publications to support the necessary clinical evidence; regulatory blessing of the FDA that MammaPrint is safe and effective; [and] regulatory blessing by FDA that our logistical room temperature methodology is validated specifically for RNA measurement in connection with MammaPrint.”
 
The RNARetain approval is especially significant for Agendia because the firm believes its methodology will put it ahead of rival diagnostics that use formalin-fixed paraffin-embedded samples.
 
“The use of RNARetain in combination with MammaPrint is even simpler than the commonly used formalin fixation and paraffin-embedding method and is specifically designed and validated to preserve RNA integrity,” he wrote.
 
“The simplification of the logistic procedure puts us even with our competitors, [like] Genomic Health, from the handling perspective and far ahead from [a] quality standpoint, as FFPE sampling was never designed for RNA measurements,” he added. “Considering the efforts it took us to validate a specifically designed method to preserve RNA integrity ... it seems quite a serious challenge to validate FFPE samples for that purpose.”
 
Genomic Health sells Oncotype Dx, a breast cancer recurrence test that uses formalin-fixed, paraffin-embedded tumor tissue in a service model to provide clinicians with a recurrence score to help guide treatment.
 
Path to Profitability
 
Sixt added that a “significant ‘pull’ from the market demonstrated through increasing active demand” also led to increased willingness from investors to back Agendia and will also ultimately make the company profitable.
 
The most recent investment should fund Agendia’s sales and marketing initiatives, though Sixt was not specific about exactly how the company will expand its current efforts. “We came to the conclusion that specific investments in marketing and sales efforts would now pay off,” he wrote.
 
“We want to demonstrate ‘proof of commercialization’ for MammaPrint and if everything goes according to plan we will be reaching profitability in 2009,” Sixt added. “However, if the MammaPrint strategy proves early on to be highly successful, it could lead to a potential increase of planned investments in ColoPrint in 2008, thus pushing profitability further into the future,” he wrote.
 

“We believe we ticked all the right boxes with MammaPrint to start serious marketing efforts.”

ColoPrint is one of two diagnostic assays that Agendia has developed alongside MammaPrint. The other, CupPrint, received a CE Mark in 2006, but Sixt has said repeatedly that the company has no plans to take it through the FDA approval process at this time. With ColoPrint however, Agendia definitely plans to seek both a CE Mark followed by FDA 510(k) clearance.
 
Like MammaPrint, ColoPrint uses a multi-gene expression signature to determine the risk for recurrence in colorectal cancer patients. Sixt wrote that the company plans to launch ColoPrint in the European Union in the first half of 2008. Laura Van ‘t Veer, Agendia’s chief scientific officer, gave an overview of ColoPrint at the Ninth World Congress on Gastrointestinal Cancer in June in Barcelona, Spain.
 
“The regulatory and commercial ColoPrint strategy is to copy what we did with MammaPrint, which includes CE-marking and FDA approval,” Sixt wrote. “After the launch of ColoPrint in EU we assume 12 months to FDA approval. We have no current plans to go for FDA approval with CupPrint,” he added.
 
In the colorectal diagnostics ring, Agendia will not stand alone. UK-based Almac Diagnostics is also planning on submitting a colorectal recurrence assay to the US Food and Drug Administration. Last month, Richard Kennedy, Almac’s vice president of clinical diagnostics, told BioArray News that the firm will probably approach the FDA about the test sometime next year. “We are at the stage where we need a larger data set for approval, so we are looking at that for the moment with [Massachusetts General Hospital] and others,” he said (see BAN 8/7/2007).
 
In May, Almac CEO and co-founder Paul Harkin wrote to BioArray News that Almac hopes, “subject to further FDA discussions, to submit the CRC Stage II test for clearance sometime in 2008" (see BAN 5/29/2007).
 
Another company planning a colorectal recurrence test is Genomic Health. The company announced in January that it has moved the test to predict the likelihood of colon cancer recurrence into “full-scale clinical development” and that it “plans to evaluate its new test in more than 3,000 patient samples through these collective studies, with the goal of making the colon cancer test service available in 2009, depending on certain variables.”

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