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Exiqon Reaffirms Plan to Pursue miRNA Dx Only Through Partnerships, Provides Few Details on Programs

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By Doug Macron

Exiqon last week said that it remains committed to advancing its pipeline of microRNA-based cancer diagnostics to market, and reaffirmed that it would only do so with the help of a partner.

However, the Danish company provided few new details about when deals may be signed or when products would be ready for commercialization.

Exiqon also reported its financial results for 2009, posting a slight increase in its net loss for the year, which included the impact of operations from Oncotech, its now-discontinued Clinical Laboratory Improvement Amendments-certified laboratory.

In late 2007, Exiqon announced that it would buy the California-based lab for $45 million in a bid to speed its entry into the miRNA diagnostics field (see RNAi News, 11/29/2007). In part, the deal was designed to provide Exiqon with a CLIA-certified facility where it could perform its miRNA tests on samples sent in by clinicians, as well as access to an established sales and marketing team.

Two years later, however, Exiqon said it would divest the unit in order to trim costs as it narrowed the focus of its diagnostics division onto miRNA-based tests only (see RNAi News, 12/17/2009). Oncotech had an existing portfolio of tests based on other biomarkers.

Also around that time, Exiqon announced that it would only commercialize its diagnostics in collaboration with industry partners, obviating the need for Oncotech's laboratory operations.

Last week the company reaffirmed this position. "The divestiture of Oncotech will help us focus on our core competencies in the area of miRNA," Exiqon President and CEO Lars Kongsbak said in the firm's annual report. "We will continue to develop our programs for colon cancer recurrence, identification of cancer of unknown primary [origin], and early detection of [colorectal] cancer in serum."

The goal of setting up "partnerships and distributorships" will also allow the company to "share the risk and cost" of developing and marketing its tests, he noted.

"Partnerships can take very different forms and vary depending on the markets addressed," he said. "This flexible approach will allow us to leverage relationships to potential partners, some of which may originate from business relationships" from the company's services division.

Currently, Exiqon's most advanced diagnostic candidate is its cancer of unknown primary origin test, which the company said is currently being clinically validated at the Danish hospital Rigshospitalet. It is expected to be ready for commercialization by 2011.

The company said in the annual report that it is exploring "the potential for an earlier commercializing of parts of this product," but that it is not providing additional details on this effort "for competitive reasons." Exiqon also did not provide any guidance on potential partnerships for this product.

The company is also working on a test dubbed miRSign for differentiating cancerous from non-cancerous tissue. Exiqon released the product for research use only last year, but said that it is currently exploring the development of the test for clinical applications. No timeline was provided for this program.

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Tests in the discovery stage include a diagnostic for identifying stage II colon cancer patients at significantly high risk of disease recurrence and for whom adjuvant chemotherapy may be an option. Exiqon said that this test will move into clinical studies once a partner has been found for the program, but provided no other details on timing. Previously, the firm had said it expected this test to reach the market in 2008, a timeline that was later pushed to early 2009 (see RNAi News, 12/11/2008).

Also in early-stage testing is a diagnostic for the early detection of colorectal cancer using miRNA signatures obtained from blood serum. Last August, the company said that initial data from this program, which is being funded with a DKK24 million ($4.3 million) grant from the Danish National Technology Foundation, was expected to be available in the first quarter of this year (see RNAi News, 8/27/2009).

In its annual report, Exiqon said that it expects to have "the relevant miRNA signature" for this test identified sometime before the end of the year. It provided no details on the work done so far.

Missing from Exiqon's pipeline were a number of development-stage miRNA-based tests that the company highlighted in its annual report last year, including tests to detect drug resistance in patients with stage II, III, and IV colon cancer and with stage II, III, and IV lung cancer; and a test for evaluating the risk of disease recurrence in stage I and II endometrial cancer patients (see RNAi News, 3/5/2009).

Kongsbak did not return a request seeking comment on the diagnostic lineup.

The Financials

For the 12-month period ended Dec. 31, 2009, Exiqon's net loss rose to DKK338.8 million from DKK335 million the year before and included the effect of the discontinued Oncotech operations.

Revenues declined 3 percent to DKK82.2 million, while product sales climbed 2 percent to DKK56.2 million.

Operating costs, meanwhile, surged to DKK188.1 million from DKK125.4 million, primarily due to the write-down of goodwill associated with the decision to divest Oncotech, Exiqon said. Research and development spending jumped to DKK114 million from DKK41.5 million in 2008.

At the end of 2009, the company had cash and cash equivalents totaling DKK45.5 million.

Looking ahead, Exiqon said that it expects 2010 revenues to be in the range of DKK80 million to DKK90 million, excluding discontinued operations. Net loss for 2010 is expected to be roughly DKK40 million.

The company continues to expect to achieve profitability in 2011.

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