Cancer diagnostics firm Neoprobe (NYSE Amex:NEOP) plans to file for U.S. regulatory approval of its cancer-tracing agent Lymphoseek next quarter.
CEO David Bupp confirmed on a conference call with investors that the Dublin, Ohio company during the second quarter would file a New Drug Application (NDA) for the tracing agent with the U.S. Food and Drug Administration.
If the NDA is approved, Neoprobe would be free to commercialize Lymphoseek, which helps surgeons identify cancerous lymph nodes in patients with breast cancer and melanoma. Cardinal Health will distribute Lymphoseek, which is a radiopharmaceutical.
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The company expects to publish the results of a phase 3 clinical trial that aims to show Lymphoseek’s superiority to vital blue dyes, which are currently used in lymphatic mapping procedures.
In the fourth quarter, Neoprobe lost $2 million, compared with a loss of $354,000 in the like quarter the prior year, according to a statement announcing its quarterly earnings. Expenses rose significantly, about 80 percent to $3.7 million, as the company tries to push Lymphoseek over the finish line. Revenue in the quarter jumped 30 percent to $3.2 million.
For the full year, the company lost $50 million compared with a loss of $40 million in 2009. Revenue increased 13 percent to $10.7 million.
With no drugs (or more specifically, tracing agents) on the market, Neoprobe generates its sales from gamma radiation detection devices that surgeons use along with radiopharmaceuticals to locate cancer.
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Also Monday, the company said it had recently completed what it called a “successful” meeting with the FDA about another yet-to-be-approved radiopharmaceutical called RIGScan. The targeting agent is used to detect tumors left behind after colon cancer surgery and will be manufactured by Princeton, N.J.-based Laureate Biopharmaceutical Services.
Neoprobe said that it would move forward with manufacturing this year and would begin clinical development of RIGScan next year. The drug has been dormant for more than a decade after the FDA rejected it in 1998, saying it didn’t do enough to benefit patients.
But long-term tracking of patients from studies originally conducted in the 1990s showed significantly higher survival rates for patients who were fully treated with RIGScan, Columbus Business First reported.
Neoprobe’s shares fell about 3 percent Monday to close at $3.81.
