By Mary Vanac
The Dublin, Ohio-based company, which makes gamma detection systems and is developing radiopharmaceuticals for cancer detection, is on the verge launching its first game-changing product — Lymphoseek — a tracing agent that identifies cancerous lymph nodes in patients with breast cancer and melanoma.
Neoprobe said July 12 it had completed a series of preliminary review meetings (PDF) with the Food & Drug Administration about the new drug application for its first tracing agent. The company expects to request a pre-NDA meeting with the FDA prior to submitting its Lymphoseek application this summer.
Earlier this month, Neoprobe began a third Phase III trial of Lymphoseek, using a $1 million Ohio Third Frontier grant and collaboration with companies including Phylogeny Inc. and Cardinal Health Inc. to support additional clinical claims for the drug.
The third trial could open the door to using Lymphoseek to locate head and neck cancers. Eventually, the radiopharmaceutical could be used to locate prostate, colon, gynecologic and gastrointestinal cancers, CFO Brent Larson said.
The additional claims also could enable Lymphoseek to realize more revenue for Neoprobe and its backers and better outcomes for cancer patients. The company’s executives see an eventual market for Lymphoseek of $370 million per year.
Neoprobe said it expects to report revenue of about $2.6 million for its second quarter — up 45 percent from a year ago — and $5.3 million for the first half of 2010, up 18 percent from the year-ago period. Increased sales volumes for its gamma detection systems were offset by slightly lower prices during both 2010 periods.
The company expects to make a formal earnings announcement during the first week of August. Next week, it is holding a conference call to provide a business update and results of its annual stockholders’ meeting.
Neoprobe recently converted $11 million in debt to equity, freeing its balance sheet from complicated debt securities. The company hopes to soon qualify for a listing on a major stock exchange, likely the NYSE Amex Equities exchange or the NASDAQ National Market.
In noontime trading, Neoprobe shares were down 4 cents to $1.93.