Medical device maker and drug developer Neoprobe Corp. (OTCBB: NEOP) expects to announce in early August that its revenue growth accelerated to 45 percent in the second quarter from a year ago.
The Dublin, Ohio, company that 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.
On Monday, Neoprobe said it had completed a series of preliminary review meetings (pdf) with the Food and Drug Administration (FDA) about the New Drug Application (NDA) 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 3 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, said Brent Larson, Neoprobe’s chief financial officer.
The additional claims also could enable Lymphoseek to realize more revenue for Neoprobe and its community, and better outcomes for cancer patients. The company’s executives see an eventual market for Lymphoseek of $370 million per year.
On Thursday, 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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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 at $1.93 on Nasdaq’s Over-The-Counter Bulletin Board.
