Neoprobe Corp. could charge a lot more for a diagnostic helper used in cancer surgery – if it gets regulatory approval – because of study results indicating the drug is superior to existing alternatives.
The Dublin biotech company (AMEX:NEOP) said Tuesday it remains on track for submitting in the third quarter its application to get approval to sell the drug Lymphoseek from the U.S. Food and Drug Administration. Investors had been hoping for a June submission.
The delay, in part, was to finish the study whose results were announced Tuesday, indicating the drug is not only safer than the current alternative but works better.
If the FDA approves a “superiority” claim on the drug’s label, the price goes up.
Executives on a Wednesday conference call said they were working with the exclusive distributor, Dublin-based Cardinal Health Inc. (NYSE:CAH), to determine the market price. The company has estimated the potential market for the drug at $450 million, but did not say what the higher price would do to that estimate.
Before his retirement, former CEO David Bupp in March had told analysts the company could justify a per-dose price of about $400 because it would replace a two-drug combo that costs that much. The two drugs are being used for a purpose not listed in their FDA labels.
If approved, Lymphoseek would be the only drug given the green light for use in an operation to seek about one to three lymph nodes that drain directly from the site of a breast or skin tumor so they can be tested for cancer’s spread.
The alternative is removing large clumps of 20 to 30 lymph nodes, which can lead to a lifetime of pain and swelling.
The FDA requires two phase III human trials before seeking sales approval. This second study reported no side effects from 500 patients receiving Lymphoseek, while some patients who received the blue dye currently used in the procedure reported adverse reactions.
More importantly, it performed better at finding the lymph nodes draining from the tumor. Lymphoseek detected 100 percent of those flagged by dye, but the dye found just 60 percent of those flagged by Lymphoseek.
When the nodes were biopsied, every one that turned out to contain cancer had been tagged by Lymphoseek while the dye missed 25 percent of the nodes with cancer.
“Lymphoseek provided clinically meaningful advantages over the blue dyes and I believe it will be a useful agent in (the lymph node mapping surgery),” said a statement from Dr. Vernon Sondak, skin cancer chief at Tampa, Fla., based Moffitt Cancer Center and Research Institute, one of the test sites.
Shares in Neoprobe hit a 52-week record high of $5.14 in Wednesday morning trading before leveling off. The low over the past year was $1.50 when it was still an over-the-counter stock. The company recently agreed to reshape its board at the suggestion of its largest investor.
Read more: Neoprobe could charge more for 'superior' drug with FDA nod | Business First
News 
Market Data 
Discover 
