Pharma

Neoprobe expects FDA decision on Lymphoseek in mid-2012

Neoprobe (NYSE Amex: NEOP) remains on track to file a New Drug Application for its drug used for cancer detection, Lymphoseek, sometime in the third quarter. Factoring in the customary 10-month review period by the U.S. Food and Drug Administration, that would make a decision on the application for the drug used in cancer treatments […]

Neoprobe (NYSE Amex: NEOP) remains on track to file a New Drug Application for its drug used for cancer detection, Lymphoseek, sometime in the third quarter.

Factoring in the customary 10-month review period by the U.S. Food and Drug Administration, that would make a decision on the application for the drug used in cancer treatments likely to come in the middle of next year, said Mark Pykett, CEO of the Dublin-Ohio  based company.

Pykett declined to be more specific on exactly when Neoprobe might file the New Drug Application (NDA) beyond stating the oft-repeated third quarter timeframe. The company plans to make a public announcement once it has filed the NDA.

“We think the filing will be viewed as an important event for the company and we want to share the information with our shareholders and the public as we meet that milestone,” he said.

Neoprobe officials and various regulatory consultants are in the midst of performing quality checks on the document, Pykett said.

Lymphoseek is a radiopharmaceutical used by surgeons to identify lymph nodes in patients with breast cancer or melanoma and to indicate whether cancer has spread to a particular lymph node.

Yesterday, the company announced plans to open a European unit that will initially be staffed virtually by U.S. employees. “It’s intended to allow us to be active in the European market to do development and commercialization work,” Pykett said. “We’re not expecting to have on-the-ground staff there” in the early going.

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Pykett declined to provide any timeframe on when Neoprobe might file for the CE Mark, which, if awarded, would give the Ohio company the right to begin selling Lymphoseek in the European Union.

Neoprobe is currently in discussions with potential European distribution and sales and marketing partners. Cardinal Health (NYSE: CAH) is handling U.S. distribution and sales and marketing of Lymphoseek.

Neoprobe puts Lymphoseek’s annual worldwide market potential at $450 million. CFO Brent Larson stressed that the number represents the drug’s “reachable” market and is in no way a revenue projection. Here’s how Larson broke down the $450 million number: U.S. ($200 million); European Union ($70 million); rest of the world ($180 million).

Neoprobe’s stock is in the midst of a nearly two-month-long 40 percent slide, brought on after a New York hedge fund manager who is shorting the stock began speaking out against the company.

However, an analyst (who told MedCity News in March that his company holds equity in Neoprobe) spoke glowingly about Lymphoseek yesterday in an interview with the Columbus Dispatch.

The drug “will do more to improve the outcome of oncology patients than probably any other product that I have seen in the last 20 years,” said  Steve Brozak, president of WBB Securities. “This is one where it’s truly different. In an environment where people are talking about healthcare rationing and reduced expectations, you have a product that’s not just superior but will provide for a new standard in the treatment of cancer.”