Pharma

Neoprobe: FDA accepts Lymphoseek New Drug Application

The U.S. Food and Drug Administration has accepted cancer diagnostics company Neoprobe‘s (NYSE Amex:NEOP) New […]

The U.S. Food and Drug Administration has accepted cancer diagnostics company Neoprobe‘s (NYSE Amex:NEOP) New Drug Application for its radiopharmaceutical Lymphoseek.

FDA acceptance of the Lymphoseek NDA is an important milestone for the Dublin, Ohio, company and provides vindication over a once-vocal hedge fund manager critic who raised questions about the design of the drug’s clinical trials.

But the much bigger milestone for Neoprobe — FDA approval of Lymphoseek — could come in the second or third quarter of 2012. Approval (not acceptance) would give Neoprobe the right to begin marketing the drug, which is a targeting agent 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.

Today’s decision from the FDA merely means that Neoprobe progresses to the next step in the lengthy regulatory review process.

CEO Mark Pykett called FDA acceptance of the Lymphoseek application a “positive step” for the company. “We now turn our focus toward preparing for next steps with the [FDA] and a potential approval of Lymphoseek in the coming months, which according to FDA guidelines we anticipate will be late in the second quarter to third quarter of 2012,” he said in a statement.

Company officials have put Lymphoseek’s worldwide market potential at $450 million.

Cardinal Health (NYSE: CAH) is handling U.S. distribution and sales and marketing of Lymphoseek.

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