After more than a decade of development and a couple regulatory delays, Navidea Biopharmaceuticals (NYSE:NAVB) finally got the FDA approval it needs to begin marketing its radiopharmaceutical Lymphoseek.
In a conference call today, company executives declined to discuss the third-party manufacturing issues raised by the FDA’s complete response letter issued in September. They said the company was able to reply to the regulatory agency within seven weeks and is happy with the current manufacturing.
Now approved for use during lymphatic mapping procedures in patients with breast cancer or melanoma, Lymphoseek binds to lymph nodes that drain from a primary tumor, helping surgeons identify tumor metastases. It’s used along with a hand-held gamma detector during surgery and is the first new drug used for lymph node mapping to be approved in more than 30 years, according to the FDA.
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Lymphoseek will be sold through a distribution agreement with Cardinal Health.
Navidea, formerly Neoprobe Corp., licensed Lymphoseek from the University of California-San Diego in 2001 and began clinical testing three years later. It had its NDA for Lymphoseek accepted in October of 2011 but has had some bumps in the way of getting the agent approved.
After opening a Boston-area commercialization office last February in preparation for the expected launch of the drug, it had its decision date pushed back by the FDA, which said it needed for more data related to chemistry and manufacturing. Then in September, the FDA declined to approve Lymphoseek based on issues with manufacturing.
On the call, CEO Mark Pykett said Navidea’s application for EU approval for Lymphoseek has been submitted and accepted and is awaiting review.
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One investor mentioned that the company’s stock hadn’t budged on news of the approval. “We don’t speculate on the market,” Pykett said. “This is a great day for Navidea.”
