Navidea Biopharmaceuticals ($NAVB) met with European regulators who hold the key to approving its Lymphoseek injectable diagnostic imaging agent, and the company said it has met the benchmarks it needs to gain market authorization.
Navidea's announcement noted that executives met recently with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. While the company cites details about what appeared to be a straightforward discussion, publishing an interpretation of how a meeting went is, in some ways, not unlike reading tea leaves. No one will know for sure until regulators come out with the final word.
"Based on feedback received at the meeting, Navidea believes that the CHMP has found the safety and efficacy data submitted in the [marketing authorization application] for breast cancer and melanoma to be acceptable," Navidea said in its statement. "The CHMP will now focus its review on the remaining areas of product specification unique to the European application and on data from the Phase III study in head and neck cancer."
But there's a twist. Navidea said that its market authorization application will remain in effect during this next phase of the European approval process. However, the "review clock will continue to be stopped" while the company works with the CHMP to address the remaining issues.
Navidea insisted in this announcement (meant to reassure investors) that it believes regulators continue to be supportive of the application, as well as the company's target of significant revenue generation for Lymphoseek beginning in 2015.
The company has made real progress with Lymphoseek. Last August, the Centers for Medicare & Medicaid Sevices approved reimbursement for the Lymphoseek diagnostic imaging aid for cancer. That's a big deal, because the U.S. market is substantial.
But the Dublin, OH, company must gain European approval in order to boost its revenue generation to sustainable levels. Navidea's revenue reached $1.1 million in 2013, compared to $79,000 in 2012, but losses from operations hit $38.4 million for the year, up from $28 million in 2012, as the commercial ramp-up in the U.S. got underway. Navidea closed on a $30 million loan from Oxford Finance earlier this month, which will support its commercialization and debt refinancing efforts.
- read the release