Project name: technetium Tc 99m tilmanocept
Peak sales estimate: Range from a few hundred million to $643 million
Approved: March 13
Companies: Navidea Biopharmaceuticals and Cardinal Health
After initially rejecting Lymphoseek in mid-2012 over a manufacturing issue, the FDA finally signed off on the novel imaging agent in March, making history of sorts. It's the first new drug approved by U.S. regulators for lymph node mapping in more than 30 years.
Lymphoseek's concept is pretty basic. It is a receptor-targeted radiopharmaceutical designed to spot lymph nodes that are most likely to be carrying cancer. By going through this diagnostic process, physicians can more easily stage a patient's cancer, which in turn helps to plan the most appropriate, targeted treatment. Its initial approval followed testing on more than 540 people, and clinicians determined that Lymphoseek performed well in comparison to the typically used blue dye. The imaging agent was also present in an average 97% of resected lymph nodes confirmed to have cancer. That level of specificity will help identify how advanced a patient's cancer is with greater detail than current radiopharmaceutical agents can achieve.
Initially, the Dublin, OH, biopharmaceutical company gained approval to use Lymphoseek for tumor mapping in patients with breast cancer or melanoma. But Navidea ($NAVB) didn't waste any time in trying to broaden Lymphoseek's market potential. In April, the company celebrated positive Phase III trial results using the diagnostic aid for head and neck cancer, and Navidea said that Lymphoseek met its primary endpoints for this gauntlet, too, with low rates of false negatives. Patients who relied on Lymphoseek also needed the removal of far fewer lymph nodes than with the "gold standard" of nodal dissection." Wasting no time, Navidea announced in December that it submitted a new drug application to the FDA to expand Lymphoseek's indication accordingly.
On Dec. 19, the European Medicines Agency continued Navidea's marketing authorization application for Lymphoseek so regulators could have extra time to evaluate data from the company's Phase III trial for head and neck cancer. Navidea CEO Mark Pykett said in a statement that the company still remains focused on European market development for Lymphoseek in 2014 and hopes to start generating European revenue in 2015. As well, It has inked distribution deals for Lymphoseek in Canada and is shipping the imaging agent to certain markets in the middle East.
Lymphoseek has significant global potential and could generate as much as $643 million in revenue annually, the industry research firm LifeSci Advisors estimated, based on launch plans developed by Navidea and marketing partner Cardinal Health.
Navidea has a lot of the pieces in place for Lymphoseek, but is still some distance away from realizing its potential. The company booked an $11.3 million net loss during the 2013 third quarter, up from a $9.1 million net loss over the same period in 2012. Revenue hit just $400,000 for the period, but that compares to zero revenue in the 2012 third quarter. In June, the company raised $25 million in debt financing from GE Capital to help ramp up Lymphoseek's commercialization, and in August, Navidea convinced Medicare to expand its reimbursement for Lymphoseek as of Oct. 1. Execs said they see that action as helping the company stabilize itself into a better position as it readies Lymphoseek's rollout.
"We are pleased with the initial stages of Lymphoseek commercialization at launch and believe that Lymphoseek continues to hold promise to become the standard of care in lymphatic mapping," Pykett said in a statement. "Our optimism stems from witnessing evidence of progress in many positive measures, including multi-fold increases in unit sales quarter over quarter, a high frequency of repeat and multi-dose ordering" and other milestones, he noted. -- Mark Hollmer (email | Twitter)
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