Navidea wants the FDA to approve a wider use of its injectable cancer imaging agent

In the last year, Navidea Biopharmaceuticals won FDA approval for its Lymphoseek injectable diagnostic imaging agent, plus a sweet Medicare coverage-prize. Now, it wants more--a broader regulatory sign-off allowing use of the substance to track more kinds of cancers.

The Dublin, OH, company ($NAVB) said it has submitted a supplemental new drug application (sNDA) seeking regulators' OK to use Lymphoseek to detect and map the spread of head and neck cancer, following the FDA's "Fast Track" designation for broader indication. Lymphoseek is already approved to do the same thing for breast cancer and melanoma. It flags lymph nodes that drain from a primary tumor and helps measure and locate cancer before surgery.

Gaining the FDA's broader blessing for these additional indications is crucial to expand the standard of care for both cancers, which typically require invasive surgery for clinicians to stage them, Navidea CEO Mark Pykett said in a statement. And if it wins approval for the breast cancer and melanoma indications, Navidea will likely continue its push to expand Lymphoseek as a tool to track prostate, thyroid, lung, colorectal and other cancers.

For Navidea to succeed, it will have to drastically increase Lymphoseek's reach. Revenue for the 2013 third quarter hit $400,000, versus zero revenue over the same period in 2012. Net losses soared, however, hitting $11.3 million, versus a $9.1 million net loss in the 2012 third quarter, as the company began to incur extra costs to support Lymphoseek's commercial launch. That means expanded indications could be the company's ultimate salvation, along with insurance reimbursement. Navidea took a big step in the right direction in August when it convinced Medicare to expand reimbursement for Lymphoseek as of Oct. 1, a move that should help increase its adoption over time.

Navidea is also focused on diversifying too, and is working on a beta-amyloid-detecting agent for Alzheimer's imaging. The company teamed with Siemens to help advanced that project. That could be a much tougher market to crack, however. The Centers for Medicare and Medicaid Services recently declined to cover the use of PET scans to detect beta amyloid development in dementia patients and CMS won't cover the procedure as a diagnostic. This is a big blow for its long-term development prospects in this space, as well as for companies like GE Healthcare ($GE) and Eli Lilly ($LLY) who recently gained approval for their PET imaging agents to help diagnose dementia patients, but not definitively screen them for Alzheimer's.

- read the release

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