Navidea Biopharmaceuticals ($NAVB) has convinced Medicare to expand reimbursement for its Lymphoseek diagnostic aid, and the company locked down a manufacturing agreement with Siemens ($SI) to cover its in-development Alzheimer's imaging tool.
First, reimbursement: The Centers for Medicare & Medicaid Services (CMS) has approved a "pass-through" billing code for Lymphoseek, which Navidea said will take effect Oct. 1 and help it expand the adoption of its mapping tool. The imaging agent, designed to map the spread of cancer in patients undergoing surgery, won FDA approval in March.
Separately, Navidea is working on NAV4694, a beta-amyloid-detecting agent, and has signed a deal with Siemens' PETNET subsidiary, tasking the German giant with manufacturing the compound as it works through Phase III trials. Under the deal, Siemens will produce the agent for clinical trials with an option to expand as it progresses. Navidea began enrollment in its Phase III study in June, charting how well NAV4694 can identify Alzheimer's-linked beta-amyloid deposits in 275 near-death patients.
That's all good news for a company scrambling to get back on schedule after a brief FDA derailment. Lymphoseek was set for a fall 2012 approval, but substandard work from a contract manufacturer pushed the FDA's decision date back 6 months and forced Navidea to shift its plans.
And while Navidea has made some commercial headway, October can't come soon enough: Last quarter, Lymphoseek accounted for about $128,000 in revenue, roughly 67% of Navidea's sales, but net losses deepened about 75% to $10.3 million. The company has borrowed $25 million from GE Capital and partnered with healthcare giant Cardinal Health to market Lymphoseek, and CEO Mark Pykett said Navidea's well on its way to profiting off the tool.
- read the Medicare announcement
- get more on the Siemens deal