News | May 08, 2013

Navidea Begins U.S. Launch of Lymphoseek Tc-99 Tracer

First new lymphatic mapping drug approved in more than 30 years

Lymphoseek

Navidea Biopharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of precision diagnostic radiopharmaceuticals, announced the U.S. launch of Lymphoseek (technetium Tc 99m tilmanocept) Injection for use in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.  Lymphoseek was approved by the U.S. Food and Drug Administration (FDA) in March 2013.

As part of Navidea’s U.S. distribution partnership, Cardinal Health is responsible for the sale and distribution of Lymphoseek to health care professionals through its existing network of nuclear pharmacies. Navidea is working closely with the company in all commercial activities and medical education programs for Lymphoseek. 

“Commercialization of Lymphoseek in the U.S. marks a pivotal milestone for Navidea, and we are pleased to deliver this innovative diagnostic imaging agent to patients with breast cancer and melanoma, as we help advance the field of precision diagnostics,” said Mark Pykett, M.D., Navidea’s president and CEO.  “With Cardinal Health’s extensive reach and pre-eminent radiopharmacy network, combined with our own medical education activities now underway to engage target physician groups, we expect to begin driving optimal adoption of Lymphoseek throughout the U.S.”

"We are very enthusiastic about exclusively supplying Lymphoseek through our more than 140 U.S. nuclear pharmacies at a time when lymphatic mapping continues to grow in importance for the diagnostic evaluation of cancer patients,” said Sandra Wisniewski, vice president of marketing and business development for Cardinal Health Nuclear Pharmacy Services. “Through our collaborative efforts with Navidea, we have completed a comprehensive range of training and education programs and have a full portfolio of commercial tools to support a successful Lymphoseek commercialization.”

Lymphoseek has been priced at $300 per patient procedure. Navidea has been working to ensure fair and equitable reimbursement for lymphatic mapping procedures using Lymphoseek. In the case of Medicare, Navidea believes these procedures are currently reimbursable under established codes, and expects to apply for and receive a unique pass-through code for Lymphoseek within a few months. Navidea and Cardinal Health will provide information and support to providers and payers to ensure that they can secure formulary status and appropriate payment.

According to the American Cancer Society, approximately 232,000 new cases of breast cancer and 77,000 new cases of melanoma are expected to be diagnosed in the United States in 2013. One of the procedures used by physicians to help in the diagnostic evaluation of breast cancer and melanoma is lymphatic mapping.  Lymphatic mapping is a widely used procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor. Navidea estimates that lymphatic mapping is utilized in approximately 70% of these patients each year in the United States.

For more information: www.lymphoseek.com

 

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