Navidea signed an exclusive partnership with Chinese drug developer Hainan Sinotau Pharmaceutical, who will take over much of the responsibility and cost in getting Lymphoseek into through regulators and on the market. Sinotau will manage the clinical trials, regulatory applications, marketing and other activities, Navidea said.
Sinotau is also paying Navidea $300,000 up front, up to $700,000 in milestones prior to Chinese regulatory approval and $1.5 million in sales milestones following market access.
"This agreement is part of our goal to make Lymphoseek available to as many physicians and cancer patients around the world as quickly and effectively as possible," Navidea president and chief business officer Thomas Tulip said in prepared remarks. "We selected Sinotau as a partner in China given their success in developing and filing for market approvals on more than 20 drugs, their pharmaceutical sales and marketing experience, and their established relationships with hospitals and clinicians throughout China."
Lymphoseek is already approved in the U.S. (as of March 2013) as a radiopharmaceutical used to highlight sentinel nodes in the body.
"Lymph nodes filter lymphatic fluid that flows from the body’s tissues. This fluid may contain cancer cells, especially if the fluid drains a part of the body containing a tumor," according to the FDA. "By surgically removing and examining the lymph nodes that drain a tumor, a procedure called a biopsy, doctors can sometimes determine if a cancer has spread."
Navidea won expanded marketing approval in June this year, allowing the company to market Lymphoseek for cancers in the head and neck, adding to previous indications for breast cancer and melanoma.
Navidea’s shares gained 2.6% today to trade at $1.40 as of about 12:05 p.m. EST.
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