Navidea inks deal with Hainan to develop, commercialize Lymphoseek in China

As part of the deal, Navidea will earn royalties on units sales, an upfront payment of $300,000, up to $700,000 in development milestone payments and up to $1.5m in sales-related milestones.

Lymphoseek is a new, receptor-targeted, small-molecule radiopharmaceutical approved in the US for use in lymphatic mapping to assist in the detection of lymph nodes in patients with breast cancer or melanoma.

It is also indicated for use in guiding sentinel lymph node biopsy in certain oral cancer patients.

The deal will see Sinotau fund and conduct clinical studies and regulatory submissions to the China Food and Drug Administration.

Sinotau will be responsible for all sales and marketing activities post approval in China exclusive of Hong Kong, Macau and Taiwan.

Navidea president and chief business officer Thomas Tulip said the deal is part of the company’s goal to make Lymphoseek available to as many physicians and cancer patients around the world as quickly and effectively as possible.

Sinotau president and CEO Xu Xinsheng said the company’s partnership combines Navidea’s expertise in radiopharmaceuticals, clinical development and manufacturing with its extensive development, regulatory, sales, and marketing capabilities.

"The goal will be to offer a novel radiopharmaceutical to potentially spare patients from unnecessary surgery and which can play a critical role in staging and directing cancer treatment," Xinsheng said.

"We look forward to giving physicians this new tool in the fight against the many types of cancers common in China, such as breast, oral, and gastric cancers and contributing to bettering the lives of those afflicted with these conditions."