Navidea Biopharmaceuticals has entered an exclusive agreement with a wholly-owned subsidiary of Hainan Sinotau Pharmaceutical Co., Ltd., a pharmaceutical organisation with a broad China focus in oncology and other therapeutic areas, who will develop and commercialise Lymphoseek (technetium Tc 99m tilmanocept) injection in China.

In exchange, Navidea will earn revenue based on unit sales to Sinotau, a royalty based on Sinotau’s sales of Lymphoseek and up to $2.5 million in milestones from Sinotau, including a $300,000 upfront payment. Lymphoseek is a novel, 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 and for use in guiding sentinel lymph node biopsy in certain oral cancer patients.

As part of the agreement, Sinotau is responsible for costs and conduct of clinical studies and regulatory applications to obtain Lymphoseek approval by the China Food and Drug Administration (CFDA). Upon approval, Sinotau will be responsible for all Lymphoseek sales, marketing, market access and medical affairs activities in  China and excluding Hong Kong, Macau and Taiwan. Navidea and Sinotau will jointly support certain pre-market planning activities with a joint commitment on clinical and market development programmes pending CFDA approval. In addition to the $300,000 upfront, Navidea is eligible for $700,000 in milestones up to and through product approval, and an additional $1.5 million in sales milestones.

“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,” said Thomas Tulip, Ph.D., president and chief business officer of Navidea. “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.”

“Our partnership combines Navidea’s expertise in radiopharmaceuticals, clinical development and manufacturing with our extensive development, regulatory, sales, and marketing capabilities,” commented Xu Xinsheng, Sinotau president and chief executive officer. “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. 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."

Lymphoseek (technetium Tc 99m tilmanocept) Injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients with breast cancer, melanoma and head and neck cancer patients with oral cavity carcinoma. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumour, which have the highest probability of harboring cancer. Lymphoseek is approved by the US Food and Drug Administration (US FDA) for use in lymphatic mapping to assist in the localisation of lymph nodes draining a primary tumour in patients with breast cancer or melanoma and for use in guiding sentinel lymph node biopsy in head and neck cancer patients with squamous cell carcinoma of the oral cavity. The Company anticipates continuing development of Lymphoseek into other solid tumour areas.