KAI banks $13M in development deal with Japan's Ono

South San Francisco-based KAI Pharmaceuticals has inked a Japanese development and marketing deal for its lead therapy, nabbing a $13 million upfront payment from Ono Pharmaceutical. Now nearing the end of a Phase II study, KAI-4169 is being tested as an IV drug for secondary hyperparathyroidism in patients with chronic kidney disease-mineral and bone disorder. Ono gets the Japanese rights to injectable formulations, promising "significant" but unspecified milestones.

"This partnership with Ono is a critical event for the KAI-4169 program, allying us with a partner that has a strong track record advancing innovative pharmaceutical products," says KAI CEO Steven James. "We are excited about the continued momentum of the KAI-4169 program, and we anticipate completing the Phase II trial and reporting top-line data by the end of this year."

"A key differentiating advantage of KAI-4169 is that it is an IV formulation that is designed to improve drug adherence. We plan to develop KAI-4169 expeditiously in Japan," said Gyo Sagara, Ono's CEO. KAI is still hanging on to the drug rights for the rest of the world.

FierceBiotech listed KAI as one of the Fierce 15 in 2006, when the spotlight at the biotech was on 9803 and a new licensing pact with a different Japanese company--Daiichi Sankyo. Soon after the biotech landed a $35 million venture round. The Japanese company, which paid $20 million upfront and promised $320 million in milestones in the deal, handed back the rights a year later. KAI has raised a total of $63 million in venture funds since it was founded in 2003.

- here's the KAI release