Ultragenyx, KHK in KRN23 Development Pact

Ultragenyx Pharmaceutical has entered into a collaboration and license agreement with Kyowa Hakko Kirin Co., Ltd. (KHK), to develop and commercialize KRN23, a recombinant fully human monoclonal IgG1 antibody intended to treat X-linked hypophosphatemia (XLH). KHK is currently completing a Phase I/II study in adults with XLH in the U.S. and Canada. The two companies plan to initiate a pediatric XLH program in 2014. XLH is a rare metabolic bone disorder caused by excessive loss of phosphate in the urine.
 
The two companies will collaborate on the development of KRN23 for the U.S., Canada and EU. Ultragenyx will lead development efforts in the XLH indication and the parties will share development costs. If approved, Ultragenyx and KHK will share commercial responsibilities and profits in the U.S. and Canada, KHK will commercialize KRN23 in the EU and Ultragenyx will commercialize KRN23 in Mexico, Central and South America. KHK will manufacture and supply KRN23 for clinical and commercial use globally.
 
“We are excited to enter into this collaboration with KHK on KRN23, a promising clinical-stage product to treat a rare and debilitating bone disease,” said Dr. Emil D. Kakkis, chief executive officer of Ultragenyx. “The collaboration combines KHK’s broad antibody-based discovery, manufacturing and development capabilities with our expertise in the clinical development of novel therapeutics for rare genetic diseases. We look forward to working closely with the KHK team, investigators, and patients on continuing development of KRN23, a much needed new therapy for XLH patients.”