Japanese mid-sized drugmaker Kyowa Hakko Kirin (TYO: 4151) has entered into a collaboration and license agreement with privately-held US clinical-stage biotech firm Ultragenyx Pharmaceutical to develop and commercialize KRN23, a recombinant fully human monoclonal IgG1 antibody, intended to treat X-linked hypophosphatemia (XLH).
Kyowa Hakko Kirin is currently completing a Phase I/II study in adults with XLH in the USA and Canada. Initiation of a pediatric XLH program is planned for 2014. Financial terms of the collaboration were not disclosed.
Under the terms of the agreement, Kyowa Hakko Kirin and Ultragenyx will collaborate on the development of KRN23 for the USA, Canada and European Union, with Ultragenyx leading development efforts in the XLH indication and the parties sharing development costs. In the USA and Canada, Kyowa Hakko Kirin and Ultragenyx will share commercial responsibilities and profits. Kyowa Hakko Kirin will commercialize KRN23 in the EU. Ultragenyx will develop and commercialize the product in Mexico and Central and South America.
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